Breast Implants Are Dangerous

Why are not more people realizing that breast implants are dangerous?

TALCOTT CONSULTING

17 PACIFIC CREST
LAGUNA NIGUEL, CA 92677
December 1, 1991
Robert LeVier, Ph.D.

Dow Corning Corp.
Mail No. C03101
Midland, MI 48686-0994

Dear Bob:

Bob, I’m disappointed in your attitude towards me as indicated by the Canadian Broadcasting Company’s “Market Place” host Jackie Perrin.

You may or may not be aware that after the DePuy Breast Implant Program was shut down at the end of 1981, I offered to consult with Dow Corning Corp. and others.

I talked to Gene Jakubczak at Dow Corning about consulting on what I had learned about the failure modes of breast implants. I also wrote the President of the American Society of Plastic and Reconstructive Surgeons offering a paper on the subject. I was rebuffed by all parties.

I remain distressed that many apparently do not wish to try to understand the simple mechanisms and hazards of failure. Dow Corning was unconvinceable in 1975-1976 and I resigned in protest. I failed to convince American Heyer-Schulte in 1976-1978, and others in 1982 when I first became independently self employed.

There was a minimal success in 1988 at the November 22 FDA Panel Review of Safety and more recently at the 1990 congressional hearing and in 1991 with the information provided at the FDA Baltimore Symposium on Silicones in Medical Devices. On second thought maybe Bristol Meyers has listened intently.

A copy of my most recent offer to explain the various failure modes and this what needs to be done is attached.

I fail to understand how you and others hope that I will be silenced by disparaging comments as to being a “Junk Scientist” I remain a proud “Materials Engineer” for having had the foresight in 1975 & 1976 to visualize that many patients would suffer from non-retrievable silicone gel when their fluid gel filled breast implants were broken by trauma.

I disagreed with Dow Corning management at the time and today and do not believe the hypothesis that the biological capsule will contain the device and/or fluid silicone gel and bleed.

I felt then that implanting fluid gel filled breast implants into humans was no different than injecting silicone fluid into the breast after the breast implant was broken by trauma. You will recall that the first closed capsulotomy was performed by a simple hug.

Injecting silicone fluid into the breast at the time was considered improper and unsafe by all concerned, FDA, Plastic Surgeons, and Dow Corning Corp.. The gel obviously would flow or be pumped to distal areas of the body and be non retrievable with unknown long term consequences.

The Dow Corning Task Force (of which I was a member) moved to accelerate the new fluid gel filled breast implant introduction in 1975 and was successful in beating device legislation to obtain grandfather status and regain market share lost to competitors who marketed fluid gel filled devices.

I remain disappointed on the follow up to the severe inflammatory response that was observed on the low crosslink density gel in the 1975-90 day studies. I also thought it interesting that the protocol on those studies could be changed to 80 day studies to meet marketing deadlines of having the data before introduction at trade shows and promises of device delivery.

It is interesting that Garry Brody MD gave a paper (but never published) on the mechanism of closed capsulotomies in 1978 that easily extrapolates to the mechanism of device rupture when fluid type gels are involved. As you know Jim Rudy, President of Heyer-Schulte, warned the industry in August 1976 about the hazard of fluid gel filled breast implants.

This was confirmed in the 1981 use of the DePuy that contained a slightly firmer, energy absorbing silicone gel. The firmer gel would not allow closed capsulotamies to be performed. It is my belief that women should have a choice as to whether they want an easily ruptured device exposing silicone to tissue (at this point two words unreadable) daily to rupture.

In 1973 a Plastic Surgeon suggested to me that a material placed in the body should not be phagocytized. Interesting, as I am sure he realized then the interactions possible with macrophages and the Immune system. Dow Corning refused in that time frame to do bolus testing in tissue planes to study the degree of transfer to the vital internal organs of various consistency silicone gels.

To my knowledge Dow Corning still has done nothing or has not acknowledged doing anything about such gel interaction with macrophages or how much gel can be transferred to the vital organs using bolus implantation’s in tissue planes.

Tissue planes are different than muscle since the fibroblasts that lay down the collagen capsule have difficulty encapsulating the fluid gel as movement of the fluid gel interferes.

believe it unlikely that the manufacturers have come forward with the data on testing of this type and that FDA should request from Dow Corning, where it was done for a directly Implantable Gel program, and from Baxter (American Heyer-Schulte) where it was done in the Edward’s Animal Laboratories in Irvine California about 1977. Mentor Corp. should be aware of the latter data and be able to obtain it for FDA.

As a person with my extensive knowledge about silicones, their physical properties, their chemical reactions, their impurities, their interaction with animals, and knowledge of the severe injuries to women; I intend to continue to speak out to protect and expand women’s rights to have a choice when given all of the information concerning silicone gel implants.

Litigation, as in the case of many other earlier medical devices, is again apparently the only way to bring forth protection to reduce the risk to additional women.

Today there are 8000 members of Command Trust network (CTN). Interesting ratios were found by teams of doctors in the Harvard Study. Out Of 360 people with sufficient damages to sue for malpractice, only 8 did file suit.

A little math says 360,000 woman may be seriously injured, or 18%. The real number is likely somewhere between that and numbers suggested by the Plastic Surgeons and Dow Corning Corp.

It is my belief that breast implantation should only be continued under an Investigative Device Exemption (IDE). Under such a plan the prospective patients would be told of the experimental nature of the device. They also should be told how much bleed and exposed gel can enter the internal organs of test animals.

I believe they should be shown data on how gal consistency relates to rupture. Attached is a copy of what I wanted to Say on this subject at the FDA/PMA panel review. I was silenced by time constraints. The lobbying effort may be working.

I am further appalled that on November 26 1991 I read that Dow Corning is promoting the current breast implants on which the panel found no proof of safety (N.Y. Times National, advertisement on page 4A).

I imagine a large portion of your inventory will be sold between now and January 6, 1991 when FDA makes a final decision on Breast Implant Status.

Claiming 30 years experience is totally untrue with the change in gel consistency and formulation changes made by manufacturers in the period 1972 through 1976. Those Implants were introduced and called standard production product with only 90 day implantation in rabbits.

I believe I have rightly testified that companies have been performing experimental surgery on humans since the early 1970s. This is based on the fact that package inserts have continuously warned of more and more hazards that were not recognized over the past decade. All of these warnings were obtained from this experimental data on humans and damages pointed out by lawsuits.

I am also unaware that actual samples of gel bleed have ever been tested for effects in tissue to see the effect of platinum complex or elastomer additives. This is extremely disappointing to me since it has been known how to obtain suitable sample quantities of bleed for this work since about 1981.

I am surprised that more scientists, engineers and technical people involved with the evolution of these devices at Dow Corning have remained employees. This may suggest new low levels of self respect, self-confidence and extreme need for their (word unreadable) and employment.

In view of the many shortcomings of testing during the evolution of silicone breast implants to date it is reasonable that the FDA Advisory Panel decision was that safety has not been demonstrated by the manufacturers.

It seems only reasonable that the manufacturers should support a moratorium while arranging for continued use of improved or at least better quantified breast implants under an expanded large Investigative Device Exemption. When litigation causes the manufacturers to take Breast Implants off of the market, an IDE will be the only path.

The better quantification needed relates to gel consistency that encourages or discourages envelope rupture (energy adsorption character), and data related to the rate of encapsulation and/or transfer of the silicone gel to the organs where long term effects are unknown.

The amounts of real bleed and it’s effect on tissue and transfer to organs should also be given. It is time to do some critical work and stop making excuses for the work that has not been done during the last 30 years.

It vill be interesting how the Judges and Juries in thousands upcoming lawsuits will decide where the “Junk Science” really lies.

Sincerely,

Thomas D Talcott


Breast implants are dangerous but natural breast enlargement products are not.