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FDA Approves Saline Breast Implants

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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.

An option for cancer patients is for doctors to rebuild their breasts using fat and tissue from other parts of the body.

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.

 

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