Last week, an advisory panel to the Food and Drug Administration held hearings on whether to recommend loosening the regulations on silicone breast implants. Outside the hearing room, Arlene Nicole Cummings, who has saline implants, said she might prefer silicone if it were available. “Women need choices,” she said. To which Kim Gandy, head of the National Organization for Women, retorted, “Choice? The choice is to be sick.”
But the advisory panel didn’t share that opinion. After rejecting an application by the Inamed Corp. on the ground that the company offered too little data on the durability of its implants, the committee approved one from the Mentor Corp., apparently based on evidence that its products have a lower rupture rate. The issue now goes to the FDA.
The split verdict came as a surprise, but any step in the direction of affording more options ought to be applauded. For too long, the FDA has denied women the freedom to decide for themselves whether the risks of silicone implants are worth the benefits. The agency’s reasons were never convincing, and they have grown even weaker as new information accumulates.
In 1992, the agency heeded warnings that silicone implants cause a host of awful ailments and largely removed them from the market. The only women allowed to get them were those in need of reconstructive surgery due to breast cancer or other diseases and those willing to enroll in tightly monitored clinical trials. Those who merely wanted to enhance their appearance–about 250,000 women a year–were out of luck, forced to resort to saline implants or do without.
The FDA’s logic never made much sense. If the silicone version presents an unacceptable health danger, why should it be available to women who have already suffered serious health problems? In either case, the purpose is cosmetic, not therapeutic.
But the health risks turned out to be greatly exaggerated. A number of scientific studies have found no link between silicone and cancer, auto-immune disorders or connective-tissue diseases. A 1999 study by the Institute of Medicine, part of the National Academy of Sciences, said that though “some women with breast implants are indeed very ill,” there is “no evidence that these women are ill because of their implants.”
That’s not to say the products are risk-free. As the institute noted, the implants often leak, and they can cause hardening or scarring of the tissue around the implant.
But all medical procedures involve some danger. Despite the real and imagined hazards of silicone implants, 90 percent of women who undergo cosmetic breast surgery choose them in countries where the choice is available.
Much of the debate on these devices is driven by a sense that it’s foolish for women to take such drastic measures just to enhance their appearance. That’s a plausible point of view, but it’s not enough to justify the ban.
For the FDA to allow silicone implants back on the market would not mean it enthusiastically endorses this type of cosmetic surgery. It would merely mean it recognizes that women should be free to make their own choices.
