F.D.A. Will Allow Breast Implants Made of Silicone - NY Times

The Food and Drug Administration yesterday lifted a 14-year ban on the use of silicone gel breast implants in the United States after decades of contentious debate and litigation over their safety.

The federal agency approved implants manufactured by two California companies, Mentor and Allergan, for breast reconstruction and cosmetic breast augmentation, but limited cosmetic use of the implants to women ages 22 and older. The decision appeared to end a controversy over the safety of silicone implants that lasted more than two decades and resulted in thousands of lawsuits by women who claimed the implants leaked and caused a number of diseases, including cancer and rheumatoid arthritis. The dispute led to the bankruptcy of the manufacturer Dow Corning, a federal moratorium on the use of the implants, and, finally, findings by both the Institute of Medicine and the Food and Drug Administration that the devices do not cause major illnesses. Because the implants made of silicone gel are softer than the saline implants currently available, plastic surgeons said they would quickly become preferred among the more than 300,000 women in this country who have breast implants each year. Critics of the decision lambasted it and said that longstanding safety concerns had not been resolved. But supporters of the implants, including leading surgeons, applauded it. ---- "We wanted to make sure that breast development had been completed before these devices had been implanted," Dr. Schultz said, adding that the agency also did not have clinical data on younger women. “We concluded that age 22 was the appropriate age for the lower limit for augmentation.” Some surgeons, who have participated in studies, will be able to implant the devices as early as Monday. For others, there will be a wait of up to several weeks because the F.D.A. is requiring them to participate in a training program before receiving shipments.