Published: Apr 29, 2014
By Charles Bankhead, Staff Writer, MedPage Today,Public Health & Policy
WASHINGTON -- The FDA has proposed reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a "high-risk device," a designation that mandates an FDA review of safety and effectiveness prior to considering approval.
The agency also wants to reclassify certain instruments used to perform POP repair as "intermediate-risk devices," as opposed to the current low-risk designation.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, of the FDA's Center for Devices and Radiological Health, said in a statement. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."
The proposal does not affect surgical mesh used to treat stress urinary incontinence (SUI), abdominal POP repair, hernia repair, and other nonurogynecologic indications. The proposal is subject to a 90-day public-comment period prior to a final decision.
The proposed reclassification follows other FDA actions and statements related to transvaginal POP repair materials going back 6 years:
October 2008 -- Released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and SUI
July 2011 -- Released an updated safety communication about serious complications associated with transvaginal POP repair with surgical mesh
July 2011 -- Released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety and effectiveness concerns
September 2011 -- FDA's Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and require premarket approval
January 2012 -- FDA ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair
Some materials to repair POP come as kits that include the mesh and instruments used to place, attach, and secure the mesh. Instruments also are sold separately from the mesh, and the FDA proposal to reclassify instruments pertains to the instruments that are not included in kits.
The FDA action represents a case of "too little, too late," according to Michael Carome, director of Public Citizen's Health Research Group, a Washington-based public health advocacy group. Public Citizen has petitioned the FDA to recall all surgical mesh products from the market.
"Today's action comes nearly 3 years after our petition and after an FDA advisory committee recommended such action," Carome said in a statement. "Moreover, the proposed timeline for full implementation of the FDA's order, if finalized, will take several more years.
"As a result of the FDA's reckless delays and inadequate action regarding surgical mesh for transvaginal POP repair, thousands of women will continue to be unnecessarily exposed to a wide array of serious risks, many of which can permanently alter women's quality of life."