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Study Casts Doubt on Breast Implant Peril : Health: Mayo Clinic report finds that recipients are no more likely to develop illnesses such as arthritis and lupus than other women.

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From Times Staff and Wire Reports

The largest study ever of breast implants finds no evidence that they cause rheumatoid arthritis or other serious diseases, challenging the claims of women who reached a $4.3-billion settlement with manufacturers.

The review, conducted at the Mayo Clinic, found that women who get implants to enlarge or reconstruct their breasts are no more likely than anybody else to develop a variety of connective-tissue disorders.

These diseases, including arthritis, lupus, scleroderma and several less common illnesses, have been linked to leaking implants. Much of the apparent evidence came from examples of individuals getting sick after receiving implants.

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However, such illnesses could be unrelated to their implants. Until now, there has been little rigorously conducted comparison to see if those who get implants have worse health than other people.

The study “should provide a lot of encouragement and reassurance to women who have been literally terrified by the unfortunate hype and hysteria that surround this,” said Dr. Sumner Slavin, a plastic surgeon at Boston’s Beth Israel Hospital.

The Mayo report is not the first epidemiological study showing no link between connective-tissue diseases and the implants. Several large studies presented at the annual meeting of the American College of Rheumatology in San Antonio in November also showed no association.

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Although no single study can prove that breast implants are safe, the researchers say theirs suggests that if there is any hazard, it is small.

The study, headed by Dr. Sherine E. Gabriel and published in today’s New England Journal of Medicine, was financed by the National Institutes of Health and the American Society of Plastic and Reconstructive Surgeons.

The researchers studied all the women given breast implants in Minnesota’s Olmsted County, home of the Mayo Clinic, from 1964 through 1991. They compared them to twice as many women the same age who did not get implants.

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Connective-tissue diseases were very rare among the women. After an average of eight years of follow-up, precisely the same proportion got these illnesses in both groups--five of the 749 implant recipients and 10 of the 1,498 in the comparison group.

One million to 2 million U.S. women are thought to have gotten breast implants. The Food and Drug Administration took implants off the market two years ago, contending that manufacturers failed to collect necessary safety data.

More than 13,000 lawsuits have been filed against Dow Corning and other manufacturers by women blaming implants for a variety of ailments. Manufacturers have agreed to the $4.3-billion settlement but have not admitted that the implants are harmful.

Dr. Marcia Angell, the journal’s executive editor, said the work cannot conclusively rule out any link between implants and connective-tissue diseases, in part because so few women studied had the diseases, “but their data are the best we have.”

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