Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.
These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.
"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 [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.
The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.
Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.
The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.
The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.
Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.