While the FDA has been very slow in tackling the major issue of Transvaginal Mesh for pelvic organ prolapse and bladder suspension, I am very pleased they are doing it by the book!! Otherwise, the efforts of thousands and thousands of injured patients might be reversed on appeal as the REGEN MESH KNEE IMPLANT has by the D.C. Circuit Court. See below...
DC Circuit Knocks FDA’s Backtrack On Knee Implant Approval
By David Siegel Law360, New York, September 26, 2014
"The D.C. Circuit ruled Friday that the U.S. Food & Drug Administration didn’t follow the proper procedure to revoke marketing clearance for a knee implant more than two years after it had initially granted it, finding the agency’s inherent authority cannot trump Congress’s rules for reclassifying medical devices.
In a split 2-1 ruling, the appeals panel reversed a lower court decision granting summary judgment in favor of the FDA, finding the agency acted improperly in reversing its prior approval of the Collagen Scaffold, a surgical mesh knee implant."
As for myself, although I highly disagree with the FDA's 510(k) PreMarket Notification Clearance process, have always sought to get mesh off the market through the existing FDA regulatory authority. Better to use the road most traveled than to try to build new roads.