FDA Considering Reclassification of Mesh as “High Risk”

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue – specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI). It is made from either porous synthetic material or biologic material.

As you will recall from our earlier blog, in September the FDA advisory panel heard from several patients describing life-altering complications from their vaginal mesh surgery. Although the FDA stopped short of pulling vaginal mesh from the market, despite pressure from consumer groups, it now appears that the FDA will make it more difficult for the manufacturers to sell these devices in the future.

According to a post at the FDA.gov website yesterday, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of POP be reclassified from Class II to Class III. Class III devices are considered high risk and would require the devices to get premarket approval with the FDA as well as require the manufacturers to prove the safety and effectiveness of the products on an ongoing basis.

In a Safety Communication on July 13, 2011, the FDA informed the medical community and patients that serious complications from use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare. At that date, the FDA did not issue the same warning with regards to the use of surgical mesh for the repair of stress urinary incontinence (SUI). However, according to the current post, the FDA is evaluating the effects of using surgical mesh for treatment of urine leakage during moments of physical activity (stress urinary incontinence) and will provide updates to their website at a later date.

In addition, the FDA will continue to assess the safety and effectiveness of the surgical mesh devices through review of adverse event reports submitted to the agency. If you have had complications from a vaginal mesh surgery, it is imperative that you report them to the FDA – a link to the reporting site can be found here.