Reprieve For Breast Implants

By MICHAEL D. LEMONICK

Should a product sold for nearly 30 years to millions of satisfied customers be abruptly taken off the market? That was the question before an advisory panel of the Food and Drug Administration last week as it held hearings on the emotionally charged issue of the safety of silicone breast implants.

The testimony was impassioned on both sides. Implant manufacturers brought out reams of safety-test data, claiming their products were essentially harmless. Some users spoke of gaining self-esteem by reshaping their bodies, and of a psychological boost in battles against breast cancer. But others told stories of pain from internal scar tissue, diseases they attributed to the implants, and deformities suffered when the prostheses ruptured or shifted. In the end, though, the panel voted unanimously to recommend that implants stay on the market, and FDA Commissioner David Kessler is expected to concur.

That is not the same as giving implants a clean bill of health. The panel also concluded that safety testing conducted by the four largest manufacturers of implants was inadequate, and called for continued tests. Said panel member Mary Davis, associate professor of pharmacology and toxicology at West Virginia University: "This should send the manufacturers a message that it is no longer business as usual."

In the three decades that breast implants have been on the market, the FDA has never before considered their safety. It did not have the authority to do so until 1976, and the agency took until 1988 to put the implants on its list of medical devices requiring the strictest scrutiny. The companies had until last July to document the implants' safety, but could not satisfy the FDA's experts.

However, 2 million women are using the devices, mostly for cosmetic purposes but also for breast reconstruction after surgery. Implants can deteriorate or spring leaks, and a manufacturing ban could leave these women no way to get a replacement. That was undoubtedly a major factor behind the panel's vote. The companies will still have to prove their products' safety, but without clear proof that the implants are unsafe, they will stay available to women who want them.