Posts Tagged ‘ Advisory Committee ’

LATEST FDA REPORT: Classify Surgical Mesh Devices for Pelvic Surgery as High Risk Class III

Sep 1st, 2011 | By
LATEST FDA REPORT: Classify Surgical Mesh Devices for Pelvic Surgery as High Risk Class III

AUGUST 31, 2011 /If a U.S. Food and Drug Administration (FDA) staff report is adopted, synthetic surgical mesh manufacturers such as Boston Scientific Corp., Johnson & Johnson, American Medical Systems and six other makers of  mesh used for pelvic organ prolapse (POP) repair may be forced to submit safety data to keep their products on
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.