FDA Approves Saline Breast Implants
And the longer women have implants, the more likely they are to suffer a side effect, the FDA says. Up to 73% of patients in one study suffered at least one side effect.
Women's health advocates condemned the FDA's decision.
"The standard of safety is at a new low at FDA," said Diana Zuckerman, of the National Center for Policy Research for Women and Families. "Here you have the benefit, which is cosmetic, and the risks, which are serious health problems."
In March, WebMD reported that Leroy Young, MD, makes a point of telling his patients that their new implants will most likely have to be replaced within the first decade of receiving them. The professor of surgery at Washington University in St. Louis notes that more surgery means risks with anesthesia, infection, bleeding, clotting, and other complications.
But in their decision, FDA officials said they approved the implants because, despite the complications and the risks of undergoing repeated surgeries, many women in the companies' studies insisted they were happy with the implants.
In March, the FDA's independent scientific advisers recommended that the products stay on the market, despite declaring that they break open and leak at "alarmingly high" rates. The panel heard hours of testimony from dozens of women claiming the implants left them in dire pain and disfigured them -- while a few cancer survivors said the implants were important for their emotional recovery.
For most women wanting breast implants, saline-filled products are the only option, since the FDA banned use of silicone gel-filled versions in 1992. No other implants are sold in the United States.
The controversy over breast implants arose in the early 1990s, when thousands of women claimed the implants gave them serious diseases, from arthritis to cancer. But after repeated scientific studies, the Institute of Medicine last year declared that implants, whether silicone gel- or saline-filled, do not cause major diseases. So the FDA's concerns about saline implants center on breast-related side effects -- pain, infection, deflation, and repeat surgeries.