Aug. 31, 2011 -- After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue.
"The current post-approval studies will continue," said William Maisel, MD, MPH, chief scientist in the FDA's Center for Devices and Radiological Health, in remarks after the meeting. "The FDA is committed to seeing them completed and making sure the follow-up rates improve."
The safety studies in question, of nearly 100,000 women with breast implants, which the FDA said were the largest ever required of manufacturers after their devices were marketed to the public, have lost track of up to 79% of the women they enrolled just three years into planned 10-year efforts.
As a result, FDA epidemiologists testified yesterday, the studies had lost the ability to find rare complications, including connective tissue diseases, that they were designed to look for.
Save or Scrap Troubled Studies?
In a second day of testimony, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to the FDA heard plenty of opinions about what should happen with the studies.
Some panelists felt the companies should be compelled by the FDA to finish the studies they had agreed to complete as a condition of the approval of their devices. They asked FDA officials what regulatory powers the agency could wield to do that.
"If you do not meet the conditions of approval the FDA does have regulatory authority to either impose civil penalties or other regulatory actions," said Mark N. Melkerson, director of the Division of Surgical, Orthopedic and Restorative Devices at the FDA's Center for Devices and Radiological Health.
The agency said it was not considering taking silicone breast implants off the market.
Some consumer advocates thought that option ought to be on the table, however.
"It has now been 25 years since FDA declared silicone breast implants a class III device, and in that period, only weak attempts have been made to assess the safety of these implants," said Kate Ryan, of the nonprofit Breast Cancer Action, which is based in San Francisco.
"Follow-up rates on the two large studies are dismal," Ryan said in testimony. "Given that these studies were a condition of approval, Mentor should have done much more to ensure it had the technical skills to locate women and provide women with incentives to participate in this important research."
Manufacturers fired back against the notion that they weren't doing enough to complete the studies.
"To imply that patient safety is not first on our radar is simply inaccurate," said Caroline Van Hove, a spokeswoman for Allergan. She said the company hoped that the meeting would give the FDA an opportunity to more fully appreciate the complexity of the required studies.
"In general, we are highly committed to collecting quality data in a way that is possible for them and possible for us," she said.