WASHINGTON — The Food and Drug Administration said on Wednesday that it plans to take a far more aggressive stance in reporting on possible medical device hazards, in some cases issuing early warnings about safety risks even before those concerns have been validated.
The move follows several high-profile lawsuits involving safety risks and medical devices, as well as a string of warnings from the FDA about various products. Among them: a hip implant that was reported to leak metal parts into patients’ bloodstreams, an internal defibrillator that was reported to stop working, and a mesh implant used to prevent female incontinence that was reported to erode.
