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. […]
Consumer advocates, like Dana Casciotti, PhD, the public health research director at the Cancer Prevention and Treatment Fund, said annual, 27-page questionnaires women were asked to complete should be shortened and simplified.
“I’ve seen copies of these questionnaires, and they are much too long” and technical, she said.
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