FDA Advisers Oppose Letting Silicone-Gel Breast Implants Back on Market After 13-Year Near-Ban

By LAURAN NEERGAARD

The Associated Press

Apr. 12, 2005 - Silicone-gel breast implants haven't been proven safe enough to lift a 13-year near-ban on their use, federal health advisers narrowly ruled Tuesday.

Manufacturer Inamed Corp. had argued that today's silicone implants are less likely to break and leak than versions sold years ago. But the Food and Drug Administration was skeptical, and its advisers voted 5-4 on Tuesday that lingering questions about how long the implants last and what happens when they break must be answered before the implants are widely sold.

Without that information, "How can we get an informed consent from our patients?" asked FDA adviser Dr. Amy Newburger, a New York dermatologist. "It makes me very uneasy. ... I don't feel secure about the safety."

That doesn't mean the implants can never be sold, the advisers stressed. No one expects implants to last a lifetime, but at the very least women need evidence about how likely they are to last 10 years, many panelists stressed.

"All of us feel very strongly that women have a choice," said Dr. Barbara Manno of Louisiana State University. But she ultimately opposed lifting the ban because Inamed has tracked patients for only three or four years to answer that question, and there are signs that the older the implants get, the more likely they are to rupture.

The decision came after emotional testimony pitting woman against woman Monday: dozens who said implants broke inside their bodies to leave them permanently damaged, and others who want implants they say feel more natural to repair cancer-ravaged breasts or make their breasts bigger.

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