By Levin Simes
January 13, 2016

FDA labels Transvaginal Mesh High-Risk

The Federal Drug Administration (FDA) has labeled Pelvic Organ Prolapse (POP) devices as “high risk”, after thousands of injuries had been reported.  The FDA noted more than 4,000 reports of adverse events or complications associated with transvaginal surgical mesh for POP or Stress Urinary Incontinence (SUI) repair from 2005 to 2010.

The FDA previously classified POP surgical mesh treatment as a moderate-risk device (Class II).  The newrecommendations, first proposed in April 2014, now classify the products ashigh-risk (Class III). The FDA has given the manufacturers of transvaginal mesh 30 months to prove that their products are as safe and effective as they contend. These new tests will require the companies to seek approval for their devices under the premarket approval program (PMA). Previously manufacturers could seek approval of new mesh devices under the FDA’s 510k program, whichmerely required them to show the devices were similar to those already approved.  By going through the 510k program, mesh manufacturers bypassed the need to conduct clinical trials toshow the efficacy and safety of their products.

The new recommendations – available here – note that patients should be aware of the risks associated with surgical mesh for transvaginal repair of POP. The FDA recommends you ask surgeons “why is surgical mesh being chosen” and “what are the alternatives”. The reason for this caution is surgical mesh may put you at risk of additional surgeries, additional complications, and the risk of life-changing complications that cannot be resolved even after additional surgeries for treatment.

Levin Simes LLP is currently litigating against the manufacturers of “POP” sling and mesh devices, and has already reached a settlement with American Medical Systems (AMS) regarding both POP devices and SUI devices. If you have a transvaginal mesh product and need to speak with a transvaginal mesh lawyer regarding a mesh lawsuit, whether POP or SUI, contact the experienced lawyers at Levin Simes LLP at or (415) 426-3000.

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