Is the Door Shut on Many Claims Over Silicone Implants?
"I think it's an excellent report," Marcia Angell, MD, executive editor of The New England Journal of Medicine, told WebMD after the announcement. "I'm not surprised by the substance of it. It's been known for a long time that there was no evidence that silicone breast implants cause disease in the rest of the body. But I was surprised a little bit by the forthrightness of it. It was unequivocal."
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."