Implants and Science

November 20, 2006

It took 14 years, but science finally trumped politics Friday, with the Food and Drug Administration's lifting of its longstanding ban on silicone-gel breast implants. Women will at last be allowed to make their own decisions about cosmetic surgery. This is especially welcome news for mastectomy patients.

The FDA removed them from the market in 1992 during the reign of Commissioner David Kessler, a politically ambitious bureaucrat who was courting support from the left. The agency cited health concerns that have long since been debunked, and silicone-gel breast implants have since been at the heart of one of the trial bar's biggest scams. Class-action lawsuits raked in billions of dollars and drove implant makers out of the business. Dow Corning went into bankruptcy. Throughout it all, the trial bar was abetted by a gullible press, only too happy to ignore the science and play up sensationalist stories of supposed "victims."

Meanwhile, as we reported in editorials at the time, study after study showed no linkage between silicone breast implants and cancer, lupus, the skin-hardening disease scleroderma or other serious illness. As far back as 1994, doctors at the Mayo Clinic found "no association between breast implants and the connective-tissue diseases and other disorders" that they studied. In 1999, the Institute of Medicine found no systemic health problems caused by implants. In 2003, an FDA advisory panel advised that the ban be removed.

Last week's FDA decision notes that women with implants still run the risk of complications from leakage -- a risk that the industry has never denied and that patients have always been informed of. In approving implants made by two companies, Allergan Inc. and Mentor Corp., the FDA urged patients to get regular MRI exams. That's surely wise, but in any case it's a risk that patients and their doctors are perfectly capable of weighing against the benefits of the procedure. One of the ugliest aspects of the breast-implant controversy has been the irresponsibility of the feminist movement, whose championship of a woman's right to "choose" doesn't extend to breast implants. It's all the more outrageous given the tens of thousands of breast-cancer victims seeking reconstructive surgery each year. Silicone-gel implants tend to feel and look more natural than the saline alternative.

It would be nice to think that the FDA's move closes the chapter on this nasty episode, but given the anti-implant crowd's reaction to Friday's announcement, that's probably too much to hope for. Kim Gandy, president of the National Organization for Women, called it a "reckless decision" and promises to seek reversal "when the new Congress takes office." Sidney Wolfe, head of Public Citizen's Health Research Group -- the Naderite outlet that spearheaded the campaign against silicone in the 1980s and is a front for the trial bar -- called breast implants "the most defective medical device ever approved by the FDA." He also vowed to seek Congressional action.

While we're glad the FDA has overturned 14 years of politicized medicine by approving silicone breast implants, it's worth remembering the enormous price that has been paid: to the credibility of the legal system, in jobs lost, and in public health. And it's worth asking what is more toxic: the silicone implants preferred by thousands of women, or the trial bar that purports to "protect" them.