WASHINGTON, D.C.--A blue-ribbon panel has concluded that silicone breast implants do not increase the risk of diseases such as lupus or cancer, rejecting a theory invoked in countless claims against manufacturers. But the report, released at a press conference here today, is unlikely to be the last chapter in the lawsuit-weary saga: The Institute of Medicine (IOM) panel cites evidence that silicone implants can leak and cause infections or painful scarring around the implants.
The IOM stepped into the thorny arena of implant science in late 1997, at the request of the Department of Health and Human Services. The 13 panelists, led by Stuart Bondurant, a professor of medicine at the University of North Carolina, Chapel Hill, examined some 2000 peer-reviewed studies and 1200 other data sets and reports. They concluded that the 1.5 million to 1.8 million women with implants are no more susceptible to serious diseases than women without implants, according to available data.
But the panel did not give implants a clean bill of health. Essentially plastic bags filled with silicone gel, implants can rupture in an unknown percentage of women--studies have cited as low as 0.3% or as high as 77%. The pain and disfigurement of breast tissue contracting around implants, as well as infections and other health risks from surgery to replace implants, are "the primary safety issue[s] with silicone breast implants," the report found. The panel recommends more research to track women with implants to get a better handle on problems like rupturing and second surgeries, and improved tests to gauge silicone concentrations in breast tissue.
The IOM panel "is simply saying over again what we already knew--that the case for autoimmune disease was extremely weak," says Yale University immunologist Charles Janeway. But he and others say the imprimatur of the nation's top medical advisory body gives that conclusion more weight, shifting the scientific focus and legal battleground from systemic disease to local problems caused by ruptured implants.