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Urogynecologists Respond To FDA on Mesh for POP


 

Expert Analysis from the Annual Meeting of the American Urogynecologic Society

PROVIDENCE, R.I. – After the Food and Drug Administration issued an updated safety communication concerning the surgical placement of transvaginal mesh to repair pelvic organ prolapse on July 13, leaders of the American Urogynecologic Society sprang into action.

The American Urogynecologic Society (AUGS) leadership alerted its members, participated in a stakeholders' conference call the following day with the FDA, polled its members, created a blog on its website, released its own recommendations, and testified before an FDA investigatory panel Sept. 8–9 regarding the safe and effective use of transvaginal mesh for both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The FDA's Safety Communication

It is beyond the scope of this report to review all the recommendations made by the FDA concerning transvaginal placement of surgical mesh for POP; for more detailed information, see

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

After a systematic review of the literature from 1996 to 2011, the FDA concluded that transvaginal POP repair with mesh may have an anatomic benefit that may not necessarily improve symptoms or quality of life over traditional nonmesh repair. They stated that in most cases, POP can be treated successfully without mesh, and mesh surgery should be chosen only after weighing associated risks and benefits.

The FDA Panel Hearing

On Sept. 8–9, the FDA convened an Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to consider the use of transvaginal mesh for POP and SUI. The 19-person panel, chaired by Dr. Tommaso Falcone of the Cleveland Clinic, included 12 physicians, 2 statisticians, and representatives of patients, consumers, and industry. Five were members of AUGS, including Dr. Cheryl B. Iglesia, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at Washington (D.C.) Hospital Center, who spoke about her experiences at the AUGS annual meeting.

The AUGS' Stand and the Panel's Recs

On Sept. 15, at the AUGS annual meeting, an update was held to inform members about new developments regarding vaginal placement of mesh. President Deborah Myers presented the AUGS leadership stance, which was also outlined in an executive summary (available on the organization's website,

www.augs.org

The AUGS statement described some of the complexities regarding the use of transvaginal mesh for pelvic reconstruction. The society indicated that it supports the FDA Safety Communication Update recommendations: that often POP can be treated successfully without mesh. However, while AUGS does not support the routine use of vaginal mesh for POP repair, it recognizes “that there may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate.”

After discussion of a number of serious adverse events associated with the use of vaginal mesh for POP repair, the panel's consensus was that the safety of such mesh is not well established. Depending on the compartment, vaginal placement of mesh for POP repair may not be more effective than traditional “native-tissue” repair without mesh, and the consensus was that the risk/benefit of vaginal placement of mesh for POP repair is not well established.

The AUGS statement indicated that there is insufficient data available to guide treatment decisions for individual patients, noting that such decisions should be made collaboratively by physicians and patients. Although outcomes reflect both surgical training and skill, many members of AUGS report excellent outcomes and low complication rates with transvaginal mesh. With this in mind, “AUGS does not support a 'blanket' withdrawal of currently available transvaginal mesh products from the market.” Instead, AUGS supports the judicious use of transvaginal mesh for POP repair performed only by surgeons with appropriate training on patients who have been fully informed of the risks and benefits of all available treatment options.

AUGS' stance on informed consent is “in sync” with the FDA. It supports a consent process that informs patients of nonsurgical options, alternative native tissue surgical repairs, and abdominal repairs, as well as possible adverse outcomes associated with mesh. The organization is planning to offer an online informed consent checklist.

Within the next 12 months, AUGS plans to develop educational and training recommendations to guide hospitals in privileging those who may conduct POP surgery using transvaginal mesh. Until those recommendations are issued, AUGS suggests “that continued placement of transvaginal mesh for POP be performed only by providers who have extensive training in pelvic surgery, maintain a high volume of surgical procedures for prolapse, have specific training in the device and method used, and are able to track both objective and subjective short-term and long-term outcomes.”

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.

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