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Re: Re: Liquid Silicone Injections

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Dearest Kenda:

Where did you get this propaganda? Silicone is not safe to be implanted into the human body. I have many people who have silicone in their bodies, and it makes no difference if it is solid, or runny like the silicone in my breast implants. Hip implants cause cancer, and they are solid, and the same goes for cheek, butt, chin...and you name it. They are all deadly!

Solid silicone becomes brittle and causes inflammation in nearby tissue. I would love to send some articles to the group on this problem.

Honey, these people are experts at lying.

Sending love to you.............Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``

Re: Re: Liquid Silicone Injections>>>>>>> >>>>>>> >>>>>>> >>>>>>> I thought this was interesting to read, it mentions silicone>>>> injections at>>>>>>> one point.>>>>>>> >>>>>>> >>>>>>> >>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?>>>>>>> by P. , Ph.D., MBA>>>>>>> >>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at>>>>>>> Nottingham University. Little practical use>>>>>> was made of these materials until>>>>>>> the 1940's when Corning Glass Works formed a working>>>> relationship with Dow>>>>>>> Chemical Company (Dow-Corning Corporation) to>>>>>> develop many uses such as high>>>>>>> temperature-resistant lubricants, rubbers,>>>>>> antifoam, mold-releasing compounds,>>>>>>> insulation, as well as medical devices.>>>>>>> >>>>>>> Silicone gel breast implants are medical device prostheses>>>>>>> used to substitute for human breast tissue for purposes of>>>> augmentation or>>>>>>> replacement following mastectomy. Implants consist of a plastic>>>> envelope or>>>>>>> shell containing a soft gelatinous mixture. The shell consists>>>> of a highly>>>>>>> cross-linked silicone polymer while the gel contents embody>>>> linear silicone>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular>>>>>>> weights with less cross-linking than the>>>>>> shell material. Silicone gel implants>>>>>>> were invented in 1963 for breast augmentation>>>>>> to replace the use of silicone>>>>>>> injections.>>>>>>> >>>>>>> Silicone gel breast implants were widely marketed and used>>>>>>> over a thirty-year period until 1992 when >> the FDA banned them for lack of>>>>>>> sufficient safety and efficacy data. The>>>>>> number of breast implant operations>>>>>>> in this time period is estimated to be>>>>>> between one and two million. In 1992,>>>>>>> when sales were ceased, there were over 87, 000 breast implant surgical>>>>>>> procedures of which 25, 676 (29%) were >> breast implant removal operations.>>>>>>> >>>>>>> Disclosure to Patients Issues Today, there is a great deal of>>>>>>> controversy regarding certain physical>>>>>> characteristics of silicone gel breast>>>>>>> implants versus what was revealed to or>>>>>> understood by patients as well as the>>>>>>> medical profession. There are at least >> six important product information>>>>>>> issues that should have been disclosed by the manufacturers in>>>> the package>>>>>>> inserts accompanying the product.>>>>>>> >>>>>>> 1. Silicones have biological activity. Contrary to popular>>>>>>> belief amongst plastic surgeons in the >> beginning, silicones were and are>>>>>>> biologically active compounds.>>>>>>> >>>>>>> Issue: There are published reports and internal company>>>>>>> documents from silicone breast implant>>>>>> manufacturers that reveal screening and>>>>>>> discovery of silicone compounds which exhibited pesticidal,>>>> antibiotic and>>>>>>> hormonal activities.>>>>>>> >>>>>>> 2. Injected silicones caused problems. The potential danger of>>>>>>> silicone compounds was published widely in>>>>>> the scientific literature revealing>>>>>>> adverse reactions to silicone injections when used for>>>> augmenting the human>>>>>>> female breast.>>>>>>> >>>>>>> Issue: Despite much evidence, a correlation between silicone>>>>>>> toxicity from direct injection with the>>>>>> possible silicone toxicity associated>>>>>>> with gel bleed from implants was never addressed.>>>>>>> >>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a>>>>>>> phenomenon, which describes the migration of>>>>>> silicone molecules contained in>>>>>>> the gel implant through the permeable shell.>>>>>> The fact that gel implants exuded>>>>>>> a "greasy" residue was well known by >> manufacturers and plastic surgeons.>>>>>>> >>>>>>> Issue: Historically, neither the patients, surgeons, nor the>>>>>>> FDA were adequately informed about the gel>>>>>> bleed while it can be documented in>>>>>>> company memos that gel bleed was known,>>>>>> discussed, and proposed to be studied>>>>>>> at least 15 years before it was revealed in product package>>>> inserts. Issue:>>>>>>> The gel material leaking from the implants>>>>>> was not characterized, and hence,>>>>>>> posed an unknown health hazard to silicone gel breast implant patients.>>>>>>> >>>>>>> 4. Gel migration is described as the movement of silicone>>>>>>> residues released from silicone gel breast>>>>>> implants throughout the body being>>>>>>> carried by phagocytic cells via the lymph>>>>>> system or by some other mechanism.>>>>>>> >>>>>>> Issue: Silicone fluids and gels have been known and observed>>>>>>> to migrate both in animals and humans as cited in company memos>>>> written and>>>>>>> papers published at least 15 years prior to>>>>>> being mentioned in product package>>>>>>> inserts.>>>>>>> >>>>>>> 5. The chemical stability of silicone gel implants in>>>>>>> biological systems should have been a critical factor when>>>> determining the>>>>>>> suitability of implant formulations for long term use.>>>>>>> >>>>>>> Issue: There is evidence both from company documents as well>>>>>>> as the scientific literature that shelf life>>>>>> or stability data were not given>>>>>>> proper consideration in the manufacture >> of silicone gel breast implants.>>>>>>> >>>>>>> Issue: Long term suitability studies for breast implants in>>>>>>> animals or stored on the shelf appear to >> be currently unknown or at least>>>>>>> unpublished by breast implant manufacturers.>>>>>>> >>>>>>> 6. The information provided in package inserts for silicone>>>>>>> gel breast implants was incomplete and>>>>>> sometimes incorrect. Such information>>>>>>> accompanying regulated medical devices should be a fair and equitable>>>>>>> representation of the safety and efficacy of the product.>>>>>>> >>>>>>> Issue: The fact that gel implants could bleed gel and that>>>>>>> the gel could migrate through tissues from>>>>>> the site of implantation failed to>>>>>>> be mentioned in package inserts for more than 15 years.>>>>>>> >>>>>>> Issue: The fact that gel implants had a limited shelf life>>>>>>> was not addressed in package inserts for more than 15 years.>>>>>>> >>>>>>> Conclusion: It is apparent that disclosure of critical>>>>>>> information to patients regarding the>>>>>> physical characteristics of silicone gel>>>>>>> breast implants was inadequate. Hence,>>>>>> patients were ill-informed when making>>>>>>> decisions regarding the safety and stability>>>>>> of the products to be implanted>>>>>>> in their body.>>>>>>> >>>>>>> >>>>>>> >>>>>>> About P. , Ph.D., MBA>>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>> >>>>>> >>>>> >>>>> >>>>> >>>> >>>> >>> >>> >>> >> > > >

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Guest guest

I think Immunosciences Lab in CA does a test for antibodies for

silicone or something???

They do a complete panel called Silicone Implant Panel Comprehensive.

(800) 950-4686

Lynda

At 09:52 AM 12/26/2006, you wrote:

>Lea,

>

>I don't know why they are still doing this, let me guess,

>$$$$$$$$$$$$$. I would love to read that article if you can get

>someone to send it too me. was told it was so safe and the

>FDA didn't know what they were talking about when they banned

>it. She totally believed it was safe, just like I thought saline

>was safe. We were all lied to equally regarding silicone. is

>not doing to good, she says her ears and nose is just falling

>off. She said, the collegen is gone? She says, her ears are like

>dried fruit? I don't know what to tell her to do, she can't find a

>doctor to help her? I get really dry skin falling off in my ears, I

>don't know why? I don't feel like there falling off though. What

>to do I have no idea. I just pray for her to get a miracle. She is

>so scared and alone. She has chronic fatigue and she doesn't think

>clearly. She is now looking for a place to test for silicone

>hypersensitivity and vitamin deficiencies. I don't know if it is

>going to do her any good to just know these things? She is trying

>to just do something instead of laying there dying. It is so sad to

>see everyone so affected from things the FDA approved. I have to

>remember at one time the FDA said, silicone injections were safe,

>then changed there minds. It is hard to believe they don't see any

>difference with silicone in a silicone shell or saline in a silicone

>shell? It is merely the same thing if you ask me. God Bless!!!!!!!!!!!!

>

>Donna

>

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Guest guest

If you look through the files section with our stories in there, you will see the very sad story of a young man, an aspiring actor, who got silicone injections in his lips. They left him disabled and unable to work. I wonder how this young man is doing today? I wish I knew. Here is his story:

Just a plea of help from a fellow silicone survivor.

In July of 1992 I was a 28 year old actor and model living in Hollywood,

California. I had stumbled into the world of modeling while I was in

college

some 9 years earlier while I was attending New York University. I had

since

then been on a number of different magazines and commercials. I sort of

wandered into the very competitive world of acting as a result of the

different print work that I had done while a model. I soon became a Union

actor and was pursuing the world of films and television.

So on that sunny July day I found my way into the offices of Dr.

Fuller MD,F.A.C.S. as a referral from a fellow actor friend of mine. I had

inquired about some skin problems that I thought needed to be checked. I

asked the Dr. what types of plastic surgery were popular with his clients.

He mentioned several different procedures and said that lip augmentation

was

popular. He elaborated by saying that there were currently 2 types of

procedures that were popular, collagen and silicone. He explained that

silicone was the more permanent of the two. I asked "isn't the silicone

causing health problems like I have seen with the women with the breast

implants?". The Dr. responded a "small amount isn't a problem" After the

consultation I made the decision to have liquid silicone injections into my

lips for the purpose of enhancing my appearance as many actors and models

do.

After the procedure I recall feeling exhausted. The next day my entire

face

was red and puffy there were deep nette lines which I never had

before.

I called the Dr. who said that was "sometimes normal" and not to

"worry" about it. The symptoms waxed and waned and as the days and months

ahead progressed I continually felt exhausted. I was not able to get out

of

the bed on some days and I was having extreme difficulty making any kind of

bowel movement. In fact two months after the injections I was taken to

Cedars Sinai after two weeks of not making a bowel movement. I was vomiting

profusely and nauseous in the following months to come. I went to several

Medical Dr.s including several Specialists which included neurologists,

psychiatrists, gastrointronologists, and naturopaths. The following year I

made my way into the offices of Acupuncturists, Massage Therapists, Colon

Hydrotherapists, Certified Nutritional Counselors, iridologists, and other

doctors therapists and counselors. My symptoms remained constant: Severe

constipation, chronic fatigue, allergies to foods, pollens, chemicals,

severe depression, memory problems and joint pain.

Two years passed and by the summer of 1994 I was seeing a Dr. A Leonard

Klepp

in Los Angeles. Dr. Klepp tested and found that I was having an allergic

reaction to nearly everything that I consumed. He asked me if I had

exposure to chemicals of any kind. After several negative responses I

revealed that I had undergone injections of silicone some two years

previous.

I then began to attempt to address my health issues from another angle.

On August 31st 1994 I underwent surgery to remove the remaining silicone in

my lips. The scars that followed were ghastly but worse yet my symptoms

didn't lessen. Instead I was just a person sick and with newfound scars on

the face. My acting and modeling career had ended.

One of the things that the silicone has robbed from my besides my physical

well being is my psychological well being. The ambitions that I once had

were gone. Replaced was my struggle just to feel halfway well. The

physical

scars left my career in shambles but worse yet my ability to just get out

of

bed was the focus of the days to come.

I left three jobs due to my health and am currently not working. The most

precious thing in my life is my daughter. Sometimes she comes to me and

asks

for my involvement in something that she is doing and sometimes I am just

too

sick to even get out of bed. This hurts me more than anything else that

the

silicone has taken away from my life. My daughter is almost 12 and nearly

7

of the 12 years that she has known me she has dealt with a sick "Daddy".

Every day I live with the hope that one day again I will have my health

back,

before my daughter is all grown up. The hellish nightmare I face every

day.

The one thing that I hold on to is the hope that a solution to this

nightmare will come. I know that the Weston Project is working on the

"antidote" and my hope is that it will be available soon.

If there is anything that I can do to help expedite the availability of the

antidote please let me know.

Sincerely,

Steve

Re: Re: Liquid Silicone Injections>>>>>>> >>>>>>> >>>>>>> >>>>>>> I thought this was interesting to read, it mentions silicone>>>> injections at>>>>>>> one point.>>>>>>> >>>>>>> >>>>>>> >>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?>>>>>>> by P. , Ph.D., MBA>>>>>>> >>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping

at>>>>>>> Nottingham University. Little practical use>>>>>> was made of these materials until>>>>>>> the 1940's when Corning Glass Works formed a working>>>> relationship with Dow>>>>>>> Chemical Company (Dow-Corning Corporation) to>>>>>> develop many uses such as high>>>>>>> temperature- resistant lubricants, rubbers,>>>>>> antifoam, mold-releasing compounds,>>>>>>> insulation, as well as medical devices.>>>>>>> >>>>>>> Silicone gel breast implants are medical device prostheses>>>>>>> used to substitute for human breast tissue for purposes of>>>> augmentation or>>>>>>> replacement following mastectomy. Implants consist of a plastic>>>>

envelope or>>>>>>> shell containing a soft gelatinous mixture. The shell consists>>>> of a highly>>>>>>> cross-linked silicone polymer while the gel contents embody>>>> linear silicone>>>>>>> polymers (specifically, polydimethylsiloxan e-PDMS) of various molecular>>>>>>> weights with less cross-linking than the>>>>>> shell material. Silicone gel implants>>>>>>> were invented in 1963 for breast augmentation>>>>>> to replace the use of silicone>>>>>>> injections.>>>>>>> >>>>>>> Silicone gel breast implants were widely marketed and used>>>>>>> over a thirty-year period until 1992 when >> the FDA banned them for lack of>>>>>>> sufficient safety

and efficacy data. The>>>>>> number of breast implant operations>>>>>>> in this time period is estimated to be>>>>>> between one and two million. In 1992,>>>>>>> when sales were ceased, there were over 87, 000 breast implant surgical>>>>>>> procedures of which 25, 676 (29%) were >> breast implant removal operations.>>>>>>> >>>>>>> Disclosure to Patients Issues Today, there is a great deal of>>>>>>> controversy regarding certain physical>>>>>> characteristics of silicone gel breast>>>>>>> implants versus what was revealed to or>>>>>> understood by patients as well as the>>>>>>> medical profession. There are at least >> six important product

information>>>>>>> issues that should have been disclosed by the manufacturers in>>>> the package>>>>>>> inserts accompanying the product.>>>>>>> >>>>>>> 1. Silicones have biological activity. Contrary to popular>>>>>>> belief amongst plastic surgeons in the >> beginning, silicones were and are>>>>>>> biologically active compounds.>>>>>>> >>>>>>> Issue: There are published reports and internal company>>>>>>> documents from silicone breast implant>>>>>> manufacturers that reveal screening and>>>>>>> discovery of silicone compounds which exhibited pesticidal,>>>> antibiotic and>>>>>>> hormonal activities.>>>>>>>

>>>>>>> 2. Injected silicones caused problems. The potential danger of>>>>>>> silicone compounds was published widely in>>>>>> the scientific literature revealing>>>>>>> adverse reactions to silicone injections when used for>>>> augmenting the human>>>>>>> female breast.>>>>>>> >>>>>>> Issue: Despite much evidence, a correlation between silicone>>>>>>> toxicity from direct injection with the>>>>>> possible silicone toxicity associated>>>>>>> with gel bleed from implants was never addressed.>>>>>>> >>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a>>>>>>> phenomenon, which describes the migration of>>>>>>

silicone molecules contained in>>>>>>> the gel implant through the permeable shell.>>>>>> The fact that gel implants exuded>>>>>>> a "greasy" residue was well known by >> manufacturers and plastic surgeons.>>>>>>> >>>>>>> Issue: Historically, neither the patients, surgeons, nor the>>>>>>> FDA were adequately informed about the gel>>>>>> bleed while it can be documented in>>>>>>> company memos that gel bleed was known,>>>>>> discussed, and proposed to be studied>>>>>>> at least 15 years before it was revealed in product package>>>> inserts. Issue:>>>>>>> The gel material leaking from the implants>>>>>> was not characterized, and

hence,>>>>>>> posed an unknown health hazard to silicone gel breast implant patients.>>>>>>> >>>>>>> 4. Gel migration is described as the movement of silicone>>>>>>> residues released from silicone gel breast>>>>>> implants throughout the body being>>>>>>> carried by phagocytic cells via the lymph>>>>>> system or by some other mechanism.>>>>>>> >>>>>>> Issue: Silicone fluids and gels have been known and observed>>>>>>> to migrate both in animals and humans as cited in company memos>>>> written and>>>>>>> papers published at least 15 years prior to>>>>>> being mentioned in product package>>>>>>> inserts.>>>>>>>

>>>>>>> 5. The chemical stability of silicone gel implants in>>>>>>> biological systems should have been a critical factor when>>>> determining the>>>>>>> suitability of implant formulations for long term use.>>>>>>> >>>>>>> Issue: There is evidence both from company documents as well>>>>>>> as the scientific literature that shelf life>>>>>> or stability data were not given>>>>>>> proper consideration in the manufacture >> of silicone gel breast implants.>>>>>>> >>>>>>> Issue: Long term suitability studies for breast implants in>>>>>>> animals or stored on the shelf appear to >> be currently unknown or at least>>>>>>> unpublished by breast

implant manufacturers.>>>>>>> >>>>>>> 6. The information provided in package inserts for silicone>>>>>>> gel breast implants was incomplete and>>>>>> sometimes incorrect. Such information>>>>>>> accompanying regulated medical devices should be a fair and equitable>>>>>>> representation of the safety and efficacy of the product.>>>>>>> >>>>>>> Issue: The fact that gel implants could bleed gel and that>>>>>>> the gel could migrate through tissues from>>>>>> the site of implantation failed to>>>>>>> be mentioned in package inserts for more than 15 years.>>>>>>> >>>>>>> Issue: The fact that gel implants had a limited shelf life>>>>>>> was

not addressed in package inserts for more than 15 years.>>>>>>> >>>>>>> Conclusion: It is apparent that disclosure of critical>>>>>>> information to patients regarding the>>>>>> physical characteristics of silicone gel>>>>>>> breast implants was inadequate. Hence,>>>>>> patients were ill-informed when making>>>>>>> decisions regarding the safety and stability>>>>>> of the products to be implanted>>>>>>> in their body.>>>>>>> >>>>>>> >>>>>>> >>>>>>> About P. , Ph.D., MBA>>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>>>

>>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>> >>>>>> >>>>> >>>>> >>>>> >>>> >>>> >>> >>> >>> >> > > >

__________________________________________________

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Guest guest

Liquid silicone injections are banned in the US.

Absolutely.

Lynda

At 01:35 PM 12/26/2006, you wrote:

>Oh, no, silicone injections are not banned -- at least not in the US! The

>plastic surgeon who almost implanted me wanted to use silicone injections to

>plump up my lips. I passed on silicone everything! He told me that the

>silicone injections last a lifetime, whereas injectable fillers do not. He

>brought in his little office girl with giant implants and plumped lips to

>show me how beautiful injected lips are. :(

>

>Kenda

>

> > Silicone injections were banned. Do any of you remember the Georgia Crime

> > Laboratory's investigations? I am afraid to

> send out the document, but someone

> > in this group must have it. Why are plastic surgeons still injecting this

> > poison into people?

> >

> > GRRRR...Lea

> > ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

> > Re: Re: Liquid Silicone Injections

> >

> >

> >

> > I thought this was interesting to read, it mentions silicone injections at

> > one point.

> >

> >

> >

> > Silicone Gel Breast Implants: Were Proper Disclosures Made?

> > by P. , Ph.D., MBA

> >

> > Introduction: Silicone, a polymer of silicon, oxygen, and

> > carbon, was invented in the late 1800's by Professor F.S. Kipping at

> > Nottingham University. Little practical use

> was made of these materials until

> > the 1940's when Corning Glass Works formed a working relationship with Dow

> > Chemical Company (Dow-Corning Corporation) to

> develop many uses such as high

> > temperature-resistant lubricants, rubbers,

> antifoam, mold-releasing compounds,

> > insulation, as well as medical devices.

> >

> > Silicone gel breast implants are medical device prostheses

> > used to substitute for human breast tissue for purposes of augmentation or

> > replacement following mastectomy. Implants consist of a plastic envelope or

> > shell containing a soft gelatinous mixture. The shell consists of a highly

> > cross-linked silicone polymer while the gel contents embody linear silicone

> > polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

> > weights with less cross-linking than the

> shell material. Silicone gel implants

> > were invented in 1963 for breast augmentation

> to replace the use of silicone

> > injections.

> >

> > Silicone gel breast implants were widely marketed and used

> > over a thirty-year period until 1992 when the FDA banned them for lack of

> > sufficient safety and efficacy data. The

> number of breast implant operations

> > in this time period is estimated to be

> between one and two million. In 1992,

> > when sales were ceased, there were over 87, 000 breast implant surgical

> > procedures of which 25, 676 (29%) were breast implant removal operations.

> >

> > Disclosure to Patients Issues Today, there is a great deal of

> > controversy regarding certain physical

> characteristics of silicone gel breast

> > implants versus what was revealed to or

> understood by patients as well as the

> > medical profession. There are at least six important product information

> > issues that should have been disclosed by the manufacturers in the package

> > inserts accompanying the product.

> >

> > 1. Silicones have biological activity. Contrary to popular

> > belief amongst plastic surgeons in the beginning, silicones were and are

> > biologically active compounds.

> >

> > Issue: There are published reports and internal company

> > documents from silicone breast implant

> manufacturers that reveal screening and

> > discovery of silicone compounds which exhibited pesticidal, antibiotic and

> > hormonal activities.

> >

> > 2. Injected silicones caused problems. The potential danger of

> > silicone compounds was published widely in

> the scientific literature revealing

> > adverse reactions to silicone injections when used for augmenting the human

> > female breast.

> >

> > Issue: Despite much evidence, a correlation between silicone

> > toxicity from direct injection with the

> possible silicone toxicity associated

> > with gel bleed from implants was never addressed.

> >

> > 3. Gel bleed from implants was documented. Gel bleed is a

> > phenomenon, which describes the migration of

> silicone molecules contained in

> > the gel implant through the permeable shell.

> The fact that gel implants exuded

> > a " greasy " residue was well known by manufacturers and plastic surgeons.

> >

> > Issue: Historically, neither the patients, surgeons, nor the

> > FDA were adequately informed about the gel

> bleed while it can be documented in

> > company memos that gel bleed was known,

> discussed, and proposed to be studied

> > at least 15 years before it was revealed in product package inserts. Issue:

> > The gel material leaking from the implants

> was not characterized, and hence,

> > posed an unknown health hazard to silicone gel breast implant patients.

> >

> > 4. Gel migration is described as the movement of silicone

> > residues released from silicone gel breast

> implants throughout the body being

> > carried by phagocytic cells via the lymph

> system or by some other mechanism.

> >

> > Issue: Silicone fluids and gels have been known and observed

> > to migrate both in animals and humans as cited in company memos written and

> > papers published at least 15 years prior to

> being mentioned in product package

> > inserts.

> >

> > 5. The chemical stability of silicone gel implants in

> > biological systems should have been a critical factor when determining the

> > suitability of implant formulations for long term use.

> >

> > Issue: There is evidence both from company documents as well

> > as the scientific literature that shelf life

> or stability data were not given

> > proper consideration in the manufacture of silicone gel breast implants.

> >

> > Issue: Long term suitability studies for breast implants in

> > animals or stored on the shelf appear to be currently unknown or at least

> > unpublished by breast implant manufacturers.

> >

> > 6. The information provided in package inserts for silicone

> > gel breast implants was incomplete and

> sometimes incorrect. Such information

> > accompanying regulated medical devices should be a fair and equitable

> > representation of the safety and efficacy of the product.

> >

> > Issue: The fact that gel implants could bleed gel and that

> > the gel could migrate through tissues from

> the site of implantation failed to

> > be mentioned in package inserts for more than 15 years.

> >

> > Issue: The fact that gel implants had a limited shelf life

> > was not addressed in package inserts for more than 15 years.

> >

> > Conclusion: It is apparent that disclosure of critical

> > information to patients regarding the

> physical characteristics of silicone gel

> > breast implants was inadequate. Hence,

> patients were ill-informed when making

> > decisions regarding the safety and stability

> of the products to be implanted

> > in their body.

> >

> >

> >

> > About P. , Ph.D., MBA

> >

> >

> >

> >

> >

> >

> >

> >

> >

>

>

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Guest guest

Hi Lea,

If you read the article, the person doesn't recommend using silicone. They

state that: Unfortunately, silicone oil injections can cause

granulomas, inflammatory nidus, macrophage activity and migration.

Kenda

> Dearest Kenda:

>

> Where did you get this propaganda? Silicone is not safe to be implanted into

> the human body. I have many people who have silicone in their bodies, and it

> makes no difference if it is solid, or runny like the silicone in my breast

> implants. Hip implants cause cancer, and they are solid, and the same goes for

> cheek, butt, chin...and you name it. They are all deadly!

>

> Solid silicone becomes brittle and causes inflammation in nearby tissue. I

> would love to send some articles to the group on this problem.

>

> Honey, these people are experts at lying.

>

> Sending love to you.............Lea

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``

> Re: Re: Liquid Silicone Injections

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>> I thought this was interesting to read, it mentions silicone

>>>>> injections at

>>>>>>>> one point.

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

>>>>>>>> by P. , Ph.D., MBA

>>>>>>>>

>>>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

>>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

>>>>>>>> Nottingham University. Little practical use

>>>>>>> was made of these materials until

>>>>>>>> the 1940's when Corning Glass Works formed a working

>>>>> relationship with Dow

>>>>>>>> Chemical Company (Dow-Corning Corporation) to

>>>>>>> develop many uses such as high

>>>>>>>> temperature-resistant lubricants, rubbers,

>>>>>>> antifoam, mold-releasing compounds,

>>>>>>>> insulation, as well as medical devices.

>>>>>>>>

>>>>>>>> Silicone gel breast implants are medical device prostheses

>>>>>>>> used to substitute for human breast tissue for purposes of

>>>>> augmentation or

>>>>>>>> replacement following mastectomy. Implants consist of a plastic

>>>>> envelope or

>>>>>>>> shell containing a soft gelatinous mixture. The shell consists

>>>>> of a highly

>>>>>>>> cross-linked silicone polymer while the gel contents embody

>>>>> linear silicone

>>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

>>>>>>>> weights with less cross-linking than the

>>>>>>> shell material. Silicone gel implants

>>>>>>>> were invented in 1963 for breast augmentation

>>>>>>> to replace the use of silicone

>>>>>>>> injections.

>>>>>>>>

>>>>>>>> Silicone gel breast implants were widely marketed and used

>>>>>>>> over a thirty-year period until 1992 when

>>> the FDA banned them for lack of

>>>>>>>> sufficient safety and efficacy data. The

>>>>>>> number of breast implant operations

>>>>>>>> in this time period is estimated to be

>>>>>>> between one and two million. In 1992,

>>>>>>>> when sales were ceased, there were over 87, 000 breast implant surgical

>>>>>>>> procedures of which 25, 676 (29%) were

>>> breast implant removal operations.

>>>>>>>>

>>>>>>>> Disclosure to Patients Issues Today, there is a great deal of

>>>>>>>> controversy regarding certain physical

>>>>>>> characteristics of silicone gel breast

>>>>>>>> implants versus what was revealed to or

>>>>>>> understood by patients as well as the

>>>>>>>> medical profession. There are at least

>>> six important product information

>>>>>>>> issues that should have been disclosed by the manufacturers in

>>>>> the package

>>>>>>>> inserts accompanying the product.

>>>>>>>>

>>>>>>>> 1. Silicones have biological activity. Contrary to popular

>>>>>>>> belief amongst plastic surgeons in the

>>> beginning, silicones were and are

>>>>>>>> biologically active compounds.

>>>>>>>>

>>>>>>>> Issue: There are published reports and internal company

>>>>>>>> documents from silicone breast implant

>>>>>>> manufacturers that reveal screening and

>>>>>>>> discovery of silicone compounds which exhibited pesticidal,

>>>>> antibiotic and

>>>>>>>> hormonal activities.

>>>>>>>>

>>>>>>>> 2. Injected silicones caused problems. The potential danger of

>>>>>>>> silicone compounds was published widely in

>>>>>>> the scientific literature revealing

>>>>>>>> adverse reactions to silicone injections when used for

>>>>> augmenting the human

>>>>>>>> female breast.

>>>>>>>>

>>>>>>>> Issue: Despite much evidence, a correlation between silicone

>>>>>>>> toxicity from direct injection with the

>>>>>>> possible silicone toxicity associated

>>>>>>>> with gel bleed from implants was never addressed.

>>>>>>>>

>>>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a

>>>>>>>> phenomenon, which describes the migration of

>>>>>>> silicone molecules contained in

>>>>>>>> the gel implant through the permeable shell.

>>>>>>> The fact that gel implants exuded

>>>>>>>> a " greasy " residue was well known by

>>> manufacturers and plastic surgeons.

>>>>>>>>

>>>>>>>> Issue: Historically, neither the patients, surgeons, nor the

>>>>>>>> FDA were adequately informed about the gel

>>>>>>> bleed while it can be documented in

>>>>>>>> company memos that gel bleed was known,

>>>>>>> discussed, and proposed to be studied

>>>>>>>> at least 15 years before it was revealed in product package

>>>>> inserts. Issue:

>>>>>>>> The gel material leaking from the implants

>>>>>>> was not characterized, and hence,

>>>>>>>> posed an unknown health hazard to silicone gel breast implant patients.

>>>>>>>>

>>>>>>>> 4. Gel migration is described as the movement of silicone

>>>>>>>> residues released from silicone gel breast

>>>>>>> implants throughout the body being

>>>>>>>> carried by phagocytic cells via the lymph

>>>>>>> system or by some other mechanism.

>>>>>>>>

>>>>>>>> Issue: Silicone fluids and gels have been known and observed

>>>>>>>> to migrate both in animals and humans as cited in company memos

>>>>> written and

>>>>>>>> papers published at least 15 years prior to

>>>>>>> being mentioned in product package

>>>>>>>> inserts.

>>>>>>>>

>>>>>>>> 5. The chemical stability of silicone gel implants in

>>>>>>>> biological systems should have been a critical factor when

>>>>> determining the

>>>>>>>> suitability of implant formulations for long term use.

>>>>>>>>

>>>>>>>> Issue: There is evidence both from company documents as well

>>>>>>>> as the scientific literature that shelf life

>>>>>>> or stability data were not given

>>>>>>>> proper consideration in the manufacture

>>> of silicone gel breast implants.

>>>>>>>>

>>>>>>>> Issue: Long term suitability studies for breast implants in

>>>>>>>> animals or stored on the shelf appear to

>>> be currently unknown or at least

>>>>>>>> unpublished by breast implant manufacturers.

>>>>>>>>

>>>>>>>> 6. The information provided in package inserts for silicone

>>>>>>>> gel breast implants was incomplete and

>>>>>>> sometimes incorrect. Such information

>>>>>>>> accompanying regulated medical devices should be a fair and equitable

>>>>>>>> representation of the safety and efficacy of the product.

>>>>>>>>

>>>>>>>> Issue: The fact that gel implants could bleed gel and that

>>>>>>>> the gel could migrate through tissues from

>>>>>>> the site of implantation failed to

>>>>>>>> be mentioned in package inserts for more than 15 years.

>>>>>>>>

>>>>>>>> Issue: The fact that gel implants had a limited shelf life

>>>>>>>> was not addressed in package inserts for more than 15 years.

>>>>>>>>

>>>>>>>> Conclusion: It is apparent that disclosure of critical

>>>>>>>> information to patients regarding the

>>>>>>> physical characteristics of silicone gel

>>>>>>>> breast implants was inadequate. Hence,

>>>>>>> patients were ill-informed when making

>>>>>>>> decisions regarding the safety and stability

>>>>>>> of the products to be implanted

>>>>>>>> in their body.

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>> About P. , Ph.D., MBA

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>>

>>>

>>

>>

>>

>

>

>

>

>

>

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You may be offered it, but that does not make it legal. It is

actually approved only for the cornea.

Lynda

At 02:46 PM 12/26/2006, you wrote:

>Not where I live. My sister was offered them last week. I am speaking of

>the liquid silicone that is used as a filler for the face, not something

>injected into the breast.

>

>Kenda

>

> > Liquid silicone injections are banned in the US.

> >

> > Absolutely.

> >

> > Lynda

> >

> >

> > At 01:35 PM 12/26/2006, you wrote:

> >

> >> Oh, no, silicone injections are not banned -- at least not in the US! The

> >> plastic surgeon who almost implanted me wanted to use silicone

> injections to

> >> plump up my lips. I passed on silicone everything! He told me that the

> >> silicone injections last a lifetime, whereas injectable fillers do not. He

> >> brought in his little office girl with giant implants and plumped lips to

> >> show me how beautiful injected lips are. :(

> >>

> >> Kenda

> >>

> >>> Silicone injections were banned. Do any of you remember the Georgia Crime

> >>> Laboratory's investigations? I am afraid to

> >> send out the document, but someone

> >>> in this group must have it. Why are plastic surgeons still injecting this

> >>> poison into people?

> >>>

> >>> GRRRR...Lea

> >>> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

> >>> Re: Re: Liquid Silicone Injections

> >>>

> >>>

> >>>

> >>> I thought this was interesting to read, it mentions silicone

> injections at

> >>> one point.

> >>>

> >>>

> >>>

> >>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

> >>> by P. , Ph.D., MBA

> >>>

> >>> Introduction: Silicone, a polymer of silicon, oxygen, and

> >>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

> >>> Nottingham University. Little practical use

> >> was made of these materials until

> >>> the 1940's when Corning Glass Works formed a working

> relationship with Dow

> >>> Chemical Company (Dow-Corning Corporation) to

> >> develop many uses such as high

> >>> temperature-resistant lubricants, rubbers,

> >> antifoam, mold-releasing compounds,

> >>> insulation, as well as medical devices.

> >>>

> >>> Silicone gel breast implants are medical device prostheses

> >>> used to substitute for human breast tissue for purposes of

> augmentation or

> >>> replacement following mastectomy. Implants consist of a plastic

> envelope or

> >>> shell containing a soft gelatinous mixture. The shell consists

> of a highly

> >>> cross-linked silicone polymer while the gel contents embody

> linear silicone

> >>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

> >>> weights with less cross-linking than the

> >> shell material. Silicone gel implants

> >>> were invented in 1963 for breast augmentation

> >> to replace the use of silicone

> >>> injections.

> >>>

> >>> Silicone gel breast implants were widely marketed and used

> >>> over a thirty-year period until 1992 when the FDA banned them for lack of

> >>> sufficient safety and efficacy data. The

> >> number of breast implant operations

> >>> in this time period is estimated to be

> >> between one and two million. In 1992,

> >>> when sales were ceased, there were over 87, 000 breast implant surgical

> >>> procedures of which 25, 676 (29%) were breast implant removal operations.

> >>>

> >>> Disclosure to Patients Issues Today, there is a great deal of

> >>> controversy regarding certain physical

> >> characteristics of silicone gel breast

> >>> implants versus what was revealed to or

> >> understood by patients as well as the

> >>> medical profession. There are at least six important product information

> >>> issues that should have been disclosed by the manufacturers in

> the package

> >>> inserts accompanying the product.

> >>>

> >>> 1. Silicones have biological activity. Contrary to popular

> >>> belief amongst plastic surgeons in the beginning, silicones were and are

> >>> biologically active compounds.

> >>>

> >>> Issue: There are published reports and internal company

> >>> documents from silicone breast implant

> >> manufacturers that reveal screening and

> >>> discovery of silicone compounds which exhibited pesticidal,

> antibiotic and

> >>> hormonal activities.

> >>>

> >>> 2. Injected silicones caused problems. The potential danger of

> >>> silicone compounds was published widely in

> >> the scientific literature revealing

> >>> adverse reactions to silicone injections when used for

> augmenting the human

> >>> female breast.

> >>>

> >>> Issue: Despite much evidence, a correlation between silicone

> >>> toxicity from direct injection with the

> >> possible silicone toxicity associated

> >>> with gel bleed from implants was never addressed.

> >>>

> >>> 3. Gel bleed from implants was documented. Gel bleed is a

> >>> phenomenon, which describes the migration of

> >> silicone molecules contained in

> >>> the gel implant through the permeable shell.

> >> The fact that gel implants exuded

> >>> a " greasy " residue was well known by manufacturers and plastic surgeons.

> >>>

> >>> Issue: Historically, neither the patients, surgeons, nor the

> >>> FDA were adequately informed about the gel

> >> bleed while it can be documented in

> >>> company memos that gel bleed was known,

> >> discussed, and proposed to be studied

> >>> at least 15 years before it was revealed in product package

> inserts. Issue:

> >>> The gel material leaking from the implants

> >> was not characterized, and hence,

> >>> posed an unknown health hazard to silicone gel breast implant patients.

> >>>

> >>> 4. Gel migration is described as the movement of silicone

> >>> residues released from silicone gel breast

> >> implants throughout the body being

> >>> carried by phagocytic cells via the lymph

> >> system or by some other mechanism.

> >>>

> >>> Issue: Silicone fluids and gels have been known and observed

> >>> to migrate both in animals and humans as cited in company memos

> written and

> >>> papers published at least 15 years prior to

> >> being mentioned in product package

> >>> inserts.

> >>>

> >>> 5. The chemical stability of silicone gel implants in

> >>> biological systems should have been a critical factor when

> determining the

> >>> suitability of implant formulations for long term use.

> >>>

> >>> Issue: There is evidence both from company documents as well

> >>> as the scientific literature that shelf life

> >> or stability data were not given

> >>> proper consideration in the manufacture of silicone gel breast implants.

> >>>

> >>> Issue: Long term suitability studies for breast implants in

> >>> animals or stored on the shelf appear to be currently unknown or at least

> >>> unpublished by breast implant manufacturers.

> >>>

> >>> 6. The information provided in package inserts for silicone

> >>> gel breast implants was incomplete and

> >> sometimes incorrect. Such information

> >>> accompanying regulated medical devices should be a fair and equitable

> >>> representation of the safety and efficacy of the product.

> >>>

> >>> Issue: The fact that gel implants could bleed gel and that

> >>> the gel could migrate through tissues from

> >> the site of implantation failed to

> >>> be mentioned in package inserts for more than 15 years.

> >>>

> >>> Issue: The fact that gel implants had a limited shelf life

> >>> was not addressed in package inserts for more than 15 years.

> >>>

> >>> Conclusion: It is apparent that disclosure of critical

> >>> information to patients regarding the

> >> physical characteristics of silicone gel

> >>> breast implants was inadequate. Hence,

> >> patients were ill-informed when making

> >>> decisions regarding the safety and stability

> >> of the products to be implanted

> >>> in their body.

> >>>

> >>>

> >>>

> >>> About P. , Ph.D., MBA

> >>>

> >>>

> >>>

> >>>

> >>>

> >>>

> >>>

> >>>

> >>>

> >>

> >>

> >

> >

> >

>

>

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Guest guest

You know if there is a way to get around what was

illegal before, they will get around it.

Lynda

At 04:38 PM 12/26/2006, you wrote:

> > You may be offered it, but that does not make it legal. It is

> > actually approved only for the cornea.

> >

> > Lynda

> >

>

>According to these sites, silicone oil is legal

>for cosmetic use, although it is not it's

>primary use. See the two areas highlighted in

>green. An amendment has been made making the use legal for cosmetic use.

>

>Kenda

>

>Topdocs.com

>

>Are micro-injections of Silicone oil legal?

>

>Yes. The FDA has approved the use of Silicone

>oil as a medical device. Its primary use is in

>the repair of retinal detachments. According to

>the Food, Drug and Cosmetic Act, a licensed

>medical practitioner may prescribe or administer

>any legally marketed device to any legitimate patient.

>

>How do micro-injections of Silicone oil work?

>

>Silicone oil is injected in micro-droplets,

>through a tiny needle at multiple points under

>the skin, to treat facial contour defects. Over

>time skin cells called fibroblasts produce new

>collagen, which in turn grows around the

>silicone droplets. More collagen growth is

>stimulated by continued injections, spread over

>time. As this progression continues, the

>collagen-encapsulated silicone droplets gradually

>fill in the depression or wrinkle.

>

>

>This is from Yes They Are Fake

>

>

>(includes Adatosil 5000, Silikon 1000, SilSkin,

>etc. when implanted subdermally)

>

>Silicone: Just the Facts Ma'am, Just the Facts

>I am sure you are aware of the controversy in

>the past regarding silicone and breast implants

>and free silicone injections. The explosion of

>the Internet and free web hosting now makes it

>possible for everyone in the world to have a

>website -- or two or more! -- of their own to

>display whatever it is they feel, believe in or

>would like to convey to the world. Even if this

>means to misinform the universe, whether on

>purpose or not -- it can be accomplished more

>easily through the Internet. In this section we

>will discuss silica, silicon and silicone. We

>will ultimately discuss how silicone is made and

>what its impacts on the body are.

>

>Silica is silicon dioxide SiO2, it occurs in a

>crystalline state, an amorphous (shapeless)

>state and in impure forms such as quartz, opal

>and sand, respectively. " In the form of

>silicates it is present in most natural water

>supplies. Typical concentrations lie between 1

>and 30 mg/L. Higher concentrations may exist in

>brackish waters and brines. " (3)

>

>Silicon is a " nonmetallic element that occurs

>combined as the most abundant element next to

>oxygen in the earth's crust and is used

>especially in alloys and electronic device "

>(Merriam-Webster). It may not BE a metal but it

>is considered semi-metallic. In other words,

> " Silicon doesn't occur in the free, elemental

>state, but is found in the form of silicon

>dioxide and complex silicates " . It was

>discovered in 1824 by Jöns Berzelius.

> " Silicon is important in plant and animal life.

>Diatoms in both fresh and salt water extract

>silica from the water to use as a component of

>their cell walls " . (1) Silicon is used in many

>household items such as transistors, micro chips

>and electronics. Hence, Silicon Valley - the computer capital.

>

>Silicone is any of the " various polymeric

>organic silicon compounds obtained as oils,

>greases, or plastics and used especially for

>water-resistant and heat-resistant lubricants,

>varnishes, binders, and electric insulators "

>(Merriam-Webster) It is also found in processed

>foods, cosmetics, medications and all sorts of

>products that you are exposed to and ingest on a

>daily basis. It is also used to lubricate

>medical devices such as tubing, hypodermic

>needles and is found in the food industry as

>being used to lubricate blenders, frozen drink

>machines, piping, cooking utensils, and machines.

>

>Silicones are synthetic polymers and are made by

>combining oxygen and silicon and in high

>temperatures and pressures can produce

>polydimethylsiloxane (PDMS). The fluids are

>made from linear chains of PDMS whereas the gels

>are lightly crosslinked to give it a thicker

>cohesive-ness. Although without a container

>such as a highly cross-linked silicone elastomer

>breast prosthesis the silicone gel takes on no

>shape of its own and is very vulnerable to

>gravity and momentum, if applicable. The

>elastomer implant shells contain very little

>free PDMS so that it remains a solid. However

>since like can not hold like for long, the

>lower-weighted molecular silicones bleed through

>the elastomer shells -- even with the presence of " protective " inner barriers.

>

>Silicone & Its Uses In the Body

>Silicone products, in their solid form, have

>been used within the body for cosmetic

>applications for years and years without

>incident other than occasional sensitivity and

>encapsulation (which happens with all foreign

>bodies inserted into the human body as this is

>its way of sealing off the foreign object from

>the body). Encapsulation is when the body forms

>a fibrous tissue capsule around a foreign body

>as it does not recognize it as its own -- why would it?

>

>Solid silicone is used to augment or reconstruct

>the cheeks, the chin, the brow bone, calves,

>pectoral areas for men, as a replacement for

>lost digits, testicles and for buttock

>augmentation. It is also used for joint

>replacements, rotary cuffs, and sockets -- as

>well as a multitude of other medical uses.

>

>Liquid silicone is not approved for injection

>into the body for cosmetic applications but is

>approved for intra-ocular use for retinal

>tamponades. Detached retinas can cause bleeding

>and blindness and silicone oil injections are

>used to help this. It is, however, not approved

>to sculpt the lips, cheeks, buttocks, face,

>etc. However since the oils (i.e. Silikon 1000

> & Adatosil 5000) are approved in general, an

>amendment makes it so physicians are allowed to

>use approved drugs and devices off label as they see fit.

>

>Unfortunately, silicone oil injections can cause

>granulomas, inflammatory nidus, macrophage activity and migration.

>

>gran*u*lo*ma (noun), plural -mas or -ma*ta

>First appeared 1861

>: a mass or nodule of chronically inflamed tissue with

>granulations that is usu. associated with an infective process

>-- gran*u*lo*ma*tous (adjective)

>

>mac*ro*phage (noun)

>[international Scientific Vocabulary]

>First appeared 1890

>: a phagocytic tissue cell of the reticuloendothelial system that may

>be fixed or freely motile, is derived from a monocyte, and functions

>in the protection of the body against infection

>and noxious substances -- called also histiocyte

>-- mac*ro*phag*ic (adjective)

>

>...macrophages and other inflammatory responses

>(including chronic) is absolutely true when it

>comes to injected or free liquid silicone within

>the body. Autoimmune disorders however have not

>been proven to be caused by silicone -- either liquid or solid.

>

>Regarding liquid silicone or (LIS), the

>infiltration of foreign substances of a certain

>molecular size/weight, can cause problems on a

>cellular level if they can not be successfully

>excreted or contained. Many may argue that the

>goal should be not to inject or otherwise

>implant mobile substances of this size such as

>silicone oils and gels is something and that ideally it should be avoided.

>

>You may have heard Silicone referred to as

>inert. Inert literally means static or

>immobile. Although in the scientific world

>'inert' is usually referring to chemically

>inert, or chemically non-reactive. Silicone may

>be chemically inert, but it may not be

>biochemically inert. Biochemically inert would

>mean that these substances wouldn't change

>composition in the body, but even the elastomer

>shell of breast implants degrade -- they don't

>last forever, nor would they cause reactions in

>the body. It's a fact, sorry.

>

>Inert, by definition, the material should not be

>able to migrate in a way that they may

>infiltrate a cellular structure, the surrounding

>subcutaneous tissue or an organ tissue, thereby

>smothering cells, and causing cell necrosis

>(death) nor would it inflame the surrounding

>tissues or cause sensitivity reactions.

>

>Personally, I don't believe that silicone-based

>oils or gels or many synthetic substances can be

>classified as inert, by definition. Reason

>being I have seen many cases of free silicone

>lip injection where the silicone has migrated to

>the chin region or even further down the neck,

>and has not stayed where it was supposed to --

>in the lip. The fact is free silicone is known

>to migrate, therefore it is not completely

>inert, by definition, when injected into the

>lips, breasts, subcutaneous tissue, wherever.

>

>The FDA recognizes and warns of the fact of

>granulomatous, inflammatory responses, migration

>and discoloration of tissue after having had

>silicone injections -- period. Silicone

>injection is still being practiced on the black

>market and in plastic surgeons' offices. As

>liquid injectable silicone (LIS) was approved

>for ophthalmic use only. Although some doctors

>are using LIS off-label for wrinkles,

>augmentation of lips, etc. advertising for such

>is illegal. I even spoke to the FDA myself; I

>have the letter to prove it. There is a

>loophole regarding the use of any product a

>physician deems suitable -- as we will discuss

>further below -- but the advertisement of off

>label use of any approved drug or device is illegal.

>

>Just remember that silicone can be problematic

>if in it's migrating, liquid or gelatinous form

>if it enters a cell and suffocates it or you

>suffer from a chronic inflammatory response. In

>fact, It is supposed to form granulomas so that

>it does not migrate -- they rely on that

>granulomatous response to impede migration.

>

>Auto Immune Disorders & Breast Implants or Silicone Implants

>Siliconosis

>This is an unofficial name that has been given

>to patients by other anti-breast implant

>activists who have 1 or more of 14 key disorders

>thought to be caused by silicone -- including

>silicone injections, solid implants and breast

>implant shells and their silicone fillers, when applicable.

>

>I know several people who had these disorders

>before they ever had any type of operation and

>the disorder never got any worse after breast

>augmentation or other types of surgeries

>involving silicone. We routinely are exposed

>to silicone in our foods, eye drops. cosmetics,

>injections or any puncture by a hypodermic

>needle (which is lubricated by silicone). Some

>may argue that yes, this is all true but we are

>not routinely exposed to such large amounts of

>silicone. Well, yes you have a point. And I

>never said that mass injections or intra tissue

>deposits of silicone were a good thing, did I?

>

>But we aren't talking about cellular level

>problems and giant cell granulomas -- we are

>talking about an immune response disease that are blamed for things such as:

>

>* alopecia (I had that from anesthesia before

>and still have it, non-implant related)

>* arthralgia (which I had before and STILL

>have, it's called wear and tear and too many motorcycle accidents)

>* carpal tunnel syndrome (which I had before

>my augmentation and do NOT know how this can be caused by silicone)

>* chest wall erythema (also a sympton of

>Empyema, whic is defined as " is defined as

>accumulation of pus or fluid with demonstrable

>bacteria in pleural space " and " Erythema is an

>abnormal redness of the skin due to dialation of

>the superficial capillaries of the skin causing

>inflammation. It can result from many different

>causes, diseases of the skin and some systemic diseases. " www.erythema.com)

>* cognitive dysfunction (which is a symptom

>of chronic fatigue syndrome, also called " yuppie

>flu " (I swear that's true!) which affects those

>from 20-40 who apparently don't get enough sleep

>and live on fast food. This disorder is often

>seen in canines which I assure you do NOT have breast implants.)

>* dry eye (also a symptom of hormonal

>imbalance and menopause, not to mention

>dehydration, and dry or warm/cold climates)

>* dry mouth (I get this, it's called

>dehydration, 75% of Americans are chronically dehydrated)

>* dysphagia (difficulty in swallowing; caused

>by all sorts of things, from structural

>disorders like tumors or bone spurs to

>functional disorders such as primary motor

>disorders, achalasia, to secondary motor disorders like scleroderma

>* chronic fatigue (see " cognitive

>dysfunction " , above) Although this is a real

>problem with those who have fibromyalgia (which

>happens regardless if one has silicone in their

>body) or Multiple Sclerosis as well.)

>* lacrimal gland enlargement (various causes)

>* parotid enlargement (various causes)

>* petechiae (a minute reddish or purplish

>spot containing blood that appears in skin or

>mucous membrane esp. in some infectious

>diseases; Merriam-Webster. Common causes are

>(credit: The Library of Medicine, HealthAnswers.com)

>* injury or trauma

>* allergic reactions to medications

>* autoimmune disorders, which are conditions

>in which the person's body creates antibodies to

>its own tissues for unknown reasons (these

>happen without ever having a silicone anything in the body)

>* liver disorders, such as cirrhosis

>* infections, such as mononucleosis and endocarditis

>* bone marrow disorders, such as leukemia

>* thrombocytopenia, a deficiency of platelets

>* nutritional deficiencies, such as a

>deficiency in vitamins C, K, or B12, or folic acid

>* medications, such as blood thinners

>* recent blood transfusions

>* medical treatment, such as radiation therapy and chemotherapy for cancer

>* birth, due to the pressure changes caused by vaginal delivery

>* aging skin

>* sepsis, or blood infection

>* violent vomiting or coughing

>

>

>* photosensitive dermatitis (can be caused by

>medications as well as metabolic disorders)

>* telangiectasia (Telangiectasias form after

>anything that causes the face to flush or blush.

>Heredity, sun damage, acne rosacea (an adult

>form of acne), hot and spicy food, exercise,

>emotions, hormones, cortisone medications and

>some other rare skin diseases can cause

>telangiectasia.) Gateway Aesthetic Institute and

>Laser Center of Salt Lake City, Utah.

>

>

>All of the above happens often without any type

>of silicone implant. I have 4 out of 14 -- do I

>have an immune response disorder? No, I had

>this all before I ever had implants. Is it

>worse now? No, it has its good days and bad

>days. Getting older stinks. I also want to add

>that I know several people with Fibromyalgia,

>Multiple Sclerosis and other disorders which

>have gotten implants since finding out of their

>conditions and report no changes either way of

>their condition. If you'd like to speak with

>them, post on the message board and they will respond.

>

>Am I sympathetic to those who believe they have

>siliconosis -- yes, of course I am. But I do

>NOT think that their disorders were caused

>solely because of their breast implants. I

>think that for some the operation (and ANY

>trauma) can trigger sickness in those who are

>prone to it. I believe there are those who are

>allergic to silicone as well as there are t hose allergic to latex.

>

>There is NO certifiable proof that breast

>implants cause immune response disorders --

>period. But there IS proof that liquid, gel

>and/or lower-weighted molecular silicone cause

>granulomas, cysts, and fibroids in response to

>inflammation of the tissues on a cellular

>level. Which of course opens up the possibility

>for infection of the thick, avascular, fibrous

>capsules which surround the silicone

>droplets. So until it is proven other wise,

>think about it before making a choice.

>

>Silicone Injections (Silicone Oil):

>(technically: purified, medical grade

>polydimethylsiloxane oil) Often referred to as

>Liquid Injectable Silicone or simply,

>LIS. Silicone, in general, has met much

>controversy over the last few decades. Some

>issues, with good reasons and others due to junk

>science. I could write pages upon pages about

>the issues which have revolved around the use of

>all forms of silicones and more pages still on

>how much it is found and used in many products

>we use on a daily basis. But since this isn't

>about the controversy of the compound itself, I

>won't. If you are interested just type in

>silicone in Google and thousands websites will

>be returned. Just be sure what you read is

>backed by real science. I will, however, cover

>the intended uses of silicone oil and the

>off-label uses, as well. I will cover the glory

>and cover the not so bright and shiny side of liquid silicone injections.

>

>Firstly, injections of silicone oil are not

>approved for cosmetic use in the United States,

>no matter what anyone tells you. The off-label

>use of an approved medical device is, however,

>allowed because of the 1997 amendment to the

>Federal Food, Drug & Cosmetic Act 6, which states:

>

>

> " Nothing in (FD & C Act) shall be construed to

>limit or interfere with the authority of a

>health care practitioner to prescribe or

>administer any legally marketed device to a

>patient for any condition or disease within a

>legitimate health care practitioner-patient relationship. "

>

>

>This means a physician can legally use any FDA

>approved drug or device, as he sees fit, if he

>believes it can effectively treat or cure your

>complaint. Both Silikon 1000 and Adato Sil-ol

>5000 (originally approved under the name

> " Adatomed Silicone Oil 0P5000 " ) -- also called

>simply Adatosil -- are approved, but for

>injection into the vitreous cavity of the eye in

>the event of retinal detachment and/or

>hemorrhage. It is intended to help save a

>person's eyesight. And it is also intended to

>be aspirated at a later date and not kept inside the body indefinitely.

>

>

>Re: Adatosil 5000: " AdatoSil 5000™ was approved

>by FDA through the Premarket Approval process

>(PMA) on November 4, 1994, pursuant to section 5

>15(d)( 1)(B) (ii) of the Act. It is indicated

>for use as a prolonged retinal tamponade in

>selected cases of complicated retinal

>detachments where other interventions are not

>appropriate for patient management. Complicated

>retinal detachments or recurrent retinal

>detachments occur most commonly in eyes with

>proliferative vitroretinopathy (PVR),

>proliferative diabetic retinopathy (PDR),

>cytomegalovirus (CMV) retinitis, giant tears,

>and following perforating injuries. AdatoSil

>5000™ is also indicated for primary use in

>detachments due to Acquired Immune Deficiency

>Syndrome (AIDS) -related CMV retinitis, and

>other viral infections. " --credit: Larry D.

>Spears Acting Director, Office of Compliance

>Center for Devices and Radiological Health (FDA)

>

>Re: SILIKON 1000: " This device is indicated for

>use as a prolonged retinal tamponade in selected

>cases of complicated retinal detachments where

>other interventions are appropriate for patient

>management. Complicated retinal detachments or

>recurrent retinal detachments occur most

>commonly in eyes with proliferative

>vitreoretinopathy (PVR), proliferative diabetic

>retinopathy (PDR), cytomegalovirus (CMV)

>retinitis, giant tears, and following

>perforating in injuries. SILIKON 1000 is also

>indicated for primary use in detachments due to

>Acquired Immune Deficiency Syndrome (AIDS)

>related CMV retinitis and other viral infections

>affecting the retina. " --credit: PMA Final

>Decisions Rendered for September 1997

>

>Re: SILISKIN: " SilSkin™ is a purified 1000cs

>silicone oil manufactured by RJ Development [a

>subsidiary of -, Inc.] and currently

>under investigation for facial soft tissue

>augmentation. At present, SilSkin is an

>investigational device limited by Federal law to

>investigational use. " --credit:

><http://richard-james.com/page0005.htm>http://richard-james.com/page0005.htm

>

>

> " Liquid Silicone Injections

>

>1.

>

>Has liquid silicone been approved by FDA for injection?

>No. FDA has not approved the marketing of liquid

>silicone for injection for any cosmetic purpose,

>including the treatment of facial defects or

>wrinkles, or enlarging the breasts. The adverse

>effects of liquid silicone injections have

>included movement of the silicone to other parts

>of the body, inflammation and discoloration of

>surrounding tissues, and the formation of

>granulomas (nodules of granulated, inflamed tissue).

>2.

>

>Can FDA prohibit doctors from promoting the

>injection of liquid silicone, since its marketing has not been approved?

>Yes. FDA prohibits manufacturers or doctors from

>marketing or promoting unapproved products such

>as liquid silicone. This means that a doctor

>cannot legally advertise or sell this material. "

>--credit: <http://www.fda.gov>http://www.fda.gov

>

>

>

> " Silicone injection into facial tissues was

>popularized in the 1960s and 1970s with the

>introduction of medical grade silicone (MDX

>4-4011) by Dow Corning. Microdroplets of

>silicone are dispersed within the dermal

>tissues. Fibrosis around these droplets

>localizes the material, and it is seemingly well

>tolerated in small amounts in the face. Silicone

>oil has many advocates among those who used it

>prior to Food and Drug Administration (FDA)

>withdrawal of approval. However, silicone,

>although chemically well tolerated, becomes

>encapsulated as a foreign body by a chronic

>inflammatory reaction. Giant cells surround the

>material and cannot process any ingested

>material, establishing a low-grade inflammatory

>nidus. Fibrous tissue surrounds and encapsulates

>the silicone; this capsule is avascular and is a

>potential site of infection. A number of late

>infections, granulomas, and palpable masses have

>been reported following silicone use. " --credit:

>Emedicine.com - Soft Tissue Implants

>

>

>The Method of Augmentation By Silicone Oil Injections

>The injection of silicone oil, and many

>injectable tissue augmentation fillers, triggers

>a foreign body response by the accumulation of

>phagocytes, macrophages, lymphocytes, etc. This

>low grade inflammation causes your body to

>respond by trying to either break it down, by

>engulfing the product and by moving it to other

>organs for excretion. Silicone oil cannot be

>broken down by the body so the lower molecular

>silicones are either engulfed and moved and the

>higher viscosities remain behind when they are

>encapsulated. The macrophage accumulation

>triggers fibroblasts to begin encapsulating the

>silicone oil, to wall it off from the rest of

>the body. Imagine the silicone as a grain of

>sand, and your body as the oyster. The body

>forms collagen layers around the silicone and

>eventually augmentation is gained in the form of

>fibrous tissue. If the body cannot find relief

>after encapsulating the silicone, it will

>continue to form more and more collagen around

>the product, eventually causing a firm

>nodule. The good thing about encapsulation is

>that it can help keep the majority of the liquid

>silicone where it was injected and hinder its

>migration into the surrounding tissues.

>

>So remember, the augmentation isn't due to the

>product itself, large amounts of silicone oil

>should not be injected for volume

>augmentation. It is the body's inflammatory

>response which triggers the formation of

>collagen that is the method of

>augmentation. The amount of collagen formed is

>dependent upon your own body's sensitivity to

>the silicone, and the purity of the product.

>

>Questions To Ask Your Physician When Getting

>Silicone Injections: (Printer-friendly Version)

>

>

>1.

>

>What is your medical training and title? Are

>you an M.D., a D.O. an R.N. or a P.A.?

>(Independently verify their credentials, if necessary)

>2.

>

>Is silicone oil approved? [see what they say,

>if they say 'yes' it's misleading because it is

>approved for last ditch efforts to stop bleeding

>in retinal detachments and ocular

>hemorrhaging. If they say yes, ask, " For

>cosmetic use? " and if they say yes, then let

>them know you know they are lying and walk out

>the door. If they say no, I usually say nothing.]

>3.

>

>How long have you been injecting silicone?

>4.

>

>What type/brand of silicone have you worked with

>in the past and what do you prefer and use now?

>(Remember which products are approved for

>injection into the human body. Also if they

>simply say Silicone 1000, do ask who

>manufactures it. Silicone 1000 only explains

>that it is a 1000 centistoke silicone oil. Even

>if they say it is medical grade, there are

>medical grades which are not intended for

>injection into the body and are intended to

>lubricate cutting surfaces. One such oil is

>Dow-Corning 360 Medical Fluid. This oil is NOT

>intended for injection into the body.)

>5.

>

>Have any of your patients had problems with

>granulomas, severe inflammation or migration?

>6.

>

>Does migration this occur over time?

>7.

>

>What's the longest you have been in contact with

>one of your patients post-treatment?

>8.

>

>Can I get silicone safely injected over other products and vice versa?

>9.

>

>What do you use for pain relief? EMLA, Regional, Local?

>10.

>

>What can I expect during the procedure?

>11.

>

>How many cc do you think I will need for my particular desires?

>12.

>

>Hoe many cc do you inject per treatment?

>13.

>

>How much do you charge per cc?

>14.

>

>What if I need only 1/2 cc at one point am I charged for the whole cc?

>15.

>

>How much can be injected in one area without

>disrupting vascularity and causing problems?

>16.

>

>Do you use a tunneling technique in the

>vermilion border; do you use a microdroplet or other technique?

>17.

>

>What can I expect post-treatment?

>18.

>

>What post-treatment instructions must I follow?

>19.

>

>Do you recommend massage or does this increase the risk of migration?

>20.

>

>How long must I wait between treatments?

>21.

>

>If I have trouble, what treatment options do you

>offer (Kenalog, excision, etc)

>22.

>

>If no treatments are offered at your practice,

>who can help me if I need it removed?

>

>

>

>Where NOT to Get Silicone Injections

>Liquid silicone can also be found in the US on

>the black market, as well as salons using

>non-medical and medical grades intended for

>lubrication of surgical instruments. Medical

>grade does not equal intended use for human

>injection. I simply implore that you do not go

>to any of these places to get silicone

>injections for any reason. There is no quality

>control, sterility is questionable and if the

>person is operating outside of a medical office

>-- there is a reason. Please do not choose to

>get silicone injections from an unlicensed

>person, in a hotel, in a salon, at someone's own home, or at your own home.

>

>If you still want to get silicone injections,

>please research your physician extensively and

>follow up on his or her credentials, please view

>updated photos (dated if possible) of the

>physician's past patients. Also ask what type

>of silicone they are using and ask to see the

>vial. The most commonly used products are

>Silikon 1000 or Adatosil 5000. Dow-Corning does

>NOT make a silicone oil intended for injection

>into the human body, no matter what they say.

>

>Allergy/Inflammation Test: There is no test one

>can take to determine if you are a good

>candidate. Either you will have problems or you

>will not. There is no definitive evidence

>regarding silicone allergy, per se. However, if

>you find that you have an allergy towards

>polymers, you may want to consider something

>else. There are persons who simply cannot tolerate foreign bodies of any kind.

>Longevity: Permanent, and difficult to remove.

>Cost: $350. to $1,500. per treatment

>Caution: Granulomas, migration, traces found in

>other organs and lymph nodes, excessive collagen

>formation, necrosis, silicone embolism.

>Available in the United States? Yes, Silikon

>1000, Adatosil 5000 are approved by the FDA,

>however not for cosmetic applications. SilSkin

>has been granted pre-market approval to conduct

>clinical trials only. Other forms of silicone

>are found and offered in the US, from imported

> " medical grade " oils to those which are not intended for human injection.

>Websites of Interest:

>

>

>Approved Silicone Oils

>

>*

>

>ADATO SIL-ol 5000 - Bausch & Lomb

>*

>

>SILIKON 1000 Product Sheet (Alcon Labs) (PDF)

>*

>

>SILIKON 1000 - Alcon Labs (PDF)

>*

>

>SILIKON 1000 PMA Approval (PDF)

>

>

>Silicone Not Intended For Injection

>

>*

>

>Dow-Corning 360 Medical Fluid Frequently Asked

>Questions (PDF) NOT FOR HUMAN INJECTION

>*

>

>Dow-Corning MDX4-4159, 50% Medical Grade Dispersion NOT FOR HUMAN INJECTION

>

>

>Silicone Removal Information:

>

>*

>

>Silicone Granuloma Management: TNFinhibitors may be effective as intervention

>

>

>Contact & Website Information:

>Alcon Laboratories, Inc. (Silikon)

>6201 South Freeway

>Fort Worth, TX 76134

>Tel: 817-551-8430

><http://www.alconlabs.com>http://www.alconlabs.com

>Bausch & Lomb (Adato Sil-ol)

>1 Bausch and Lomb Pl

>Rochester, NY

>Tel: 585-338-6000

><http://www.bausch.com>http://www.bausch.com - (SilSkin)

>Centennial Park

>2 Centennial Drive

>Peabody, MA 01960

>Tel: 978.532.0666

><http://www.richard-james.com>http://www.richard-james.com

>

>Update! 04/09/02: I spoke with Diane ,

>vice president for the company which

>manufactures SilSkin today. Mrs.

>advised that although a silicone product,

>SilSkin is " different " than Adatosil or

>Dow-Corning silicone and that trials are

>beginning for their product for cosmetic

>applications. Only time will tell if there will

>be problems associated with this new product as

>in the past with other silicone products. If

>anyone has personal experience or knowledge of this product, please contact me.

>Update! 03/25/03: I met with Diane at

>the American Academy of Dermatology Meeting in

>San Francisco (Mar. 21-25, 2003) and viewed some

>before and after photos and was given some

>clinical data of their progress so far. I would

>still like to speak to any patientswho are participating in the clinicals.

>

>

>

>References:

>(1) Institute of Medicine (IOM) - Information

>for Women about the Safety of Silicone, Nat'l Academy Press

>(2) Independent Review Group, UK - Silicone Gel Breast Implants Home Page

>(3) APHA Standard Methods, 19th ed., p. 4-118, method 4500-Si D (1995).

>ASTM D 859-94, Silica in Water.

>EPA Methods for Chemical Analysis of Water and Wastes, method 370.1 (1983).

>(4) Brown SL, Middleton MS, Berg WA, Soo MS,

>Pennello G. Prevalence of rupture of silicone

>gel breast implants in a population of women in

>Birmingham, Alabama. American Journal of Roentgenology 2000;175:1-8.

>

>Kenda

>

>

> > You may be offered it, but that does not make it legal. It is

> > actually approved only for the cornea.

> >

> > Lynda

> >

> >

> > At 02:46 PM 12/26/2006, you wrote:

> >

> >> Not where I live. My sister was offered them last week. I am speaking of

> >> the liquid silicone that is used as a filler for the face, not something

> >> injected into the breast.

> >>

> >> Kenda

> >>

> >>> Liquid silicone injections are banned in the US.

> >>>

> >>> Absolutely.

> >>>

> >>> Lynda

> >>>

> >>>

> >>> At 01:35 PM 12/26/2006, you wrote:

> >>>

> >>>> Oh, no, silicone injections are not banned

> -- at least not in the US! The

> >>>> plastic surgeon who almost implanted me wanted to use silicone

> >> injections to

> >>>> plump up my lips. I passed on silicone everything! He told me that the

> >>>> silicone injections last a lifetime,

> whereas injectable fillers do not. He

> >>>> brought in his little office girl with

> giant implants and plumped lips to

> >>>> show me how beautiful injected lips are. :(

> >>>>

> >>>> Kenda

> >>>>

> >>>>> Silicone injections were banned. Do any

> of you remember the Georgia Crime

> >>>>> Laboratory's investigations? I am afraid to

> >>>> send out the document, but someone

> >>>>> in this group must have it. Why are

> plastic surgeons still injecting this

> >>>>> poison into people?

> >>>>>

> >>>>> GRRRR...Lea

> >>>>> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

> >>>>> Re: Re: Liquid Silicone Injections

> >>>>>

> >>>>>

> >>>>>

> >>>>> I thought this was interesting to read, it mentions silicone

> >> injections at

> >>>>> one point.

> >>>>>

> >>>>>

> >>>>>

> >>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

> >>>>> by P. , Ph.D., MBA

> >>>>>

> >>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

> >>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

> >>>>> Nottingham University. Little practical use

> >>>> was made of these materials until

> >>>>> the 1940's when Corning Glass Works formed a working

> >> relationship with Dow

> >>>>> Chemical Company (Dow-Corning Corporation) to

> >>>> develop many uses such as high

> >>>>> temperature-resistant lubricants, rubbers,

> >>>> antifoam, mold-releasing compounds,

> >>>>> insulation, as well as medical devices.

> >>>>>

> >>>>> Silicone gel breast implants are medical device prostheses

> >>>>> used to substitute for human breast tissue for purposes of

> >> augmentation or

> >>>>> replacement following mastectomy. Implants consist of a plastic

> >> envelope or

> >>>>> shell containing a soft gelatinous mixture. The shell consists

> >> of a highly

> >>>>> cross-linked silicone polymer while the gel contents embody

> >> linear silicone

> >>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

> >>>>> weights with less cross-linking than the

> >>>> shell material. Silicone gel implants

> >>>>> were invented in 1963 for breast augmentation

> >>>> to replace the use of silicone

> >>>>> injections.

> >>>>>

> >>>>> Silicone gel breast implants were widely marketed and used

> >>>>> over a thirty-year period until 1992 when

> the FDA banned them for lack of

> >>>>> sufficient safety and efficacy data. The

> >>>> number of breast implant operations

> >>>>> in this time period is estimated to be

> >>>> between one and two million. In 1992,

> >>>>> when sales were ceased, there were over 87, 000 breast implant surgical

> >>>>> procedures of which 25, 676 (29%) were

> breast implant removal operations.

> >>>>>

> >>>>> Disclosure to Patients Issues Today, there is a great deal of

> >>>>> controversy regarding certain physical

> >>>> characteristics of silicone gel breast

> >>>>> implants versus what was revealed to or

> >>>> understood by patients as well as the

> >>>>> medical profession. There are at least

> six important product information

> >>>>> issues that should have been disclosed by the manufacturers in

> >> the package

> >>>>> inserts accompanying the product.

> >>>>>

> >>>>> 1. Silicones have biological activity. Contrary to popular

> >>>>> belief amongst plastic surgeons in the

> beginning, silicones were and are

> >>>>> biologically active compounds.

> >>>>>

> >>>>> Issue: There are published reports and internal company

> >>>>> documents from silicone breast implant

> >>>> manufacturers that reveal screening and

> >>>>> discovery of silicone compounds which exhibited pesticidal,

> >> antibiotic and

> >>>>> hormonal activities.

> >>>>>

> >>>>> 2. Injected silicones caused problems. The potential danger of

> >>>>> silicone compounds was published widely in

> >>>> the scientific literature revealing

> >>>>> adverse reactions to silicone injections when used for

> >> augmenting the human

> >>>>> female breast.

> >>>>>

> >>>>> Issue: Despite much evidence, a correlation between silicone

> >>>>> toxicity from direct injection with the

> >>>> possible silicone toxicity associated

> >>>>> with gel bleed from implants was never addressed.

> >>>>>

> >>>>> 3. Gel bleed from implants was documented. Gel bleed is a

> >>>>> phenomenon, which describes the migration of

> >>>> silicone molecules contained in

> >>>>> the gel implant through the permeable shell.

> >>>> The fact that gel implants exuded

> >>>>> a " greasy " residue was well known by

> manufacturers and plastic surgeons.

> >>>>>

> >>>>> Issue: Historically, neither the patients, surgeons, nor the

> >>>>> FDA were adequately informed about the gel

> >>>> bleed while it can be documented in

> >>>>> company memos that gel bleed was known,

> >>>> discussed, and proposed to be studied

> >>>>> at least 15 years before it was revealed in product package

> >> inserts. Issue:

> >>>>> The gel material leaking from the implants

> >>>> was not characterized, and hence,

> >>>>> posed an unknown health hazard to silicone gel breast implant patients.

> >>>>>

> >>>>> 4. Gel migration is described as the movement of silicone

> >>>>> residues released from silicone gel breast

> >>>> implants throughout the body being

> >>>>> carried by phagocytic cells via the lymph

> >>>> system or by some other mechanism.

> >>>>>

> >>>>> Issue: Silicone fluids and gels have been known and observed

> >>>>> to migrate both in animals and humans as cited in company memos

> >> written and

> >>>>> papers published at least 15 years prior to

> >>>> being mentioned in product package

> >>>>> inserts.

> >>>>>

> >>>>> 5. The chemical stability of silicone gel implants in

> >>>>> biological systems should have been a critical factor when

> >> determining the

> >>>>> suitability of implant formulations for long term use.

> >>>>>

> >>>>> Issue: There is evidence both from company documents as well

> >>>>> as the scientific literature that shelf life

> >>>> or stability data were not given

> >>>>> proper consideration in the manufacture

> of silicone gel breast implants.

> >>>>>

> >>>>> Issue: Long term suitability studies for breast implants in

> >>>>> animals or stored on the shelf appear to

> be currently unknown or at least

> >>>>> unpublished by breast implant manufacturers.

> >>>>>

> >>>>> 6. The information provided in package inserts for silicone

> >>>>> gel breast implants was incomplete and

> >>>> sometimes incorrect. Such information

> >>>>> accompanying regulated medical devices should be a fair and equitable

> >>>>> representation of the safety and efficacy of the product.

> >>>>>

> >>>>> Issue: The fact that gel implants could bleed gel and that

> >>>>> the gel could migrate through tissues from

> >>>> the site of implantation failed to

> >>>>> be mentioned in package inserts for more than 15 years.

> >>>>>

> >>>>> Issue: The fact that gel implants had a limited shelf life

> >>>>> was not addressed in package inserts for more than 15 years.

> >>>>>

> >>>>> Conclusion: It is apparent that disclosure of critical

> >>>>> information to patients regarding the

> >>>> physical characteristics of silicone gel

> >>>>> breast implants was inadequate. Hence,

> >>>> patients were ill-informed when making

> >>>>> decisions regarding the safety and stability

> >>>> of the products to be implanted

> >>>>> in their body.

> >>>>>

> >>>>>

> >>>>>

> >>>>> About P. , Ph.D., MBA

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>

> >>>>

> >>>

> >>>

> >>>

> >>

> >>

> >

> >

> >

>

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Dearest Kenda:

In the article that you posted, it said that the FDA did not approve silicone injections. In my opinion silicone should never be used in the human body.

I guess we an agree to disagree....Love you.....Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`````

Re: Re: Liquid Silicone Injections>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> I thought this was interesting to read, it mentions silicone>>>>> injections at>>>>>>>> one point.>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?>>>>>>>> by P. , Ph.D., MBA>>>>>>>> >>>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and>>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at>>>>>>>> Nottingham University. Little practical use>>>>>>> was made of these materials until>>>>>>>> the 1940's when Corning Glass Works formed a working>>>>> relationship with Dow>>>>>>>> Chemical Company (Dow-Corning Corporation) to>>>>>>> develop many uses such as high>>>>>>>> temperature-resistant lubricants, rubbers,>>>>>>> antifoam, mold-releasing compounds,>>>>>>>> insulation, as well as medical devices.>>>>>>>> >>>>>>>> Silicone gel breast implants are medical device prostheses>>>>>>>> used to substitute for human breast tissue for purposes of>>>>> augmentation or>>>>>>>> replacement following mastectomy. Implants consist of a plastic>>>>> envelope or>>>>>>>> shell containing a soft gelatinous mixture. The shell consists>>>>> of a highly>>>>>>>> cross-linked silicone polymer while the gel contents embody>>>>> linear silicone>>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular>>>>>>>> weights with less cross-linking than the>>>>>>> shell material. Silicone gel implants>>>>>>>> were invented in 1963 for breast augmentation>>>>>>> to replace the use of silicone>>>>>>>> injections.>>>>>>>> >>>>>>>> Silicone gel breast implants were widely marketed and used>>>>>>>> over a thirty-year period until 1992 when >>> the FDA banned them for lack of>>>>>>>> sufficient safety and efficacy data. The>>>>>>> number of breast implant operations>>>>>>>> in this time period is estimated to be>>>>>>> between one and two million. In 1992,>>>>>>>> when sales were ceased, there were over 87, 000 breast implant surgical>>>>>>>> procedures of which 25, 676 (29%) were >>> breast implant removal operations.>>>>>>>> >>>>>>>> Disclosure to Patients Issues Today, there is a great deal of>>>>>>>> controversy regarding certain physical>>>>>>> characteristics of silicone gel breast>>>>>>>> implants versus what was revealed to or>>>>>>> understood by patients as well as the>>>>>>>> medical profession. There are at least >>> six important product information>>>>>>>> issues that should have been disclosed by the manufacturers in>>>>> the package>>>>>>>> inserts accompanying the product.>>>>>>>> >>>>>>>> 1. Silicones have biological activity. Contrary to popular>>>>>>>> belief amongst plastic surgeons in the >>> beginning, silicones were and are>>>>>>>> biologically active compounds.>>>>>>>> >>>>>>>> Issue: There are published reports and internal company>>>>>>>> documents from silicone breast implant>>>>>>> manufacturers that reveal screening and>>>>>>>> discovery of silicone compounds which exhibited pesticidal,>>>>> antibiotic and>>>>>>>> hormonal activities.>>>>>>>> >>>>>>>> 2. Injected silicones caused problems. The potential danger of>>>>>>>> silicone compounds was published widely in>>>>>>> the scientific literature revealing>>>>>>>> adverse reactions to silicone injections when used for>>>>> augmenting the human>>>>>>>> female breast.>>>>>>>> >>>>>>>> Issue: Despite much evidence, a correlation between silicone>>>>>>>> toxicity from direct injection with the>>>>>>> possible silicone toxicity associated>>>>>>>> with gel bleed from implants was never addressed.>>>>>>>> >>>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a>>>>>>>> phenomenon, which describes the migration of>>>>>>> silicone molecules contained in>>>>>>>> the gel implant through the permeable shell.>>>>>>> The fact that gel implants exuded>>>>>>>> a "greasy" residue was well known by >>> manufacturers and plastic surgeons.>>>>>>>> >>>>>>>> Issue: Historically, neither the patients, surgeons, nor the>>>>>>>> FDA were adequately informed about the gel>>>>>>> bleed while it can be documented in>>>>>>>> company memos that gel bleed was known,>>>>>>> discussed, and proposed to be studied>>>>>>>> at least 15 years before it was revealed in product package>>>>> inserts. Issue:>>>>>>>> The gel material leaking from the implants>>>>>>> was not characterized, and hence,>>>>>>>> posed an unknown health hazard to silicone gel breast implant patients.>>>>>>>> >>>>>>>> 4. Gel migration is described as the movement of silicone>>>>>>>> residues released from silicone gel breast>>>>>>> implants throughout the body being>>>>>>>> carried by phagocytic cells via the lymph>>>>>>> system or by some other mechanism.>>>>>>>> >>>>>>>> Issue: Silicone fluids and gels have been known and observed>>>>>>>> to migrate both in animals and humans as cited in company memos>>>>> written and>>>>>>>> papers published at least 15 years prior to>>>>>>> being mentioned in product package>>>>>>>> inserts.>>>>>>>> >>>>>>>> 5. The chemical stability of silicone gel implants in>>>>>>>> biological systems should have been a critical factor when>>>>> determining the>>>>>>>> suitability of implant formulations for long term use.>>>>>>>> >>>>>>>> Issue: There is evidence both from company documents as well>>>>>>>> as the scientific literature that shelf life>>>>>>> or stability data were not given>>>>>>>> proper consideration in the manufacture >>> of silicone gel breast implants.>>>>>>>> >>>>>>>> Issue: Long term suitability studies for breast implants in>>>>>>>> animals or stored on the shelf appear to >>> be currently unknown or at least>>>>>>>> unpublished by breast implant manufacturers.>>>>>>>> >>>>>>>> 6. The information provided in package inserts for silicone>>>>>>>> gel breast implants was incomplete and>>>>>>> sometimes incorrect. Such information>>>>>>>> accompanying regulated medical devices should be a fair and equitable>>>>>>>> representation of the safety and efficacy of the product.>>>>>>>> >>>>>>>> Issue: The fact that gel implants could bleed gel and that>>>>>>>> the gel could migrate through tissues from>>>>>>> the site of implantation failed to>>>>>>>> be mentioned in package inserts for more than 15 years.>>>>>>>> >>>>>>>> Issue: The fact that gel implants had a limited shelf life>>>>>>>> was not addressed in package inserts for more than 15 years.>>>>>>>> >>>>>>>> Conclusion: It is apparent that disclosure of critical>>>>>>>> information to patients regarding the>>>>>>> physical characteristics of silicone gel>>>>>>>> breast implants was inadequate. Hence,>>>>>>> patients were ill-informed when making>>>>>>>> decisions regarding the safety and stability>>>>>>> of the products to be implanted>>>>>>>> in their body.>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> About P. , Ph.D., MBA>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>> >>>>>>> >>>>>> >>>>>> >>>>>> >>>>> >>>>> >>>> >>>> >>>> >>> >> >> >> > > > > > >

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Kenda, could you please send me a clean copy of the article by Dr. . It has been forwarded so many times that it makes it difficult to read.

Thank you in advance...love always..........Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Re: Re: Liquid Silicone Injections>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> I thought this was interesting to read, it mentions silicone>>>>> injections at>>>>>>>> one point.>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?>>>>>>>> by P. , Ph.D., MBA>>>>>>>> >>>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and>>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at>>>>>>>> Nottingham University. Little practical use>>>>>>> was made of these materials until>>>>>>>> the 1940's when Corning Glass Works formed a working>>>>> relationship with Dow>>>>>>>> Chemical Company (Dow-Corning Corporation) to>>>>>>> develop many uses such as high>>>>>>>> temperature-resistant lubricants, rubbers,>>>>>>> antifoam, mold-releasing compounds,>>>>>>>> insulation, as well as medical devices.>>>>>>>> >>>>>>>> Silicone gel breast implants are medical device prostheses>>>>>>>> used to substitute for human breast tissue for purposes of>>>>> augmentation or>>>>>>>> replacement following mastectomy. Implants consist of a plastic>>>>> envelope or>>>>>>>> shell containing a soft gelatinous mixture. The shell consists>>>>> of a highly>>>>>>>> cross-linked silicone polymer while the gel contents embody>>>>> linear silicone>>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular>>>>>>>> weights with less cross-linking than the>>>>>>> shell material. Silicone gel implants>>>>>>>> were invented in 1963 for breast augmentation>>>>>>> to replace the use of silicone>>>>>>>> injections.>>>>>>>> >>>>>>>> Silicone gel breast implants were widely marketed and used>>>>>>>> over a thirty-year period until 1992 when >>> the FDA banned them for lack of>>>>>>>> sufficient safety and efficacy data. The>>>>>>> number of breast implant operations>>>>>>>> in this time period is estimated to be>>>>>>> between one and two million. In 1992,>>>>>>>> when sales were ceased, there were over 87, 000 breast implant surgical>>>>>>>> procedures of which 25, 676 (29%) were >>> breast implant removal operations.>>>>>>>> >>>>>>>> Disclosure to Patients Issues Today, there is a great deal of>>>>>>>> controversy regarding certain physical>>>>>>> characteristics of silicone gel breast>>>>>>>> implants versus what was revealed to or>>>>>>> understood by patients as well as the>>>>>>>> medical profession. There are at least >>> six important product information>>>>>>>> issues that should have been disclosed by the manufacturers in>>>>> the package>>>>>>>> inserts accompanying the product.>>>>>>>> >>>>>>>> 1. Silicones have biological activity. Contrary to popular>>>>>>>> belief amongst plastic surgeons in the >>> beginning, silicones were and are>>>>>>>> biologically active compounds.>>>>>>>> >>>>>>>> Issue: There are published reports and internal company>>>>>>>> documents from silicone breast implant>>>>>>> manufacturers that reveal screening and>>>>>>>> discovery of silicone compounds which exhibited pesticidal,>>>>> antibiotic and>>>>>>>> hormonal activities.>>>>>>>> >>>>>>>> 2. Injected silicones caused problems. The potential danger of>>>>>>>> silicone compounds was published widely in>>>>>>> the scientific literature revealing>>>>>>>> adverse reactions to silicone injections when used for>>>>> augmenting the human>>>>>>>> female breast.>>>>>>>> >>>>>>>> Issue: Despite much evidence, a correlation between silicone>>>>>>>> toxicity from direct injection with the>>>>>>> possible silicone toxicity associated>>>>>>>> with gel bleed from implants was never addressed.>>>>>>>> >>>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a>>>>>>>> phenomenon, which describes the migration of>>>>>>> silicone molecules contained in>>>>>>>> the gel implant through the permeable shell.>>>>>>> The fact that gel implants exuded>>>>>>>> a "greasy" residue was well known by >>> manufacturers and plastic surgeons.>>>>>>>> >>>>>>>> Issue: Historically, neither the patients, surgeons, nor the>>>>>>>> FDA were adequately informed about the gel>>>>>>> bleed while it can be documented in>>>>>>>> company memos that gel bleed was known,>>>>>>> discussed, and proposed to be studied>>>>>>>> at least 15 years before it was revealed in product package>>>>> inserts. Issue:>>>>>>>> The gel material leaking from the implants>>>>>>> was not characterized, and hence,>>>>>>>> posed an unknown health hazard to silicone gel breast implant patients.>>>>>>>> >>>>>>>> 4. Gel migration is described as the movement of silicone>>>>>>>> residues released from silicone gel breast>>>>>>> implants throughout the body being>>>>>>>> carried by phagocytic cells via the lymph>>>>>>> system or by some other mechanism.>>>>>>>> >>>>>>>> Issue: Silicone fluids and gels have been known and observed>>>>>>>> to migrate both in animals and humans as cited in company memos>>>>> written and>>>>>>>> papers published at least 15 years prior to>>>>>>> being mentioned in product package>>>>>>>> inserts.>>>>>>>> >>>>>>>> 5. The chemical stability of silicone gel implants in>>>>>>>> biological systems should have been a critical factor when>>>>> determining the>>>>>>>> suitability of implant formulations for long term use.>>>>>>>> >>>>>>>> Issue: There is evidence both from company documents as well>>>>>>>> as the scientific literature that shelf life>>>>>>> or stability data were not given>>>>>>>> proper consideration in the manufacture >>> of silicone gel breast implants.>>>>>>>> >>>>>>>> Issue: Long term suitability studies for breast implants in>>>>>>>> animals or stored on the shelf appear to >>> be currently unknown or at least>>>>>>>> unpublished by breast implant manufacturers.>>>>>>>> >>>>>>>> 6. The information provided in package inserts for silicone>>>>>>>> gel breast implants was incomplete and>>>>>>> sometimes incorrect. Such information>>>>>>>> accompanying regulated medical devices should be a fair and equitable>>>>>>>> representation of the safety and efficacy of the product.>>>>>>>> >>>>>>>> Issue: The fact that gel implants could bleed gel and that>>>>>>>> the gel could migrate through tissues from>>>>>>> the site of implantation failed to>>>>>>>> be mentioned in package inserts for more than 15 years.>>>>>>>> >>>>>>>> Issue: The fact that gel implants had a limited shelf life>>>>>>>> was not addressed in package inserts for more than 15 years.>>>>>>>> >>>>>>>> Conclusion: It is apparent that disclosure of critical>>>>>>>> information to patients regarding the>>>>>>> physical characteristics of silicone gel>>>>>>>> breast implants was inadequate. Hence,>>>>>>> patients were ill-informed when making>>>>>>>> decisions regarding the safety and stability>>>>>>> of the products to be implanted>>>>>>>> in their body.>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> About P. , Ph.D., MBA>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>>> >>>>>>> >>>>>>> >>>>>> >>>>>> >>>>>> >>>>> >>>>> >>>> >>>> >>>> >>> >> >> >> > > > > > >

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Kenda,

Let's look at this subject another way. Even if legal or not legal. Are they safe? Common sense tells us no. The injections makes slews of people sick and there is no cure. Would it matter if we had big puffy lips or big breast when we are dying from that. It is not so important when these products make you so sick you can't get out of bed or remember what you are doing from one minute to the next. I have read tons of warning that you should never let any surgeon talk you into silicone injections, it is dangerous and it has killed so many woman. God Bless!!!!!!!!!!!!!

Donna

Re: Re: Liquid Silicone Injections

As I posted earlier, it is completely legal. The doctor has broken no laws.

Kenda

> The doctor should be reported.

>

> Lynda <cossprivatei> wrote: You may be offered it, but that does

> not make it legal. It is

> actually approved only for the cornea.

>

> Lynda

>

> At 02:46 PM 12/26/2006, you wrote:

>

>> Not where I live. My sister was offered them last week. I am speaking of

>> the liquid silicone that is used as a filler for the face, not something

>> injected into the breast.

>>

>> Kenda

>>

>>> Liquid silicone injections are banned in the US.

>>>

>>> Absolutely.

>>>

>>> Lynda

>>>

>>>

>>> At 01:35 PM 12/26/2006, you wrote:

>>>

>>>> Oh, no, silicone injections are not banned -- at least not in the US! The

>>>> plastic surgeon who almost implanted me wanted to use silicone

>> injections to

>>>> plump up my lips. I passed on silicone everything! He told me that the

>>>> silicone injections last a lifetime, whereas injectable fillers do not. He

>>>> brought in his little office girl with giant implants and plumped lips to

>>>> show me how beautiful injected lips are. :(

>>>>

>>>> Kenda

>>>>

>>>>> Silicone injections were banned. Do any of you remember the Georgia Crime

>>>>> Laboratory's investigations? I am afraid to

>>>> send out the document, but someone

>>>>> in this group must have it. Why are plastic surgeons still injecting this

>>>>> poison into people?

>>>>>

>>>>> GRRRR...Lea

>>>>> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

>>>>> Re: Re: Liquid Silicone Injections

>>>>>

>>>>>

>>>>>

>>>>> I thought this was interesting to read, it mentions silicone

>> injections at

>>>>> one point.

>>>>>

>>>>>

>>>>>

>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

>>>>> by P. , Ph.D., MBA

>>>>>

>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

>>>>> Nottingham University. Little practical use

>>>> was made of these materials until

>>>>> the 1940's when Corning Glass Works formed a working

>> relationship with Dow

>>>>> Chemical Company (Dow-Corning Corporation) to

>>>> develop many uses such as high

>>>>> temperature-resistant lubricants, rubbers,

>>>> antifoam, mold-releasing compounds,

>>>>> insulation, as well as medical devices.

>>>>>

>>>>> Silicone gel breast implants are medical device prostheses

>>>>> used to substitute for human breast tissue for purposes of

>> augmentation or

>>>>> replacement following mastectomy. Implants consist of a plastic

>> envelope or

>>>>> shell containing a soft gelatinous mixture. The shell consists

>> of a highly

>>>>> cross-linked silicone polymer while the gel contents embody

>> linear silicone

>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

>>>>> weights with less cross-linking than the

>>>> shell material. Silicone gel implants

>>>>> were invented in 1963 for breast augmentation

>>>> to replace the use of silicone

>>>>> injections.

>>>>>

>>>>> Silicone gel breast implants were widely marketed and used

>>>>> over a thirty-year period until 1992 when the FDA banned them for lack of

>>>>> sufficient safety and efficacy data. The

>>>> number of breast implant operations

>>>>> in this time period is estimated to be

>>>> between one and two million. In 1992,

>>>>> when sales were ceased, there were over 87, 000 breast implant surgical

>>>>> procedures of which 25, 676 (29%) were breast implant removal operations.

>>>>>

>>>>> Disclosure to Patients Issues Today, there is a great deal of

>>>>> controversy regarding certain physical

>>>> characteristics of silicone gel breast

>>>>> implants versus what was revealed to or

>>>> understood by patients as well as the

>>>>> medical profession. There are at least six important product information

>>>>> issues that should have been disclosed by the manufacturers in

>> the package

>>>>> inserts accompanying the product.

>>>>>

>>>>> 1. Silicones have biological activity. Contrary to popular

>>>>> belief amongst plastic surgeons in the beginning, silicones were and are

>>>>> biologically active compounds.

>>>>>

>>>>> Issue: There are published reports and internal company

>>>>> documents from silicone breast implant

>>>> manufacturers that reveal screening and

>>>>> discovery of silicone compounds which exhibited pesticidal,

>> antibiotic and

>>>>> hormonal activities.

>>>>>

>>>>> 2. Injected silicones caused problems. The potential danger of

>>>>> silicone compounds was published widely in

>>>> the scientific literature revealing

>>>>> adverse reactions to silicone injections when used for

>> augmenting the human

>>>>> female breast.

>>>>>

>>>>> Issue: Despite much evidence, a correlation between silicone

>>>>> toxicity from direct injection with the

>>>> possible silicone toxicity associated

>>>>> with gel bleed from implants was never addressed.

>>>>>

>>>>> 3. Gel bleed from implants was documented. Gel bleed is a

>>>>> phenomenon, which describes the migration of

>>>> silicone molecules contained in

>>>>> the gel implant through the permeable shell.

>>>> The fact that gel implants exuded

>>>>> a "greasy" residue was well known by manufacturers and plastic surgeons.

>>>>>

>>>>> Issue: Historically, neither the patients, surgeons, nor the

>>>>> FDA were adequately informed about the gel

>>>> bleed while it can be documented in

>>>>> company memos that gel bleed was known,

>>>> discussed, and proposed to be studied

>>>>> at least 15 years before it was revealed in product package

>> inserts. Issue:

>>>>> The gel material leaking from the implants

>>>> was not characterized, and hence,

>>>>> posed an unknown health hazard to silicone gel breast implant patients.

>>>>>

>>>>> 4. Gel migration is described as the movement of silicone

>>>>> residues released from silicone gel breast

>>>> implants throughout the body being

>>>>> carried by phagocytic cells via the lymph

>>>> system or by some other mechanism.

>>>>>

>>>>> Issue: Silicone fluids and gels have been known and observed

>>>>> to migrate both in animals and humans as cited in company memos

>> written and

>>>>> papers published at least 15 years prior to

>>>> being mentioned in product package

>>>>> inserts.

>>>>>

>>>>> 5. The chemical stability of silicone gel implants in

>>>>> biological systems should have been a critical factor when

>> determining the

>>>>> suitability of implant formulations for long term use.

>>>>>

>>>>> Issue: There is evidence both from company documents as well

>>>>> as the scientific literature that shelf life

>>>> or stability data were not given

>>>>> proper consideration in the manufacture of silicone gel breast implants.

>>>>>

>>>>> Issue: Long term suitability studies for breast implants in

>>>>> animals or stored on the shelf appear to be currently unknown or at least

>>>>> unpublished by breast implant manufacturers.

>>>>>

>>>>> 6. The information provided in package inserts for silicone

>>>>> gel breast implants was incomplete and

>>>> sometimes incorrect. Such information

>>>>> accompanying regulated medical devices should be a fair and equitable

>>>>> representation of the safety and efficacy of the product.

>>>>>

>>>>> Issue: The fact that gel implants could bleed gel and that

>>>>> the gel could migrate through tissues from

>>>> the site of implantation failed to

>>>>> be mentioned in package inserts for more than 15 years.

>>>>>

>>>>> Issue: The fact that gel implants had a limited shelf life

>>>>> was not addressed in package inserts for more than 15 years.

>>>>>

>>>>> Conclusion: It is apparent that disclosure of critical

>>>>> information to patients regarding the

>>>> physical characteristics of silicone gel

>>>>> breast implants was inadequate. Hence,

>>>> patients were ill-informed when making

>>>>> decisions regarding the safety and stability

>>>> of the products to be implanted

>>>>> in their body.

>>>>>

>>>>>

>>>>>

>>>>> About P. , Ph.D., MBA

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>

>>>

>>>

>>

>>

>

>

>

>

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Rogene,

I have ask to go to Dr. Kolb and she is just too sick.

Donna

Re: Re: Liquid Silicone Injections

Donna,

Is there anyway can afford to go to a detox center like Dr. Kolb's?

Rogene

BSBanshee1aol wrote:

Lea,

I don't know why they are still doing this, let me guess, $$$$$$$$$$$$$. I would love to read that article if you can get someone to send it too me. was told it was so safe and the FDA didn't know what they were talking about when they banned it. She totally believed it was safe, just like I thought saline was safe. We were all lied to equally regarding silicone. is not doing to good, she says her ears and nose is just falling off. She said, the collegen is gone? She says, her ears are like dried fruit? I don't know what to tell her to do, she can't find a doctor to help her? I get really dry skin falling off in my ears, I don't know why? I don't feel like there falling off though. What to do I have no idea. I just pray for her to get a miracle. She is so scared and alone. She has chronic fatigue and she doesn't think clearly. She is now looking for a place to test for silicone hypersensitivity and vitamin deficiencies. I don't know if it is going to do her any good to just know these things? She is trying to just do something instead of laying there dying. It is so sad to see everyone so affected from things the FDA approved. I have to remember at one time the FDA said, silicone injections were safe, then changed there minds. It is hard to believe they don't see any difference with silicone in a silicone shell or saline in a silicone shell? It is merely the same thing if you ask me. God Bless!!!!!!!!!!!!

Donna

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Lynda,

SO true, in fact 's doctor did the silicone injections around 3 years ago on her, legally. He found a loop hole with the FDA, yet it was very hush hush she claims. She ask me not to give her last name nor her doctor's name, so I won't do that. However, I did some searching on this doctor and she is telling the truth as to those regards. I wish could warn woman, but wants to remain a secret, like most woman who are now embarrassed of there decisions in life. I wished we could find someone like who is willing to go public and see what she did to help herself get better. I have had just no luck with this. I asked to go back to the ER if she can't breath, she claims the ER told her the next visit they get from her she will be put in the Mental ward. When I ask her to go there and tell them she had the silicone injections, she gets angry and refuses. She never told the ER she had the injections, it is written in an article that this is the problem, most are either embarrased or don't connect the two. This is why this crap continues, it is a secret... I wish her health and happiness, but unless she is willing to tell a doctor the truth, I don't see her ever getting any help. I don't know what else to do and she is very hard to talk to regarding this, she has some mental issues from the poisons. If any suggestions please respond.

Donna

Re: Re: Liquid Silicone Injections

You know if there is a way to get around what was

illegal before, they will get around it.

Lynda

At 04:38 PM 12/26/2006, you wrote:

> > You may be offered it, but that does not make it legal. It is

> > actually approved only for the cornea.

> >

> > Lynda

> >

>

>According to these sites, silicone oil is legal

>for cosmetic use, although it is not it's

>primary use. See the two areas highlighted in

>green. An amendment has been made making the use legal for cosmetic use.

>

>Kenda

>

>Topdocs.com

>

>Are micro-injections of Silicone oil legal?

>

>Yes. The FDA has approved the use of Silicone

>oil as a medical device. Its primary use is in

>the repair of retinal detachments. According to

>the Food, Drug and Cosmetic Act, a licensed

>medical practitioner may prescribe or administer

>any legally marketed device to any legitimate patient.

>

>How do micro-injections of Silicone oil work?

>

>Silicone oil is injected in micro-droplets,

>through a tiny needle at multiple points under

>the skin, to treat facial contour defects. Over

>time skin cells called fibroblasts produce new

>collagen, which in turn grows around the

>silicone droplets. More collagen growth is

>stimulated by continued injections, spread over

>time. As this progression continues, the

>collagen-encapsulated silicone droplets gradually

>fill in the depression or wrinkle.

>

>

>This is from Yes They Are Fake

>

>

>(includes Adatosil 5000, Silikon 1000, SilSkin,

>etc. when implanted subdermally)

>

>Silicone: Just the Facts Ma'am, Just the Facts

>I am sure you are aware of the controversy in

>the past regarding silicone and breast implants

>and free silicone injections. The explosion of

>the Internet and free web hosting now makes it

>possible for everyone in the world to have a

>website -- or two or more! -- of their own to

>display whatever it is they feel, believe in or

>would like to convey to the world. Even if this

>means to misinform the universe, whether on

>purpose or not -- it can be accomplished more

>easily through the Internet. In this section we

>will discuss silica, silicon and silicone. We

>will ultimately discuss how silicone is made and

>what its impacts on the body are.

>

>Silica is silicon dioxide SiO2, it occurs in a

>crystalline state, an amorphous (shapeless)

>state and in impure forms such as quartz, opal

>and sand, respectively. "In the form of

>silicates it is present in most natural water

>supplies. Typical concentrations lie between 1

>and 30 mg/L. Higher concentrations may exist in

>brackish waters and brines. " (3)

>

>Silicon is a "nonmetallic element that occurs

>combined as the most abundant element next to

>oxygen in the earth's crust and is used

>especially in alloys and electronic device"

>(Merriam-Webster). It may not BE a metal but it

>is considered semi-metallic. In other words,

>"Silicon doesn't occur in the free, elemental

>state, but is found in the form of silicon

>dioxide and complex silicates". It was

>discovered in 1824 by Jöns Berzelius.

>"Silicon is important in plant and animal life.

>Diatoms in both fresh and salt water extract

>silica from the water to use as a component of

>their cell walls". (1) Silicon is used in many

>household items such as transistors, micro chips

>and electronics. Hence, Silicon Valley - the computer capital.

>

>Silicone is any of the "various polymeric

>organic silicon compounds obtained as oils,

>greases, or plastics and used especially for

>water-resistant and heat-resistant lubricants,

>varnishes, binders, and electric insulators"

>(Merriam-Webster) It is also found in processed

>foods, cosmetics, medications and all sorts of

>products that you are exposed to and ingest on a

>daily basis. It is also used to lubricate

>medical devices such as tubing, hypodermic

>needles and is found in the food industry as

>being used to lubricate blenders, frozen drink

>machines, piping, cooking utensils, and machines.

>

>Silicones are synthetic polymers and are made by

>combining oxygen and silicon and in high

>temperatures and pressures can produce

>polydimethylsiloxane (PDMS). The fluids are

>made from linear chains of PDMS whereas the gels

>are lightly crosslinked to give it a thicker

>cohesive-ness. Although without a container

>such as a highly cross-linked silicone elastomer

>breast prosthesis the silicone gel takes on no

>shape of its own and is very vulnerable to

>gravity and momentum, if applicable. The

>elastomer implant shells contain very little

>free PDMS so that it remains a solid. However

>since like can not hold like for long, the

>lower-weighted molecular silicones bleed through

>the elastomer shells -- even with the presence of "protective" inner barriers.

>

>Silicone & Its Uses In the Body

>Silicone products, in their solid form, have

>been used within the body for cosmetic

>applications for years and years without

>incident other than occasional sensitivity and

>encapsulation (which happens with all foreign

>bodies inserted into the human body as this is

>its way of sealing off the foreign object from

>the body). Encapsulation is when the body forms

>a fibrous tissue capsule around a foreign body

>as it does not recognize it as its own -- why would it?

>

>Solid silicone is used to augment or reconstruct

>the cheeks, the chin, the brow bone, calves,

>pectoral areas for men, as a replacement for

>lost digits, testicles and for buttock

>augmentation. It is also used for joint

>replacements, rotary cuffs, and sockets -- as

>well as a multitude of other medical uses.

>

>Liquid silicone is not approved for injection

>into the body for cosmetic applications but is

>approved for intra-ocular use for retinal

>tamponades. Detached retinas can cause bleeding

>and blindness and silicone oil injections are

>used to help this. It is, however, not approved

>to sculpt the lips, cheeks, buttocks, face,

>etc. However since the oils (i.e. Silikon 1000

> & Adatosil 5000) are approved in general, an

>amendment makes it so physicians are allowed to

>use approved drugs and devices off label as they see fit.

>

>Unfortunately, silicone oil injections can cause

>granulomas, inflammatory nidus, macrophage activity and migration.

>

>gran*u*lo*ma (noun), plural -mas or -ma*ta

>First appeared 1861

>: a mass or nodule of chronically inflamed tissue with

>granulations that is usu. associated with an infective process

>-- gran*u*lo*ma*tous (adjective)

>

>mac*ro*phage (noun)

>[international Scientific Vocabulary]

>First appeared 1890

>: a phagocytic tissue cell of the reticuloendothelial system that may

>be fixed or freely motile, is derived from a monocyte, and functions

>in the protection of the body against infection

>and noxious substances -- called also histiocyte

>-- mac*ro*phag*ic (adjective)

>

>...macrophages and other inflammatory responses

>(including chronic) is absolutely true when it

>comes to injected or free liquid silicone within

>the body. Autoimmune disorders however have not

>been proven to be caused by silicone -- either liquid or solid.

>

>Regarding liquid silicone or (LIS), the

>infiltration of foreign substances of a certain

>molecular size/weight, can cause problems on a

>cellular level if they can not be successfully

>excreted or contained. Many may argue that the

>goal should be not to inject or otherwise

>implant mobile substances of this size such as

>silicone oils and gels is something and that ideally it should be avoided.

>

>You may have heard Silicone referred to as

>inert. Inert literally means static or

>immobile. Although in the scientific world

>'inert' is usually referring to chemically

>inert, or chemically non-reactive. Silicone may

>be chemically inert, but it may not be

>biochemically inert. Biochemically inert would

>mean that these substances wouldn't change

>composition in the body, but even the elastomer

>shell of breast implants degrade -- they don't

>last forever, nor would they cause reactions in

>the body. It's a fact, sorry.

>

>Inert, by definition, the material should not be

>able to migrate in a way that they may

>infiltrate a cellular structure, the surrounding

>subcutaneous tissue or an organ tissue, thereby

>smothering cells, and causing cell necrosis

>(death) nor would it inflame the surrounding

>tissues or cause sensitivity reactions.

>

>Personally, I don't believe that silicone-based

>oils or gels or many synthetic substances can be

>classified as inert, by definition. Reason

>being I have seen many cases of free silicone

>lip injection where the silicone has migrated to

>the chin region or even further down the neck,

>and has not stayed where it was supposed to --

>in the lip. The fact is free silicone is known

>to migrate, therefore it is not completely

>inert, by definition, when injected into the

>lips, breasts, subcutaneous tissue, wherever.

>

>The FDA recognizes and warns of the fact of

>granulomatous, inflammatory responses, migration

>and discoloration of tissue after having had

>silicone injections -- period. Silicone

>injection is still being practiced on the black

>market and in plastic surgeons' offices. As

>liquid injectable silicone (LIS) was approved

>for ophthalmic use only. Although some doctors

>are using LIS off-label for wrinkles,

>augmentation of lips, etc. advertising for such

>is illegal. I even spoke to the FDA myself; I

>have the letter to prove it. There is a

>loophole regarding the use of any product a

>physician deems suitable -- as we will discuss

>further below -- but the advertisement of off

>label use of any approved drug or device is illegal.

>

>Just remember that silicone can be problematic

>if in it's migrating, liquid or gelatinous form

>if it enters a cell and suffocates it or you

>suffer from a chronic inflammatory response. In

>fact, It is supposed to form granulomas so that

>it does not migrate -- they rely on that

>granulomatous response to impede migration.

>

>Auto Immune Disorders & Breast Implants or Silicone Implants

>Siliconosis

>This is an unofficial name that has been given

>to patients by other anti-breast implant

>activists who have 1 or more of 14 key disorders

>thought to be caused by silicone -- including

>silicone injections, solid implants and breast

>implant shells and their silicone fillers, when applicable.

>

>I know several people who had these disorders

>before they ever had any type of operation and

>the disorder never got any worse after breast

>augmentation or other types of surgeries

>involving silicone. We routinely are exposed

>to silicone in our foods, eye drops. cosmetics,

>injections or any puncture by a hypodermic

>needle (which is lubricated by silicone). Some

>may argue that yes, this is all true but we are

>not routinely exposed to such large amounts of

>silicone. Well, yes you have a point. And I

>never said that mass injections or intra tissue

>deposits of silicone were a good thing, did I?

>

>But we aren't talking about cellular level

>problems and giant cell granulomas -- we are

>talking about an immune response disease that are blamed for things such as:

>

>* alopecia (I had that from anesthesia before

>and still have it, non-implant related)

>* arthralgia (which I had before and STILL

>have, it's called wear and tear and too many motorcycle accidents)

>* carpal tunnel syndrome (which I had before

>my augmentation and do NOT know how this can be caused by silicone)

>* chest wall erythema (also a sympton of

>Empyema, whic is defined as "is defined as

>accumulation of pus or fluid with demonstrable

>bacteria in pleural space" and "Erythema is an

>abnormal redness of the skin due to dialation of

>the superficial capillaries of the skin causing

>inflammation. It can result from many different

>causes, diseases of the skin and some systemic diseases." www.erythema.com)

>* cognitive dysfunction (which is a symptom

>of chronic fatigue syndrome, also called "yuppie

>flu" (I swear that's true!) which affects those

>from 20-40 who apparently don't get enough sleep

>and live on fast food. This disorder is often

>seen in canines which I assure you do NOT have breast implants.)

>* dry eye (also a symptom of hormonal

>imbalance and menopause, not to mention

>dehydration, and dry or warm/cold climates)

>* dry mouth (I get this, it's called

>dehydration, 75% of Americans are chronically dehydrated)

>* dysphagia (difficulty in swallowing; caused

>by all sorts of things, from structural

>disorders like tumors or bone spurs to

>functional disorders such as primary motor

>disorders, achalasia, to secondary motor disorders like scleroderma

>* chronic fatigue (see "cognitive

>dysfunction", above) Although this is a real

>problem with those who have fibromyalgia (which

>happens regardless if one has silicone in their

>body) or Multiple Sclerosis as well.)

>* lacrimal gland enlargement (various causes)

>* parotid enlargement (various causes)

>* petechiae (a minute reddish or purplish

>spot containing blood that appears in skin or

>mucous membrane esp. in some infectious

>diseases; Merriam-Webster. Common causes are

>(credit: The Library of Medicine, HealthAnswers.com)

>* injury or trauma

>* allergic reactions to medications

>* autoimmune disorders, which are conditions

>in which the person's body creates antibodies to

>its own tissues for unknown reasons (these

>happen without ever having a silicone anything in the body)

>* liver disorders, such as cirrhosis

>* infections, such as mononucleosis and endocarditis

>* bone marrow disorders, such as leukemia

>* thrombocytopenia, a deficiency of platelets

>* nutritional deficiencies, such as a

>deficiency in vitamins C, K, or B12, or folic acid

>* medications, such as blood thinners

>* recent blood transfusions

>* medical treatment, such as radiation therapy and chemotherapy for cancer

>* birth, due to the pressure changes caused by vaginal delivery

>* aging skin

>* sepsis, or blood infection

>* violent vomiting or coughing

>

>

>* photosensitive dermatitis (can be caused by

>medications as well as metabolic disorders)

>* telangiectasia (Telangiectasias form after

>anything that causes the face to flush or blush.

>Heredity, sun damage, acne rosacea (an adult

>form of acne), hot and spicy food, exercise,

>emotions, hormones, cortisone medications and

>some other rare skin diseases can cause

>telangiectasia.) Gateway Aesthetic Institute and

>Laser Center of Salt Lake City, Utah.

>

>

>All of the above happens often without any type

>of silicone implant. I have 4 out of 14 -- do I

>have an immune response disorder? No, I had

>this all before I ever had implants. Is it

>worse now? No, it has its good days and bad

>days. Getting older stinks. I also want to add

>that I know several people with Fibromyalgia,

>Multiple Sclerosis and other disorders which

>have gotten implants since finding out of their

>conditions and report no changes either way of

>their condition. If you'd like to speak with

>them, post on the message board and they will respond.

>

>Am I sympathetic to those who believe they have

>siliconosis -- yes, of course I am. But I do

>NOT think that their disorders were caused

>solely because of their breast implants. I

>think that for some the operation (and ANY

>trauma) can trigger sickness in those who are

>prone to it. I believe there are those who are

>allergic to silicone as well as there are t hose allergic to latex.

>

>There is NO certifiable proof that breast

>implants cause immune response disorders --

>period. But there IS proof that liquid, gel

>and/or lower-weighted molecular silicone cause

>granulomas, cysts, and fibroids in response to

>inflammation of the tissues on a cellular

>level. Which of course opens up the possibility

>for infection of the thick, avascular, fibrous

>capsules which surround the silicone

>droplets. So until it is proven other wise,

>think about it before making a choice.

>

>Silicone Injections (Silicone Oil):

>(technically: purified, medical grade

>polydimethylsiloxane oil) Often referred to as

>Liquid Injectable Silicone or simply,

>LIS. Silicone, in general, has met much

>controversy over the last few decades. Some

>issues, with good reasons and others due to junk

>science. I could write pages upon pages about

>the issues which have revolved around the use of

>all forms of silicones and more pages still on

>how much it is found and used in many products

>we use on a daily basis. But since this isn't

>about the controversy of the compound itself, I

>won't. If you are interested just type in

>silicone in Google and thousands websites will

>be returned. Just be sure what you read is

>backed by real science. I will, however, cover

>the intended uses of silicone oil and the

>off-label uses, as well. I will cover the glory

>and cover the not so bright and shiny side of liquid silicone injections.

>

>Firstly, injections of silicone oil are not

>approved for cosmetic use in the United States,

>no matter what anyone tells you. The off-label

>use of an approved medical device is, however,

>allowed because of the 1997 amendment to the

>Federal Food, Drug & Cosmetic Act 6, which states:

>

>

>"Nothing in (FD & C Act) shall be construed to

>limit or interfere with the authority of a

>health care practitioner to prescribe or

>administer any legally marketed device to a

>patient for any condition or disease within a

>legitimate health care practitioner-patient relationship."

>

>

>This means a physician can legally use any FDA

>approved drug or device, as he sees fit, if he

>believes it can effectively treat or cure your

>complaint. Both Silikon 1000 and Adato Sil-ol

>5000 (originally approved under the name

>"Adatomed Silicone Oil 0P5000") -- also called

>simply Adatosil -- are approved, but for

>injection into the vitreous cavity of the eye in

>the event of retinal detachment and/or

>hemorrhage. It is intended to help save a

>person's eyesight. And it is also intended to

>be aspirated at a later date and not kept inside the body indefinitely.

>

>

>Re: Adatosil 5000: "AdatoSil 5000â„¢ was approved

>by FDA through the Premarket Approval process

>(PMA) on November 4, 1994, pursuant to section 5

>15(d)( 1)(B) (ii) of the Act. It is indicated

>for use as a prolonged retinal tamponade in

>selected cases of complicated retinal

>detachments where other interventions are not

>appropriate for patient management. Complicated

>retinal detachments or recurrent retinal

>detachments occur most commonly in eyes with

>proliferative vitroretinopathy (PVR),

>proliferative diabetic retinopathy (PDR),

>cytomegalovirus (CMV) retinitis, giant tears,

>and following perforating injuries. AdatoSil

>5000â„¢ is also indicated for primary use in

>detachments due to Acquired Immune Deficiency

>Syndrome (AIDS) -related CMV retinitis, and

>other viral infections." --credit: Larry D.

>Spears Acting Director, Office of Compliance

>Center for Devices and Radiological Health (FDA)

>

>Re: SILIKON 1000: "This device is indicated for

>use as a prolonged retinal tamponade in selected

>cases of complicated retinal detachments where

>other interventions are appropriate for patient

>management. Complicated retinal detachments or

>recurrent retinal detachments occur most

>commonly in eyes with proliferative

>vitreoretinopathy (PVR), proliferative diabetic

>retinopathy (PDR), cytomegalovirus (CMV)

>retinitis, giant tears, and following

>perforating in injuries. SILIKON 1000 is also

>indicated for primary use in detachments due to

>Acquired Immune Deficiency Syndrome (AIDS)

>related CMV retinitis and other viral infections

>affecting the retina." --credit: PMA Final

>Decisions Rendered for September 1997

>

>Re: SILISKIN: "SilSkinâ„¢ is a purified 1000cs

>silicone oil manufactured by RJ Development [a

>subsidiary of -, Inc.] and currently

>under investigation for facial soft tissue

>augmentation. At present, SilSkin is an

>investigational device limited by Federal law to

>investigational use." --credit:

><http://richard-james.com/page0005.htm>http://richard-james.com/page0005.htm

>

>

>"Liquid Silicone Injections

>

>1.

>

>Has liquid silicone been approved by FDA for injection?

>No. FDA has not approved the marketing of liquid

>silicone for injection for any cosmetic purpose,

>including the treatment of facial defects or

>wrinkles, or enlarging the breasts. The adverse

>effects of liquid silicone injections have

>included movement of the silicone to other parts

>of the body, inflammation and discoloration of

>surrounding tissues, and the formation of

>granulomas (nodules of granulated, inflamed tissue).

>2.

>

>Can FDA prohibit doctors from promoting the

>injection of liquid silicone, since its marketing has not been approved?

>Yes. FDA prohibits manufacturers or doctors from

>marketing or promoting unapproved products such

>as liquid silicone. This means that a doctor

>cannot legally advertise or sell this material."

>--credit: <http://www.fda.gov>http://www.fda.gov

>

>

>

>"Silicone injection into facial tissues was

>popularized in the 1960s and 1970s with the

>introduction of medical grade silicone (MDX

>4-4011) by Dow Corning. Microdroplets of

>silicone are dispersed within the dermal

>tissues. Fibrosis around these droplets

>localizes the material, and it is seemingly well

>tolerated in small amounts in the face. Silicone

>oil has many advocates among those who used it

>prior to Food and Drug Administration (FDA)

>withdrawal of approval. However, silicone,

>although chemically well tolerated, becomes

>encapsulated as a foreign body by a chronic

>inflammatory reaction. Giant cells surround the

>material and cannot process any ingested

>material, establishing a low-grade inflammatory

>nidus. Fibrous tissue surrounds and encapsulates

>the silicone; this capsule is avascular and is a

>potential site of infection. A number of late

>infections, granulomas, and palpable masses have

>been reported following silicone use." --credit:

>Emedicine.com - Soft Tissue Implants

>

>

>The Method of Augmentation By Silicone Oil Injections

>The injection of silicone oil, and many

>injectable tissue augmentation fillers, triggers

>a foreign body response by the accumulation of

>phagocytes, macrophages, lymphocytes, etc. This

>low grade inflammation causes your body to

>respond by trying to either break it down, by

>engulfing the product and by moving it to other

>organs for excretion. Silicone oil cannot be

>broken down by the body so the lower molecular

>silicones are either engulfed and moved and the

>higher viscosities remain behind when they are

>encapsulated. The macrophage accumulation

>triggers fibroblasts to begin encapsulating the

>silicone oil, to wall it off from the rest of

>the body. Imagine the silicone as a grain of

>sand, and your body as the oyster. The body

>forms collagen layers around the silicone and

>eventually augmentation is gained in the form of

>fibrous tissue. If the body cannot find relief

>after encapsulating the silicone, it will

>continue to form more and more collagen around

>the product, eventually causing a firm

>nodule. The good thing about encapsulation is

>that it can help keep the majority of the liquid

>silicone where it was injected and hinder its

>migration into the surrounding tissues.

>

>So remember, the augmentation isn't due to the

>product itself, large amounts of silicone oil

>should not be injected for volume

>augmentation. It is the body's inflammatory

>response which triggers the formation of

>collagen that is the method of

>augmentation. The amount of collagen formed is

>dependent upon your own body's sensitivity to

>the silicone, and the purity of the product.

>

>Questions To Ask Your Physician When Getting

>Silicone Injections: (Printer-friendly Version)

>

>

>1.

>

>What is your medical training and title? Are

>you an M.D., a D.O. an R.N. or a P.A.?

>(Independently verify their credentials, if necessary)

>2.

>

>Is silicone oil approved? [see what they say,

>if they say 'yes' it's misleading because it is

>approved for last ditch efforts to stop bleeding

>in retinal detachments and ocular

>hemorrhaging. If they say yes, ask, "For

>cosmetic use?" and if they say yes, then let

>them know you know they are lying and walk out

>the door. If they say no, I usually say nothing.]

>3.

>

>How long have you been injecting silicone?

>4.

>

>What type/brand of silicone have you worked with

>in the past and what do you prefer and use now?

>(Remember which products are approved for

>injection into the human body. Also if they

>simply say Silicone 1000, do ask who

>manufactures it. Silicone 1000 only explains

>that it is a 1000 centistoke silicone oil. Even

>if they say it is medical grade, there are

>medical grades which are not intended for

>injection into the body and are intended to

>lubricate cutting surfaces. One such oil is

>Dow-Corning 360 Medical Fluid. This oil is NOT

>intended for injection into the body.)

>5.

>

>Have any of your patients had problems with

>granulomas, severe inflammation or migration?

>6.

>

>Does migration this occur over time?

>7.

>

>What's the longest you have been in contact with

>one of your patients post-treatment?

>8.

>

>Can I get silicone safely injected over other products and vice versa?

>9.

>

>What do you use for pain relief? EMLA, Regional, Local?

>10.

>

>What can I expect during the procedure?

>11.

>

>How many cc do you think I will need for my particular desires?

>12.

>

>Hoe many cc do you inject per treatment?

>13.

>

>How much do you charge per cc?

>14.

>

>What if I need only 1/2 cc at one point am I charged for the whole cc?

>15.

>

>How much can be injected in one area without

>disrupting vascularity and causing problems?

>16.

>

>Do you use a tunneling technique in the

>vermilion border; do you use a microdroplet or other technique?

>17.

>

>What can I expect post-treatment?

>18.

>

>What post-treatment instructions must I follow?

>19.

>

>Do you recommend massage or does this increase the risk of migration?

>20.

>

>How long must I wait between treatments?

>21.

>

>If I have trouble, what treatment options do you

>offer (Kenalog, excision, etc)

>22.

>

>If no treatments are offered at your practice,

>who can help me if I need it removed?

>

>

>

>Where NOT to Get Silicone Injections

>Liquid silicone can also be found in the US on

>the black market, as well as salons using

>non-medical and medical grades intended for

>lubrication of surgical instruments. Medical

>grade does not equal intended use for human

>injection. I simply implore that you do not go

>to any of these places to get silicone

>injections for any reason. There is no quality

>control, sterility is questionable and if the

>person is operating outside of a medical office

>-- there is a reason. Please do not choose to

>get silicone injections from an unlicensed

>person, in a hotel, in a salon, at someone's own home, or at your own home.

>

>If you still want to get silicone injections,

>please research your physician extensively and

>follow up on his or her credentials, please view

>updated photos (dated if possible) of the

>physician's past patients. Also ask what type

>of silicone they are using and ask to see the

>vial. The most commonly used products are

>Silikon 1000 or Adatosil 5000. Dow-Corning does

>NOT make a silicone oil intended for injection

>into the human body, no matter what they say.

>

>Allergy/Inflammation Test: There is no test one

>can take to determine if you are a good

>candidate. Either you will have problems or you

>will not. There is no definitive evidence

>regarding silicone allergy, per se. However, if

>you find that you have an allergy towards

>polymers, you may want to consider something

>else. There are persons who simply cannot tolerate foreign bodies of any kind.

>Longevity: Permanent, and difficult to remove.

>Cost: $350. to $1,500. per treatment

>Caution: Granulomas, migration, traces found in

>other organs and lymph nodes, excessive collagen

>formation, necrosis, silicone embolism.

>Available in the United States? Yes, Silikon

>1000, Adatosil 5000 are approved by the FDA,

>however not for cosmetic applications. SilSkin

>has been granted pre-market approval to conduct

>clinical trials only. Other forms of silicone

>are found and offered in the US, from imported

>"medical grade" oils to those which are not intended for human injection.

>Websites of Interest:

>

>

>Approved Silicone Oils

>

>*

>

>ADATO SIL-ol 5000 - Bausch & Lomb

>*

>

>SILIKON 1000 Product Sheet (Alcon Labs) (PDF)

>*

>

>SILIKON 1000 - Alcon Labs (PDF)

>*

>

>SILIKON 1000 PMA Approval (PDF)

>

>

>Silicone Not Intended For Injection

>

>*

>

>Dow-Corning 360 Medical Fluid Frequently Asked

>Questions (PDF) NOT FOR HUMAN INJECTION

>*

>

>Dow-Corning MDX4-4159, 50% Medical Grade Dispersion NOT FOR HUMAN INJECTION

>

>

>Silicone Removal Information:

>

>*

>

>Silicone Granuloma Management: TNFinhibitors may be effective as intervention

>

>

>Contact & Website Information:

>Alcon Laboratories, Inc. (Silikon)

>6201 South Freeway

>Fort Worth, TX 76134

>Tel: 817-551-8430

><http://www.alconlabs.com>http://www.alconlabs.com

>Bausch & Lomb (Adato Sil-ol)

>1 Bausch and Lomb Pl

>Rochester, NY

>Tel: 585-338-6000

><http://www.bausch.com>http://www.bausch.com - (SilSkin)

>Centennial Park

>2 Centennial Drive

>Peabody, MA 01960

>Tel: 978.532.0666

><http://www.richard-james.com>http://www.richard-james.com

>

>Update! 04/09/02: I spoke with Diane ,

>vice president for the company which

>manufactures SilSkin today. Mrs.

>advised that although a silicone product,

>SilSkin is "different" than Adatosil or

>Dow-Corning silicone and that trials are

>beginning for their product for cosmetic

>applications. Only time will tell if there will

>be problems associated with this new product as

>in the past with other silicone products. If

>anyone has personal experience or knowledge of this product, please contact me.

>Update! 03/25/03: I met with Diane at

>the American Academy of Dermatology Meeting in

>San Francisco (Mar. 21-25, 2003) and viewed some

>before and after photos and was given some

>clinical data of their progress so far. I would

>still like to speak to any patientswho are participating in the clinicals.

>

>

>

>References:

>(1) Institute of Medicine (IOM) - Information

>for Women about the Safety of Silicone, Nat'l Academy Press

>(2) Independent Review Group, UK - Silicone Gel Breast Implants Home Page

>(3) APHA Standard Methods, 19th ed., p. 4-118, method 4500-Si D (1995).

>ASTM D 859-94, Silica in Water.

>EPA Methods for Chemical Analysis of Water and Wastes, method 370.1 (1983).

>(4) Brown SL, Middleton MS, Berg WA, Soo MS,

>Pennello G. Prevalence of rupture of silicone

>gel breast implants in a population of women in

>Birmingham, Alabama. American Journal of Roentgenology 2000;175:1-8.

>

>Kenda

>

>

> > You may be offered it, but that does not make it legal. It is

> > actually approved only for the cornea.

> >

> > Lynda

> >

> >

> > At 02:46 PM 12/26/2006, you wrote:

> >

> >> Not where I live. My sister was offered them last week. I am speaking of

> >> the liquid silicone that is used as a filler for the face, not something

> >> injected into the breast.

> >>

> >> Kenda

> >>

> >>> Liquid silicone injections are banned in the US.

> >>>

> >>> Absolutely.

> >>>

> >>> Lynda

> >>>

> >>>

> >>> At 01:35 PM 12/26/2006, you wrote:

> >>>

> >>>> Oh, no, silicone injections are not banned

> -- at least not in the US! The

> >>>> plastic surgeon who almost implanted me wanted to use silicone

> >> injections to

> >>>> plump up my lips. I passed on silicone everything! He told me that the

> >>>> silicone injections last a lifetime,

> whereas injectable fillers do not. He

> >>>> brought in his little office girl with

> giant implants and plumped lips to

> >>>> show me how beautiful injected lips are. :(

> >>>>

> >>>> Kenda

> >>>>

> >>>>> Silicone injections were banned. Do any

> of you remember the Georgia Crime

> >>>>> Laboratory's investigations? I am afraid to

> >>>> send out the document, but someone

> >>>>> in this group must have it. Why are

> plastic surgeons still injecting this

> >>>>> poison into people?

> >>>>>

> >>>>> GRRRR...Lea

> >>>>> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

> >>>>> Re: Re: Liquid Silicone Injections

> >>>>>

> >>>>>

> >>>>>

> >>>>> I thought this was interesting to read, it mentions silicone

> >> injections at

> >>>>> one point.

> >>>>>

> >>>>>

> >>>>>

> >>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

> >>>>> by P. , Ph.D., MBA

> >>>>>

> >>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

> >>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

> >>>>> Nottingham University. Little practical use

> >>>> was made of these materials until

> >>>>> the 1940's when Corning Glass Works formed a working

> >> relationship with Dow

> >>>>> Chemical Company (Dow-Corning Corporation) to

> >>>> develop many uses such as high

> >>>>> temperature-resistant lubricants, rubbers,

> >>>> antifoam, mold-releasing compounds,

> >>>>> insulation, as well as medical devices.

> >>>>>

> >>>>> Silicone gel breast implants are medical device prostheses

> >>>>> used to substitute for human breast tissue for purposes of

> >> augmentation or

> >>>>> replacement following mastectomy. Implants consist of a plastic

> >> envelope or

> >>>>> shell containing a soft gelatinous mixture. The shell consists

> >> of a highly

> >>>>> cross-linked silicone polymer while the gel contents embody

> >> linear silicone

> >>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

> >>>>> weights with less cross-linking than the

> >>>> shell material. Silicone gel implants

> >>>>> were invented in 1963 for breast augmentation

> >>>> to replace the use of silicone

> >>>>> injections.

> >>>>>

> >>>>> Silicone gel breast implants were widely marketed and used

> >>>>> over a thirty-year period until 1992 when

> the FDA banned them for lack of

> >>>>> sufficient safety and efficacy data. The

> >>>> number of breast implant operations

> >>>>> in this time period is estimated to be

> >>>> between one and two million. In 1992,

> >>>>> when sales were ceased, there were over 87, 000 breast implant surgical

> >>>>> procedures of which 25, 676 (29%) were

> breast implant removal operations.

> >>>>>

> >>>>> Disclosure to Patients Issues Today, there is a great deal of

> >>>>> controversy regarding certain physical

> >>>> characteristics of silicone gel breast

> >>>>> implants versus what was revealed to or

> >>>> understood by patients as well as the

> >>>>> medical profession. There are at least

> six important product information

> >>>>> issues that should have been disclosed by the manufacturers in

> >> the package

> >>>>> inserts accompanying the product.

> >>>>>

> >>>>> 1. Silicones have biological activity. Contrary to popular

> >>>>> belief amongst plastic surgeons in the

> beginning, silicones were and are

> >>>>> biologically active compounds.

> >>>>>

> >>>>> Issue: There are published reports and internal company

> >>>>> documents from silicone breast implant

> >>>> manufacturers that reveal screening and

> >>>>> discovery of silicone compounds which exhibited pesticidal,

> >> antibiotic and

> >>>>> hormonal activities.

> >>>>>

> >>>>> 2. Injected silicones caused problems. The potential danger of

> >>>>> silicone compounds was published widely in

> >>>> the scientific literature revealing

> >>>>> adverse reactions to silicone injections when used for

> >> augmenting the human

> >>>>> female breast.

> >>>>>

> >>>>> Issue: Despite much evidence, a correlation between silicone

> >>>>> toxicity from direct injection with the

> >>>> possible silicone toxicity associated

> >>>>> with gel bleed from implants was never addressed.

> >>>>>

> >>>>> 3. Gel bleed from implants was documented. Gel bleed is a

> >>>>> phenomenon, which describes the migration of

> >>>> silicone molecules contained in

> >>>>> the gel implant through the permeable shell.

> >>>> The fact that gel implants exuded

> >>>>> a "greasy" residue was well known by

> manufacturers and plastic surgeons.

> >>>>>

> >>>>> Issue: Historically, neither the patients, surgeons, nor the

> >>>>> FDA were adequately informed about the gel

> >>>> bleed while it can be documented in

> >>>>> company memos that gel bleed was known,

> >>>> discussed, and proposed to be studied

> >>>>> at least 15 years before it was revealed in product package

> >> inserts. Issue:

> >>>>> The gel material leaking from the implants

> >>>> was not characterized, and hence,

> >>>>> posed an unknown health hazard to silicone gel breast implant patients.

> >>>>>

> >>>>> 4. Gel migration is described as the movement of silicone

> >>>>> residues released from silicone gel breast

> >>>> implants throughout the body being

> >>>>> carried by phagocytic cells via the lymph

> >>>> system or by some other mechanism.

> >>>>>

> >>>>> Issue: Silicone fluids and gels have been known and observed

> >>>>> to migrate both in animals and humans as cited in company memos

> >> written and

> >>>>> papers published at least 15 years prior to

> >>>> being mentioned in product package

> >>>>> inserts.

> >>>>>

> >>>>> 5. The chemical stability of silicone gel implants in

> >>>>> biological systems should have been a critical factor when

> >> determining the

> >>>>> suitability of implant formulations for long term use.

> >>>>>

> >>>>> Issue: There is evidence both from company documents as well

> >>>>> as the scientific literature that shelf life

> >>>> or stability data were not given

> >>>>> proper consideration in the manufacture

> of silicone gel breast implants.

> >>>>>

> >>>>> Issue: Long term suitability studies for breast implants in

> >>>>> animals or stored on the shelf appear to

> be currently unknown or at least

> >>>>> unpublished by breast implant manufacturers.

> >>>>>

> >>>>> 6. The information provided in package inserts for silicone

> >>>>> gel breast implants was incomplete and

> >>>> sometimes incorrect. Such information

> >>>>> accompanying regulated medical devices should be a fair and equitable

> >>>>> representation of the safety and efficacy of the product.

> >>>>>

> >>>>> Issue: The fact that gel implants could bleed gel and that

> >>>>> the gel could migrate through tissues from

> >>>> the site of implantation failed to

> >>>>> be mentioned in package inserts for more than 15 years.

> >>>>>

> >>>>> Issue: The fact that gel implants had a limited shelf life

> >>>>> was not addressed in package inserts for more than 15 years.

> >>>>>

> >>>>> Conclusion: It is apparent that disclosure of critical

> >>>>> information to patients regarding the

> >>>> physical characteristics of silicone gel

> >>>>> breast implants was inadequate. Hence,

> >>>> patients were ill-informed when making

> >>>>> decisions regarding the safety and stability

> >>>> of the products to be implanted

> >>>>> in their body.

> >>>>>

> >>>>>

> >>>>>

> >>>>> About P. , Ph.D., MBA

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>>

> >>>>

> >>>>

> >>>

> >>>

> >>>

> >>

> >>

> >

> >

> >

>

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Kenda,

Make sure the name of the injection he is offering woman, research it and maybe call the FDA, they could let you know if it is legal. I have heard that some was banned, yet others found a loop hole to line there wallets. Bottom line it is not safe. I was offered silicone breast implants after I got my saline implants. Even though they banned silicone breast implants and they were not suppose to be on the market, they would put them in anyone if they had saline implants in already. I didn't even have to be in the study. It is a scam with loop holes everywhere. They are killing woman and plenty of PS out there will not do the silicone injections, just a few who found the loop hole. I have read articles prior to getting implants and it said, never let a PS inject silicone straight into your skin, it is dangerous and banned for most. I will try to find some of these articles for you to read. In the mean time I would call the FDA and see if that procedure your Sister was offered is even legal. Please tell her not to fall for there lies of safe and there for life. It may last for life Yes, I am sure it would be hard to get silicone out of your body. There for life, sick for life. God Bless!!!!!!!!!!

Donna

Re: Re: Liquid Silicone Injections

As I posted earlier, it is completely legal. The doctor has broken no laws.

Kenda

> The doctor should be reported.

>

> Lynda <cossprivatei> wrote: You may be offered it, but that does

> not make it legal. It is

> actually approved only for the cornea.

>

> Lynda

>

> At 02:46 PM 12/26/2006, you wrote:

>

>> Not where I live. My sister was offered them last week. I am speaking of

>> the liquid silicone that is used as a filler for the face, not something

>> injected into the breast.

>>

>> Kenda

>>

>>> Liquid silicone injections are banned in the US.

>>>

>>> Absolutely.

>>>

>>> Lynda

>>>

>>>

>>> At 01:35 PM 12/26/2006, you wrote:

>>>

>>>> Oh, no, silicone injections are not banned -- at least not in the US! The

>>>> plastic surgeon who almost implanted me wanted to use silicone

>> injections to

>>>> plump up my lips. I passed on silicone everything! He told me that the

>>>> silicone injections last a lifetime, whereas injectable fillers do not. He

>>>> brought in his little office girl with giant implants and plumped lips to

>>>> show me how beautiful injected lips are. :(

>>>>

>>>> Kenda

>>>>

>>>>> Silicone injections were banned. Do any of you remember the Georgia Crime

>>>>> Laboratory's investigations? I am afraid to

>>>> send out the document, but someone

>>>>> in this group must have it. Why are plastic surgeons still injecting this

>>>>> poison into people?

>>>>>

>>>>> GRRRR...Lea

>>>>> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

>>>>> Re: Re: Liquid Silicone Injections

>>>>>

>>>>>

>>>>>

>>>>> I thought this was interesting to read, it mentions silicone

>> injections at

>>>>> one point.

>>>>>

>>>>>

>>>>>

>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

>>>>> by P. , Ph.D., MBA

>>>>>

>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

>>>>> Nottingham University. Little practical use

>>>> was made of these materials until

>>>>> the 1940's when Corning Glass Works formed a working

>> relationship with Dow

>>>>> Chemical Company (Dow-Corning Corporation) to

>>>> develop many uses such as high

>>>>> temperature-resistant lubricants, rubbers,

>>>> antifoam, mold-releasing compounds,

>>>>> insulation, as well as medical devices.

>>>>>

>>>>> Silicone gel breast implants are medical device prostheses

>>>>> used to substitute for human breast tissue for purposes of

>> augmentation or

>>>>> replacement following mastectomy. Implants consist of a plastic

>> envelope or

>>>>> shell containing a soft gelatinous mixture. The shell consists

>> of a highly

>>>>> cross-linked silicone polymer while the gel contents embody

>> linear silicone

>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

>>>>> weights with less cross-linking than the

>>>> shell material. Silicone gel implants

>>>>> were invented in 1963 for breast augmentation

>>>> to replace the use of silicone

>>>>> injections.

>>>>>

>>>>> Silicone gel breast implants were widely marketed and used

>>>>> over a thirty-year period until 1992 when the FDA banned them for lack of

>>>>> sufficient safety and efficacy data. The

>>>> number of breast implant operations

>>>>> in this time period is estimated to be

>>>> between one and two million. In 1992,

>>>>> when sales were ceased, there were over 87, 000 breast implant surgical

>>>>> procedures of which 25, 676 (29%) were breast implant removal operations.

>>>>>

>>>>> Disclosure to Patients Issues Today, there is a great deal of

>>>>> controversy regarding certain physical

>>>> characteristics of silicone gel breast

>>>>> implants versus what was revealed to or

>>>> understood by patients as well as the

>>>>> medical profession. There are at least six important product information

>>>>> issues that should have been disclosed by the manufacturers in

>> the package

>>>>> inserts accompanying the product.

>>>>>

>>>>> 1. Silicones have biological activity. Contrary to popular

>>>>> belief amongst plastic surgeons in the beginning, silicones were and are

>>>>> biologically active compounds.

>>>>>

>>>>> Issue: There are published reports and internal company

>>>>> documents from silicone breast implant

>>>> manufacturers that reveal screening and

>>>>> discovery of silicone compounds which exhibited pesticidal,

>> antibiotic and

>>>>> hormonal activities.

>>>>>

>>>>> 2. Injected silicones caused problems. The potential danger of

>>>>> silicone compounds was published widely in

>>>> the scientific literature revealing

>>>>> adverse reactions to silicone injections when used for

>> augmenting the human

>>>>> female breast.

>>>>>

>>>>> Issue: Despite much evidence, a correlation between silicone

>>>>> toxicity from direct injection with the

>>>> possible silicone toxicity associated

>>>>> with gel bleed from implants was never addressed.

>>>>>

>>>>> 3. Gel bleed from implants was documented. Gel bleed is a

>>>>> phenomenon, which describes the migration of

>>>> silicone molecules contained in

>>>>> the gel implant through the permeable shell.

>>>> The fact that gel implants exuded

>>>>> a "greasy" residue was well known by manufacturers and plastic surgeons.

>>>>>

>>>>> Issue: Historically, neither the patients, surgeons, nor the

>>>>> FDA were adequately informed about the gel

>>>> bleed while it can be documented in

>>>>> company memos that gel bleed was known,

>>>> discussed, and proposed to be studied

>>>>> at least 15 years before it was revealed in product package

>> inserts. Issue:

>>>>> The gel material leaking from the implants

>>>> was not characterized, and hence,

>>>>> posed an unknown health hazard to silicone gel breast implant patients.

>>>>>

>>>>> 4. Gel migration is described as the movement of silicone

>>>>> residues released from silicone gel breast

>>>> implants throughout the body being

>>>>> carried by phagocytic cells via the lymph

>>>> system or by some other mechanism.

>>>>>

>>>>> Issue: Silicone fluids and gels have been known and observed

>>>>> to migrate both in animals and humans as cited in company memos

>> written and

>>>>> papers published at least 15 years prior to

>>>> being mentioned in product package

>>>>> inserts.

>>>>>

>>>>> 5. The chemical stability of silicone gel implants in

>>>>> biological systems should have been a critical factor when

>> determining the

>>>>> suitability of implant formulations for long term use.

>>>>>

>>>>> Issue: There is evidence both from company documents as well

>>>>> as the scientific literature that shelf life

>>>> or stability data were not given

>>>>> proper consideration in the manufacture of silicone gel breast implants.

>>>>>

>>>>> Issue: Long term suitability studies for breast implants in

>>>>> animals or stored on the shelf appear to be currently unknown or at least

>>>>> unpublished by breast implant manufacturers.

>>>>>

>>>>> 6. The information provided in package inserts for silicone

>>>>> gel breast implants was incomplete and

>>>> sometimes incorrect. Such information

>>>>> accompanying regulated medical devices should be a fair and equitable

>>>>> representation of the safety and efficacy of the product.

>>>>>

>>>>> Issue: The fact that gel implants could bleed gel and that

>>>>> the gel could migrate through tissues from

>>>> the site of implantation failed to

>>>>> be mentioned in package inserts for more than 15 years.

>>>>>

>>>>> Issue: The fact that gel implants had a limited shelf life

>>>>> was not addressed in package inserts for more than 15 years.

>>>>>

>>>>> Conclusion: It is apparent that disclosure of critical

>>>>> information to patients regarding the

>>>> physical characteristics of silicone gel

>>>>> breast implants was inadequate. Hence,

>>>> patients were ill-informed when making

>>>>> decisions regarding the safety and stability

>>>> of the products to be implanted

>>>>> in their body.

>>>>>

>>>>>

>>>>>

>>>>> About P. , Ph.D., MBA

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>

>>>

>>>

>>

>>

>

>

>

>

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Kenda,

Don't surprise me I also have this flaky stuff in my ears, I know I had a fungal infection, maybe I still do. How do you get rid of that for good? I will try the dandruff shampoo to see if that works, if I don't get a bad reaction from the chemicals in that shampoo. It is a fighting battle we just have to see what will work and what won't work. I will pass this along to , thank you so much.

Does anyone remember that ladies name who had the silicone injections and went around on all the talk shows? If so maybe we could find her and see what she did to survive the injections. God Bless!!!!!!!!!!!!!!!!

Donna

Re: Re: Liquid Silicone Injections

Dried, flaking skin in your ears can be a sign of a fungal infection. My

dermatologist treats this by using a dandruff shampoo and taking your pinky

and cleaning your ear with the shampoo, then rinse.

Kenda

>

> I don't know why they are still doing this, let me guess, $$$$$$$$$$$$$. I

> would love to read that article if you can get someone to send it too me.

> was told it was so safe and the FDA didn't know what they were talking

> about

> when they banned it. She totally believed it was safe, just like I thought

> saline was safe. We were all lied to equally regarding silicone. is

> not

> doing to good, she says her ears and nose is just falling off. She said, the

> collegen is gone? She says, her ears are like dried fruit? I don't know

> what to tell her to do, she can't find a doctor to help her? I get really dry

> skin falling off in my ears, I don't know why? I don't feel like there

> falling

> off though. What to do I have no idea. I just pray for her to get a miracle.

> She is so scared and alone. She has chronic fatigue and she doesn't think

> clearly. She is now looking for a place to test for silicone hypersensitivity

> and vitamin deficiencies. I don't know if it is going to do her any good to

> just know these things? She is trying to just do something instead of laying

> there dying. It is so sad to see everyone so affected from things the FDA

> approved. I have to remember at one time the FDA said, silicone injections

> were

> safe, then changed there minds. It is hard to believe they don't see any

> difference with silicone in a silicone shell or saline in a silicone shell?

> It is

> merely the same thing if you ask me. God Bless!!!!!!!!!!!!

>

> Donna

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Kenda,

I am so sorry and remember I did have implants, so brain dead to say it mildly. I am so glad you are not getting implants and I believe you have made the proper decision. Please make sure your sister does not fall for there scams either. I didn't think you would get the silicone, just wondered if the doctor is doing this legally is all. They sure know how to jump through loops regarding that pocket book lining. I wished I had bought me the used car I needed when I spent the money on my "safe" salines. Oh well can't turn back the hands of time, but I can warn others to not do this to there bodies. God Bless!!!!!!!!!!!!!!!!

Donna

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Hi Lea,

Yes, the FDA didn't approve silicone injections except for use with corneal

problems. Because there is an amendment that allows doctor to use products

at their discretion, they can use silicone for cosmetic use. This is how

they got around using Retin A for wrinkling when it was first brought out to

treat acne. The author of the article didn't support silicone use in the

body.

I was talking one day to the aesthetician at my dermatologist's office about

silicone injections because she had a patient that had received them. The

patient was very displeased with the way she looked but couldn't do anything

about it because the procedure is permanent. That's reason enough not to

ever use it, let alone the horrible side effects.

Kenda

> Dearest Kenda:

>

> In the article that you posted, it said that the FDA did not approve

> silicone injections. In my opinion silicone should never be used in the human

> body.

>

> I guess we an agree to disagree....Love you.....Lea

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`````

> Re: Re: Liquid Silicone Injections

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>> I thought this was interesting to read, it mentions silicone

>>>>>> injections at

>>>>>>>>> one point.

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

>>>>>>>>> by P. , Ph.D., MBA

>>>>>>>>>

>>>>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

>>>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

>>>>>>>>> Nottingham University. Little practical use

>>>>>>>> was made of these materials until

>>>>>>>>> the 1940's when Corning Glass Works formed a working

>>>>>> relationship with Dow

>>>>>>>>> Chemical Company (Dow-Corning Corporation) to

>>>>>>>> develop many uses such as high

>>>>>>>>> temperature-resistant lubricants, rubbers,

>>>>>>>> antifoam, mold-releasing compounds,

>>>>>>>>> insulation, as well as medical devices.

>>>>>>>>>

>>>>>>>>> Silicone gel breast implants are medical device prostheses

>>>>>>>>> used to substitute for human breast tissue for purposes of

>>>>>> augmentation or

>>>>>>>>> replacement following mastectomy. Implants consist of a plastic

>>>>>> envelope or

>>>>>>>>> shell containing a soft gelatinous mixture. The shell consists

>>>>>> of a highly

>>>>>>>>> cross-linked silicone polymer while the gel contents embody

>>>>>> linear silicone

>>>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various

>>>>>>>>> molecular

>>>>>>>>> weights with less cross-linking than the

>>>>>>>> shell material. Silicone gel implants

>>>>>>>>> were invented in 1963 for breast augmentation

>>>>>>>> to replace the use of silicone

>>>>>>>>> injections.

>>>>>>>>>

>>>>>>>>> Silicone gel breast implants were widely marketed and used

>>>>>>>>> over a thirty-year period until 1992 when

>>>> the FDA banned them for lack of

>>>>>>>>> sufficient safety and efficacy data. The

>>>>>>>> number of breast implant operations

>>>>>>>>> in this time period is estimated to be

>>>>>>>> between one and two million. In 1992,

>>>>>>>>> when sales were ceased, there were over 87, 000 breast implant

>>>>>>>>> surgical

>>>>>>>>> procedures of which 25, 676 (29%) were

>>>> breast implant removal operations.

>>>>>>>>>

>>>>>>>>> Disclosure to Patients Issues Today, there is a great deal of

>>>>>>>>> controversy regarding certain physical

>>>>>>>> characteristics of silicone gel breast

>>>>>>>>> implants versus what was revealed to or

>>>>>>>> understood by patients as well as the

>>>>>>>>> medical profession. There are at least

>>>> six important product information

>>>>>>>>> issues that should have been disclosed by the manufacturers in

>>>>>> the package

>>>>>>>>> inserts accompanying the product.

>>>>>>>>>

>>>>>>>>> 1. Silicones have biological activity. Contrary to popular

>>>>>>>>> belief amongst plastic surgeons in the

>>>> beginning, silicones were and are

>>>>>>>>> biologically active compounds.

>>>>>>>>>

>>>>>>>>> Issue: There are published reports and internal company

>>>>>>>>> documents from silicone breast implant

>>>>>>>> manufacturers that reveal screening and

>>>>>>>>> discovery of silicone compounds which exhibited pesticidal,

>>>>>> antibiotic and

>>>>>>>>> hormonal activities.

>>>>>>>>>

>>>>>>>>> 2. Injected silicones caused problems. The potential danger of

>>>>>>>>> silicone compounds was published widely in

>>>>>>>> the scientific literature revealing

>>>>>>>>> adverse reactions to silicone injections when used for

>>>>>> augmenting the human

>>>>>>>>> female breast.

>>>>>>>>>

>>>>>>>>> Issue: Despite much evidence, a correlation between silicone

>>>>>>>>> toxicity from direct injection with the

>>>>>>>> possible silicone toxicity associated

>>>>>>>>> with gel bleed from implants was never addressed.

>>>>>>>>>

>>>>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a

>>>>>>>>> phenomenon, which describes the migration of

>>>>>>>> silicone molecules contained in

>>>>>>>>> the gel implant through the permeable shell.

>>>>>>>> The fact that gel implants exuded

>>>>>>>>> a " greasy " residue was well known by

>>>> manufacturers and plastic surgeons.

>>>>>>>>>

>>>>>>>>> Issue: Historically, neither the patients, surgeons, nor the

>>>>>>>>> FDA were adequately informed about the gel

>>>>>>>> bleed while it can be documented in

>>>>>>>>> company memos that gel bleed was known,

>>>>>>>> discussed, and proposed to be studied

>>>>>>>>> at least 15 years before it was revealed in product package

>>>>>> inserts. Issue:

>>>>>>>>> The gel material leaking from the implants

>>>>>>>> was not characterized, and hence,

>>>>>>>>> posed an unknown health hazard to silicone gel breast implant

>>>>>>>>> patients.

>>>>>>>>>

>>>>>>>>> 4. Gel migration is described as the movement of silicone

>>>>>>>>> residues released from silicone gel breast

>>>>>>>> implants throughout the body being

>>>>>>>>> carried by phagocytic cells via the lymph

>>>>>>>> system or by some other mechanism.

>>>>>>>>>

>>>>>>>>> Issue: Silicone fluids and gels have been known and observed

>>>>>>>>> to migrate both in animals and humans as cited in company memos

>>>>>> written and

>>>>>>>>> papers published at least 15 years prior to

>>>>>>>> being mentioned in product package

>>>>>>>>> inserts.

>>>>>>>>>

>>>>>>>>> 5. The chemical stability of silicone gel implants in

>>>>>>>>> biological systems should have been a critical factor when

>>>>>> determining the

>>>>>>>>> suitability of implant formulations for long term use.

>>>>>>>>>

>>>>>>>>> Issue: There is evidence both from company documents as well

>>>>>>>>> as the scientific literature that shelf life

>>>>>>>> or stability data were not given

>>>>>>>>> proper consideration in the manufacture

>>>> of silicone gel breast implants.

>>>>>>>>>

>>>>>>>>> Issue: Long term suitability studies for breast implants in

>>>>>>>>> animals or stored on the shelf appear to

>>>> be currently unknown or at least

>>>>>>>>> unpublished by breast implant manufacturers.

>>>>>>>>>

>>>>>>>>> 6. The information provided in package inserts for silicone

>>>>>>>>> gel breast implants was incomplete and

>>>>>>>> sometimes incorrect. Such information

>>>>>>>>> accompanying regulated medical devices should be a fair and equitable

>>>>>>>>> representation of the safety and efficacy of the product.

>>>>>>>>>

>>>>>>>>> Issue: The fact that gel implants could bleed gel and that

>>>>>>>>> the gel could migrate through tissues from

>>>>>>>> the site of implantation failed to

>>>>>>>>> be mentioned in package inserts for more than 15 years.

>>>>>>>>>

>>>>>>>>> Issue: The fact that gel implants had a limited shelf life

>>>>>>>>> was not addressed in package inserts for more than 15 years.

>>>>>>>>>

>>>>>>>>> Conclusion: It is apparent that disclosure of critical

>>>>>>>>> information to patients regarding the

>>>>>>>> physical characteristics of silicone gel

>>>>>>>>> breast implants was inadequate. Hence,

>>>>>>>> patients were ill-informed when making

>>>>>>>>> decisions regarding the safety and stability

>>>>>>>> of the products to be implanted

>>>>>>>>> in their body.

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>> About P. , Ph.D., MBA

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>

>>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>

>>>

>>>

>>

>>

>>

>>

>>

>>

>

>

>

>

>

>

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Guest guest

Hi Lea,

Is it in the archives? I didn't keep the article.

Kenda

> Kenda, could you please send me a clean copy of the article by Dr.

> . It has been forwarded so many times that it makes it difficult to read.

>

> Thank you in advance...love always..........Lea

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> Re: Re: Liquid Silicone Injections

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>> I thought this was interesting to read, it mentions silicone

>>>>>> injections at

>>>>>>>>> one point.

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

>>>>>>>>> by P. , Ph.D., MBA

>>>>>>>>>

>>>>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

>>>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

>>>>>>>>> Nottingham University. Little practical use

>>>>>>>> was made of these materials until

>>>>>>>>> the 1940's when Corning Glass Works formed a working

>>>>>> relationship with Dow

>>>>>>>>> Chemical Company (Dow-Corning Corporation) to

>>>>>>>> develop many uses such as high

>>>>>>>>> temperature-resistant lubricants, rubbers,

>>>>>>>> antifoam, mold-releasing compounds,

>>>>>>>>> insulation, as well as medical devices.

>>>>>>>>>

>>>>>>>>> Silicone gel breast implants are medical device prostheses

>>>>>>>>> used to substitute for human breast tissue for purposes of

>>>>>> augmentation or

>>>>>>>>> replacement following mastectomy. Implants consist of a plastic

>>>>>> envelope or

>>>>>>>>> shell containing a soft gelatinous mixture. The shell consists

>>>>>> of a highly

>>>>>>>>> cross-linked silicone polymer while the gel contents embody

>>>>>> linear silicone

>>>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various

>>>>>>>>> molecular

>>>>>>>>> weights with less cross-linking than the

>>>>>>>> shell material. Silicone gel implants

>>>>>>>>> were invented in 1963 for breast augmentation

>>>>>>>> to replace the use of silicone

>>>>>>>>> injections.

>>>>>>>>>

>>>>>>>>> Silicone gel breast implants were widely marketed and used

>>>>>>>>> over a thirty-year period until 1992 when

>>>> the FDA banned them for lack of

>>>>>>>>> sufficient safety and efficacy data. The

>>>>>>>> number of breast implant operations

>>>>>>>>> in this time period is estimated to be

>>>>>>>> between one and two million. In 1992,

>>>>>>>>> when sales were ceased, there were over 87, 000 breast implant

>>>>>>>>> surgical

>>>>>>>>> procedures of which 25, 676 (29%) were

>>>> breast implant removal operations.

>>>>>>>>>

>>>>>>>>> Disclosure to Patients Issues Today, there is a great deal of

>>>>>>>>> controversy regarding certain physical

>>>>>>>> characteristics of silicone gel breast

>>>>>>>>> implants versus what was revealed to or

>>>>>>>> understood by patients as well as the

>>>>>>>>> medical profession. There are at least

>>>> six important product information

>>>>>>>>> issues that should have been disclosed by the manufacturers in

>>>>>> the package

>>>>>>>>> inserts accompanying the product.

>>>>>>>>>

>>>>>>>>> 1. Silicones have biological activity. Contrary to popular

>>>>>>>>> belief amongst plastic surgeons in the

>>>> beginning, silicones were and are

>>>>>>>>> biologically active compounds.

>>>>>>>>>

>>>>>>>>> Issue: There are published reports and internal company

>>>>>>>>> documents from silicone breast implant

>>>>>>>> manufacturers that reveal screening and

>>>>>>>>> discovery of silicone compounds which exhibited pesticidal,

>>>>>> antibiotic and

>>>>>>>>> hormonal activities.

>>>>>>>>>

>>>>>>>>> 2. Injected silicones caused problems. The potential danger of

>>>>>>>>> silicone compounds was published widely in

>>>>>>>> the scientific literature revealing

>>>>>>>>> adverse reactions to silicone injections when used for

>>>>>> augmenting the human

>>>>>>>>> female breast.

>>>>>>>>>

>>>>>>>>> Issue: Despite much evidence, a correlation between silicone

>>>>>>>>> toxicity from direct injection with the

>>>>>>>> possible silicone toxicity associated

>>>>>>>>> with gel bleed from implants was never addressed.

>>>>>>>>>

>>>>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a

>>>>>>>>> phenomenon, which describes the migration of

>>>>>>>> silicone molecules contained in

>>>>>>>>> the gel implant through the permeable shell.

>>>>>>>> The fact that gel implants exuded

>>>>>>>>> a " greasy " residue was well known by

>>>> manufacturers and plastic surgeons.

>>>>>>>>>

>>>>>>>>> Issue: Historically, neither the patients, surgeons, nor the

>>>>>>>>> FDA were adequately informed about the gel

>>>>>>>> bleed while it can be documented in

>>>>>>>>> company memos that gel bleed was known,

>>>>>>>> discussed, and proposed to be studied

>>>>>>>>> at least 15 years before it was revealed in product package

>>>>>> inserts. Issue:

>>>>>>>>> The gel material leaking from the implants

>>>>>>>> was not characterized, and hence,

>>>>>>>>> posed an unknown health hazard to silicone gel breast implant

>>>>>>>>> patients.

>>>>>>>>>

>>>>>>>>> 4. Gel migration is described as the movement of silicone

>>>>>>>>> residues released from silicone gel breast

>>>>>>>> implants throughout the body being

>>>>>>>>> carried by phagocytic cells via the lymph

>>>>>>>> system or by some other mechanism.

>>>>>>>>>

>>>>>>>>> Issue: Silicone fluids and gels have been known and observed

>>>>>>>>> to migrate both in animals and humans as cited in company memos

>>>>>> written and

>>>>>>>>> papers published at least 15 years prior to

>>>>>>>> being mentioned in product package

>>>>>>>>> inserts.

>>>>>>>>>

>>>>>>>>> 5. The chemical stability of silicone gel implants in

>>>>>>>>> biological systems should have been a critical factor when

>>>>>> determining the

>>>>>>>>> suitability of implant formulations for long term use.

>>>>>>>>>

>>>>>>>>> Issue: There is evidence both from company documents as well

>>>>>>>>> as the scientific literature that shelf life

>>>>>>>> or stability data were not given

>>>>>>>>> proper consideration in the manufacture

>>>> of silicone gel breast implants.

>>>>>>>>>

>>>>>>>>> Issue: Long term suitability studies for breast implants in

>>>>>>>>> animals or stored on the shelf appear to

>>>> be currently unknown or at least

>>>>>>>>> unpublished by breast implant manufacturers.

>>>>>>>>>

>>>>>>>>> 6. The information provided in package inserts for silicone

>>>>>>>>> gel breast implants was incomplete and

>>>>>>>> sometimes incorrect. Such information

>>>>>>>>> accompanying regulated medical devices should be a fair and equitable

>>>>>>>>> representation of the safety and efficacy of the product.

>>>>>>>>>

>>>>>>>>> Issue: The fact that gel implants could bleed gel and that

>>>>>>>>> the gel could migrate through tissues from

>>>>>>>> the site of implantation failed to

>>>>>>>>> be mentioned in package inserts for more than 15 years.

>>>>>>>>>

>>>>>>>>> Issue: The fact that gel implants had a limited shelf life

>>>>>>>>> was not addressed in package inserts for more than 15 years.

>>>>>>>>>

>>>>>>>>> Conclusion: It is apparent that disclosure of critical

>>>>>>>>> information to patients regarding the

>>>>>>>> physical characteristics of silicone gel

>>>>>>>>> breast implants was inadequate. Hence,

>>>>>>>> patients were ill-informed when making

>>>>>>>>> decisions regarding the safety and stability

>>>>>>>> of the products to be implanted

>>>>>>>>> in their body.

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>> About P. , Ph.D., MBA

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>>

>>>>>>>>

>>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>

>>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>

>>>

>>>

>>

>>

>>

>>

>>

>>

>

>

>

>

>

>

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Guest guest

Donna,

I am not an advocate of using any type of silicone in the body, which is why

I have not had the injections or implants. All I stated earlier was the

procedure was legal and that the doctor who recommended them to my sister

could not be reported for having done anything wrong. You have

misinterpreted my post.

Kenda

> Kenda,

>

> Let's look at this subject another way. Even if legal or not legal. Are they

> safe? Common sense tells us no. The injections makes slews of people sick

> and there is no cure. Would it matter if we had big puffy lips or big breast

> when we are dying from that. It is not so important when these products make

> you so sick you can't get out of bed or remember what you are doing from one

> minute to the next. I have read tons of warning that you should never let any

> surgeon talk you into silicone injections, it is dangerous and it has killed

> so many woman. God Bless!!!!!!!!!!!!!

>

> Donna

>

>

> Re: Re: Liquid Silicone Injections

>

>

> As I posted earlier, it is completely legal. The doctor has broken no laws.

>

> Kenda

>

>> The doctor should be reported.

>>

>> Lynda <coss@...> wrote: You may be offered it, but that does

>> not make it legal. It is

>> actually approved only for the cornea.

>>

>> Lynda

>>

>> At 02:46 PM 12/26/2006, you wrote:

>>

>>> Not where I live. My sister was offered them last week. I am speaking of

>>> the liquid silicone that is used as a filler for the face, not something

>>> injected into the breast.

>>>

>>> Kenda

>>>

>>>> Liquid silicone injections are banned in the US.

>>>>

>>>> Absolutely.

>>>>

>>>> Lynda

>>>>

>>>>

>>>> At 01:35 PM 12/26/2006, you wrote:

>>>>

>>>>> Oh, no, silicone injections are not banned -- at least not in the US! The

>>>>> plastic surgeon who almost implanted me wanted to use silicone

>>> injections to

>>>>> plump up my lips. I passed on silicone everything! He told me that the

>>>>> silicone injections last a lifetime, whereas injectable fillers do not. He

>>>>> brought in his little office girl with giant implants and plumped lips to

>>>>> show me how beautiful injected lips are. :(

>>>>>

>>>>> Kenda

>>>>>

>>>>>> Silicone injections were banned. Do any of you remember the Georgia Crime

>>>>>> Laboratory's investigations? I am afraid to

>>>>> send out the document, but someone

>>>>>> in this group must have it. Why are plastic surgeons still injecting this

>>>>>> poison into people?

>>>>>>

>>>>>> GRRRR...Lea

>>>>>> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

>>>>>> Re: Re: Liquid Silicone Injections

>>>>>>

>>>>>>

>>>>>>

>>>>>> I thought this was interesting to read, it mentions silicone

>>> injections at

>>>>>> one point.

>>>>>>

>>>>>>

>>>>>>

>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?

>>>>>> by P. , Ph.D., MBA

>>>>>>

>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and

>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at

>>>>>> Nottingham University. Little practical use

>>>>> was made of these materials until

>>>>>> the 1940's when Corning Glass Works formed a working

>>> relationship with Dow

>>>>>> Chemical Company (Dow-Corning Corporation) to

>>>>> develop many uses such as high

>>>>>> temperature-resistant lubricants, rubbers,

>>>>> antifoam, mold-releasing compounds,

>>>>>> insulation, as well as medical devices.

>>>>>>

>>>>>> Silicone gel breast implants are medical device prostheses

>>>>>> used to substitute for human breast tissue for purposes of

>>> augmentation or

>>>>>> replacement following mastectomy. Implants consist of a plastic

>>> envelope or

>>>>>> shell containing a soft gelatinous mixture. The shell consists

>>> of a highly

>>>>>> cross-linked silicone polymer while the gel contents embody

>>> linear silicone

>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various molecular

>>>>>> weights with less cross-linking than the

>>>>> shell material. Silicone gel implants

>>>>>> were invented in 1963 for breast augmentation

>>>>> to replace the use of silicone

>>>>>> injections.

>>>>>>

>>>>>> Silicone gel breast implants were widely marketed and used

>>>>>> over a thirty-year period until 1992 when the FDA banned them for lack of

>>>>>> sufficient safety and efficacy data. The

>>>>> number of breast implant operations

>>>>>> in this time period is estimated to be

>>>>> between one and two million. In 1992,

>>>>>> when sales were ceased, there were over 87, 000 breast implant surgical

>>>>>> procedures of which 25, 676 (29%) were breast implant removal operations.

>>>>>>

>>>>>> Disclosure to Patients Issues Today, there is a great deal of

>>>>>> controversy regarding certain physical

>>>>> characteristics of silicone gel breast

>>>>>> implants versus what was revealed to or

>>>>> understood by patients as well as the

>>>>>> medical profession. There are at least six important product information

>>>>>> issues that should have been disclosed by the manufacturers in

>>> the package

>>>>>> inserts accompanying the product.

>>>>>>

>>>>>> 1. Silicones have biological activity. Contrary to popular

>>>>>> belief amongst plastic surgeons in the beginning, silicones were and are

>>>>>> biologically active compounds.

>>>>>>

>>>>>> Issue: There are published reports and internal company

>>>>>> documents from silicone breast implant

>>>>> manufacturers that reveal screening and

>>>>>> discovery of silicone compounds which exhibited pesticidal,

>>> antibiotic and

>>>>>> hormonal activities.

>>>>>>

>>>>>> 2. Injected silicones caused problems. The potential danger of

>>>>>> silicone compounds was published widely in

>>>>> the scientific literature revealing

>>>>>> adverse reactions to silicone injections when used for

>>> augmenting the human

>>>>>> female breast.

>>>>>>

>>>>>> Issue: Despite much evidence, a correlation between silicone

>>>>>> toxicity from direct injection with the

>>>>> possible silicone toxicity associated

>>>>>> with gel bleed from implants was never addressed.

>>>>>>

>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a

>>>>>> phenomenon, which describes the migration of

>>>>> silicone molecules contained in

>>>>>> the gel implant through the permeable shell.

>>>>> The fact that gel implants exuded

>>>>>> a " greasy " residue was well known by manufacturers and plastic surgeons.

>>>>>>

>>>>>> Issue: Historically, neither the patients, surgeons, nor the

>>>>>> FDA were adequately informed about the gel

>>>>> bleed while it can be documented in

>>>>>> company memos that gel bleed was known,

>>>>> discussed, and proposed to be studied

>>>>>> at least 15 years before it was revealed in product package

>>> inserts. Issue:

>>>>>> The gel material leaking from the implants

>>>>> was not characterized, and hence,

>>>>>> posed an unknown health hazard to silicone gel breast implant patients.

>>>>>>

>>>>>> 4. Gel migration is described as the movement of silicone

>>>>>> residues released from silicone gel breast

>>>>> implants throughout the body being

>>>>>> carried by phagocytic cells via the lymph

>>>>> system or by some other mechanism.

>>>>>>

>>>>>> Issue: Silicone fluids and gels have been known and observed

>>>>>> to migrate both in animals and humans as cited in company memos

>>> written and

>>>>>> papers published at least 15 years prior to

>>>>> being mentioned in product package

>>>>>> inserts.

>>>>>>

>>>>>> 5. The chemical stability of silicone gel implants in

>>>>>> biological systems should have been a critical factor when

>>> determining the

>>>>>> suitability of implant formulations for long term use.

>>>>>>

>>>>>> Issue: There is evidence both from company documents as well

>>>>>> as the scientific literature that shelf life

>>>>> or stability data were not given

>>>>>> proper consideration in the manufacture of silicone gel breast implants.

>>>>>>

>>>>>> Issue: Long term suitability studies for breast implants in

>>>>>> animals or stored on the shelf appear to be currently unknown or at least

>>>>>> unpublished by breast implant manufacturers.

>>>>>>

>>>>>> 6. The information provided in package inserts for silicone

>>>>>> gel breast implants was incomplete and

>>>>> sometimes incorrect. Such information

>>>>>> accompanying regulated medical devices should be a fair and equitable

>>>>>> representation of the safety and efficacy of the product.

>>>>>>

>>>>>> Issue: The fact that gel implants could bleed gel and that

>>>>>> the gel could migrate through tissues from

>>>>> the site of implantation failed to

>>>>>> be mentioned in package inserts for more than 15 years.

>>>>>>

>>>>>> Issue: The fact that gel implants had a limited shelf life

>>>>>> was not addressed in package inserts for more than 15 years.

>>>>>>

>>>>>> Conclusion: It is apparent that disclosure of critical

>>>>>> information to patients regarding the

>>>>> physical characteristics of silicone gel

>>>>>> breast implants was inadequate. Hence,

>>>>> patients were ill-informed when making

>>>>>> decisions regarding the safety and stability

>>>>> of the products to be implanted

>>>>>> in their body.

>>>>>>

>>>>>>

>>>>>>

>>>>>> About P. , Ph.D., MBA

>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>>

>>>

>>>

>>

>>

>>

>>

>

>

>

> ________________________________________________________________________

> Check out the new AOL. Most comprehensive set of free safety and security

> tools, free access to millions of high-quality videos from across the web,

> free AOL Mail and more.

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Kenda,

Oh well let them think you are crazy. In the mean time make sure you tell your sister that according to Dr. Blais, after around 10 years the silicone shell starts to be broken down by the body. She should have them redone if she really wants to be healthy and remain well. I am so glad you are not going to get them and really I wonder why the heck I ever did this anyway. I wish I could turn it back. Well just because both your sister have had good luck doesn't mean that you will. I realize that there are woman out there who had implants for years and years without problems. Yet, myself I was sick from day one, since mine were leaky and defective. YUCK!!!!!!!!!! I know this doesn't happen to everyone but chances are it could be you, just like it was myself. I knew of the risk and complications, etc. really tried to do my home work, I was willing to even have to get another surgery down the road. However, I was never warned of Mold, Fungi, Bacteria, leaky defective products, etc. If I had been warned I might not have done it to begin with like yourself. If I would have decided to do it after knowing the truth, then I would have known 3 weeks Post-op. This is the whole problem we are not properly informed, educated to truly give an honest informed consent. What a scam and besides small breast are in style anyway healthy and fit is more attractive than fake breast that have mold in them. YUCK!!!!!!!!

Big Hugs,

Donna

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Rogene,

I don't think so if anyone knows of one or can find one, she lives in New York, Ny.

Thanks for writing you are a blessing.

Donna

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Hi Donna,

No problem. :) My sister didn't get the silicone injections but she does

have silicone implants, has for 11 years. In fact, both of my sisters are

implanted. So far, both of them are still healthy. They think I'm crazy

for being so cautious and not getting them too.

Kenda

> Kenda,

>

> I am so sorry and remember I did have implants, so brain dead to say it

> mildly. I am so glad you are not getting implants and I believe you have made

> the

> proper decision. Please make sure your sister does not fall for there scams

> either. I didn't think you would get the silicone, just wondered if the

> doctor

> is doing this legally is all. They sure know how to jump through loops

> regarding that pocket book lining. I wished I had bought me the used car I

> needed

> when I spent the money on my " safe " salines. Oh well can't turn back the

> hands of time, but I can warn others to not do this to there bodies. God

> Bless!!!!!!!!!!!!!!!!

>

> Donna

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Is there any detox centers near her? Or a good naturopath? Rogene BSBanshee1@... wrote: Rogene, I have ask to go to Dr. Kolb and she is just too sick. Donna Re:

Re: Liquid Silicone Injections Donna, Is there anyway can afford to go to a detox center like Dr. Kolb's? RogeneBSBanshee1aol wrote: Lea, I don't know why they are still doing this, let me guess, $$$$$$$$$$$$$. I would love to read that article if you can get someone to send it too me. was told it was so safe and the FDA didn't know what they were talking about when they banned it. She totally believed it was safe, just like I thought saline was safe. We were all lied to equally regarding silicone. is

not doing to good, she says her ears and nose is just falling off. She said, the collegen is gone? She says, her ears are like dried fruit? I don't know what to tell her to do, she can't find a doctor to help her? I get really dry skin falling off in my ears, I don't know why? I don't feel like there falling off though. What to do I have no idea. I just pray for her to get a miracle. She is so scared and alone. She has chronic fatigue and she doesn't think clearly. She is now looking for a place to test for silicone hypersensitivity and vitamin deficiencies. I don't know if it is going to do her any good to just know these things? She is trying to just do something instead of laying there dying. It is so sad to see everyone so affected from things the FDA approved. I have to remember at one time the FDA said, silicone injections were safe,

then changed there minds. It is hard to believe they don't see any difference with silicone in a silicone shell or saline in a silicone shell? It is merely the same thing if you ask me. God Bless!!!!!!!!!!!! Donna Check out the new AOL. Most comprehensive set of free safety and security tools, free access to millions of high-quality videos from across the web, free AOL Mail and more.

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Thank you, Kenda:

I am so worried that you might get breast implants because some of these doctors are so convincing. Many women are being implanted here in Edmonton because of the oil sands. These precious women are being used by the men who come to Edmonton on weekends for a good time. This is sad, but we cannot stop women from having these devices. We know of a group of people who are taking the women to where the men are working. This is illegal, but if we were to report these people we would be in danger.

Honey, we checked Dr. out, and he seems to be talking from both sides of his mouth. I plan on cleaning the article up, and then we will fax it to Dr. Blais to get his opinion.

Another thing that I wanted to tell you is that I know of three sisters just out of town who all have silicone breast implants. The one sister has had her implants for 30 years, and she ended up in ICU for one month. The doctors took hours to clean her out. She had silicone on her back, and she told me that she had almost died from heart and lung problems. Her sisters will not have their implants removed because they are in denial. Most women do not die; however, they live a life of suffering. It took me almost 19 years to find out that most all of my health problems were from my ruptured breast implants. My left eye has been bloodshot for three days, and this keeps happening to me...it must be from MS!

Sending love to you........Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`````````````

Re: Re: Liquid Silicone Injections>>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> I thought this was interesting to read, it mentions silicone>>>>>> injections at>>>>>>>>> one point.>>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> Silicone Gel Breast Implants: Were Proper Disclosures Made?>>>>>>>>> by P. , Ph.D., MBA>>>>>>>>> >>>>>>>>> Introduction: Silicone, a polymer of silicon, oxygen, and>>>>>>>>> carbon, was invented in the late 1800's by Professor F.S. Kipping at>>>>>>>>> Nottingham University. Little practical use>>>>>>>> was made of these materials until>>>>>>>>> the 1940's when Corning Glass Works formed a working>>>>>> relationship with Dow>>>>>>>>> Chemical Company (Dow-Corning Corporation) to>>>>>>>> develop many uses such as high>>>>>>>>> temperature-resistant lubricants, rubbers,>>>>>>>> antifoam, mold-releasing compounds,>>>>>>>>> insulation, as well as medical devices.>>>>>>>>> >>>>>>>>> Silicone gel breast implants are medical device prostheses>>>>>>>>> used to substitute for human breast tissue for purposes of>>>>>> augmentation or>>>>>>>>> replacement following mastectomy. Implants consist of a plastic>>>>>> envelope or>>>>>>>>> shell containing a soft gelatinous mixture. The shell consists>>>>>> of a highly>>>>>>>>> cross-linked silicone polymer while the gel contents embody>>>>>> linear silicone>>>>>>>>> polymers (specifically, polydimethylsiloxane-PDMS) of various >>>>>>>>> molecular>>>>>>>>> weights with less cross-linking than the>>>>>>>> shell material. Silicone gel implants>>>>>>>>> were invented in 1963 for breast augmentation>>>>>>>> to replace the use of silicone>>>>>>>>> injections.>>>>>>>>> >>>>>>>>> Silicone gel breast implants were widely marketed and used>>>>>>>>> over a thirty-year period until 1992 when >>>> the FDA banned them for lack of>>>>>>>>> sufficient safety and efficacy data. The>>>>>>>> number of breast implant operations>>>>>>>>> in this time period is estimated to be>>>>>>>> between one and two million. In 1992,>>>>>>>>> when sales were ceased, there were over 87, 000 breast implant >>>>>>>>> surgical>>>>>>>>> procedures of which 25, 676 (29%) were >>>> breast implant removal operations.>>>>>>>>> >>>>>>>>> Disclosure to Patients Issues Today, there is a great deal of>>>>>>>>> controversy regarding certain physical>>>>>>>> characteristics of silicone gel breast>>>>>>>>> implants versus what was revealed to or>>>>>>>> understood by patients as well as the>>>>>>>>> medical profession. There are at least >>>> six important product information>>>>>>>>> issues that should have been disclosed by the manufacturers in>>>>>> the package>>>>>>>>> inserts accompanying the product.>>>>>>>>> >>>>>>>>> 1. Silicones have biological activity. Contrary to popular>>>>>>>>> belief amongst plastic surgeons in the >>>> beginning, silicones were and are>>>>>>>>> biologically active compounds.>>>>>>>>> >>>>>>>>> Issue: There are published reports and internal company>>>>>>>>> documents from silicone breast implant>>>>>>>> manufacturers that reveal screening and>>>>>>>>> discovery of silicone compounds which exhibited pesticidal,>>>>>> antibiotic and>>>>>>>>> hormonal activities.>>>>>>>>> >>>>>>>>> 2. Injected silicones caused problems. The potential danger of>>>>>>>>> silicone compounds was published widely in>>>>>>>> the scientific literature revealing>>>>>>>>> adverse reactions to silicone injections when used for>>>>>> augmenting the human>>>>>>>>> female breast.>>>>>>>>> >>>>>>>>> Issue: Despite much evidence, a correlation between silicone>>>>>>>>> toxicity from direct injection with the>>>>>>>> possible silicone toxicity associated>>>>>>>>> with gel bleed from implants was never addressed.>>>>>>>>> >>>>>>>>> 3. Gel bleed from implants was documented. Gel bleed is a>>>>>>>>> phenomenon, which describes the migration of>>>>>>>> silicone molecules contained in>>>>>>>>> the gel implant through the permeable shell.>>>>>>>> The fact that gel implants exuded>>>>>>>>> a "greasy" residue was well known by >>>> manufacturers and plastic surgeons.>>>>>>>>> >>>>>>>>> Issue: Historically, neither the patients, surgeons, nor the>>>>>>>>> FDA were adequately informed about the gel>>>>>>>> bleed while it can be documented in>>>>>>>>> company memos that gel bleed was known,>>>>>>>> discussed, and proposed to be studied>>>>>>>>> at least 15 years before it was revealed in product package>>>>>> inserts. Issue:>>>>>>>>> The gel material leaking from the implants>>>>>>>> was not characterized, and hence,>>>>>>>>> posed an unknown health hazard to silicone gel breast implant >>>>>>>>> patients.>>>>>>>>> >>>>>>>>> 4. Gel migration is described as the movement of silicone>>>>>>>>> residues released from silicone gel breast>>>>>>>> implants throughout the body being>>>>>>>>> carried by phagocytic cells via the lymph>>>>>>>> system or by some other mechanism.>>>>>>>>> >>>>>>>>> Issue: Silicone fluids and gels have been known and observed>>>>>>>>> to migrate both in animals and humans as cited in company memos>>>>>> written and>>>>>>>>> papers published at least 15 years prior to>>>>>>>> being mentioned in product package>>>>>>>>> inserts.>>>>>>>>> >>>>>>>>> 5. The chemical stability of silicone gel implants in>>>>>>>>> biological systems should have been a critical factor when>>>>>> determining the>>>>>>>>> suitability of implant formulations for long term use.>>>>>>>>> >>>>>>>>> Issue: There is evidence both from company documents as well>>>>>>>>> as the scientific literature that shelf life>>>>>>>> or stability data were not given>>>>>>>>> proper consideration in the manufacture >>>> of silicone gel breast implants.>>>>>>>>> >>>>>>>>> Issue: Long term suitability studies for breast implants in>>>>>>>>> animals or stored on the shelf appear to >>>> be currently unknown or at least>>>>>>>>> unpublished by breast implant manufacturers.>>>>>>>>> >>>>>>>>> 6. The information provided in package inserts for silicone>>>>>>>>> gel breast implants was incomplete and>>>>>>>> sometimes incorrect. Such information>>>>>>>>> accompanying regulated medical devices should be a fair and equitable>>>>>>>>> representation of the safety and efficacy of the product.>>>>>>>>> >>>>>>>>> Issue: The fact that gel implants could bleed gel and that>>>>>>>>> the gel could migrate through tissues from>>>>>>>> the site of implantation failed to>>>>>>>>> be mentioned in package inserts for more than 15 years.>>>>>>>>> >>>>>>>>> Issue: The fact that gel implants had a limited shelf life>>>>>>>>> was not addressed in package inserts for more than 15 years.>>>>>>>>> >>>>>>>>> Conclusion: It is apparent that disclosure of critical>>>>>>>>> information to patients regarding the>>>>>>>> physical characteristics of silicone gel>>>>>>>>> breast implants was inadequate. Hence,>>>>>>>> patients were ill-informed when making>>>>>>>>> decisions regarding the safety and stability>>>>>>>> of the products to be implanted>>>>>>>>> in their body.>>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> About P. , Ph.D., MBA>>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>>> >>>>>>>> >>>>>>>> >>>>>>> >>>>>>> >>>>>>> >>>>>> >>>>>> >>>>> >>>>> >>>>> >>>> >>> >>> >>> >> >> >> >> >> >> > > > > > >

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I don't know of a good naturopath in NY . . . but there have to be many! . . . Hopefully someone will chime in with a suggestion about how to find a good one. . . . Unfortunately, they're not all good. My only suggestion is to find a private health food store and ask for a recommendation. . . Unfortunately the people working at franchise stores aren't likely to know of one - but they might! RogeneBSBanshee1@... wrote: Rogene, I don't think so if anyone knows of one or can find one, she lives in New York, Ny. Thanks for writing you are a blessing. Donna

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We have several reference websites available for finding natural and alternative doctors.

Check out these websites:

http://www.healthy.net/asp/templates/center.asp?centerid=53

http://www.acam.org/dr_search/

http://www.alternativesforhealing.com/cgi_bin/practitioner_home.php

Patty

Re: Re: Liquid Silicone Injections

I don't know of a good naturopath in NY . . . but there have to be many! . . . Hopefully someone will chime in with a suggestion about how to find a good one. . . . Unfortunately, they're not all good.

My only suggestion is to find a private health food store and ask for a recommendation. . . Unfortunately the people working at franchise stores aren't likely to know of one - but they might!

RogeneBSBanshee1aol (DOT) com wrote:

Rogene,

I don't think so if anyone knows of one or can find one, she lives in New York, Ny.

Thanks for writing you are a blessing.

Donna

__________________________________________________

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