This column was written by Sally Satel, M.D..
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.
1 / 2
National Review Online