The first FDA order involves the reclassification of these highly controversial medical devices from class II to class III. Class II devices generally include moderate-risk devices, whereas class III generally include high-risk devices.
The second order requires manufacturers to submit a premarket approval (PMA) 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 rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. Manufacturers and makes include J&J Gynecare transvaginal mesh; Bard Avaulta transvaginal mesh; and AMS transvaginal mesh.
The FDA notes that these changes do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
Gynecologists began implanting surgical mesh for the abdominal repair of POP in the 1970s and in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device.
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The FDA has issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures. Additionally, the agency convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair. In January, 2012, the FDA issued orders to manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP, and in May that same year, the agency proposed the two reclassifications which this week have become mandatory.