FDA plans to limit silicone gel implants to controlled studies

April 16, 1992|By Knight-Ridder News Service

WASHINGTON -- Silicone gel breast implants, one of the most popular cosmetic surgeries in the United States, will be available only to a limited number of women who will test their safety, FDA Commissioner David Kessler is to announce today.

Breast cancer patients and those disfigured by birth defects or injuries will have the best chance to obtain the implants if their doctor is convinced it is necessary for their well-being, a Food and Drug Administration official familiar with the plan said.

Only about 5,000 women will be permitted to increase their breast size for cosmetic reasons in the next three to five years, an industry official estimated.

Silicone gel implants will be available only to women willing to take part in controlled studies, transforming what was often an outpatient procedure in a plastic surgeon's office into an experimental procedure, FDA and other sources said.

Dr. Kessler's decision, to be disclosed at a morning news conference, will put the official stamp on a dramatic restructuring of a multimillion-dollar industry that has altered the bodies of more than 1 million American women.

Last year, about 100,000 women received silicone gel breast implants, experts say. Of that number, about 20,000 were cancer patients or were disfigured.

Experts predict that most women seeking breast augmentation will turn to the only available alternative, saline-filled silicone pouches, another product that has not yet been determined safe by the FDA.

Researchers are expected to study -- for at least three years -- all women implanted with the controversial silicone pouches in an effort to determine whether they are safe or are indeed the cause of cancer, autoimmune diseases and other health problems, as critics charge.

Before receiving implants, women will be required to sign a five-page consent form outlining the risks, which include: painful scar tissue around the implant, leaks, a possible hindrance to mammography detecting early breast cancers as well as concerns about cancer, birth defects and autoimmune diseases.

The commissioner's decision is expected to mirror a Feb. 20 recommendation by an FDA advisory panel that availability of implants be restricted to women willing to participate in strictly monitored studies.

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