Currently, postmarketing surveillance is voluntary and not inclusive of all vaginal meshes. AUGS recommends that the FDA invoke its power under section 522 of the Food and Drug Administration Modernization Act of 1997 to require postmarketing surveillance by means of a postmarket registry and/or national database of all users of vaginally placed mesh, to track both positive and negative anatomic and subjective outcomes. Until the registry is created, AUGS recommends all surgeons track their own outcomes.
The most contentious issue concerns the type of clinical evidence needed to support continued use of mesh already in the marketplace and future technology. Currently available mesh were generally approved as class II devices under the 510(k) process, often with another legally marketed, predicate device as control.
"Many things we deal with are class II, requiring general or special controls," said Dr. Matthew Barber of the Cleveland Clinic, president-elect of AUGS. Class III devices require a premarket approval application (PMA), and such devices are often considered high risk, life sustaining, life supporting or of substantial health importance, or present unreasonable risk or injury. Like drugs, class III devices require independent assessment of safety and effectiveness prior to marketing.
"There may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."
AUGS stated that it supports mandatory clinical trials for transvaginal mesh for POP and is in favor of a requirement that premarket notifications or PMAs include clinical trials that use patient-centered outcomes and long-term patient follow-up. The studies should be prospective, and can be cohort studies, registries or randomized, controlled trials, but randomized controlled trials are not required. Clinical trials should have a minimum of 1-year of follow-up with an additional 2-4 years of patient follow-up, and FDA reporting for new prolapse mesh devices or for significant modifications of existing devices. AUGS supports keeping transvaginal mesh devices as class II devices, and would assist the FDA in developing special controls if required by the FDA.
"The bottom line is, we want them to leave slings alone and place them into a registry," remarked Dr. Myers of Brown Medical School, Providence, R.I..
Setting Standards and Evaluating Vaginal Mesh
The panel called for stricter standards than currently exist or requested by AUGS, recommending that premarket evaluation of vaginal mesh for POP was needed, and that the control arm for such studies be women undergoing surgical repair of POP without the use of mesh. Therefore, class II special controls would not be sufficient, and the panel’s consensus was that vaginal mesh for POP repair be reclassified from class II to class III. The panel felt that there were enough data available to support the use of mesh for abdominal sacral colpopexy. There was no need for clinical performance data for new mesh products similar to products already on the market, and postmarketing surveillance was not needed.
AUGS also clearly makes the distinction between the use of mesh for prolapse and use for SUI. It "strongly opposes withdrawal of synthetic mesh devices for surgical treatment of SUI and does not feel any change in the current regulatory status of synthetic mesh for this use is warranted." Noting the considerable evidence supporting its use, AUGS asserts that midurethral slings, placed either by a retropubic or transobturator approach, is the current standard of care for the surgical treatment of SUI. AUGS supports establishing a postmarket registry for mesh used for SUI, and appropriate premarket clinical trials for devices significantly different from those that are currently available.
The situation is still in flux. Recommendations made by the advisory panel are not mandatory, noted Dr. Iglesia. "If the recommendations are adopted by the FDA, it will take several years to take effect, and existing products will stay on the market."
During the question-and-answer session following the AUGS update, it was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP, with some extolling their use and others overwhelmed by the need to repair mesh-related complications, especially mesh implanted by inadequately trained practitioners.
No financial disclosures were listed for Dr. Myers, Dr. Barber, or Dr. Iglesia.