The Politics of Women's Health
Implants Still Not Safe
An op ed by plastic surgeon Edward Melmed and OBOS director Judy Norsigian. Previously published in the Boston Globe, February 2, 2007. Reposted with permission.
The Food and Drug Administration recently approved the use of silicone gel implants for use in breast augmentation. However, the FDA's stamp of approval doesn't mean implants are safe. There remain considerable risks that women must consider before walking into the operating room.
We have heard from hundreds of women who have struggled with health problems they believed to be the direct result of their silicone breast implants. One woman was hospitalized with serious symptoms that subsided only after her silicone implants were removed. Other women have repeatedly mentioned such problems as connective tissue disease, chronic fatigue, dizziness, and various pain-inducing muscular deformities.
Beyond anecdotal evidence, the FDA's own research concludes silicone gel implants will eventually break, most within 10 years. Some plastic surgeons say the newer silicone implants will break and leak far less often, but there is little evidence to support this claim. Moreover, silicone that gets into the lymph nodes (and from there to the lungs and liver) poses greater risks than leaking saline, which can be absorbed more easily by the body. Invasive surgery is required to try to remove the gel, but the body's immune system may be already compromised, and the breast deformed.
In terms of cost, silicone implants are about $1,000 more expensive than saline implants -- and this represents just the beginning. The FDA has made it clear that patients will need a breast MRI after three years, and every year after that for the rest of their lives. An MRI for one breast ranges from $1,600 to $5,000. In addition, follow-up surgery to replace a leaking implant is usually more expensive than the initial procedure.
Most troubling is that the FDA endorsement was made without adequate safety assessments. The medical community still does not have a clear picture of how many women have become sick due to a leaking implant. There are also no well-designed studies examining the effect of leaking silicone on breast milk. And there is a significant, unanswered question about the existence of platinum in the breast milk of women with silicone implants -- some believing that platinum is dangerous. We should have understood the effects of platinum before approving the product.
Perhaps the greatest indicator that the FDA has proceeded too quickly is that, according to its latest ruling, silicone manufacturers must conduct a study of at least 80,000 implant recipients over the next 10 years to determine the long-term safety and efficacy of the implants. Should this kind of study not be conducted before giving the green light, not after? Should we not understand the long-term risks before sending a product to market?
History is repeating itself. Today's silicone implants are essentially the same ones that hit the market in 1981. The silicone implants back then, like those on the market today, have too high a risk of rupture.
Furthermore, the FDA was unable to conclude in the early 1990s that silicone gel implants were safe or effective because of the shortcomings of the research. It is a similar situation today.
Women are essentially the experimental lab rats into whom the so-called new and improved "fifth generation" of silicone will be implanted. This is no way to conduct scientific studies.
Women considering the silicone option need to be fully aware of the lack of data showing these implants are safe. It may be hard to resist the ads for a more "beautiful" body and a "happier you," but doing so may avoid health problems and enhance long-term well-being.© Copyright 2007 The New York Times Company.
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