Politics and pulchritude

To Dr. Sheri Slezak, the Food and Drug Administration's 1992 hearings on silicone-gel breast implants seemed more like a political convention than a gathering of scientific minds.

Attendees donned buttons and waved signs, like party faithful pushing candidates.


"People emotionally and fervently believe in whatever side they are on," said Slezak, an associate professor of plastic surgery at the University of Maryland School of Medicine.

More than 11 years after the FDA banned the sale of the implants for general use, that remains as true as ever.


Last week's rejection of Inamed Corp.'s application to market the product widely - and the agency's proposal for revised guidelines that call on all manufacturers to provide more safety information - has re-ignited the debate over both the science and the politics of the gel implants.

"The science is political," said Nora Jacobson, a University of Toronto public health sciences professor and author of Cleavage: Technology, Controversy and the Ironies of the Man-Made Breast. "If you look at the things the FDA considers in making decisions, values are part of the way those decisions are made and [part of] the way you weigh certain risks and benefits. You can't do that simply through a scientific formula."

FDA officials acknowledge that they have learned much in the past decade that has assured them about the safety of the gel-filled implants. Numerous studies have discounted any link between implants and serious disease, including cancer and autoimmune conditions such as lupus and rheumatoid arthritis.

But, now, the focus seems to have shifted to other potential problems that rupture and leakage might cause, particularly in the area of the breast.

"I am concerned that this may just be an excuse not to approve them, because these devices have been widely used since 1964," said Dr. Marcia Angell, senior lecturer on social medicine at Harvard Medical School and former editor of the New England Journal of Medicine.

"I find it a little paternalistic that the FDA, which I think is perhaps not fastidious enough about drugs and other devices, is so very fastidious about this device."

Those who oppose the implants' reintroduction say we need to know more about why they break and the consequences when they do. Implant advocates counter that virtually no FDA-regulated product is without risk and wonder whether any amount of data will satisfy the agency against a backdrop of public skepticism over their cosmetic use.

The FDA banned silicone implants for breast augmentation in 1992 after a flood of complaints from women who said they had caused serious problems. Since then, they have been available only to women - many of them breast cancer patients - participating in clinical trials.


Cosmetically, many women prefer silicone because it looks more natural. But those seeking surgery to enlarge their breasts since the ban have had to look elsewhere. Most have chosen saline implants as an alternative.

Slezak and other surgeons who routinely use the silicone variety in breast reconstruction concede that the implants are neither permanent nor perfect.

"They are like everything else in life. There are good things about them and there are bad things about them," Slezak said. But that does not mean they are unfit for general use.

"I thought the decision in '92 was totally political," Slezak said. "To me, implants are either safe or unsafe. It can't be deemed safe in one situation - in reconstruction - and unsafe in augmentation."

Dr. Maurice Nahabedian, director of aesthetic and reconstructive breast surgery at Johns Hopkins Hospital, thinks it might take a generation before cosmetic silicone implants are available again - no matter how convincing the scientific case becomes.

"There's a minority of people that have a very strong voice on these matters," he said. "I think that makes it difficult for silicone implants to come back on the market."