The risk of silicone implants

January 13, 1992

Dr. David Kessler, commissioner of the Food and Drug Administration, made a reasoned move when he asked for a moratorium on silicone breast implant surgery. It has been a decade since the FDA first expressed skepticism about the safety of these implants, but nothing substantive has been done.

Though the FDA recognized silicone implants as possible health risks in 1981, the government was gripped for a decade by a fervent commitment to deregulation, and the agency, under Reagan-appointee Frank Young -- dragged its feet. Finally, in 1990 Kessler -- an energetic advocate of a revitalized FDA -- asked implant manufacturers to turn in safety data.

The information compiled by the $300 million-a-year industry, though it did not prove the implants were safe, did not make a strong enough case for banning the implants, either. Given the lack of definitive proof, the FDA allowed the implants to remain on the market. But a malpractice case against Dow Corning, the largest manufacturer of silicone implants, has since revealed that the company had its own studies which showed the implants can leak or rupture. Internal memos between company executives suggested that they knew it, too, but didn't inform the federal agency.

Two million women in America now are living with silicone breast implants. With 10,000 women having the surgery every month, a moratorium is the only defensible action until the FDA can reassess all the data to at last determine whether the implants pose a health risk.

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