Are silicone breast implants dangerous? What FDA says now
(CBS) Are silicone breast implants safe? After a two-day meeting that aimed to make sure implant safety studies were legitimate, the FDA has a verdict:
Yes, they're safe.
"Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe," Dr. William Maisel, chief scientist for the FDA's Center for Devices, told the New York Times. "We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days."
Consumer groups, including the National Organization for Women Foundation and the National Research Center for Women and Families, had asked the FDA to take Johnson and Johnson's silicone implants - manufactured by its subsidiary Mentor - off the market. They contend the company hadn't provided enough long-term safety data, collecting only 21 percent of three year follow-up data on 40,000 women. Another manufacturer, Allergan, only collected two-year data on its implants from 60 percent of participants. Silicone implants were previously banned for 14 years until 2006, when the FDA approved these two implants.
"It's unacceptable that many patients Mentor and Allergan were supposed to track were lost," Jan Erickson, spokesperson for the National Organization for Women Foundation, told Reuters. "Mentor's approval should be rescinded right away. And Allergan should be required to conduct further studies."
The FDA agreed the drug company studies didn't track as many patients as it had hoped, and will work with Mentor and Allergan to complete their studies.
Silicone implants are not risk-free. Women may experience ruptures, hardening in the area surrounding the implants, scarring, pain, and infections - some of which may warrant removal.
An FDA report in June said as many as one in five women with silicone implants will likely need them removed within 10 years, CBS News reported.
Worldwide, five to 10 million women have breast implants.
The FDA has more on breast implant safety.
