An independent panel of US scientists convened at the request of Congress has concluded that silicone breast implants do not cause any major disease but that they do frequently leak and rupture, causing local problems such as scarring, infection, and disfigurement. These last symptoms may result in the need for further surgery.
The panel was formed by 13 members of the Institute of Medicine, a private, non-profit arm of the National Academy of Sciences. Its report is expected to help stem the wave of litigation over breast implants.
About 1.8 million women have had silicone breast implants since they were introduced in 1962, in most cases for cosmetic reasons. In the 1980s, some women with ruptured implants began complaining of ill defined symptom complexes such as fatigue and muscle and joint pains, and concern was raised that the implants caused autoimmune diseases.
In 1992 the Food and Drug Administration banned silicone gel implants, pending research into the issue. Saline filled breast implants were exempted from the ban, and silicone gel implants for reconstructive surgery after mastectomy were also exempt.
Meanwhile, several well publicised large monetary settlements initiated a flood of lawsuits against the makers of silicone breast implants, ultimately resulting in a declaration of bankruptcy by Dow Corning, the largest manufacturer of silicone breast implants.
Last year Dow Corning agreed to pay out $3.2bn (£2bn) to compensate 176000 women who filed a class action lawsuit against it.
Despite successful litigation, evidence supporting the claims has been scanty. Over 20 studies failed to confirm a link between silicone implants and cancers or autoimmune diseases, such as rheumatoid arthritis, scleroderma, and multiple sclerosis.
In reaching its decision, the Institute of Medicine evaluated over 1200 papers and 17 epidemiological studies. The report suggested that complaints linked to implants are largely anecdotal. “Syndromes of the type ascribed to implants generally involve symptoms that are nonspecific and common in the general population,” the report said.
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FDA
Silicone gel implants do not cause major disease, says US scientists