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Data do not support ban on silicone breast implants
By Sally Satel, USA Today,
4/10/05

Ever since women began enlarging their breasts with implants, feminists have been upset. So, predictably, when a Food and Drug Administration advisory panel begins hearings today to consider approval of silicone-gel-filled breast implants, feminist health activists will urge them to reject the devices as unsafe. But the data emphatically do not justify their concern.

Unfortunately, women can't depend on such groups as the National Organization for Women to give them the facts. It is 13 years since FDA imposed a voluntary moratorium on silicone implants, motivated by case reports that they caused connective tissue diseases (e.g., lupus, scleroderma). Within a few months, the ban was partly lifted so women could get implants after a mastectomy if they agreed to be tracked by the FDA.

To date, at least 20 studies show no evidence that implants, broken or intact, cause connective tissue diseases. Many of these studies included women followed for an average of a decade or more after getting implants. No rigorous study has shown evidence of disease. Still, feminist groups keep pumping out the misinformation.

In a letter regarding the FDA hearings sent to Rep. Nathan Deal, chairman of the health subcommittee of the House Energy and Commerce Committee, groups including Feminist Majority, National Women's Health Network and the National Council of Women's Organizations insisted that rupture and silicone leakage can lead to "serious health problems." Their fears are based solely on anecdotes.

True, no device lasts forever. Data from the sole examination of rupture-incidence rates, published in 2003 in Archives of Surgery, indicate that about 20% of modern implants rupture within 10 years of cosmetic augmentation. Even so, there is no greater incidence of connective tissue disease in women with ruptured implants than those without implants, according to exhaustive analyses from the Institute of Medicine (1999), the U.K. Independent Review Panel on Silicone Gel Breast Implants (1998) and the National Cancer Institute (2004).

Last July, the journal of Plastic and Reconstructive Surgery published a study that for the first time tracked women whose implants had already ruptured, and then assessed them two years later. After monitoring 64 Danish women with at least one ruptured implant, the authors found no change in immunologic markers (indicators of connective tissue disease).

What's more, the popular implants today in Europe and South America are the "third generation" devices. They have sturdy silicone gel — imagine thick, clear gelatin — that typically keeps its shape even if torn. Fourth-generation devices, likened to gummy bears, are in the approval pipeline at the FDA and are in use in many developed countries, but not in the USA or Canada.

What about detection of breast cancer? The women's groups say implants interfere with mammogram results. This is a dangerous half-truth. Yes, implants often decrease visibility of breast tissue on mammography (to compensate, radiologists use a positioning technique to get better views), but the critical question is whether this delays diagnosis. Here, the consensus is strong that women with implants who develop cancer are not diagnosed at later stages than women in the general population. Survival of implanted women with cancer is the same as cancer patients without implants.

The time is right for the FDA to grant approval of silicone implants for cosmetic use. A reasonable approach would be for the agency to stipulate that augmented women become part of active post-marketing surveillance. The ample data about rupture rates and well-replicated inability to find a link between implants and systemic disease suggest acceptable risk for informed consumers.

The objections of feminists are driven by body politics that say that women should not alter their bodies to please men. Apparently, a woman has the right to choose what she does to her body as long as she chooses the right thing.

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