FDA and Vaginal Mesh

By mwilkes

  • FDA Public Health Notification

    FDA first warns of complication associated with transvaginal mesh

  • FDA Public Health Notification

    Second FDA warning of complications associated with transvaginal mesh.

  • AUGS/ACOG Committee Opinion

    AUGS/ACOG publish a document recommending that vaginal mesh repair should be reserved for high-risk patients only where benefits clearly outweigh the risks of the procedure.

  • Device Class Change

    FDA reclassifies transvaginal mesh from a Class II medical device to Class III medical device. Industry is now required to perform clinical trials before placing a product on the market. This applies to new products only.

  • FDA Pulls Mesh off the Market

    The FDA mandates that sales and manufacturing of transvaginal mesh stops. Due to failure to prove safety and effectiveness.