Current Data on Vaginal Mesh Implants Does not Satisfy the FDA

What was once a fast-growing sector of medical surgery, vaginal mesh implants to treat pelvic organ prolapse (POP) saw flat sales throughout 2011. The FDA has been studying transvaginal mesh complications for several years now. This past July, the agency said in a safety communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs, representing a fivefold increase in adverse event reports related to such procedures. During the same period, the FDA received 1,371 reports of complications relating to SUI repairs. It is expected that the number of transvaginal mesh lawsuits will only rise.

Last summer the FDA issued a warning about the risks of problems when vaginal mesh products are used, especially for repair of pelvic organ prolapse. The federal health regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives. Transvaginal mesh complications reported to the agency have included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The FDA also said in its July communication that its review had not seen any evidence that POP repair with transvaginal mesh offered additional benefits compared to other treatment methods.

A growing number of transvaginal mesh lawsuits have been filed in courts across the country by women who say that vaginal sling manufacturers created defective products and failed to warn doctors or patients adequately about the risk of complications. Manufacturers that have been targeted by vaginal mesh product liability lawsuits include Johnson & Johnson’s Ethicon unit, C.R. Bard, Boston Scientific, and American Medical Systems (AMS). The FDA has suggested that companies design the studies in such a way that they could satisfy requirements for premarket approval applications for products that would be used in transvaginal POP procedures. the FDA suggested companies design the studies in such a way that they could satisfy requirements for premarket approval applications for products that would be used in transvaginal POP procedures.