The committee’s recommendation isn’t binding–FDA Commissioner David Kessler has until early January to take official action–but it brings a long-simmering debate to a head. Silicone implants had already been on the market for more than a decade by 1976, when the FDA started regulating medical devices. Like hundreds of other products, they were automatically approved, with the understanding that manufacturers would have to document their safety later.
No one denies that breast implants can cause trouble. The scar tissue that forms around the gel-filled sac often contracts, leaving the breast hard and misshapen. Alleviating the problem can require further surgery. In addition, the implants sometimes erode or rupture, bleeding silicone into the body. Unhappy patients have blamed such leakage for harmful immune reactions and even cancer. Neither link has been scientifically established, but experts agree there is legitimate cause for concern.
Rather than tackling safety issues directly last week, implant defenders focused their testimony on the bright side of breast enlargement. The American Society of Plastic and Reconstructive Surgeons circulated a survey of 592 patients in which 93 percent said they were satisfied. (An estimated 2 million U.S. women have received silicone implants, 80 percent to augment healthy breasts.) Dow Corning Wright and other manufacturers used before pictures to tout successful operations. The companies also submitted clinical evidence, including surveys of patients’ medical records. But the panel declared the evidence inadequate. Even James Potchen of Michigan State University, the lone panelist who voted to accept Dow Corning’s data, said he was “appalled” that after selling implants for nearly 30 years, the company hadn’t conducted more rigorous safety studies.
So why did the committee vote against curtailing sales? Panel members say they saw no evidence of an overt health hazard and didn’t want to appear to favor alternatives, such as saline-filled implants, because none has been proven safer than the silicone models. Members also acknowledged that silicone implants have made the prospect of a mastectomy less horrific by providing a quick way to restore a lost breast. If the implants were suddenly banned, they reasoned, more women might avoid testing and treatment for breast cancer.
Kessler must rule on the committee’s recommendation by Jan. 6. Meanwhile, the manufacturers say they would be happy to launch the extensive studies the panel demanded. But until those studies are completed, women receiving implants will remain guinea pigs in an unfinished experiment.
