FDA proposes reclassification of transvaginal mesh

May 5, 2014

The FDA recently issued two proposed orders that, if finalized, would reclassify surgical mesh for transvaginal pelvic organ prolapse from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.

The FDA recently issued two proposed orders that, if finalized, would reclassify surgical mesh for transvaginal pelvic organ prolapse from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse [POP] and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health.

Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

Surgical mesh indicated for surgical treatments of stress urinary incontinence (SUI), abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of this proposed order.

The proposed orders are not the first time that the FDA has weighed in on mesh:

  • In 2008, the agency communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and SUI in an FDA Public Health Notification.

  • In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the agency also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns.

  • In September 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require premarket approvals.

  • Beginning in January 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

The FDA said it would take comments on the proposed order for 90 days.

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