FDA approves silicone implants
The F.D.A. decided silicone breast implants were cool with them.
The F.D.A. lifted a 14-year ban on the use of silicone gel breast implants in the U.S. following many years of debate over their safety.
The federal agency approved implants manufactured by two California companies, Mentor and Allergan, both for breast reconstruction and for cosmetic breast augmentation. But the agency restricted cosmetic use of the implants to women aged 22 and older.
Because the implants containing silicone gel are softer than 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 agency said yesterday that the approval should not have been granted, citing safety concerns.
Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, called the implants “the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’ ”
Silicone breast implants were never officially approved in the United States but were available under a grandfather provision allowing the use of medical devices. Following complaints in the 1980s and 1990s that women developed cancer and autoimmune diseases as a result of ruptured implants, silicone implant makers were forced to take their products off the United States market in 1991, except for treating mastectomy patients and some other special cases and only when the patients were enrolled in clinical studies.
In 1999, the Institute of Medicine, an arm of the National Academic of Sciences, said there was no definitive evidence that silicone implants were associated with connective tissue disease or cancer.
Dr. Scott L. Spear, the chief of plastic surgery at Georgetown University who has conducted clinical research for Allergan, said the devices have been improved since the early 1990s.
“The shells themselves are made of different materials, a barrier shell, that is relatively much more impermeable,” Dr. Spear said. “The shells are thicker than in ‘91, much thicker than they were in earlier generations. The material inside is more cohesive, the stuff tends to stick together.”
Canadian regulators cleared the implants for sale and implantation in October.
nytimes
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