Big Surge in Transvaginal Mesh Lawsuits Likely

Lawsuits involving <"">transvaginal mesh devices used in pelvic organ prolapse (POP) surgery are expected to surge, according to a report from Bloomberg News. More than 600 such lawsuits have already been filed against transvaginal mesh manufacturers, and personal injury lawyers are getting an “amazing number of calls” from women who say they’ve suffered painful and debilitating complications because of the mesh.

Inquiries to personal injury lawyers spiked after the U.S. Food & Drug Administration (FDA) warned on July 13 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, pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Last week, a group of FDA advisors backed a proposal by agency staff to reclassify transvaginal mesh as a Class III (high risk) medical device. Currently, the devices are classified as moderate risk (Class II), making them eligible for the 510(k) approval process, which does not require human trials before a device is brought to market. The majority of advisors on the FDA panel also agreed that the agency should require the manufacturers of transvaginal mesh devices currently on the market to conduct postmarketing studies to assess their safety and effectiveness in POP repair.

According to the Bloomberg report, about 270 lawsuits are pending against Johnson & Johnson, the global leader in transvaginal mesh. Other companies facing transvaginal mesh lawsuits include C.R. Bard, Boston Scientific, and American Medical Systems. Such lawsuits allege that mesh makers knew of safety risks and failed to disclose them and that the products were defective. None of the cases have gone to trial yet.

The controversy is also having an impact on transvaginal mesh sales, Bloomberg said. According to one analyst, C.R. Bard, which estimated the global prolapse mesh market at $175 million, saw its own pelvic prolapse business fall about 30 percent in 2010 due to what it called “regulatory delays” on product approvals.

About 300,000 women in the U.S. had POP surgeries last year, including more than 70,000 who received transvaginal mesh, Bloomberg said.

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