The Food and Drug Administration is tightening its regulation of surgical mesh to repair pelvic organ prolapse transvaginally or through the vagina, citing continued safety risks including severe pelvic pain and organ perforation.
The agency is reclassifying surgical mesh used for transvaginal repair of pelvic organ prolapse from a class II to a class III medical device, moving the devices from the moderate-risk to high-risk category. The FDA is also requiring device manufacturers to submit a premarket approval application that supports the safety and effectiveness of surgical mesh. The premarket approval application requirement only applies to mesh used for transvaginal repair of pelvic organ prolapse, not to mesh used for other indications, such as stress urinary incontinence or abdominal repair of pelvic organ prolapse.
The first mesh device for transvaginal repair of pelvic organ prolapse was cleared for use by the FDA in 2002 and five manufacturers are currently marketing the product, according to the FDA.
For products that are already on the market, manufacturers have 30 months to comply with the premarket approval application requirements.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, said in a statement. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
This is the latest move by the FDA to signal to physicians and patients that surgical mesh should be used with caution when treating pelvic organ prolapse.
In 2008 and 2011, the FDA issued warnings about increased adverse events reports for surgical mesh used in urogynecological procedures. And in 2012, the agency instructed manufacturers to conduct postmarket surveillance studies on surgical mesh used for tranvaginal repair of pelvic organ prolapse.
The agency first proposed reclassifying surgical mesh to a class III device and requiring premarket approval in May 2014.
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