FDA Approves Use of Silicone Breast Implants
FDA on Friday approved the use of silicone breast implants manufactured by Santa Barbara-based Mentor and Irvine-based Allergan for breast reconstruction and cosmetic breast augmentation, but the agency limited cosmetic use to women ages 22 and older, the New York Times reports (Saul, New York Times, 11/18).
Most breast implants, which often are given to women who have undergone a mastectomy to treat breast cancer, contain saline solution. Silicone breast implants were banned in 1992 because of safety concerns.
Mentor and Inamed, which now is part of Allergen, applied to sell silicone implants, and FDA in July and September 2005 gave both applications preliminary approval pending the meeting of certain conditions (American Health Line, 10/24).
The approval stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants, the Washington Post reports. In addition, FDA is requiring both companies to conduct a study among at least 40,000 implant recipients over the next 10 years to determine the long-term safety and efficacy of the implants and provide the findings to the government (Brown/Lee, Washington Post, 11/18).
Women also will need to receive magnetic resonance imaging every two to three years to ensure the implants are not leaking, according to Daniel Schultz, director of FDA's Center for Devices and Radiological Health (Allday, San Francisco Chronicle, 11/18). According to Schultz, the agency's decision that the sale of the implants is in the best interest of women was based on company-sponsored studies, as well as on long-term use of the implants worldwide.
Mentor on Friday launched a Web site to advertise their product, called Memory Gel.
The approval is a "triumph of science," Richard D'Amico, president-elect of the American Society of Plastic Surgeons, said, adding, "We've always felt that the science would bear out the use of the implants" (New York Times, 11/18).
Kenneth Phillips -- chief of the department of plastic, reconstructive and cosmetic surgery at Kaiser Permanente -- said, "It's been a long time coming. The FDA has really scrutinized the subject and looked at a lot of research" (San Francisco Chronicle, 11/18).
Amy Allina, program director at the National Women's Health Network, said the agency failed to answer basic safety questions, including how long the implants would last without rupturing and the potential health effects if the silicone leaked to other parts of the body (New York Times, 11/18).
Susan Wood -- a research professor at George Washington University's School of Public Health and Health Services and former FDA official for women's health -- said she is disappointed by the approval because the agency did not demonstrate that the implants are safe. "Given that the approval has gone through, we have to insist on getting adequate information for both patients and surgeons so that we ultimately will know whether or not these are products that women should be using," Wood said (Washington Post, 11/18).
Allergen President Michael Ball said the implants should be widely available in about two weeks (San Francisco Chronicle, 11/18).
"It took 14 years, but science finally trumped politics ... with the [FDA]'s lifting of its longstanding ban on silicone-gel breast implants," a Wall Street Journal editorial says. "While we're glad the FDA has overturned 14 years of politicized medicine, ... it's worth remembering the enormous price that has been paid: to the credibility of the legal system, in jobs lost and in public health," the editorial says, adding that the approval is "especially welcome news for mastectomy patients."
According to the editorial, "It would be nice to think that the FDA's move closes the chapter on this nasty episode, but given the anti-implant crowd's reaction to Friday's announcement, that's probably too much to hope for" (Wall Street Journal, 11/20).
NPR's "Weekend Edition Saturday" reported on FDA's approval of the silicone breast implants. The segment includes comments from Schultz; Scott Spear, a plastic surgeon in Washington, D.C.; and a woman who opposes silicone implants after her experiences in the 1980s (Knox, "Weekend Edition Saturday," NPR, 11/18).
Audio of the segment is available online.
NPR's "All Things Considered" on Friday reported on FDA's approval of silicone breast implants. The segment includes comments from Schultz ("All Things Considered," NPR, 11/17).
Audio of the segment is available online.