US lifts 14-year-old silicone implant ban

The FDA approval covers breast reconstruction and cosmetic breast augmentation for women aged 22 and above

The Food and Drug Administration on Friday 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.

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. 8220;For us, it8217;s a triumph of science,8221; said Dr Richard A D8217;Amico, president-elect of the American Society of Plastic Surgeons.

Dr Daniel G Schultz, director of the FDA8217;s Center for Devices and Radiological Health, said the agency8217;s review, based on company-sponsored studies as well as long-term use of the implants abroad, had determined that their sale is in the best interest of women.

But Schultz warned no device is foolproof and that there was a possibility women would have to have the implants replaced at some point, sometimes because they rupture. Studies have found that the majority of women with silicone implants would have a rupture at some point.

Dr Sidney Wolfe, chief of Public Citizen8217;s Health Research Group, called the implants 8220;the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires 8216;reasonable assurance of safety.8217;8217;

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Amy Allina, programme director at the National Women8217;s Health Network, predicted the companies would begin a 8220;massive, massive marketing campaign,8221; and women might be taken in by it and assume the FDA8217;s stamp of approval means implants are safe.

8211;STEPHANIE SAUL