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Implant Data Still Uncertain Authority Can’t Guarantee There Is No Risk Of Disease

Women with silicone breast implants are not at a big risk of such diseases as lupus, the nation’s top drug regulator told Congress on Tuesday. But that doesn’t guarantee there is no risk, he said.

Food and Drug Commissioner David Kessler said he can’t estimate how likely these women are to have implants fall apart inside their breasts and flood their bodies with a pound of silicone gel. Some studies suggest 71 percent of these women will eventually experience such a rupture.

And he couldn’t say if certain women, perhaps as many as 10,000, are particularly vulnerable to the effects of this silicone and will be at some increased risk for devastating diseases.

“As a doc, I’d love to be more reassuring,” Kessler told a congressional hearing. But if his own mother needed an implant, Kessler said, he wouldn’t have enough data to give her clear advice.

Some 1 million American women have the implants, and thousands claim the implants have injured them, including causing severe autoimmune diseases such as lupus and rheumatoid arthritis. Implant manufacturers have agreed to a $4.25 billion court settlement with about 280,000 women, but that settlement is in jeopardy because there may not be enough money.

Implant manufacturers insist the products are safe, citing studies, including one of 80,000 women published in June, that found no link with autoimmune diseases. Some other doctors argue the implants are very dangerous.

Lawmakers assailed Kessler at a congressional hearing Tuesday for severely restricting women’s access to the implants since 1992. That year, the FDA banned silicone implants for purely cosmetic surgery, but allowed them for breast cancer victims as long as those women agreed to be in clinical trials, run by 1,400 surgeons nationwide, that would determine if the implants were safe.

Critics say the FDA’s refusal to declare implants safe makes women delay getting tested for breast cancer because they fear they can’t get reconstructive surgery if they are ill.

“The issue today is whether the FDA is killing women,” said Rep. David McIntosh, R-Ind.

Tags: health

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