A Food and Drug Administration advisory committee held a second day of hearings Tuesday on the safety of breast implants. The panel heard from patients, plastic surgeons and manufacturers.
By Laurie McGinley Laurie McGinley Reporter covering health and medicine Email Bio Follow March 26 at 6:38 PM Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding of the risks — which includes a rare cancer that is linked to several deaths around the world — posed by the devices.
During the sometimes emotionally wrenching hearing on implants, several women testified that they had not been adequately warned of risks posed by implants and were harmed by the devices. But the panel did not appear to reach consensus on recommending that any implants be taken off the market, including certain textured ones that have been linked to cancer. Many patients and advocates called for such a ban, but several panel members said they opposed the step at this time.
Diana Zuckerman, a longtime advocate who is president of the National Center for Health Research, said the recommendations from the panel “were rather vague,” but she said the meeting was important because it allowed women to tell their stories to the FDA and the surgery panel. “We don’t know what comes next, but I’m hopeful,” she said after the meeting.
The advisory committee, which includes plastic surgeons, epidemiologists and biomaterials experts, did not take formal votes over the two-day hearing. Instead, it discussed questions posed by the FDA. Indeed, much of the two-day session underscored the difficulty of making regulatory decisions in the absence of reliable, long-term data about the effects of implants. Committee members complained, for example, about a lack of control groups in studies that would allow researchers to compare patients with implants with people who do not have them.
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