Re: Re: Liquid Silicone Injections

[Guest guest]

Hi Terri,

There are definitely bad people in every profession but I don't believe ALL

plastic surgeons are bad people and liars.

Kenda

> Kenda,

> At the time I got mine in 1985 I specifically did not want anything

> to do with silicone, my ps lied and said they were completely saline

> all salt water, That I know now was a lie. I wouldn't have ever known

> because he never had any records and if I hadn't had them removed and

> identiified I would have never known he lied and put in bilumen which

> is saline and silicone gel. I call it fraud.

> Terri P

>

>

>

>

>

>>

>> Rogene,

>>

>> I don't blame most of the plastic surgeons for implanting women and

> not

>> believing them when they become ill. It is our allmighty, trusting

> government

>> who is brainwashing MD's and the public alike. Not all doctors are

> money

>> driven. I think if most understood that implants really do cause

> illness, some

>> would choose to scrutinize which patients they implant. Of course

> there are

>> bad doctors, as there are bad attorneys or bad car salesman or bad

> anything

>> else.

>>

>> Kenda

>>

>>>

>>> I know another plastic surgeon whose life turned upside down and

> became

>> a living hell. . . .I don't know if it was God's justice or not -

> but it certainly can

>> happen!

>>>

>>> We can't afford to waste our energy hating them though! It only

> gets in the

>> way ofour own healing!

>>>

>>> I wrote to . . . . Have you invited her to the

> group? . . . anyone can

>> send an invitation from the group page.

>>>

>>> Rogene

>>>

>>

>

>

[Guest guest]

Christene . . . you are so right! . . .you brought tears to my eyes. I hope you are feeling better! I'm not typing much - recovering from a broken right arm.usmcprincess3002 <usmcprincess3002@...> wrote: Hi Ladies! I know it's been a while but I'm still out here recovering from the removal and the subsequent divorce! I happened to see this note these words really stood out for me..."and I can only pray for God to send her a miracle as

he did myself." Donna? Ma'am I realize we don't know each other and all, but I have to wonder if God is not utilizing you, your presence, experiences, and resources as part of her miracle? Christene )>> Rogene,> > Yes, this is scary that some PS kill themselves and there family in the > process. I hate to think that my PS left me for dead, maybe he didn't know, the > truth only lies with him. It is weird that about 2 or 3 months after I had my > implants removed, my original PS collapsed, he had to get a colostomy bag, and > now is very sick waiting a liver transplant. He had hepatitis when he did my > surgery. I did get my liver functions test and it came back ok. It makes me > wonder is this bad carma, cause he knew what

was wrong with me and left me to > die or did God just have enough of him killing women and making women sick. > It is a scary process and I thank God that I am not a PS who does this > horrible stuff to women for a buck. I pray he ask for forgiveness and feel sorry for > him when he has to answer to God why he did these things for money and > material things. He collected expensive arts and went to France all the time, he > had lots of money. I heard he had to sell his house and business and living in > with a close relative. I heard he has lost lots of weight like 100lbs and > yellow. I went back to him OMG lots of time begging for him to tell me what was > wrong with me cause other doctor's didn't know. He laughed and told me to > wait a year I would heal. It was the hardest and most awful year of my life. > God have mercy on him if He knew what was

wrong with me the whole time. He may > know have to wait years for his liver transplant and I guess understands how > horrible the feeling is. I forgive him for what He did to me because I have to > and don't need the enemies and bad carma on myself someday. I hope he gets > well someday and is spared by God like myself.> > is very sick and she can't care for herself too good. She is not ready > to go to a home and is very scared she will end up in one soon. I would hate > to think that I may have to go to a nursing home someday. I really don't > like them places and hope I don't ever end up there. I know that if I didn't get > them implants out I would probably be in one know coma toasted and not > knowing anyone or anything. I just thought we might be able to send a prayer > or ask her how she is doing from time to time, she is alone in

this mess. I > talked to her today and she felt a little better and told me that I gave her > some hope, thinking she may find a doctor and maybe detox. I know I layed in > my bed for months and months straight with no support, no doctor to help me and > no hope. When I found support and some ray of hope I started fighting for my > life. Maybe this is the encouragement needs, for someone to believe > her that she has silicone poison and a ray of hope of some sort. Even if she > can follow the diet and Dr. Kolb protocol, who knows she may save herself from a > nursing home. I can only pray for God to send her a miracle as he did > myself. I guess it will be God's fate and 's strenght and will to survive. > The Eye of the Tiger!!!!!!!!!!!!! I just can't write her off yet because God > does work miracles. I did give her Dr. Kolb's site for

the protocol. She is > not comfy with the medicine the other doctor's want her to take so that is out > of the question I guess. Maybe if other's here e-mail her at > _foxfires44@..._ (mailto:foxfires44@...) and tell of woman doing better on the > Plaquenil she may change her mind. Thanks so much for helping. God > Bless!!!!!!!!!!!!!!> > Donna>

[Guest guest]

Christene,

God works in mysterious ways and we all know this is a mysterious illness to most doctors. I know when I was desperate for answers when I was sick and left for dead. I prayed a lot and talked with God. I went to church and begged God for answers so I could see my kids grow up and not die at the age of 37. I had nowhere else to turn for help. I thought of standing up when all the other people were standing up talking of there sicknesses and asking for prayer. I was so sick I did not do it, I was also embarrassed that vanity did this to me. I think about going back to that church and telling of my miracle that day I found support the following week and 3 weeks later I had explant with Dr. Kolb. It is scary because my original PS at one point was going to give me a deal, $750.00, to remove my implants, right in his own office. They described how he would do the procedure, you just sit in a chair he numbs you, he then makes a small slice under the crease and pops them and pulls them out. I was so sick and with so much brain fog at the time I am surprised I didn't fall for that ordeal. They assured me once again that nothing was wrong with the implants and I just paid so much money for them, it would be a shame to get them out now. I totally believe my life was spared by God and he sent me to the right place to get the truth behind the whole scam. I am grateful and hope to help lots of woman someday if I get better. I am not ashamed that I got breast implants, I was lied too. I hid my BA from lots of people, however when I got sick I told everyone who ask what happened to me. I waited 10 years for implants, I knew it was not what God gave me and went around and around in my head about vanity. God made me with a wonderful heart and in my life I have helped so many people. I think this is why he spared my life. I have had to learn patients with my illness, that was something I never had prior to implants. I was always in a hurry, things had to be perfect, cleaning and material things. That has all changed and I can't help but think back to something my father-in-law told me when he got cancer. He said, you know Donna you don't have nothing if you don't have your health. He was so correct and I helped that man for two years to fight cancer, he was blessed to live those two years since most doctors gave him 6 weeks to live. I would bring my Son to see him faithfully everyday, mow his 14 acres of grass, plow his garden barefooted with the roto tiller and go to church with him. I have seen miracles in my life and a firm believer of them happening. One day I had someone speak to me in the garden, yes I answered this voice back, shaking my head and saying OK. It told me my father in law would be healed with faith and if he believed of his healing to go to church and to tell everyone of his healings. I went to church that Wednesday, my father-in-law was there, I got baptized that day, he was anointed in oils. I know he was not healed forever, but two years was better than 6 weeks. My Son was only around 2 when we got the news his Grandpa was dying, my Son remembers him still since he lived 2 years longer. I am Thankful I got to help this man and seen miracle works from God. I think it totally affected my life forever. I knew when no man or doctor would help me who to turn too for answers. I am praying for and if nothing else will try to be there for her to have a shoulder to cry on and just vent... This is the scariest thing we can ever go threw, but if we make it to heaven someday, we will be whole again. God Bless!!!!!!!!!!!!!!!

Donna

[Guest guest]

Rogene,

This is true about some doctors. My family practitioner was clueless, talking saline is safe saltwater. They know the truth now, just like I do. My doctor when I told him I was sick since getting saline implants, said, well you got a nice set of boobs out of the deal. That made me mad as I told him in a nasty tone, what good are nice boobs if you are sick. I never spoke to him again. I still go to his office and see his nurse practitioner, she will never get breast implants since seeing me. She had to take the nasty stitches out of my areola's cut all the way around, take out my nasty drains. We talked in disbelief together and she told me she had no idea. I made her promise me if any woman with implants come in here with mysterious illnesses that she would ask them if they had breast implants and then give them my phone number. She agreed to do this and was very puzzled as to why this goes on and read some research from support sites. The other doctor won't even look at me, the next time I see him I will say my boobs are not sick any longer and I got some well boobs since getting them out. I can only hope to educate as many people as I can through my horrific experience with implants. I really think some doctor's are clueless, but PS I just can't believe they don't know of things that can go wrong with the breast implants they insert into woman. I sometimes just want to back step every doctor I ever seen through my ordeal, tell them they were wrong so they don't do this to another woman. It is a mess and the public need to be told the truth. What bothers me the most is that we are wrote off as crazy and they don't believe you when you tell them saline. I have learned a lot and the most important thing I learned through this whole ordeal, is not to be my own worst critic. I am myself and no doctor can change me safely, I give up on all thoughts of ever getting cosmetic surgery again.. I accept the way God made me and have to realize beauty is only skin deep. God Bless!!!!!!!!!!!

Donna

[Guest guest]

has been trying to order this dryer, OMG what a mess. I guess she tried to order it thru this site on the net www.laundry-alternative.com/drying she is not completely capable of much, she turns words around and very repetitive. She ask the sale man if she could return if it didn't fit in her house. He refuses to sell it to her now. I even called these people myself and asked to speak to someone, no return calls. is chemical sensitive and claims she needs this dryer. I know nothing about the dryers and wondered if anyone here has and also if we could find someone else to sell a dryer. This is amazing how some people can be so cruel. We are only talking about a couple hundred dollars and a very sick woman. I just don't get it, when people get sick it is like sorry we don't want to help or deal with you. Please if anyone has any information or help with how to get the dryer she needs, let me know. Thanks!!!!!!!!!!!!!!1

Donna

[Guest guest]

Donna, Maybe I got the wrong webpage - but the dryer I saw wouldn't help her anyway. She needs to be using only "green" products for cleaning. . . . Some of our ladies can recommend brands. If drying is an issue, hanging clothes up to air dry is completely safe. Absolutely no dryer sheets. RogeneBSBanshee1@... wrote: has been

trying to order this dryer, OMG what a mess. I guess she tried to order it thru this site on the net www.laundry-alternative.com/drying she is not completely capable of much, she turns words around and very repetitive. She ask the sale man if she could return if it didn't fit in her house. He refuses to sell it to her now. I even called these people myself and asked to speak to someone, no return calls. is chemical sensitive and claims she needs this dryer. I know nothing about the dryers and wondered if anyone here has and also if we could find someone else to sell a dryer. This is amazing how some people can be so cruel. We are only talking about a couple hundred dollars and a very sick woman. I just don't get it, when people get sick it is like sorry we don't want to help or deal with you. Please if anyone has any information or

help with how to get the dryer she needs, let me know. Thanks!!!!!!!!!!!!!!1 Donna

[Guest guest]

Rogene,

Thanks how interesting, so now what only use green cleaners? If anyone could recommend something and is pretty much allergic to everything. Thanks for the help!!!!!!!!!!

Donna

[Guest guest]

Rogene,

Thanks so much I will pass this on to . She feels somewhat better just finally finding others who believe she is sick from the silicone injections. It is amazing how we can feel a little better just by hearing you are not crazy. I did some searching and was sent a link from a health clinic who deals with lots of Trans gendered patients who are constantly getting the silicone injections at pump parties. I ask them if they could help . First they ask me is she Trans gender. I say NO Then basically told me well then no help here for her. I am like just because she is not Trans gender means no help. I finally just ask her can you tell me what the doctor does when a Trans gender comes to the clinic. She said all we do is make sure they are breathing ok and send them out the door. There is no medicine for cure or relief. So basically it made me give up any hope what so ever. I am back to the miracle from God is the only way will overcome this horrific ordeal. Please pray for her. She is trying daily to accept how sick she really is and thinks she may have to go to a home really soon. She doesn't want to and she is trying to fight for her life. She is tired and weak. She says, she has been sick for 20 years, but never connected the two. She thought she had what the doctors were telling her fibro, arthritis, osteoporosis, etc. She feels relived to have found us and thanks me non stop for trying to help her and letting her vent. She faces mostly what we go through doctors not knowing how to treat her, doctors being rude. Doctor's yelling at her when she mentioned silicone poisoning, telling her she is self diagnosing herself. Blah Blah Blah.............. Please just pray for . God Bless!!!!!!!!!!

Donna

[Guest guest]

Hi Terri,

I really believe that not all doctors know that implants are health risks. I

have enlightened several who thought silicone was risky, saline were

completely safe. There are very few women on this list in comparison to

all of the women in the US that are implanted. Every doctor needs to hear

from sick, implanted women to know that implants are causing women to become

ill. I understand that sick women were lied to and told implants were/are

safe. I was told the same thing. But do you really believe that all

doctors know that implants are not safe? I'm probably in the minority but I

believe it is our mighty FDA brainwashing the doctors and patients alike.

Kenda

>

> Donna,

> I totally agree with you, They know and they still play dumb it is

> all about the money any body who says it is not is lying to

> themselves. This many women are not lying we are sick and it is

> legitimite. We no longer need validation from others we have each

> other. The ones who have gone in our foot steps before us and we are

> in the footsteps now. We will be the women that others will be

> looking to when their time comes to get sick, it is just so sad we

> don't have more medical professional help on our side we are sure

> going to need it. We do have some doctors out there who do care about

> us

> Terri P

>

>

>

>

>>

>> Rogene,

>>

>> This is true about some doctors. My family practitioner was

> clueless,

>> talking saline is safe saltwater. They know the truth now, just

> like I do. My

>> doctor when I told him I was sick since getting saline implants,

> said, well you

>> got a nice set of boobs out of the deal. That made me mad as I

> told him in a

>> nasty tone, what good are nice boobs if you are sick. I never

> spoke to him

>> again. I still go to his office and see his nurse practitioner,

> she will never

>> get breast implants since seeing me. She had to take the nasty

> stitches out of

>> my areola's cut all the way around, take out my nasty drains. We

> talked in

>> disbelief together and she told me she had no idea. I made her

> promise me if any

>> woman with implants come in here with mysterious illnesses that she

> would ask

>> them if they had breast implants and then give them my phone

> number. She

>> agreed to do this and was very puzzled as to why this goes on and

> read some

>> research from support sites. The other doctor won't even look at

> me, the next time

>> I see him I will say my boobs are not sick any longer and I got

> some well

>> boobs since getting them out. I can only hope to educate as many

> people as I can

>> through my horrific experience with implants. I really think some

> doctor's

>> are clueless, but PS I just can't believe they don't know of things

> that can go

>> wrong with the breast implants they insert into woman. I sometimes

> just want

>> to back step every doctor I ever seen through my ordeal, tell them

> they were

>> wrong so they don't do this to another woman. It is a mess and the

> public

>> need to be told the truth. What bothers me the most is that we are

> wrote off as

>> crazy and they don't believe you when you tell them saline. I have

> learned a

>> lot and the most important thing I learned through this whole

> ordeal, is not

>> to be my own worst critic. I am myself and no doctor can change me

> safely, I

>> give up on all thoughts of ever getting cosmetic surgery again.. I

> accept the

>> way God made me and have to realize beauty is only skin

> deep.

>> God Bless!!!!!!!!!!!

>>

>> Donna

>>

>

>

[Guest guest]

Donna . . . There are tons of products . . . Some of our women use them. This is what I found with a websearch for green cleaning products". http://www.google.com/search?sourceid=navclient & ie=UTF-8 & rls=HPIA,HPIA:2006-31,HPIA:en & q=green+cleaning+products I know that diluted vinegar can clean almost anything, Rogene .

[Guest guest]

Many of us have become chemically sensitive after implants. This gradually gets much better after detoxing . . . part of chemical sensitivity is depression that lessens significantly when one is not in contact with chemicals. A lot of chemicals are in cosmetic products. Rogene BSBanshee1@... wrote: Rogene, Thanks so much I will pass this on to . She feels somewhat better just finally finding others who believe she is sick from the silicone injections. It is amazing how we can feel a little better just by hearing you are not crazy. I did some searching and was sent a link from a health clinic who deals with lots of Trans gendered patients who are constantly getting the silicone injections at pump parties. I ask them if they could help . First they ask me is she Trans gender. I say NO Then basically told me well then no help here for her. I am like just because she is not Trans gender means no help. I finally just ask her can you tell me what the doctor does when a Trans gender comes to the clinic. She said all we do is make sure they are breathing ok and send them out the door. There is no medicine for cure or relief. So basically it made me give up any hope what so

ever. I am back to the miracle from God is the only way will overcome this horrific ordeal. Please pray for her. She is trying daily to accept how sick she really is and thinks she may have to go to a home really soon. She doesn't want to and she is trying to fight for her life. She is tired and weak. She says, she has been sick for 20 years, but never connected the two. She thought she had what the doctors were telling her fibro, arthritis, osteoporosis, etc. She feels relived to have found us and thanks me non stop for trying to help her and letting her vent. She faces mostly what we go through doctors not knowing how to treat her, doctors being rude. Doctor's yelling at her when she mentioned silicone poisoning, telling her she is self diagnosing herself. Blah Blah Blah.............. Please just pray for . God Bless!!!!!!!!!! Donna

[Guest guest]

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

[Guest guest]

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

[Guest guest]

Thanks Lynda I will pass this on to . God Bless!!!!!!!

Donna

[Guest guest]

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

[Guest guest]

Donna, when I asked Dr. Blais about this he told me that a ruptured silicone breast implant was more deadly than a silicone injection. I could be wrong, because I do get things wrong, but I am pretty sure that is what he told me. Silicone injections would go into the bloodstream and that would seem more deadly. I hope that your friend will get well, but she might have to have more surgery to repair the damage.

There is a lady in the US who has had her face deformed by silicone injections. She used to be on many talk shows and she did not die!

Sending love and hope......Lea

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

Re: Re: Liquid Silicone Injections

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

[Guest guest]

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

>

>

>

>

>

>

>

>

>

[Guest guest]

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

[Guest guest]

Hi Lea,

Unless the silicone was injected into a vein, the silicone injection would

not go directly into the blood stream. I would guess they aren't considered

as dangerous as a ruptured implant because there is so little silicone used

in injections -- unless someone gets an extensive amount of injections,

which would be pretty atypical. Usually they are used for plumping up

wrinkled areas or lips.

Kenda

> Donna, when I asked Dr. Blais about this he told me that a ruptured silicone

> breast implant was more deadly than a silicone injection. I could be wrong,

> because I do get things wrong, but I am pretty sure that is what he told me.

> Silicone injections would go into the bloodstream and that would seem more

> deadly. I hope that your friend will get well, but she might have to have more

> surgery to repair the damage.

>

> There is a lady in the US who has had her face deformed by silicone

> injections. She used to be on many talk shows and she did not die!

>

> Sending love and hope......Lea

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

>

>

> Re: Re: Liquid Silicone Injections

>

>

>

> 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

>

>

>

>

[Guest guest]

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

>>>

>>>

>>>

>>>

>>>

>>>

>>>

>>>

>>>

>>

>>

>

>

>

[Guest guest]

> 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)( (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 

" 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 

" 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  Bausch & Lomb (Adato Sil-ol)

1 Bausch and Lomb Pl

Rochester, NY

Tel:  585-338-6000

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

Centennial Park

2 Centennial Drive

Peabody, MA 01960

Tel: 978.532.0666

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

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>

>>>

>>>

>>

>>

>

>

>

[Guest guest]

The amendment was made in 1997.

Kenda

> 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)( (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

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>>

>>>>>>

>>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>

>>>

>>>

>>

>

>

>

[Guest guest]

Donna, Is there anyway can afford to go to a detox center like Dr. Kolb's? RogeneBSBanshee1@... 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

[Guest guest]

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.LyndaAt 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> >>>> >>>> >>>> >>>> >>>> >>>> >>>> >>>> >>>> >>> >>> >> >> >>>

[Guest guest]

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

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>>

>>>>

>>>>

>>>

>>>

>>>

>>

>>

>

>

>

>