FDA Mesh Announcements

    On January 4, 2016 the FDA announced that transvaginal mesh implants for pelvic organ prolapse were being moved from Class II devices (generally moderate risk devices) to Class III devices (generally high risk devices) and that more rigorous clinical data would have to be provided for new products in this category. This is not a new or unexpected announcement but may bring questions from your patients or referring physicians. 

    Prior to Monday, transvaginal mesh received FDA approval through the 510(k) process which required only a predicate device for these new products to be released and used.  This meant no actual patient clinical data had to be submitted on the new product (industry could utilize the data from the predicate device) and it could be on the market in as little as three months from the initial FDA submission. Transvaginal mesh implants for prolapse were able to use full-length midurethral slings as their predicate device.  Again, this meant they did not have to submit actual clinical data on their new product.  If sufficient complications arise from new medical devices under the 510(k) process, the FDA can require more detailed information be collected and submitted to them regarding the product. This process is known as Section 522 under the FDA Medical Devices and Radiation-Emitting Division and requires post-market surveillance of the particular product.

    Helpful Links

    January 4th FDA Press Release on Up Classification of Transvaginal Mesh Products

    FDA Surgical Urogyncologic Mesh Implants Fact Sheet

    AUGS Informed Consent Toolkit

    Archived Documents and Position Statements

    Useful Downloads

    Up Classification Talking Points for Physicians

    FDA Recommendations for Patients Undergoing Treatment for Prolapse

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