FDA Rejects Ban On Controversial Vaginal Mesh Products
By Jeff Overley (July 15, 2014, 5:16 PM EDT) -- The U.S. Food and Drug Administration has rejected a request from advocacy group Public Citizen to order recalls of existing surgical mesh products and ban their future sale, according to a letter released Monday that said a recent proposal to more rigorously review the devices is sufficient for now.
In its response to a 2011 petition from Public Citizen, the FDA noted that it proposed earlier this year to require premarket approval of surgical mesh products used for transvaginal repair operations. The devices have been targeted in thousands of lawsuits alleging serious side effects, such as pain and incontinence, and for...
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