FDA Cracks down on Transvaginal Mesh Devices

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

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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