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Silicone Breast Implants Do Not Cause Disease, Experts Say

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March 15, 2000 (New York) -- Women with silicone breast implants do not appear to have a higher risk of developing connective-tissue diseases and diseases of the immune system such as rheumatoid arthritis and lupus, a new report says. The report, in Thursday's issue of The New England Journal of Medicine, is one of several in recent years to refute the theory that the implants can cause these diseases.

"There was no evidence of an association between breast implants ... and any of the individual connective-tissue diseases, all definite connective-tissue diseases combined, or other autoimmune or rheumatic conditions," say Esther C. Janowsky, MD, PhD, and colleagues at the University of North Carolina at Chapel Hill. Last year, an expert panel of the Institute of Medicine came to a similar conclusion after reviewing about 3,000 published studies and hearing from women with implants and experts.

The FDA banned sales of silicone-filled breast implants in 1992, following reports of high rates of rupture as well as diseases such as rheumatoid arthritis, lupus, scleroderma, and the "dry-eye" condition known as Sjögren's syndrome. Since then, there have been intense medical and legal debates over the relationship between the implants and such diseases. Dow Corning Corp. has agreed to pay $3.2 billion to breast implant recipients who have become ill, and has filed for bankruptcy as a result of litigation relating to the implants. Other manufacturers have collectively agreed to a settlement of approximately $3 billion to be paid out to women who believe they have become ill from their implants.

Janowsky and her colleagues analyzed data from 20 published reports of associations between silicone breast implants and connective-tissue disease. In addition to finding no evidence of excessive risk of these diseases in women with silicone implants, the researchers estimated that such women account for less than 1% of all new cases of rheumatoid arthritis, lupus, Sjögren's syndrome, and similar diseases diagnosed in U.S. women each year.

But the researchers say that many of the studies they looked at did not address factors other than implants that could account for increased risk of these diseases. They also note that most studies fail to include the participants' reasons for getting the implants -- whether cosmetic or for reconstruction after breast cancer -- which they say may have affected their symptoms.

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