Is the Door Shut on Many Claims Over Silicone Implants?

From the WebMD Archives

Dec. 28, 1999 (Atlanta) -- Silicone gel breast implants have been around for nearly four decades, and about a quarter of that time the manufacturers of the implants have been mired in controversy and lawsuits. Is it possible that the end of the millennium brings the end of breast implants, the end of the controversy, or both? Don't count on it.

Dow Corning Corp. developed silicone gel implants for commercial use in 1962. Other manufacturers introduced breast implants in the late 1960s. Since that time, estimates of the number of women who have had silicone implants approach 2 million, with about 70% getting them for cosmetic reasons and the rest for reconstruction after mastectomy.

The safety of breast implants became a national issue when women who became ill began to sue the manufacturers. Until this point, little research had been done on safety issues regarding breast implants. In 1992, the FDA called for a moratorium on the use of silicone gel implants until more study was done. Like many medical devices, silicone implants were on the market before FDA regulations required the devices to be shown safe and effective by manufacturers.

Dow Corning eventually agreed to pay $3.2 billion and filed for bankruptcy due to the litigation. Other manufacturers agreed to pool resources and settle for about an additional $3 billion. Women could choose to opt out of those settlements and pursue their own lawsuits.

That implants could rupture, and cause resulting localized problems because of the leakage of the silicone, was never denied by any of the parties involved. But many women blamed the implants for even worse problems like lupus, rheumatoid arthritis, body aches, and fatigue.

Studies over the following years began to cast doubts, in the minds of many, but not everybody, that there was no clear association between the implants and these diseases. In late 1998, a four-member scientific panel appointed by a U.S. district judge said it found no proven links.

Then, early this summer, an independent panel of 13 scientists formed by the Institute of Medicine (IOM) at the request of Congress to review past and current studies on the safety of silicone breast implants, also found no link. The reaction was strong, and there was a lot of talk afterwards. There has been much less talk since.

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"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."

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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]."

Stuart Bondurant, MD, IOM panel chair and dean emeritus of the University of North Carolina School of Medicine, said at the time of the report's unveiling "I don't think the committee expects this [report] to be the definitive and last word."

Zuckerman echoed that sentiment. In an article she wrote soon after the uproar quieted down, she said, "the number of studies is not as important as their quality. When well-designed research has studied larger numbers of patients who have had implants for a longer period of time, then we will have the answers that so many women are waiting for."

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