On Wednesday an FDA advisory panel recommended that silicone breast implants be permitted back on the market after an 11-year ban. A story in yesterday's New York Times by science reporter Gina Kolata, who has long treated unsubstantiated claims about the hazards of implants with appropriate skepticism, brought home the significance of the decision. Kolata reported that Michael Miller, a Houston plastic surgeon who served on the advisory committee,
suggested that the panel's problem reflected a deeper issue. Safety, he said, is a ratio of benefit to risk, and when it comes to implants, few agree on benefits.
Some who testified at the meeting felt so strongly that breast implants were unnecessary, and even immoral, that not even a perfect safety record would persuade them that they should be sold. Others saw such an enormous benefit that they were willing to accept substantial risk.
The risks of the device, in contrast, "are pretty clear," Dr. Miller said. There is a short-term risk, primarily of rupture or contracture. As for long-term risks, of diseases like cancer, chronic fatigue, lupus, arthritis and neurological disorders, they have not shown up in large epidemiological studies, he said.
"What we have to avoid is getting into the business of deciding for people what the benefit is," Dr. Miller said. "The person who wants the surgery has to go through the risk-benefit exercise in their own mind. A large amount of latitude has to be given to people to decide for themselves."