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Is the Door Shut on Many Claims Over Silicone Implants?

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Advocates of the 1992 ban on silicone breast implants were incensed, again. "It's a war of the spin control artists on both sides of the issue arguing about what the studies show," Diana Zuckerman, PhD, was reported as saying. "Many of the studies have been funded by Dow or by plastic surgeons, and so, not surprisingly, they are designed in a way that tends to show there are no problems. ... I couldn't say, based on what we know so far, whether or not breast implants cause systemic disease." Zuckerman is executive director of the National Center for Policy Research for Women and Families.

Not surprisingly, the primary silicone implant manufacturer, Dow Corning, was pleased with the IOM findings. At a press conference attended by Dow Corning research and legal staff, host Barbara Carmichael, vice-president and chief information officer for Dow Corning, said, "The IOM study provides additional, solid evidence that breast implants do not cause disease." Dow no longer manufactures silicone breast implants.

As for the FDA, the IOM report "hasn't qualitatively changed our understanding of the problem," David Feigal, director of the FDA's Center for Devices and Radiological Health said at the time.

Gary Solomon, MD, who treats women with silicone breast implants suffering from connective tissue disease, spoke with WebMD about this issue prior to the release of the IOM data. "I firmly believe implants cause some -- but not all -- women to be ill," says Solomon, who is with the Hospital for Joint Diseases Orthopedic Institute and New York University School of Medicine. "I think that the research that's been done to date hasn't adequately addressed the issue of safety. ... Studies that have been done by the Mayo Clinic, Harvard Medical School, [etc.] have been well-designed, well thought-out studies, but ... they were looking for classic connective tissue disease, which is not the disease people are reporting in women with implants. ... They don't address the issue of whether there is an atypical disease present."

According to a press release issued by the IOM, however, the committee took into account the possibility that silicone breast implant patients are suffering from a nonspecific or atypical connective tissue disease. The researchers found no link between the implants and a "unique disease syndrome."

Angell, a longtime critic of the FDA, lay media, and legal response to unfounded claims of the danger of silicone breast implants, has a strong reaction to the argument that the studies conducted to date are not appropriate. "[The IOM report is] one of a series of authoritative, unbiased reports to look at this matter," Angell tells WebMD. "The British Department of Health did, the AMA did, the American College of Rheumatology, [and] Judge Pointer's national science panel. They all have said the same thing. But this is a very prestigious body. The report was thorough, comprehensive, authoritative. I think it ought to finally lay the matter to rest [scientifically]."

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