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    FDA takes stronger action on transvaginal mesh for POP

    Editor’s Note: A previous version of this article contained an inaccurate description of the type of mesh included in the FDA’s action. The article has been updated.
     

    The FDA has issued two final orders to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally.    

    One leading expert predicted the orders would have significant future implications for the use of surgical mesh for transvaginal repair of POP.

    Read: Mesh outcomes linked to provider volume

    The first order reclassifies these mesh medical devices from class II (which generally includes moderater-risk devices) to class III (which generally includes high-risk devices), and the other requires manufacturers to submit a premarket approval application to support a device’s safety and effectiveness for transvaginal POP repair.

    The FDA said in a press release that the orders apply only to mesh devices marketed for the transvaginal repair of POP and do not affect the use of surgical mesh for other indications, including stress urinary incontinence and 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, MD, MPH, of the FDA’s Center for Devices and Radiological Health, in the FDA release.

    “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures,” Dr. Maisel added.

    Manufacturers of surgical mesh to treat POP transvaginally will have 30 months to submit a premarket approval for devices that are already on the market. Manufacturers of new devices must submit a premarket approval before those devices can be approved for marketing, according to the FDA.

    Next: Urologist J. Christian Winters, MD, comments on orders

    Lisette Hilton
    Lisette Hilton, president of Words Come Alive, has written about health care, the science and business of medicine, fitness and wellness ...

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