I.A.S. IMPLANT AWARENESS SOCIETY

Page 3 There were serious medical problems resulting from these (liquid silicone) injections, including deaths. In 1965 the FDA classified silicone injections as a drug under the FDA's jurisdiction, and began to regulate the device. Dow Corning Corp. applied for a Notice of Claimed Investigational Exemption for a New Drug (IND) for facial augmentation in 1965; breast augmentation was not permitted in the study because of the known medical risks. The FDA has never approved silicone injections for sale for human use.

Page 4 Because of the recognized dangers of liquid silicone injections, silicone gel breast prostheses were made available in the early 1960's. It was believed that the replacement of liquid silicone with silicone gel in a silicone envelope would prevent the silicone from migrating to other parts of the body. These implants were first used prior to Federal regulations requiring proof of safety and efficacy for most medical devices (came under the grandfather clause).

Page 4 The FDA's authority to regulate breast implants is based on the 1976 Medical Device Amendments. This law required FDA to issue regulations classifying all medical devices into one of three classes; only the highest risk devices (Class III) would require proof of safety and effectiveness. Prior to 1976, a small number of devices, including liquid injectable silicone, were regulated as drugs, but silicone implants were not.

Whereas silicone injections were immediately classified as a Class III medical device as a result of the 1976 law, thus requiring proof of safety and effectiveness, the FDA did not immediately classify breast implants. Manufacturers and plastic surgeons argued that the implants had been safely used for more than 10 years, and the FDA did not use its authority to require manufacturers to prove safety and effectiveness. By the late 1970's, many scientists and physicians had expressed serious concerns about the safety of breast implants to the FDA.

However, in 1978, an FDA advisory panel, which included several plastic surgeons, proposed classifying the implants as Class II. Despite that recommendation, in January 1982, the FDA published its proposed rule to classify silicone breast implants as Class III in the Federal Register. The FDA advisory panel met again in January of 1983 and unanimously recommended that the FDA classify silicone gel breast implants as class III devices. Finally, the FDA classified

silicone and saline breast implants as Class III devices in June 1988. (all of the above is word for word out of the report) However, the safety of both has yet to be established and that was 9 years ago. Although silicone is off the market except by special physician request, saline is very popular and it is estimated that in the USA alone 356 women are implanted daily with these devices that have yet to be proven safe. The year 1990 was the deadline for proven safety.

Today, all implanted women sign a special waver absolving the manufacturer, doctor, and hospital and pay between $3,000 to $7,000 US for implantation. Would you sign a waver against a car for ALL possible defects? I think not.

An implant in the 1970's cost 25 cents to manufacture. A plastic surgeon can do five or six breast implants, a face lift, a nose job, and eyelid surgery in a single day in his surgical suite. Many infections arise from operations done in these suites.

I cannot understand doctors participating in this. Is it for the business dollars the pharmaceutical companies and plastic surgeons earn? There is so much real evidence printed in Medical Journals about the harm done to a woman's body with all breast implants.

No woman is given medication to help her body accept these devices, and the body treats all foreign implanted objects the same. It does not matter if it's the breast, heart, liver, or kidney, the body knows it is foreign.

Adella Matthew

President