FDA Cracks down on Transvaginal Mesh Devices

FierceMedicalDevices reported that the FDA is doubling down on transvaginal mesh devices amid growing safety concerns.
According to FDM:

The agency is reclassifying surgical transvaginal mesh devices for pelvic organ prolapse (POP) from Class II to Class III, which is typically reserved for high-risk devices. Regulators are also requiring that manufacturers submit a premarket approval (PMA) application “to support the safety and effectiveness” of their products, the FDA said in a statement.

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