Regulating vanity

Arthur Caplan

November 20, 1991|By Arthur Caplan

IT IS not often that one can see naked professional self-interest on display in public. But the current battle over whether the Food and Drug Administration should ban breast implants made of silicone gel is about as close as you can get.

At least 2 million women in the United States have had silicone-gel breast implants. More than 75 percent of them just wanted biggerbreasts. A large number of American men find women with large breasts attractive, and women know this.

It is important to add that a smaller but growing percentage of women have had implants for other reasons. These are women who have lost their breasts to cancer and have had implants to repair the effects of mastectomies. These women seemed to be on the minds of the FDA advisory panel when it unanimously recommended last week that the implants be allowed to stay on the market.

Still, while many women have had implants for restorative reasons, more than three times as many have had them for the far less compelling reason of fulfilling some men's fantasies. Despite the panel's recommendation, when the FDA issues its decision about the implants, it should be to severely restrict availability.

Dozens of women have complained to the FDA and its advisory panel that they have been made sick when their implants broke and leaked silicone gel into their bodies. The FDA has never tested the implants for safety. They were in use long before the FDA got the authority to regulate them. The same panel that recommended keeping the implants on the market also agreed that the evidence for their safety was inadequate. So, no woman can know precisely what risks she faces when implants are put into her body.

Self-interest reared its ugly head when America's plastic surgeons, in cahoots with companies that make silicone-gel implants, realized that the FDA might stall this gravy train unless more data are produced. Did the American Society of Plastic and Reconstructive Surgery, the main trade organization of those doing implants, decide to recommend that the FDA take a cautious approach to the use of implants simply to make breasts bigger? Were the manufacturers urging caution that some problems may exist for a medical device whose overwhelming use is cosmetic? Nah. They decided they had better do something to protect their meal ticket.

An all-out, multimillion-dollar campaign was put together to bring women to Washington, D.C., to fight any effort to restrict the use of implants. Women, the surgeons and manufacturers say, should have the "right to choose."

This is a great slogan. It seems to have persuaded the advisory panel to keep implants on the market for now. Unfortunately, it is as phony as a silicone-inflated breast.

I guess women should have the right to choose to inflate their breasts if they wish, although I cannot see why any medical organization would think it important to honor that preference -- especially when so many Americans go without having their basic health-care needs met. But no woman, whether trying to cope with a mastectomy or the desire to fulfill male fantasies, can be said to have a choice if no one can tell her what risks are associated with silicone-gel implants.

The FDA really has no choice. Its blue-ribbon panel says the available data on safety is not adequate. The FDA should ignore the self-interested bleating of the breast-implant industry and restrict the use of silicone-gel implants to restorative purposes until those who manufacture and implant these devices can show they are reasonably safe. Vanity is not reason enough to ignore safety.

Arthur Caplan is director of the Center for Biomedical Ethics at A the University of Minnesota.

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