WASHINGTON (Nov. 20) — The Food and Drug Administration has ended a 14-year ban on the sale of silicone-gel breast implants, to the pleasure of the two remaining manufacturers of the devices and the consternation of women's health advocates.
After years of clinical trials and other studies, the FDA has found no convincing evidence linking silicone gel with cancer or connective tissue disease in women, said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
However, the two implant makers, Mentor Corp. and Allergan Corp., must among other things warn prospective recipients that they probably will require further breast surgeries after the implants are inserted, and conduct a large post-approval study with the core study continued over 10 years.
"We are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options," said Joshua H. Levine, Mentor president and CEO, in a news release.
However, Diana Zuckerman, president of the National Research Center for Women & Families, said the FDA had "reached a new low" with this decision. "If a woman lives for 25 years after getting these implants, she will need to remove them at least once, probably twice, and possibly more than that," Zuckerman said. "If she doesn't, the implants are likely to break inside her body."
The thousands of lawsuits filed in the wake of the 1992 FDA ban led Dow Corning Corp., inventor of silicone breast implants, to stop making the devices and spend years in Chapter 11 reorganization.