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Is the Door Shut on Many Claims Over Silicone Implants?.

WebMD Health News

Dec. 28, 1999 (Atlanta) -- Silicone gel breast implants have been around for nearly four decades, and about a quarter of that time the manufacturers of the implants have been mired in controversy and lawsuits. Is it possible that the end of the millennium brings the end of breast implants, the end of the controversy, or both? Don't count on it.

Dow Corning Corp. developed silicone gel implants for commercial use in 1962. Other manufacturers introduced breast implants in the late 1960s. Since that time, estimates of the number of women who have had silicone implants approach 2 million, with about 70% getting them for cosmetic reasons and the rest for reconstruction after mastectomy.

The safety of breast implants became a national issue when women who became ill began to sue the manufacturers. Until this point, little research had been done on safety issues regarding breast implants. In 1992, the FDA called for a moratorium on the use of silicone gel implants until more study was done. Like many medical devices, silicone implants were on the market before FDA regulations required the devices to be shown safe and effective by manufacturers.

Dow Corning eventually agreed to pay $3.2 billion and filed for bankruptcy due to the litigation. Other manufacturers agreed to pool resources and settle for about an additional $3 billion. Women could choose to opt out of those settlements and pursue their own lawsuits.

That implants could rupture, and cause resulting localized problems because of the leakage of the silicone, was never denied by any of the parties involved. But many women blamed the implants for even worse problems like lupus, rheumatoid arthritis, body aches, and fatigue.

Studies over the following years began to cast doubts, in the minds of many, but not everybody, that there was no clear association between the implants and these diseases. In late 1998, a four-member scientific panel appointed by a U.S. district judge said it found no proven links.

Then, early this summer, an independent panel of 13 scientists formed by the Institute of Medicine (IOM) at the request of Congress to review past and current studies on the safety of silicone breast implants, also found no link. The reaction was strong, and there was a lot of talk afterwards. There has been much less talk since.

"I think it's an excellent report," Marcia Angell, MD, executive editor of The New England Journal of Medicine, told WebMD after the announcement. "I'm not surprised by the substance of it. It's been known for a long time that there was no evidence that silicone breast implants cause disease in the rest of the body. But I was surprised a little bit by the forthrightness of it. It was unequivocal."

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