Breast surgery is a $300 million U.S. industry--or was, until a U.S. Food Band Drug Administration advisory panel recommended last month that the use of silicone-gel implants be severely limited. Breast augmentation and reconstruction have been the most popular forms of plastic surgery in the United States, accounting for more than 130,000 operations annually. Fees range as high as $5,500. Facing the loss of a substantial and lucrative part of their practices, some surgeons are furious at the FDA-and ready to do battle for their livelihoods. Armed with the belief that the advisory panel was stacked against them and that some under-endowed women need breast implants for self-esteem, the American Society of Plastic and Reconstructive Surgeons has launched a $3.5 million campaign to convince the public and the FDA that the devices do more good than harm.
Dr. Norman Cole, president of the ASPRS, has urged the organization's 4,300 members to call on the government to remove FDA Commissioner Dr. David Kessler from the entire implant decisionmaking process. Kessler "does not have an objective attitude about implants," Cole charges, and he believes the commissioner's "personal bias" is contagious. Women now are far less likely than before to seek implants, Cole says, " because of the incredible fright that has been instilled into them by the politicians and the media." No one at the FDA would comment.
The plastic surgeons say they know why the 24-member panel recommended restricting implants. For one thing, no plastic surgeons were among the nine panel members with voting status. Some panelists had a clear bias against implants, says Dr. Edward S. Truppman, president of the American Society for Aesthetic Plastic Surgery. One of them, psychologist Rita Freedman, wrote to Kessler in December that cosmetic implants "perpetuate the myth of the Barbie Doll's body." Two nonvoting panelists had served as expert witnesses in product-liability trials against implant makers. Panelist Alexander Baumgarten, professor of laboratory medicine at Yale, defends the voting members' integrity. "We didn't have any particular interest or connection with implants or court cases," he says. "Anyone with any conflict of interest was moved to consultant status."
With the future of breast implants in limbo, plastic surgeons are almost as confused as their patients. " We would not have this problem today," says Dr. William Shaw, a plastic surgeon at the University of California, Los Angeles, if the FDA had established standards for implants 30 years ago when they came on the market. Says Houston plastic surgeon Dr. Charles W. Bailey Jr.: "This is the first time I've been in a position where I was unable to go to a library or a journal or call an expert and obtain reliable information."
Dr. Norman Anderson, professor of surgery at Johns Hopkins and the FDA panel member who flagged Kessler about damaging internal Dow Corning memos, has little patience with colleagues who are trying to interfere with regulation of breast implants. Their stand, he says, is "more befitting a trade association than a professional organization" and reflects "the needs of a vested-interest group." It's easy to understand why some plastic surgeons might feel threatened by a virtual ban on implants. The far greater threat, however, would be to women's health--if the devices aren't as safe as some surgeons say they are.