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A Month After FDA OKs Return, Austrian Study Raises Safety Issues

Silicone Breast Implants: New Concerns

Implants Extensively Studied continued...

But Renee Carter, of the National Research Center for Women and Families, tells WebMD that the relatively new research methods used in the Austrian study team allow closer scientific scrutiny than was possible in the past.

"For a long time, we considered silicone implants to be inert when they were placed in body," she says. "This research suggests that they are recognized as foreign, and that they may not only start, but fuel, an inflammatory response."

On the other hand, plastic surgeon Bruce Cunningham, MD, tells WebMD the Austrian research falls far short of proving a link between silicone-filled breast implants and autoimmune diseases like rheumatoid arthritis and lupus.

"The fact is that proteins attach to all kinds of biomedical devices implanted in the body," he says. "But it is a huge leap of faith to reach the conclusion that the presence of these proteins is responsible for triggering these autoimmune phenomena."

Study after study has failed to show a link between silicone-filled breast implants and a greater incidence of disease in the women who have them, Cunningham says.

Cunningham is a professor of plastic surgery at the University of Minnesota and the immediate past president of the American Society for Plastic and Reconstructive Surgeons.

"The FDA just approved these devices, after studying the data for the last 14 years," he says. "If they thought for a moment that there was a valid concern about connective tissue disease -- or any disease -- they would never have done that."

Diana Zuckerman, PhD, president of the National Research Center for Women and Families, says FDA decision-makers ignored critical evidence suggesting an increase in autoimmune symptoms among women with implants.

"The disturbing thing about the FDA decision is that there were so many unanswered questions," Zuckerman says. "What was the rush? There is plenty of reason to be concerned that at least some women are having bad reactions to silicone implants."

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