FDA Ups Requirements for POP Surgical Mesh
The FDA is ratcheting up requirements for surgical mesh for transvaginal repair of pelvic organ prolapse, issuing two final orders that address safety risks.
One order reclassifies the devices from moderate-risk Class II to high-risk Class III, based on the determination that general controls and special controls are not adequate to assure safety and effectiveness.
The second order requires manufacturers to file a premarket approval application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns — including severe pelvic pain and organ perforation — through a PMA pathway to demonstrate safety and effectiveness, the FDA says.
Several companies, including Boston Scientific, Medtronic’s Covidien, Johnson & Johnson’s Ethicon and C.R. Bard Inc., have been facing legal action brought forth by women claiming personal injury while using their products.
The orders apply only to mesh devices marketed for the transvaginal repair of POP and not other indications, such as stress urinary incontinence or abdominal repair of POP.
Manufacturers will have 30 months to submit a PMA application for devices that are already on the market. Manufacturers of new devices must submit a PMA application before their products can be approved for marketing.
The FDA intends to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures, says William Maisel, deputy director of science and chief scientist for the Center for Devices and Radiological Health.
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