The FDA has scheduled a fall meeting to shape future regulation surrounding transvaginal implantation of surgical mesh in treatment of pelvic organ prolapse on the heels of agency reports that the risks associated with the device may not be worth the benefits.
The FDA released a draft guidance yesterday warning that placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to unnecessary risk without offering clinical benefit above safer options.
The agency announced a forthcoming meeting to be held September 8 and 9, 2011, to consider the risks and benefits of the mesh as used for POP in light of adverse events, and to consider the treatment as an option for urinary incontinence.
The latest warning updates 2008 communications 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, according to the release.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” warned 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.”