Date: Tue, 2 May 2000 15:49:41 -0700

I.A.S. IMPLANT AWARENESS SOCIETY

102 - 6086 Boundary Drive West

Surrey, B.C., Canada V3X 2B3

Telephone: (604) 572-8486

April 25, 2000

Chairman Tom Bliley

2409 Rayborn House Office Bldg

Washington, DC 20515

Dear Congressman Bliley:

I am writing to you, as Chairman of the Commerce Committee, about saline breast implants. I am a Canadian woman who is also the president of I.A.S. Implant Awareness Society, a non-profit charity, registered in the province of British Columbia, that provides help to thousands of women in Canada, the U.S.A., and other countries.

Congressman Bliley, my experience working face to face with many hundreds of women who are desperately ill from both saline and silicone implants has caused me to spend many hours researching silicone that is in both the shell and the gel. Going back as far as 1960 to 1975, I have yet to find one positive document in the medical libraries that will state silicone to be a safe substance in the body of animals or humans.

The libraries are full of documents to such an extent that I cannot comprehend, believe, or understand that the FDA could possibly not know the truth about this very toxic substance. The plastic surgeon’s own renowned journals contain a plethora of documentation on how unsatisfactory breast implants are. Although there are hundreds of documents, I will only mention a few. All are taken from the Journals of Plastic & Reconstructive Surgery.

In 1966: Dr. Herbert Lipshutz said that a total of 71 patients underwent 88 implants manufactured by Dow Corning and known as silastic, medical grade, however 11 had to be removed. In a letter to the editor, Dr Joseph Sadusk, Jr. stated, "the technique is regarded as an experimental one, neither the safety nor the efficacy of which has been established". Dr. Alex Kelly, et al, stated, "The most difficult problem in this procedure is the slough of the skin over the prosthesis".

In 1967: Dr. John E. Hoopes, et al, states, "Six patients who developed cancer of the breast following augmentation constitute the basis of the present report."

In 1970: "silicone cysts were reported as frequent as with silicone injections. The returns did reveal one case of carcinoma."

The term "grandfathered" originated in America in 1910 and has tenuous legal status in U.S. courts. Furthermore, it is my understanding that, when an injustice could result in seriously jeopardizing the security of the person, or hint that it might even infringe on a person, it is not an option and cannot be used in that instance. From what I have learned, I do not see how the FDA or Health Canada can justify using the grandfather clause when breast implants are causing injury to thousands of persons, including children.

Other health problems have been discovered by Douglas R Shanklin, M.D. who wrote: "From a basic knowledge of immunopathology, however, one can predict with some assurance that children sensitized immunologically in utero to siloxanes will have often severe, potentially fatal reactions to any subsequent internal use of a silicone device, including but not limited to Port-A-Cath or Med-I-Port silicone catheters used for long term intravenous fluid administration. Young girls with in utero sensitization would be at risk should they choose later to have quasi-permanent sterilization using any one of several devices on the market for that purpose, such as the Falope Ring and the Filishe Clip, both of which contain silicone."

Heart pacemakers often have silicone insulation. Silicone implant survivors will not successfully be able to have the help of this life-saving medical device. What rational thinking woman, if she understood all of this, would opt for a non-life-saving breast implant over a life-saving device for herself and her children. Silicone is a biologically incompatible agent, especially for placement in the human body, is declared in many medical peer-reviewed documentation. The truth must be told now at all costs or we will lose confidence in the FDA. Millions of interested people as well as the sick women are following closely what is taking place.

The Acta volume 36, supplement III, 1975 Pharmacologica et Toxicologica, a 147-page Scandinavian Report found in medical libraries, affirms silicone to be extremely toxic substance that crosses the placental barrier. I have a copy of this report and it contains three chapters by Le Vier. R.R. of Dow Corning on the toxicity of silicone.

I read with great interest your letter to Jane Henney M.D., and was elated with your factual accurate account on the saline implant problems. How can these same implants be called "safe and effective" when they have so clearly been shown to be "unsafe", soon growing bacteria and fungi inside after implantation? How can they truly be effective while causing encapsulation and requiring so many more surgeries in an attempt to attain effectiveness. Women are never guaranteed the promised result. The plastic surgeons consent form uses this "safe and effective" term extensively; it is very misleading and should be discontinued at once. It is a type of false advertizing.

Congressman Bliley, these devices were dangerous and, forty years later, they are still dangerous in spite of so called upgrades. They never should have been on the market to begin with. You will notice that the Journals of Plastic & Reconstructive Surgery shifted away from telling how toxic silicone was in the 60’s. In 1977, that is when our plastic surgeons named four small-breast diseases, Hypomastia, Hypogenesis, Hypoplasia, and Hypoplastia. A promotion in Vol. 64, No 6, December 1997 in their journals stated, "medical grade silicone is virtually nonreactive in long-term implantation", and Vol 62. No 6, December 1978 refers to, "the rapid tissue in-growth and biocompatibility of Proplastic implant".

It has been stated in the International Journal of Occupational Medicine and Toxicology, Vol. 4, No. 1, January-March 1995 (there are 28 M.D.’s editors, and associate editors) "for the doctor who sees patients with a certain pattern of exposure and disease presentation, all that is needed is MEDICAL PROBABILITY". Hill M.D. (1965) has argued that "constant clinical observations, temporal relationship with exacerbation after placement and remission after removal, and dose-response curve coupled with experimental plausibility, are sufficient to establish causation". All of Hill’s criteria have been satisfied in silicone gel and saline breast implant related studies.

I appreciate more than words can tell your sincere honest desire to help the sick women and children who have been caught up in this most heinous crime against women and children in the twentieth century. The FDA must now stand up to the manufacturers and great men like yourself will be the only way it will be done. I have seen copies of letters personally written to Jane Henney M.D. and no answers were given. They were not heard and answers did not relate. We can only depend on men like yourself to help us with the FDA. Many women have asked me to write you and they look forward to your help. I will be posting this letter out to approximately 80,000 women in Canada and the USA. who follow my documentation and letters to Government.

Congressman Bliley, I will be happy to give you additional information.

Sincerely,

Adella Matthew

President