Not For Vanity’s Sake

Since the Food and Drug Administration declared a moratorium on silicone-gel implants last month, hundreds of thousands of American women have struggled to make sense of the claims and counterclaims being made about the little bag of gel in their breasts. Outspoken patients and plaintiff lawyers have blamed the implants for everything from rashes to cancer and deadly neurological disorders. Implant manufacturers and most doctors, on the other hand, have just as vigorously insisted that the prostheses are safe.

Last week an expert medical panel appointed by the FDA did its best to close out the debate. The panel declared that allegations of safety risks are inconclusive at best and recommended that the implants remain on the market. However, because so much uncertainty remains, the experts urged doctors to use the devices only for reconstruction after surgery; tight restrictions were placed on using them for breast augmentation. That would exclude up to 80% of women who have historically received the implants. The recommendations are subject to approval by FDA Commissioner David Kessler, who typically follows the advice of his expert panels.

The new safety questions had emerged over the past several months in lawsuits against silicone manufacturer Dow Corning Corp., as well as in testimonials from several medical specialists. The panel concluded that many allegations, including the suggestion that the implants caused cancer or neurological damage, were scientifically groundless. But it gave more credence to reports of recipients suffering rheumatoid arthritis and scleroderma, a rare connective-tissue disorder. The experts also found that the silicone sacs could rupture 5% to 10% of the time — far more frequently than Dow Corning had previously conceded. “You can buy a tire with a 40,000-mile guarantee,” remarked a panel member, “but no one really knows the useful life of a breast implant.”

These suspected problems, said the panel, justified withholding the embattled devices from women whose need was less pressing. The experts also noted that women who get the implants for cosmetic reasons tend to be younger than other patients, and therefore more susceptible to problems that may arise over a longer period of time. A few women will be permitted silicone for breast enhancement, but only if they agree to take part in strictly monitored safety trials.

The 500,000 to 2 million women who already have implants ought to check their breasts regularly for any change in shape or texture that might indicate rupture, the panel advised. Torn sacs should be removed immediately. In the meantime, the FDA and Dow Corning are planning intensive safety studies to resolve lingering doubts. Unfortunately, preliminary data will not be available for two to three years. That is a long wait for assurances that should have been part of the package years ago.