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Nearly 60,000 Vaginal Mesh Lawsuit Claims Filed Against Seven Different Pelvic Mesh Manufacturers
Date:7/14/2014

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Court records additionally show litigation is pending in Superior Court of New Jersey, Atlantic County, against two vaginal mesh manufacturers that are involved in the federal litigation. As of June 16, 2014, C.R. Bard Inc. has 1,379 complaints pending in the state court. (In re: Pelvic Mesh Litigation/Bard, No. L-6339-10) In the second consolidated litigation, Ethicon Inc. has 5,060 vaginal mesh lawsuits pending (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10)
[jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-June-16-2014.pdf, June 16, 2014]

According to the U.S. Food & Drug Administration (FDA), the surgical mesh devices support the bladder, uterus and bowel when they become so weak that they drop from their normal position and bulge (prolapse) into the vagina. The FDA issued warnings in 2008 and 2011 about the transvaginal mesh after receiving reports from women complaining of mesh erosion, vaginal scarring, pain and other complications. Due to continued complaints, the regulatory agency in April 2014, called for a reclassification of transvaginal mesh from a “moderate risk” device to a “high-risk” device. The FDA explained that moderate risk devices are eligible for the agency’s 510(k) clearance process, which means a manufacturer is not required to conduct human clinical trials of a product before its sold on the market. Under the FDA’s proposal, reclassifying transvaginal mesh as a high-risk device means manufacturers are now required to conduct human clinical trials and provide clinical data about the safety and effectiveness of the device if they want to continue selling their product.
[fda.gov/newsevents/newsroom/pressannouncements/ucm395192.htm, April 29, 2014]
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm, July 13, 2011]

Bloomberg reported that one day after the FDA's announcement on its proposal to reclassify the mesh device, Endo International announce
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