Transvaginal Mesh for POP Repair Should be Classified "High Risk," FDA Panel SaysSep 9, 2011 | Parker Waichman LLP
An advisory panel for the U.S. Food & Drug Administration (FDA) voiced support for an agency proposal to reclassify transvaginal mesh devices used to repair pelvic organ prolapse (POP) as high risk, or Class III. If the FDA does go forward with the change, manufacturers of would be required to conduct premarket clinical trials of transvaginal mesh devices before they could be marketed for POP surgery.
Currently, transvaginal mesh devices are marketed as moderate risk, or Class II medical devices. They are eligible for the FDA’s 510(k) approval process, which means they don’t have to be subjected to human testing before they are brought to market. But a growing number of serious complications, including mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence, have been associated with transvaginal mesh, especially when it is used in POP repair.
Since 2009, the FDA has received roughly 2,800 complaints about transvaginal mesh complications, of which more than 1,500 involved use of the mesh in POP repair. In many of these instances, additional surgery was required, and even then, many women did not experience complete relief of their symptoms. At least seven deaths have been connected to the devices.
The FDA proposed reclassifying transvaginal mesh as a high risk device in a staff report released last week. Yesterday, during the first of a two-day meeting to assess the safety of the devices in POP repair, a majority of outside advisors on the agency’s Obstetrics-Gynecology Devices Panel voiced support of the move, though no formal vote was taken. The panel also backed the agency’s proposal that manufacturers conduct postmarket studies of devices currently on the market.
POP is painful condition which occurs when the femal pelvic organs drop from its normal position, usually due to weakening of the vaginal wall from childbirth, hysterectomy or menopause. About 75,000 women undergo POP repair with transvaginal mesh every year, though there are other procedures that also treat the problem. In a July alert, the FDA voiced doubts as to whether transvaginal mesh devices offered any additional benefit over other POP procedures.
The growing numbers of transvaginal mesh complications have led to more than 500 lawsuits against companies that market such products including Johnson & Johnson, Boston Scientific, American Medical Systems and C.R. Bard.