continued letter to Sen. Enzi Silicone Gel Breast Implants/Women's Health Issue

[Guest guest]

Note: forwarded message attached.

Rogene, you may also post this e-mail out to those who care to read it. This e-mail is my response to the e-mail sent from Adam B.( with Senator Enzi'soffice)I believe my concerns are extremely valid and other researchers have agreed.Thanks, CFM/ Fuchs-sey

From: " sey" <fuchsmorrissey@...>CC: Fuchssey@...Subject: continued letter to Sen. Enzi Silicone Gel Breast Implants/Women's Health IssueDate: Fri, 14 Oct 2005 16:26:42 +0000

Dear Adam, Thank you very much for reply. Appreciated. Also, in the past I have contacted Senators Bond and Talent, but never get a response back like from Bond, (typical for him) and Talent sends some form letter (via e-mail) thanking me for contacting him...and then my concern has been buried somewhere because they both seem to have more important agendas, I guess. I guess next week I will again try to contact them both. Thanks for the direction.

Roy Blunt did send me back a nice e-mail or letter (can not recall which) some time ago when I contacted him. But of course in the past he has really tried to help with breast implant issues from what I observed concerning Missouri women & implants. He seems like a good guy who wants to uphold the oath of First, do no harm.

Kenny Hulshof, (Member of Congress) always responded back to me! He too tried to be of help with breast implant issues, which I was grateful. He will always have my vote too. He is a good guy & really tries/tried to help those in Missouri who suffer like many have in the Show Me State from breast implant exposure. He seems to want to uphold the oath of First, do no harm.

I can tell you that in the past democrats have been great help in the cause of breast implant issues in Missouri, because when I contacted Joe Maxwell he was of great help to me when we were trying to pass our Informed Consent bill in Missouri. Then, years ago when the Missouri Supreme Court agreed to hear the Missouri State Medical Association to block the new informed consent bill on breast implants, I did make contact with Assistant Attorney General, Klahr years ago. Nice guy. He heard my voice along with the very valid concerns I expressed to him.

I sent him all of my medical records to take note that plastic surgeons really are not "telling all", but of course breast implant companies have a problem too with NOT "telling all" , not being forthcoming about silicone gel breast implants, even the ones you all are currently investigating with Mentor and Inamed. And those implants you all are investigating have not been fully studied either meaning no long term studies, (neither in the offspring) just like breast implants of the past so they really are NO different. The breast implant companies wants everyone to think the so-called new silicone gel breast implants (the lot numbers they are using) are safer. This is false. They are still silicone gel breast implants. I will explain more below in my e-mail. Please continue to read it. Remember Adam, they ARE silicone gel breast implants so nothing has changed. And where are their many, MANY years of studies proving these devices are safe? Because problems will NOT show up in people until many years down the road. Same is true with the offspring, as I have well experienced first hand.

Anyway, The Missouri Supreme Court upheld the Informed Consent for Breast implants, but this will not do any good if silicone gel breast implants (the two recent Mentor and Inamed applications) may be FDA approved, are oneday placed on the market, because the breast implant companies did NOT "tell all"/they were NOT being fully forthcoming. Long term studies have not been done on Mentors and Inamed's new silicone gel breast implants.

You say that your understanding is that the silicone gel breast implants now up for approval are "very different" from the implants that caused me grief from 1976-2005. Or caused other women hellish experiences and/or illness from silicone gel breast implants of the past.Sir, they are SILICONE gel breast implants and one must ALWAYS KEEP IN MIND (please Adam/Senator Enzi, keep that open mind which is valid to helping humanity) that: An adjuvant is a substance that can enhance the immune response to a foreign material (such as protein). Remember ENHANCE ~ EXERT ~ INDUCE a foreign material (silicone) such as a protein - which protein excesses are common in many diseases, primarily those that stimulate the immune response, such as lupus, multiple myeloma/MGUS, and similar conditions. Similar conditions like multiple sclerosis, scleroderma, dermatomyositis, cancers, other diseases of autoimmunity that may present as classic disease or disease-like. (Please show these words to a open minded scientist or physician with knowledge. They will understand)

The problem is that these so-called new breast implants of Mentors and Inamed you all are currently investigating (just like silicone gel breast implants of the past) are not crafted, not tailored to the variants of certain key genes to avoid the sensitivity, adverse reactions, exerting of the human immune response into disease and/or syndromes (that may present as classic disease or disease-like) and/or death.Then there are the offspring who will be exposed to the new silicone gel breast implants just like those offspring of the past who NOW HAVE their own chemical makeup tainted for a lifetime. This most certainly is not good medicine and is not upholding one's oath of First, do no harm.

Please understand that silicone gel breast implants are no different than Vioxx/Bextra or those types of drugs, because silicone gel breast implants just like Vioxx/Bextra or smoking or Agent Orange, or Gulf War or medicines/ vaccines/ dentistry/ medical devices (starting with silicone gel breast implants) ELEVATE -INDUCE-EXERT- ENHANCE the disease risk by affecting the variants of certain key genes (whatever those genes may be) which is NOT the cause of one's genetics at all. It is the cause of NOT BEING INFORMED to the truth of the volumes the human body is saying when disease or harm presents itself after the time factor of expousre to a silicone gel breast implant. Denial of the truth in medicine is not good.What everyone within the medical community is allowing (at their own free will) is the exerting of the human immune response which is NOT upholding the oath of First, do NO harm.

The breast implant companies (Mentor and Inamed) along with the FDA and others within the medical community are now are at a crossroad (to really for once in their lifetime) to use the big money (from Mentor and Inamed) and apply it to good, long standing studies for a change. This should have been done 40 plus years ago, not just now in 2005 or in 2006.IF silcone gel breast implants are allowed to be FDA approved these two companies (Mentor and Inamed) will NOT HAVE TO uphold their oath of First, do no harm EVER with good, truly needed dispassionate studies that should be carried out over a long period of time. IF they get away with this then this is going to open the flood gates even wider for others in industry to follow low standards and harm will continue on for generations to come...Human life is priceless. Make them/make industry/ MAKE Mentor and Innamed stand up to uphold their oath of First, do no harm to that highest of high standard for a change...this is all I am asking of everyone. Because Mentor and Inamed have NOT done this so far in their history of being in business! They have failed (at their own free will) to uphold their oath of First, do no harm.

For me this was never about legal aspects. For me this has always been about medical aspects and trying to uphold the oath of First, do no harm to that highest of high standand. This is why I say what I do in my e-mails to you all as I have been saying the same thing now for well over a decade...I always thought that America did the "right thing" and when I see those who have all of the medical degrees and education not upholding their oath of First, do no harm to that highest of high standard, then the USA really has failed as a nation. Those with the medical degrees and all of the education (far more than I will ever have) are the ones who seem to be really wisdomless. They are consistent about being inconsistent.

Even the FDA's own scientists have found silicone gel breast implants to be harmful, yet Dr. Crawford, the veterinarian (I am glad he left the agency. He needed to) and that so-called FDA blue ribbon panel have say they noted the science on silicone gel breast implants, yet turn around and say there is no science confirming silicone gel breast implants to cause disease. What studies were they really viewing? Were they all mentally okay? ...well silicone gel breast implants are extremely capable of EXERTING ~ ENHANCING ~ INDUCING the human immune response. All because this adjuvant /any silicone gel breast implant (new Mentor and Inamed ones included) have not been crafted, nor tailored to the variants of certain key genes along with an adjuvant being a substance that CAN and DOES enhance the immune response to a foreign material (such as protein). Explain this to the human immune response, because it IS STILL going to speak volumes to being exposed to these devices of the future presenting with diseases. Do you all really think that the human immune response is going to be able to ascertain the new "silicone" gel breast implants from the past "silicone" gel breast implants? Because of the great lack of LONG TERM studies Mentor and Inamed fail to really produce any fully informing study of proving the newer "silicone gel" devices to be safe. This is a real problem and can be devasting to many lives of the future if this knowledge is not taken into consideration. So Adam/Senator Enzi, I ask you all to continue to keep in mind that an adjuvant is a substance that enhance/exert/induce the human immune response to a foreign material *such as protein*. Remember enhance a foreign material (silicone) such as a protein which protein excesses are common in many diseases that may be elevated presenting as classic disease or disease-like like what has indeed happened to many women, children too. With your knowing and embracing this scientific knowledge one would have to rethink the approval of any future silicone gel breast implants placed on the market by Mentor and Inamed. From Scientific Methods, How Science Solves Man's Problems Volume 13, 1963, states "Open-mindedness is also vital to a scientific attitude. This means the ability to FACE THE FACTS as they are regardless of what one has previously thought. It includes the ability to accept new and sometimes even distasteful ideas. The worker in science must FACE FACTS whether they are pleasant or unpleasant". It continues " Scientists must be able to change their thinking to adapt to their theories to NEW FACTS as they are discovered. The mind cannot be made up once and for all. New knowledge may make a change in thinking necessary. This is another way of saying that man's understanding is always less than perfect. What is accepted as true often is relatively, and not absolutely true." SEE? This knowlege of understanding comes OVER TIME...and Mentor and Inamed have failed to do LONG TERM STUDIES on their new silicone gel breast implants....so please, beware. Because silicone gel breast implants are silicone gel breast implants (new or old devices) and the human body will speak volumes to the exerting process over time with disease and other health issues.

"A scientific truth offers an explanation that is acceptable only in light of what is known at a particular time"....and to date Mentor and Inamed have NOT done long term, indepth studies...so now, to date these newer silicone gel breast implants (produced by Mentor and Inamed) may look good in the little time they have studied the devices, but after the time factor of exposure (over the long term) along with the known fact that an adjuvant is a substance that can enhance the immune response to a foreign material (such as protein). Remember enhance a foreign material (silicone) such as a protein which protein excesses are common in many diseases like cancers and diseases of autoimmunity that may be elevated into whatever disease risk presenting as classic disease or disease-like.Please refer to: Summary Statement published March 17, 1993 from the Study of Adjuvant Effect of Silicone Gel reads as follows: "Dow Corning's and Dr. Naim's studies concluded that under specific experimental conditions silicone gel can fuction as an immune adjuvant in laboratory rats...well, this happens in humans too. I have taken the time to better explain this in my above e-mail.

I do hope you all have really heard my voice, because my concerns in my last e-mail and in this e-mail both are extremely valid to help everyone in our nation and the world (not just in my own little family) so that we all (in unity) may be able to uphold the oath of First, do no harm to that highest of high standard now, and for the generations to come.Being a past 1976 teenage breast implant patient with the breast implant experience has enabled me to better understand the faults and errors medicine displays to humanity.I hope you all are better informed, so that you too do not fall into the same trap as I did. Like placing trust in the breast implant companies.In our nation there is enough suffering...we can prevent the suffering from breast implants, if we have been told the truth in the first place. This is why I am e-mailing you again.

Take care, Fuchs-sey915 Rustic DriveMacon, Missouri 63552phone: 660-385-4621

Fuchssey@...

From: "Briddell, Adam (HELP Committee)" <Adam_Briddell@...>" sey" <fuchsmorrissey@...>Subject: RE: Silicone Gel Breast Implants/Women's Health IssueDate: Fri, 14 Oct 2005 09:11:15 -0400

Thank you for sharing your story with the committee. Your experience will inform our work on this issue. You should know that our investigation is limited to two recent Mentor and Inamed applications. Our understanding is that the implants now up for approval are very different from the implants that have caused you and your family so much grief.

Also, as Committees do not often act on behalf of individual constituents, I want to encourage you to share your experience with the Senators from Missouri. They may have additional information or services that they can offer you. Their contact information is:

Bond, - (R - MO)

274 RUSSELL SENATE OFFICE BUILDING WASHINGTON DC 20510

(202) 224-5721

Web Form: bond.senate.gov/contact/contactme.cfm

Talent, - (R - MO)

493 RUSSELL SENATE OFFICE BUILDING WASHINGTON DC 20510

(202) 224-6154

Web Form: talent.senate.gov/Contact/default.cfm?pagemode=1

Best wishes,

Adam Briddell Investigative Advisor U.S. Senate Committee on Health, Education, Labor & Pensions Senator Mike Enzi - Chairman 202-224-7229 Phone 202-228-0934 Fax adam_briddell@...

From: sey [mailto:fuchsmorrissey@...] Sent: Wednesday, October 12, 2005 3:31 PMBriddell, Adam (HELP Committee)Cc: Fuchssey@...Subject: Silicone Gel Breast Implants/Women's Health Issue

ATTEN: Adam Briddell, Investigative Advisor

Please forward my e-mail to:

Senator Mike Enzi

Chairman, U.S. Senate Committe on Health,

Education, Labor and Pension

RE: Silicone Gel Breast Implants

(Adam, I know this is long, but I needed to e-mail

you so that you & Senator Enzi knew I was out

here suffering this. Take care, )

Dear Senator Mike Enzi,My name is Fuchs-sey from Macon, Missouri. I am contacting you on behalf of women's health issues; breast implants, the 2nd generation/ the offspring who have been exposed to these damning devices,(silicone gel breast implants) via the placental barrier through fetal cells. Breast feeding is just extra "hits" of this adjuvant and the catalysts, like platinum.

I am not a scientist or nor am I a physician, but more importantly I am a wife, (I have been married to my husband, since 1978) mother and past 1976 McGhan/3M teenage silicone gel breast implant patient. I opted for silicone gel breast implants seven days after my 18th birthday in 1976 in hopes of correcting a congenital deformity of my chest wall. I had silicone gel breast implants from 1976-1993. The three sets of breast implants I had in my body did NOT help my situation at all, they just made my situation worse. In 1993 at the age of 35 years old I had a mastectomy of both breasts, (the extremely failed breast implants attached) because of my totally failed silicone gel breast implants, that contained platinum excesses.Senator Enzi, I fully regret ever opting for silicone gel breast implants which did NOT improve my life in any way. I fully regret placing my trust in my plastic surgeon, my trust in the breast implants & those companies, and my trust in the FDA to uphold their oath of First, do no harm concerning breast implants, which these devices do harm humans, and the offspring do indeed take "hits" via the placental barrier through fetal cells. Where are the studies on the offspring Senator Enzi?

Where are all their many, many years of studies? Breast implants have been on the market for over 45 years plus, so where are all of the many, many studies on the offspring taking "hits" via the placental barrier through fetal cells? Silicone gel breast implants were under moratorium since 1992, so where are all the studies on the offspring? They had plenty of time to do many studies, so where are the studies when it concerns the offspring being exposed to silicone gel breast implants? Of course in medicine they can make their study fall the way they want no matter if it is the truth or not.

Are our children in AMERICA not that important that these big companies failed to step up to the plate early on and do studies proving the implants to be safe via the placental barrier and with breastfeeding? They do not want to spend their money to do the right thing to uphold their oath of First, do NO harm. This is a shame. Well, I have the evidence in human form, and so do many other mothers who are suffering the same plight with their children.

Our concerns are dismissed because the medical community/the breast implant companies/plastic surgeons/FDA and other medical organizations (IOM, NCI, NIH) place business as usual ahead of their oath of First, do no harm and the sake of the children, the generations to come who will be exposed to the damning devices. They rather cover their own tail while many suffer the exposure from their self-serving ways of products placed out to general population that exert the human immune response, also via the placental barrier through fetal cells.

Sir, I want you to know my breast implants were a birthday present from my parents and to date, (October 2005 at the age of almost 48 years old. I will be 48 yrs old November 16th, 2005) I am still trying to blow out the candle on this gift, but the flame has gotten way out of control. I figured the flame will be out the day I die or my children die.

Now, only am I very disfigured on my chest wall from the breast implants. I have health concerns caused from my toxic, very failed silicone gel breast implants, as well as my three daughters who have health issues elevated from the exposure to my failed breast implants. But of course the companies have not studied the offspring fully nor tracked the outcome of children exposed to breast implants, so they are further bushwhacking the generations to come if silicone gel breast implants are placed back on the market. This has been their free will choice and this is not upholding their oath of First, do no harm to that highest of high standard if silicone gel breast implants make it back on the market. The breast implant companies rather not spend their money on good dispassionate studies, so their CEO's can retire with alot in their pockets.

Last year I had myself along with two of my three daughters tested for platinum in the urine. Our middle daughter could not be tested because she was away at college & was unable to make it home.

The results are as followed:

myself- 17.1 ug/L (parts per billion per liter of urine)

1st born daughter: 15.3 ug/L

3rd born daughter: 16.9 ug/L

I understand your investigation to date is limited to specific accusations regarding the 2005 FDA Advisory Committee panel meeting and the PMA's reviewed at that meeting. The problem is the breast implant companies along with the plastic surgeons, who act as enablers are making a free will choice to make a mockery of everyone (you, me, the medical community as a whole and all of humanity and the innocent generations to come) by not upholding their oath of First, do no harm. They failed by NOT "telling all" about silicone gel breast implants. They only disclose what they want to, but there is more to the story as many have suffered as they failed to "tell all" in the 2005 FDA meetings and with the PMA's that were being reviewed at that meeting. This is being self-serving.

Also, the offspring, the generations to come are forgotten souls when it comes to the breast implant issues. Children on this earth now and the generations to come have no voice. I guess this is why mother's are placed on this earth, so that children do have a voice, so I also am contacting you on behalf of the children, (all children) who have been exposed to their mother's breast implants. I am their voice seeing I myself am a past teenage breast implant patient whos children were exposed to very failed silicone gel breast implants. I have walked the walk and I am very capable of talking the talk.

Our youngest daughter, has scleroderma in the form of PSS. She has problems swallowing and this may wax and wane, but the swallowing problem has gotten worse. is in the 10th grade. She also suffers with a very severe bone dysplasia of the hands and feet. Her hands and feet are the size of an 11-15 month old baby & have fused. Meaning they will not be growing anymore. She also has AN, acanthosis nigricans which is black skin on top of the shiny scleroderma skin. She has learning delays and other health issues. She is going through an advanced aging process, and I do have her in many studies. She is basically being used as a lab animal, like I was when I opted for silicone gel breast implants in my youth. I really think our lives are of more value than this, but someone needs to uphold the oath of First, do no harm, so this is why I have tried to get our family into studies. But in research they can make their studies fall the way they want no matter if it is the truth or not.

I believe our is a McGhan/3M silicone gel breast implant birth defect and one day she is going to die a McGhan/3M silicone gel breast implant birth defect. And not one soul will ever be able to take this fact away from this young girl no matter how hard everyone tries to get around the FDA moratorium on silicone gel breast implants with their "words of art" or "medical words of art" to cover their own tail of the medical harm they have caused.Gosh Senator Enzi, even the FDA's own scientists have studies showing that silicone gel implants are harmful, but of course the FDA does NOT listen to their own scientists...this is why good scientists are leaving the FDA lately. Everyone is fed up with the FDA, along with the medical community selling their souls to the highest bidder, industry.

In the case of breast implants that would be selling one's soul to Mentor and Inamed. Inamed which is really McGhan who made my breast implant lot numbers. Inamed, McGhan whatever name they want to call themselves they still cause harm to patients who should think twice before they place their trust in what they ever market...because all they care about is business as usual, not about upholding their oath of First, do no harm with silicone gel breast implants. This is poor medicine.

Also, I would like to share with you some of what is in my medical records when I had the failed devices submitted for review and evaluation.

My records state: " Indeed , the implant appears to have lost original contour in addition to its structural integrity. Macroscopic examination reveals that nearly all the silicone gel content was extravasated outsede the prosthesis. The remaining silicone gel has lost it's transparent and colorless nature and acquired a slight yellowish tint. Color changes in the gel are indicative of chemical alteration in the medium. A moderate number of fine precipitates are noted in the gel medium. Under the microscope, these particles appear as fine, needle-like, aggregated structures and granular formations. They appear to have chemical and biological origins. We have found that chemical aggregates are composed of metals which can induce immunogenic reactions when prolonged contact with living tissues".

The records continue to state: " More importantly, silicone particles were seen in close contact with blood vessels. The proximity of the blood vessels to the silicone particles, indicates that they were transported elsewhere through the systemic vasculature. Also of significance is the fact that the internal zones as well as the surrounding areas of mammary glands dislayed infiltrated silicone gel particles.

Large clacified plates containing infiltrated silicone particles were also noted in the tissue. Calcified structures were formed in response to the deleterious presence of metal in the silicone gel. These metals migrate into the surrounding tissue from bleeding or ruptured implants".

In more medical records taken from a review of my failed McGhan/ 3M implants states: " Both the inner and outer shells had been ruptured for many years prior to explanation. Highlights also include a MAJOR PRODUCTION DEFECT on the left implant which CONSISTS OF A DEBONDED GEL FILL HOLE SEAL. This defect confirms that the devices which contains a DEGRADED FLUID GEL DEVOID OF STABILITY AND SHAPE MEMORY WITH A LUMPY DISPERSION. This type of presentation is typical of incorrectly formulated filling substances. It should be noted that Ms. sey received devices manufactured by the same production facility and embodying major production problems from the outset.

The capsules are noteworthy for deep infiltration with oil and gel, as well as structural features such as opening and fenestration. Contrary to opinions occasionally expressed in some quarters, such capsules amount to open structures that have no protective value against the release of oils and gel impurities into the user's system".

Also in my records it states: " The patch workmanship is very poor with evidence of errors in assembly and improper use of adhesive for sealant as well as PLATINUM EXCESSES AS EVIDENCED BY A BLACK DISCOLORATION on the patch edge. The item was defective from the outset as it shows an open gel fill hole which was never correctly sealed. It leaks oil grossly and has potential for severe adverse reaction. Both implants are creditable with the release of large quantities of mobile, invasive gel which deeply penetrated tissues. The capsules are remarkable for irregularities, fenestrations and the development for granulomatous tissue. They reflect all the attributes of periprosthetic tissue exposed to uncontained gel for a long period of time."

The records continue to state: " Her history is further remarkable for use of electrosurgical techniques in a OIL- CONTAMINATED FIELD. This procedure has potential for long term sequelae." (HAS ANYONE BROUGHT UP THE USE OF THE BOVIE/ELECTROSURGICAL TECHNIQUES WITH SILICONE GEL BREAST IMPLANTS? Because it is not good to use a bovie and silicone gel breast implants. Ask Dr. Blais from Canada. He can explain why)

The records speak more of the platinum: " The gel feill hole is exposed and the sealant is partly debonded from the shell or alternately bonding never took place. Platinum discoloration is visible on the patch edge. This material is plartly detached from the substrate. The valve stem is laden with fine debris indicating leakage. The patch workmanship is poor with irregular peripheral cutting. The gel is turbid and has fluid characteristics consistent with an improperly polymerized product.

Senator Enzi, I bet nobody addressed alot of these concerns above (what I have brought up in my e-mail) in the 2005 FDA Advisory Committee panel meeting and in the PMA's reviewed at that meeting...but they should have because this happens to many people...it happened to me. If they failed to have addressed these issues like what I have stated in my above e-mail then they are failing to uphold their oath of First, do no harm to that highest of high standard.

MY POOR CHILDREN. I exposed my children to this via the placental barrier then I breastfed all of them with this toxic soup (the adjuvant, the catalysts/ platinum) deemed breastmilk...and everyone in the medical community thinks this is harmless? Well, what one does not know will hurt someone! Staying in denial like a drinker is not good, so I will not play the enabler to the medical community and this is why my voice needs to be heard. They need to fix this huge problem THEY MADE for many as they have failed to uphold their oath of First, do no harm to that highest of high standard.

Suffer the little children? They did, they have and will continue to suffer if silicone gel breast implants are FDA approved.

Thank you for your time. Fuchs-sey

915 Rustic DriveMacon, Missouri 63552

phone: 660-385-4621

Fuchssey@...

><< image001.gif >>

[Guest guest]

I'm resending this because this letter tells the truth

so plainly and I'm not sure the archives support

attachments! - Rogene

--- sey <fuchsmorrissey@...>

wrote:

> From: " sey " <fuchsmorrissey@...>

> saxony01@...

> Subject: RE: continued letter to Sen. Enzi Silicone

> Gel Breast Implants/Women's Health

> Issue

> Date: Tue, 18 Oct 2005 23:25:45 +0000

>

---------------------------------

Rogene, you may also post this e-mail out to those who

care to read it.

This e-mail is my response to the e-mail sent from

Adam B.( with Senator Enzi's

office)

I believe my concerns are extremely valid and other

researchers have agreed.

Thanks, CFM/ Fuchs-sey

---------------------------------

From: " sey " <fuchsmorrissey@...>

CC: Fuchssey@...

Subject: continued letter to Sen. Enzi Silicone Gel

Breast Implants/Women's Health Issue

Date: Fri, 14 Oct 2005 16:26:42 +0000

Dear Adam,

Thank you very much for reply. Appreciated. Also, in

the past I have contacted Senators Bond and Talent,

but never get a response back like from Bond, (typical

for him) and Talent sends some form letter (via

e-mail) thanking me for contacting him...and then my

concern has been buried somewhere because they both

seem to have more important agendas, I guess.

I guess next week I will again try to contact them

both. Thanks for the direction.

Roy Blunt did send me back a nice e-mail or letter

(can not recall which) some time ago when I contacted

him. But of course in the past he has really tried to

help with breast implant issues from what I observed

concerning Missouri women & implants. He seems like a

good guy who wants to uphold the oath of First, do no

harm.

Kenny Hulshof, (Member of Congress) always responded

back to me! He too tried to be of help with breast

implant issues, which I was grateful. He will always

have my vote too. He is a good guy & really

tries/tried to help those in Missouri who suffer like

many have in the Show Me State from breast implant

exposure. He seems to want to uphold the oath of

First, do no harm.

I can tell you that in the past democrats have been

great help in the cause of breast implant issues in

Missouri, because when I contacted Joe Maxwell he was

of great help to me when we were trying to pass our

Informed Consent bill in Missouri. Then, years ago

when the Missouri Supreme Court agreed to hear the

Missouri State Medical Association to block the new

informed consent bill on breast implants, I did make

contact with Assistant Attorney General, Klahr

years ago. Nice guy. He heard my voice along with the

very valid concerns I expressed to him.

I sent him all of my medical records to take note

that plastic surgeons really are not " telling all " ,

but of course breast implant companies have a problem

too with NOT " telling all " , not being forthcoming

about silicone gel breast implants, even the ones you

all are currently investigating with Mentor and

Inamed.

And those implants you all are investigating have

not been fully studied either meaning no long term

studies, (neither in the offspring) just like breast

implants of the past so they really are NO different.

The breast implant companies wants everyone to think

the so-called new silicone gel breast implants (the

lot numbers they are using) are safer. This is false.

They are still silicone gel breast implants. I will

explain more below in my e-mail. Please continue to

read it.

Remember Adam, they ARE silicone gel breast implants

so nothing has changed. And where are their many, MANY

years of studies proving these devices are safe?

Because problems will NOT show up in people until many

years down the road. Same is true with the offspring,

as I have well experienced first hand.

Anyway, The Missouri Supreme Court upheld the Informed

Consent for Breast implants, but this will not do any

good if silicone gel breast implants (the two recent

Mentor and Inamed applications) may be FDA approved,

are oneday placed on the market, because the breast

implant companies did NOT " tell all " /they were NOT

being fully forthcoming. Long term studies have not

been done on Mentors and Inamed's new silicone gel

breast implants.

You say that your understanding is that the silicone

gel breast implants now up for approval are " very

different " from the implants that caused me grief from

1976-2005. Or caused other women hellish experiences

and/or illness from silicone gel breast implants of

the past.

Sir, they are SILICONE gel breast implants and one

must ALWAYS KEEP IN MIND (please Adam/Senator Enzi,

keep that open mind which is valid to helping

humanity) that: An adjuvant is a substance that can

enhance the immune response to a foreign material

(such as protein). Remember ENHANCE ~ EXERT ~ INDUCE a

foreign material (silicone) such as a protein - which

protein excesses are common in many diseases,

primarily those that stimulate the immune response,

such as lupus, multiple myeloma/MGUS, and similar

conditions. Similar conditions like multiple

sclerosis, scleroderma, dermatomyositis, cancers,

other diseases of autoimmunity that may present as

classic disease or disease-like. (Please show these

words to a open minded scientist or physician with

knowledge. They will understand)

The problem is that these so-called new breast

implants of Mentors and Inamed you all are currently

investigating (just like silicone gel breast implants

of the past) are not crafted, not tailored to the

variants of certain key genes to avoid the

sensitivity, adverse reactions, exerting of the human

immune response into disease and/or syndromes (that

may present as classic disease or disease-like)

and/or death.

Then there are the offspring who will be exposed to

the new silicone gel breast implants just like those

offspring of the past who NOW HAVE their own chemical

makeup tainted for a lifetime. This most certainly is

not good medicine and is not upholding one's oath of

First, do no harm.

Please understand that silicone gel breast implants

are no different than Vioxx/Bextra or those types of

drugs, because silicone gel breast implants just like

Vioxx/Bextra or smoking or Agent Orange, or Gulf War

or medicines/ vaccines/ dentistry/ medical devices

(starting with silicone gel breast implants) ELEVATE

-INDUCE-EXERT- ENHANCE the disease risk by affecting

the variants of certain key genes (whatever those

genes may be) which is NOT the cause of one's genetics

at all. It is the cause of NOT BEING INFORMED to the

truth of the volumes the human body is saying when

disease or harm presents itself after the time factor

of expousre to a silicone gel breast implant. Denial

of the truth in medicine is not good.

What everyone within the medical community is allowing

(at their own free will) is the exerting of the human

immune response which is NOT upholding the oath of

First, do NO harm.

The breast implant companies (Mentor and Inamed) along

with the FDA and others within the medical community

are now are at a crossroad (to really for once in

their lifetime) to use the big money (from Mentor and

Inamed) and apply it to good, long standing studies

for a change. This should have been done 40 plus years

ago, not just now in 2005 or in 2006.

IF silcone gel breast implants are allowed to be FDA

approved these two companies (Mentor and Inamed) will

NOT HAVE TO uphold their oath of First, do no harm

EVER with good, truly needed dispassionate studies

that should be carried out over a long period of time.

IF they get away with this then this is going to open

the flood gates even wider for others in industry to

follow low standards and harm will continue on for

generations to come...Human life is priceless.

Make them/make industry/ MAKE Mentor and Innamed stand

up to uphold their oath of First, do no harm to that

highest of high standard for a change...this is all I

am asking of everyone. Because Mentor and Inamed have

NOT done this so far in their history of being in

business! They have failed (at their own free will) to

uphold their oath of First, do no harm.

For me this was never about legal aspects. For me this

has always been about medical aspects and trying to

uphold the oath of First, do no harm to that highest

of high standand. This is why I say what I do in my

e-mails to you all as I have been saying the same

thing now for well over a decade...I always thought

that America did the " right thing " and when I see

those who have all of the medical degrees and

education not upholding their oath of First, do no

harm to that highest of high standard, then the USA

really has failed as a nation. Those with the medical

degrees and all of the education (far more than I will

ever have) are the ones who seem to be really

wisdomless. They are consistent about being

inconsistent.

Even the FDA's own scientists have found silicone gel

breast implants to be harmful, yet Dr. Crawford, the

veterinarian (I am glad he left the agency. He needed

to) and that so-called FDA blue ribbon panel have say

they noted the science on silicone gel breast

implants, yet turn around and say there is no science

confirming silicone gel breast implants to cause

disease. What studies were they really viewing? Were

they all mentally okay?

....well silicone gel breast implants are extremely

capable of EXERTING ~ ENHANCING ~ INDUCING the human

immune response. All because this adjuvant /any

silicone gel breast implant (new Mentor and Inamed

ones included) have not been crafted, nor tailored to

the variants of certain key genes along with an

adjuvant being a substance that CAN and DOES enhance

the immune response to a foreign material (such as

protein). Explain this to the human immune response,

because it IS STILL going to speak volumes to being

exposed to these devices of the future presenting with

diseases.

Do you all really think that the human immune response

is going to be able to ascertain the new " silicone "

gel breast implants from the past " silicone " gel

breast implants? Because of the great lack of LONG

TERM studies Mentor and Inamed fail to really produce

any fully informing study of proving the newer

" silicone gel " devices to be safe. This is a real

problem and can be devasting to many lives of the

future if this knowledge is not taken into

consideration.

So Adam/Senator Enzi, I ask you all to continue to

keep in mind that an adjuvant is a substance that

enhance/exert/induce the human immune response to a

foreign material *such as protein*. Remember enhance a

foreign material (silicone) such as a protein which

protein excesses are common in many diseases that may

be elevated presenting as classic disease or

disease-like like what has indeed happened to many

women, children too.

With your knowing and embracing this scientific

knowledge one would have to rethink the approval of

any future silicone gel breast implants placed on the

market by Mentor and Inamed.

From Scientific Methods, How Science Solves Man's

Problems Volume 13, 1963, states " Open-mindedness is

also vital to a scientific attitude. This means the

ability to FACE THE FACTS as they are regardless of

what one has previously thought. It includes the

ability to accept new and sometimes even distasteful

ideas. The worker in science must FACE FACTS whether

they are pleasant or unpleasant " .

It continues " Scientists must be able to change their

thinking to adapt to their theories to NEW FACTS as

they are discovered. The mind cannot be made up once

and for all. New knowledge may make a change in

thinking necessary. This is another way of saying that

man's understanding is always less than perfect. What

is accepted as true often is relatively, and not

absolutely true. " SEE? This knowlege of understanding

comes OVER TIME...and Mentor and Inamed have failed to

do LONG TERM STUDIES on their new silicone gel breast

implants....so please, beware. Because silicone gel

breast implants are silicone gel breast implants (new

or old devices) and the human body will speak volumes

to the exerting process over time with disease and

other health issues.

" A scientific truth offers an explanation that is

acceptable only in light of what is known at a

particular time " ....and to date Mentor and Inamed

have NOT done long term, indepth studies...so now, to

date these newer silicone gel breast implants

(produced by Mentor and Inamed) may look good in the

little time they have studied the devices, but after

the time factor of exposure (over the long term) along

with the known fact that an adjuvant is a substance

that can enhance the immune response to a foreign

material (such as protein). Remember enhance a foreign

material (silicone) such as a protein which protein

excesses are common in many diseases like cancers and

diseases of autoimmunity that may be elevated into

whatever disease risk presenting as classic disease or

disease-like.

Please refer to: Summary Statement published March 17,

1993 from the Study of Adjuvant Effect of Silicone Gel

reads as follows: " Dow Corning's and Dr. Naim's

studies concluded that under specific experimental

conditions silicone gel can fuction as an immune

adjuvant in laboratory rats...well, this happens in

humans too. I have taken the time to better explain

this in my above e-mail.

I do hope you all have really heard my voice, because

my concerns in my last e-mail and in this e-mail both

are extremely valid to help everyone in our nation and

the world (not just in my own little family) so that

we all (in unity) may be able to uphold the oath of

First, do no harm to that highest of high standard

now, and for the generations to come.

Being a past 1976 teenage breast implant patient with

the breast implant experience has enabled me to better

understand the faults and errors medicine displays to

humanity.

I hope you all are better informed, so that you too do

not fall into the same trap as I did. Like placing

trust in the breast implant companies.

In our nation there is enough suffering...we can

prevent the suffering from breast implants, if we have

been told the truth in the first place. This is why I

am e-mailing you again.

Take care,

Fuchs-sey

915 Rustic Drive

Macon, Missouri 63552

phone: 660-385-4621

Fuchssey@...

---------------------------------

From: " Briddell, Adam (HELP Committee) "

<Adam_Briddell@...>

" sey " <fuchsmorrissey@...>

Subject: RE: Silicone Gel Breast Implants/Women's

Health Issue

Date: Fri, 14 Oct 2005 09:11:15 -0400

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Thank you for sharing your story with the

committee. Your experience will inform our work on

this issue. You should know that our investigation is

limited to two recent Mentor and Inamed applications.

Our understanding is that the implants now up for

approval are very different from the implants that

have caused you and your family so much grief.

Also, as Committees do not often act on behalf of

individual constituents, I want to encourage you to

share your experience with the Senators from Missouri.

They may have additional information or services that

they can offer you. Their contact information is:

Bond, - (R - MO)

274 RUSSELL SENATE OFFICE BUILDING WASHINGTON DC 20510

(202) 224-5721

Web Form: bond.senate.gov/contact/contactme.cfm

Talent, - (R - MO)

493 RUSSELL SENATE OFFICE BUILDING WASHINGTON DC 20510

(202) 224-6154

Web Form:

talent.senate.gov/Contact/default.cfm?pagemode=1

Best wishes,

Adam Briddell

Investigative Advisor

U.S. Senate Committee on Health, Education, Labor &

Pensions

Senator Mike Enzi - Chairman

202-224-7229 Phone

202-228-0934 Fax

adam_briddell@...

---------------------------------

From: sey

[mailto:fuchsmorrissey@...]

Sent: Wednesday, October 12, 2005 3:31 PM

Briddell, Adam (HELP Committee)

Cc: Fuchssey@...

Subject: Silicone Gel Breast Implants/Women's Health

Issue

ATTEN: Adam Briddell, Investigative Advisor

Please forward my e-mail to:

Senator Mike Enzi

Chairman, U.S. Senate Committe on Health,

Education, Labor and Pension

RE: Silicone Gel Breast Implants

(Adam, I know this is long, but I needed

to e-mail

you so that you & Senator Enzi knew I

was out

here suffering this. Take care, )

Dear Senator Mike Enzi,

My name is Fuchs-sey from Macon, Missouri.

I am contacting you on behalf of women's health

issues; breast implants, the 2nd generation/ the

offspring who have been exposed to these damning

devices,(silicone gel breast implants) via the

placental barrier through fetal cells. Breast feeding

is just extra " hits " of this adjuvant and the

catalysts, like platinum.

I am not a scientist or nor am I a physician, but more

importantly I am a wife, (I have been married to my

husband, since 1978) mother and past 1976

McGhan/3M teenage silicone gel breast implant patient.

I opted for silicone gel breast implants seven days

after my 18th birthday in 1976 in hopes of correcting

a congenital deformity of my chest wall. I had

silicone gel breast implants from 1976-1993. The three

sets of breast implants I had in my body did NOT help

my situation at all, they just made my situation

worse. In 1993 at the age of 35 years old I had a

mastectomy of both breasts, (the extremely failed

breast implants attached) because of my totally failed

silicone gel breast implants, that contained platinum

excesses.

Senator Enzi, I fully regret ever opting for silicone

gel breast implants which did NOT improve my life in

any way. I fully regret placing my trust in my plastic

surgeon, my trust in the breast implants & those

companies, and my trust in the FDA to uphold their

oath of First, do no harm concerning breast implants,

which these devices do harm humans, and the offspring

do indeed take " hits " via the placental barrier

through fetal cells. Where are the studies on the

offspring Senator Enzi?

Where are all their many, many years of studies?

Breast implants have been on the market for over 45

years plus, so where are all of the many, many studies

on the offspring taking " hits " via the placental

barrier through fetal cells? Silicone gel breast

implants were under moratorium since 1992, so where

are all the studies on the offspring? They had plenty

of time to do many studies, so where are the studies

when it concerns the offspring being exposed to

silicone gel breast implants? Of course in medicine

they can make their study fall the way they want no

matter if it is the truth or not.

Are our children in AMERICA not that important that

these big companies failed to step up to the plate

early on and do studies proving the implants to be

safe via the placental barrier and with breastfeeding?

They do not want to spend their money to do the right

thing to uphold their oath of First, do NO harm. This

is a shame. Well, I have the evidence in human form,

and so do many other mothers who are suffering the

same plight with their children.

Our concerns are dismissed because the medical

community/the breast implant companies/plastic

surgeons/FDA and other medical organizations (IOM,

NCI, NIH) place business as usual ahead of their oath

of First, do no harm and the sake of the children, the

generations to come who will be exposed to the damning

devices. They rather cover their own tail while many

suffer the exposure from their self-serving ways of

products placed out to general population that exert

the human immune response, also via the placental

barrier through fetal cells.

Sir, I want you to know my breast implants were a

birthday present from my parents and to date, (October

2005 at the age of almost 48 years old. I will be 48

yrs old November 16th, 2005) I am still trying to blow

out the candle on this gift, but the flame has gotten

way out of control. I figured the flame will be out

the day I die or my children die.

Now, only am I very disfigured on my chest wall from

the breast implants. I have health concerns caused

from my toxic, very failed silicone gel breast

implants, as well as my three daughters who have

health issues elevated from the exposure to my failed

breast implants. But of course the companies have not

studied the offspring fully nor tracked the outcome of

children exposed to breast implants, so they are

further bushwhacking the generations to come if

silicone gel breast implants are placed back on the

market. This has been their free will choice and this

is not upholding their oath of First, do no harm to

that highest of high standard if silicone gel breast

implants make it back on the market. The breast

implant companies rather not spend their money on good

dispassionate studies, so their CEO's can retire with

alot in their pockets.

Last year I had myself along with two of my three

daughters tested for platinum in the urine. Our middle

daughter could not be tested because she was away at

college & was unable to make it home.

The results are as followed:

myself- 17.1 ug/L (parts per billion per liter of

urine)

1st born daughter: 15.3 ug/L

3rd born daughter: 16.9 ug/L

I understand your investigation to date is limited to

specific accusations regarding the 2005 FDA Advisory

Committee panel meeting and the PMA's reviewed at that

meeting. The problem is the breast implant companies

along with the plastic surgeons, who act as enablers

are making a free will choice to make a mockery of

everyone (you, me, the medical community as a whole

and all of humanity and the innocent generations to

come) by not upholding their oath of First, do no

harm. They failed by NOT " telling all " about silicone

gel breast implants. They only disclose what they want

to, but there is more to the story as many have

suffered as they failed to " tell all " in the 2005 FDA

meetings and with the PMA's that were being reviewed

at that meeting. This is being self-serving.

Also, the offspring, the generations to come are

forgotten souls when it comes to the breast implant

issues. Children on this earth now and the

generations to come have no voice. I guess this is why

mother's are placed on this earth, so that children do

have a voice, so I also am contacting you on behalf of

the children, (all children) who have been exposed to

their mother's breast implants. I am their voice

seeing I myself am a past teenage breast implant

patient whos children were exposed to very failed

silicone gel breast implants. I have walked the walk

and I am very capable of talking the talk.

Our youngest daughter, has scleroderma in the

form of PSS. She has problems swallowing and this may

wax and wane, but the swallowing problem has gotten

worse. is in the 10th grade. She also suffers

with a very severe bone dysplasia of the hands and

feet. Her hands and feet are the size of an 11-15

month old baby & have fused. Meaning they will not be

growing anymore. She also has AN, acanthosis nigricans

which is black skin on top of the shiny scleroderma

skin. She has learning delays and other health issues.

She is going through an advanced aging process, and I

do have her in many studies. She is basically being

used as a lab animal, like I was when I opted for

silicone gel breast implants in my youth. I really

think our lives are of more value than this, but

someone needs to uphold the oath of First, do no harm,

so this is why I have tried to get our family into

studies. But in research they can make their studies

fall the way they want no matter if it is the truth or

not.

I believe our is a McGhan/3M silicone gel

breast implant birth defect and one day she is going

to die a McGhan/3M silicone gel breast implant birth

defect. And not one soul will ever be able to take

this fact away from this young girl no matter how hard

everyone tries to get around the FDA moratorium on

silicone gel breast implants with their " words of art "

or " medical words of art " to cover their own tail of

the medical harm they have caused.

Gosh Senator Enzi, even the FDA's own scientists have

studies showing that silicone gel implants are

harmful, but of course the FDA does NOT listen to

their own scientists...this is why good scientists are

leaving the FDA lately. Everyone is fed up with the

FDA, along with the medical community selling their

souls to the highest bidder, industry.

In the case of breast implants that would be selling

one's soul to Mentor and Inamed. Inamed which is

really McGhan who made my breast implant lot numbers.

Inamed, McGhan whatever name they want to call

themselves they still cause harm to patients who

should think twice before they place their trust in

what they ever market...because all they care about is

business as usual, not about upholding their oath of

First, do no harm with silicone gel breast implants.

This is poor medicine.

Also, I would like to share with you some of what is

in my medical records when I had the failed devices

submitted for review and evaluation.

My records state: " Indeed , the implant appears to

have lost original contour in addition to its

structural integrity. Macroscopic examination reveals

that nearly all the silicone gel content was

extravasated outsede the prosthesis. The remaining

silicone gel has lost it's transparent and colorless

nature and acquired a slight yellowish tint. Color

changes in the gel are indicative of chemical

alteration in the medium. A moderate number of fine

precipitates are noted in the gel medium. Under the

microscope, these particles appear as fine,

needle-like, aggregated structures and granular

formations. They appear to have chemical and

biological origins. We have found that chemical

aggregates are composed of metals which can induce

immunogenic reactions when prolonged contact with

living tissues " .

The records continue to state: " More importantly,

silicone particles were seen in close contact with

blood vessels. The proximity of the blood vessels to

the silicone particles, indicates that they were

transported elsewhere through the systemic

vasculature. Also of significance is the fact that the

internal zones as well as the surrounding areas of

mammary glands dislayed infiltrated silicone gel

particles.

Large clacified plates containing infiltrated silicone

particles were also noted in the tissue. Calcified

structures were formed in response to the deleterious

presence of metal in the silicone gel. These metals

migrate into the surrounding tissue from bleeding or

ruptured implants " .

In more medical records taken from a review of my

failed McGhan/ 3M implants states: " Both the inner

and outer shells had been ruptured for many years

prior to explanation. Highlights also include a MAJOR

PRODUCTION DEFECT on the left implant which CONSISTS

OF A DEBONDED GEL FILL HOLE SEAL. This defect confirms

that the devices which contains a DEGRADED FLUID GEL

DEVOID OF STABILITY AND SHAPE MEMORY WITH A LUMPY

DISPERSION. This type of presentation is typical of

incorrectly formulated filling substances. It should

be noted that Ms. sey received devices

manufactured by the same production facility and

embodying major production problems from the outset.

The capsules are noteworthy for deep infiltration with

oil and gel, as well as structural features such as

opening and fenestration. Contrary to opinions

occasionally expressed in some quarters, such capsules

amount to open structures that have no protective

value against the release of oils and gel impurities

into the user's system " .

Also in my records it states: " The patch workmanship

is very poor with evidence of errors in assembly and

improper use of adhesive for sealant as well as

PLATINUM EXCESSES AS EVIDENCED BY A BLACK

DISCOLORATION on the patch edge. The item was

defective from the outset as it shows an open gel fill

hole which was never correctly sealed. It leaks oil

grossly and has potential for severe adverse reaction.

Both implants are creditable with the release of large

quantities of mobile, invasive gel which deeply

penetrated tissues. The capsules are remarkable for

irregularities, fenestrations and the development for

granulomatous tissue. They reflect all the attributes

of periprosthetic tissue exposed to uncontained gel

for a long period of time. "

The records continue to state: " Her history is

further remarkable for use of electrosurgical

techniques in a OIL- CONTAMINATED FIELD. This

procedure has potential for long term sequelae. " (HAS

ANYONE BROUGHT UP THE USE OF THE BOVIE/ELECTROSURGICAL

TECHNIQUES WITH SILICONE GEL BREAST IMPLANTS? Because

it is not good to use a bovie and silicone gel breast

implants. Ask Dr. Blais from Canada. He can explain

why)

The records speak more of the platinum: " The gel

feill hole is exposed and the sealant is partly

debonded from the shell or alternately bonding never

took place. Platinum discoloration is visible on the

patch edge. This material is plartly detached from the

substrate. The valve stem is laden with fine debris

indicating leakage. The patch workmanship is poor with

irregular peripheral cutting. The gel is turbid and

has fluid characteristics consistent with an

improperly polymerized product.

Senator Enzi, I bet nobody addressed alot of these

concerns above (what I have brought up in my e-mail)

in the 2005 FDA Advisory Committee panel meeting and

in the PMA's reviewed at that meeting...but they

should have because this happens to many people...it

happened to me. If they failed to have addressed these

issues like what I have stated in my above e-mail then

they are failing to uphold their oath of First, do no

harm to that highest of high standard.

MY POOR CHILDREN. I exposed my children to this via

the placental barrier then I breastfed all of them

with this toxic soup (the adjuvant, the catalysts/

platinum) deemed breastmilk...and everyone in the

medical community thinks this is harmless? Well, what

one does not know will hurt someone! Staying in denial

like a drinker is not good, so I will not play the

enabler to the medical community and this is why my

voice needs to be heard. They need to fix this huge

problem THEY MADE for many as they have failed to

uphold their oath of First, do no harm to that highest

of high standard.

Suffer the little children? They did, they have and

will continue to suffer if silicone gel breast

implants are FDA approved.

Thank you for your time.

Fuchs-sey

915 Rustic Drive

Macon, Missouri 63552

phone: 660-385-4621

Fuchssey@...

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