The Breastapo are at it again, trying to dictate what American women should and shouldn’t do with their breasts. On August 9 they were at the National Press Club, speaking out against the recent FDA decision to approve marketing of silicone breast implants (under FDA negotiable conditions) for cosmetic augmentation. The National Council of Women’s Organizations hosted the event and featured speakers from the National Organization of Women, the National Women’s Health Network, and Public Citizen, among others.
We are “so concerned about this… because it is uniquely a women’s issue,” said Martha Burk, spokeswomen for all women “and it uniquely affects the health and lives of many, many women. No one wants another Dalkon Shield.” “They’re making women sick,” Kim Gandy of NOW weighed in. “Women will risk a lifetime of grave complications from faulty breast implants because the Bush administration and their appointees value short-term profits over women’s long-term health.”
But what do the data say?
Study after study confirms silicone implants do not cause disease. 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 1990s, litigation against the silicone-implant industry flourished in the absence of any scientific proof that women were made ill by implants. Dow Corning Corporation, once the biggest implant maker, filed for bankruptcy in 1995 to pay $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. During the conference they focused on silicone leakage and the serious health problems that ensue.
However, 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; the 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 who had suffered implant ruptures, detecting the ruptures with MRI and assessing 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 gummy 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 a letter to Congress last spring, women’s groups alleged 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.
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 correcting these problems may require additional surgery. But women who are told of these risks should be able to make informed decisions for themselves.
The objections of the Breastapo are driven by feminist body politics which say that women should love their bodies as they are, not change them to please men. Apparently, in the feminist mind, a woman only has the right to choose what she does to her body as long as she chooses the “right” thing.