One undercurrent: Inadequacy of post-approval studies and spotty adverse event reporting, leading to incomplete data with which panelists could form opinions.
It was a busy year for FDA’s expert advisory committees, called on to tackle many of its biggest medical device questions in 2019, new and old.
Repeated meetings aren’t necessarily a negative, said Diana Zuckerman, president at the National Center for Health Research since 1999.
“We can’t think of these public meetings as a bad outcome … We wish that people weren’t being harmed by breast implants, by mesh, by Essure, and so on. But if they are being harmed, then I’d much rather there be a public meeting about it then to have it covered up,” Zuckerman said. “For breast implants especially, it’s made an enormous difference in terms of public awareness.”?
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