FDA may revoke 510(k) clearances for transvaginal mesh products

August 31, 2011 By MassDevice staff

Transvaginal mesh products may have their 510(k) clearance revoked and sellers like Boston Scientific Corp. (NYSE:BSX) and Johnson & Johnson (NYSE:JNJ) may have to submit new clinical safety data in order to keep the devices on the market.

The latest report from the watchdog agency’s Obstetrics and Gynecology Devices Panel recommends bumping the devices, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.

The new recommendations follow last month’s warnings, which in turn updated 2008 reports that addressed concerns about adverse events associated with the transvaginal placement of the mesh.

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.

Just yesterday Boston Scientific Corp. and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient. Lawsuits were filed against C.R. Bard Inc. (NYSE:BCR) for its Avaulta transvaginal mesh, filed earlier this month.

"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications."

Consumer watchdog group Public Citizen filed a petition with the FDA earlier this month asking the agency to issue a recall for all transvaginal mesh products.

An FDA advisory panel is scheduled to hold a two-day meeting on Sept. 8 and 9 to develop recommendations for the use of transvaginal mesh.

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