Ever since women have been enlarging their breasts with implants, feminists have been upset. So predictably, today when an FDA advisory panel begins hearings to consider approval of silicone gel-filled breast implants, feminist health activists will urge them to reject the devices, claiming they are unsafe.
But the data emphatically do not justify their concerns. Study after study confirms silicone implants do not cause disease. Unfortunately women can’t depend on groups like the National Organization for Women to give them the facts.
It is now 13 years since FDA Commissioner David Kessler 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 for mastectomy patients–though the women had to agree to be tracked by the FDA in case there were complications.
Throughout the ’90s, litigation against the silicon-implant industry flourished in the absence of any scientific proof that women were made ill. Dow Corning Corp., once the biggest implant makers, filed for bankruptcy in 1995 to pay a $3.2 billion to settle about 440,000 women’s claims. Considering earlier successful lawsuits, the company chose to settle and thus limit its liability, lest it go out of business altogether. To date at least 20 studies show no evidence that implants–intact or broken–cause connective-tissue diseases. Many of these studies included women followed for an average of ten years after their implants, and some for up to three decades. No rigorously designed study showed any evidence of disease.
Still, the feminist health groups keep pumping out misinformation. In a recent 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, Center for Women’s Policy Studies, National Women’s Health Network, and the National Council of Women’s Organizations insisted that ruptures and the resulting silicone leakage can lead to “serious health problems.”
Wrong. These fears are based solely on anecdotes. In contrast, careful studies show that leaked silicone is not harmful. No device lasts forever, true, and early versions of implants, which have been around since the 1960s, did rupture regularly, at rates of at least 50 percent after 15 years. But, generally, the silicone did not migrate past the fibrous capsule that naturally forms around the implant. Data from the sole examination of rupture incidence rates published in 2003 in The Archives of Surgery indicate that about 20 percent of modern implants rupture within ten years of cosmetic augmentation.
Several respected medical entities have concluded that there is no greater incidence of collagen vascular disease in women with ruptured implants than in those without implants. These include analyses from the Institute of Medicine Report, Safety of Silicone Breast Implants (1999), commissioned by the U.S. Congress; U.K. Independent Review Panel on Silicone Gel Breast Implants (1998); the National Science Panel (1998); and the National Institutes of Health (2004).
And last July, a key study appeared in The Journal of Plastic and Reconstructive Surgery. It was the first to track individual women whose implants had ruptured, as detected with magnetic resonance imaging (MRI), and assess potential damage two years later. After monitoring 64 Danish women with at least one ruptured implant, the authors found no change in immunologic markers (indicators of collagen vascular disease). Most striking, in three-quarters of the implants in those 64 women, the rupture was contained in the fibrous capsule, and most of the women did not even know the device had torn. In only four percent of the ruptured implants did small amounts of silicone escape the fibrous capsule.
What’s more, the popular implants today in Europe and South America are “third-generation” devices. They have sturdy silicone gel–imagine thick, clear Jell-o–that typically keeps its shape even if torn. Fourth-generation devices–likened to Gummi Bears–are in the approval pipeline at the FDA and already in use in many developed countries, but not in the U.S. and Canada.
What about detection of breast cancer? In their letter, the womens’ groups allege that implants interfered with mammogram results. This is a dangerous half-truth. Yes, implants often do decrease visibility of breast tissue on mammographies (to compensate, radiologists use a specific positioning technique to get better views), but the critical question is whether this delays diagnosis. And here the consensus is strong that women with implants who develop cancer are not diagnosed at later stages than women in the general population are. Survival rates are the same both for cancer patients with implants and without them.
But no matter what the data say, these women’s groups won’t be satisfied. They are demanding at least ten years of follow-up data on ruptures from Inamed, the Santa Barbara-based company seeking implant approval this week. But the company already submitted three years of follow-up on more than 900 women (and plans to collect data on them for seven more years) and is also submitting European studies containing information on women with implants for at least a decade.
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 an active, ongoing post-marketing study. The ample data about rupture rates and the well-replicated inability to find a link between implants and systemic disease suggest acceptable risk for informed consumers. Fears of serious health risks amount to a tempest in a C-Cup, as The New Republic memorably put it. Yes, there are sometimes local problems such as pain or hardening of the implant, and they may require additional surgery. But women who are told of these risks should be able to make informed decisions.
The objections of women’s health activists are driven by feminist body politics which say women should love their bodies as they are, not change them to please men. Apparently, in the feminist mind, a woman has the right to choose what she does to her body as long as she chooses the right thing.
–Sally Satel M.D. is a scholar at the American Enterprise Institute and co-author with Christina Hoff Sommers of One Nation Under Therapy, published this month by St. Martin’s. A shorter version of this appeared in USA Today on April 11, 2005.