The FDA issued a Safety Communication about the risk of transvaginal mesh complications in July of this year; however, on August 25, the consumer advocacy group Public Citizen addressed a petition to the FDA commissioner calling for the administration to:
(1) ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP)– which were used in an estimated 67,500 surgical procedures 2 in the U.S. in 2010 — because these devices (a) offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh; and (b) have high rates of serious complications, many of which require additional surgical intervention and some of which are not amenable to surgical correction and result in permanent life-altering harm, therefore presenting “an unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device under the device law, 21 U.S.C. § 360f and 21 C.F.R. § 895.21(a);
(2) order all manufacturers of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to recall these products; and
(3) require that any non-absorbable surgical mesh product specifically designed and labeled for transvaginal repair of POP that is proposed for marketing in the future be classified as a class III device and be approved for marketing only under a premarket approval application (PMA) that includes data from well-designed, prospective clinical trials that provide a reasonable assurance that the surgical mesh product is safe and effective.
In the petition, the writers cite the 510(k) premarket notification process (specifically, the lack of testing to prove safety and efficacy using this system); various trials, studies and systematic reviews; commercial interests taking precedence over patient safety, as well as the FDA’s own review of its Manufacturer and User Facility Device Experience (MAUDE) Database which reported that “the overall increase in the number of serious adverse event reports is cause for concern.” Subsequently, the advocacy group concludes that the overall risk-benefit assessment is no longer positive and therefore, use of the meshes should be ceased.
Previously, Public Citizen had placed transvaginal mesh on its “Best Pills, Worst Pills” Do Not Use List. Although in the past the publication had not addressed medical devices, the group indicated that an exception was made because of the serious risk of complications from transvaginal placement of surgical mesh. The advocacy group addressed the mesh’s link to a risk of eroding through the vaginal tissue, causing pain, infection, bleeding and urinary problems, as well as the risk of organ perforation during the surgical procedure to install it.
– Transvaginal Mesh for Pelvic Organ Prolapse Shouldn’t Be Used, Group Warns
– Institute of Medicine: Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years
– Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices