The move to take a more aggressive posture in reporting potential risks with medical devices follows several high profile lawsuits involving the safety and risks of medical products. Among them a hip implant, a defibrillator that stopped working, and a mesh implant to prevent incontinence in women, which has been reported to erode. The FDA has an established system of issuing public warnings, however they have historically waited to release information until after analyzing adverse events, of which hundreds of thousands are submitted each year.
