Three transvaginal mesh multidistrict litigations involving various devices made by Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc. have been transferred to the federal Court in Charleston West Virginia and assigned to Chief Judge Joseph R. Goodwin.
A fourth MDL, involving C.R. Bard’s Avaulta mesh products, had already been transferred to Judge Goodwin. In a Transfer Order dated February 7, the U.S. Judicial Panel on Multidistrict Litigation stated that the Southern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the transvaginal mesh litigation.
Transvaginal mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. Recently, the FDA ordered more than 30 manufacturers of transvaginal mesh products to conduct studies of their safety.
FDA staff has proposed that such devices be moved to the agency’s high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness