Dear Silicone Sisters,Diana Zuckerman, Ph.D., the scientist who initiated the report to Congress on the FDA's Regulation of Silicone Breast Implants, 1992, says that with the FDA's approval of saline implants in spring 2000, and I quote, "the FDA has set a new low standard" see her web site  

Manufacturers and surgeons will earn $800 million a year on saline implants alone. This is the simple reason why you will not hear a plastic surgeon and most doctors talk negatively about breast implants. They are part of this huge cash machine. The simple and safe salt water in saline is not simple or safe long. Saline has a shelf life, and no hospital will wash a scratch with out-dated saline, yet it is being constantly told to women; how safe it; and that in the breast it remains good. It begins turning septic in less than two years time.  

The following documentation is taken, with permission, directly from Dr. Pierre Blais ; report to the FDA in April 2000. Dr. Blais is a former Canadian Government researcher and Senior Scientific Advisor. He made 14 recommendations to the FDA and 12 have been implemented.  

Field reports on failures and adverse reactions from saline inflatable breast prostheses are not comprehensive. There is a history of under-reporting which has worsened significantly since 1990. Field report data do not realistically assess the extent or severity of complications.  

Published information is sparse and incomplete. There is suppression of information regarding untoward events and service failure of the items. Any committee engaged in review of safety and efficacy of saline inflatable prostheses will not have access to all data. Much of it is unpublished.  

Amongst all commercially made saline inflatable prostheses, there is not one currently in use which could be construed as being substantially equivalent to a product made before May 28, 1976, the watershed date for U.S. FDA medical device regulations. The products have undergone drastic changes at regular intervals as product design fashions, production machinery, and raw material vendors changed. This view is confirmed in manufacturer advertisements and promotional material to physicians and the public where the products are claimed to be novel and significantly improved from what was made previously. To date (March 2000), there has been no perceptible change in the lackluster performance of the products. More than eighteen manufacturers have made such products. About seven remain active.  

Less than 5% of new users are breast cancer patients, nearly unchanged for the last two decades. About 9 - 10% of current users are for ;replacement ; patients with earlier implants that failed and left them disfigured. This number is rising, reflecting maturation, failures and; wear out; of poorly made saline inflatable devices inserted in the mid-nineties.  

Lack of durability, fluid leakage, frequent replacements, adverse reactions, and litigation have surrounded this technology from the outset. Late-nineties saline inflatable implants still have short service lives. Usage continues to rise, driven by misleading promotion.  

The capsules which form around the prostheses are difficult to assess. They are not "normal" connective tissue structures. Such capsules can contain large amounts of prosthetic debris and modified natural substances with scope for adverse effects. Typically, they incorporate prosthetic debris, oils, coarse mineral deposits, and denatured tissue.  

Risks to infants from breast milk contaminated by low-level infective prosthetic effluents are not well documented. It is contrary to common logic to assume safety of human breast milk derived from bearers of leaky saline inflatable prostheses with colonized aqueous fluids. Furthermore, breast engorgement followed by lactation has disruptive effects, even on non-augmented breasts. For an unstable augmented breast where severed ligaments and reattached muscles are often present, there are strong risks that the cosmetic effect for which the procedure was done will be lost thus motivating the user to undergo more corrective surgery with attendant risks.  

A woman's choice is to keep her infant from harm. She can only do this with ALL OF THE INFORMATION. When you opt for breast implants, you remove some choices in your life. Kind of like breaking the law, when we do that we have a record that will always affect our choices. Getting a breast implant removes some of our choices.  

Saline breast implants gradually lose the filling charge because of filling port failure, shell perforation, creasing, and material deterioration. As implants age, shells become porous and valves incompetent. This not only causes outflow of the filling fluid but allows blood product and occasional micro-organisms to enter the filling fluid. This process sets in insidiously well before deflation is noticed, growth of bacteria and algae then takes place stimulated by decaying blood and proteins from the host. The growing organisms often reach florid quantities several years after implantation. The shells ultimately fail releasing grossly contaminated fluid into the host. Diagnosis is difficult as symptoms appear unrelated to the faulty implants. In more severe cases, the space around the implant and the upper chest become filled with infectious fluid and the device may extrude through the skin. Such situations are frequently life threatening.  

Losing choices over breast implants is reaching into obtaining health insurance in the U.S.A. Many women are being refused explantation there today, along with $350 to $500 monthly premiums that exclude anything to do with breast implants. Will Canada follow in the same footsteps? This would mean that premiums deducted mandatorily, on the job or in the private sector, would not cover implant related doctor visits. Your employer, if he pays some of the premium would know if you have implants. Yes, breast implants are becoming a very expensive choice, paying for implantation, surgeries in between, explantation, and also doctor visits. It is morally wrong for any government to allow breast implants on the market and then to recoup lost revenue, as is being done in the U.S.A., and at the same time agreeing with the manufacturers and plastic surgeons that they are "safe and effective". Are we missing something here???? duh!!!!!!!!!!!!  

Breast implants "are the least effective and most problematic devices That's ever been approved," says Cindy Pearsons, executive director of the consumer advocacy group the National Woman's Health Network. "The complications continue to rise with each successive year after surgery, and implants usually have a negative impact on a woman's health."  

The FDA's New BREAST IMPLANT BOOKLET 2000 (71 pages) is on the web.

Enquiries are invited,  

Adella Matthew