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FDA Announcement on Transvaginal Mesh for Prolapse

April 18, 2019 10:40 AM

AUGS received notice from the FDA on Tuesday, April 16, of the simultaneous public notice, “FDA Takes Action to Protect Women’s Health; Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices”. The notice orders all manufacturers of surgical mesh products for transvaginal repair of prolapse to stop selling and distributing their products in the U.S. immediately. The remaining manufacturers producing transvaginal mesh kits are Boston Scientific, that markets the Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast, that markets Restorelle DirectFix Anterior.

Given the ongoing confusion in lay and medical press, it is worth highlighting that the FDA Announcement does not apply to the use of mesh in mid-urethral slings or to treat prolapse using sacral colpopexy. AUGS position on midurethral slings is unchanged from the AUGS/SUFU Position Statement: Mesh Midurethral Slings for Stress Urinary Incontinence (supported by ACOG).

The FDA decision was reportedly based on the recommendations of the FDA Advisory Panel held in February of this year. This Panel was tasked with recommending how the FDA should evaluate the risks and benefits of these devices as required by the premarket approval required for Class III devices. I testified on behalf of AUGS at the Advisory Panel, and my testimony supported the Panel’s recommendations that favorable evaluation of these devices should be based on evidence of superior efficacy compared to native tissue repairs, in order to offset the risks of complications unique to transvaginal mesh prolapse procedures. The written testimony can be accessed here. The panel recommended evidence of superiority at 36 months follow-up.

The FDA Announcement was surprising, as 36-month data on these devices have yet to be published through the peer-review process. Several NIH funded studies are in the final stages of completion and publication, but the FDA depended instead on the PMAs submitted by the two manufacturers. It is also frustrating to many practicing FPMRS providers who offer transvaginal mesh prolapse procedures to women who have failed prior native tissue repairs, or those with a significant risk of failure. The benefit-risk analysis for such patients may make this a useful option for such patients, a point I highlighted in my testimony. I specifically noted the importance of supporting research and surgical registries to better define utility of transvaginal mesh for such sub-populations of high-risk prolapse patients.

AUGS supports providing choices for women who suffer from pelvic floor disorders through the use of shared decision making. The shared decision making process requires that a surgeon have treatment options with clearly delineated benefits and risks, from which a patient can choose the option that best aligns with her values and priorities. With the transvaginal mesh kits taken off the market, some surgeons counselling women may feel obliged to offer transvaginal procedures using mesh fashioned in a myriad of techniques and modifications. Unfortunately, this will set back our collective experience by jeopardizing meaningful data collection and analysis.

Boston Scientific and Coloplast have 10 days to notify the FDA of their plans to remove their products from the market. This could impact those of you who have surgeries using their devices planned in the near future. It will also create anxiety for those patients who have had prior surgeries with these devices. Reassurance and longitudinal assessment is recommended for asymptomatic patients who have had transvaginal mesh for prolapse and are not having problems. For those suffering form complications, I direct you to the ACOG Committee Opinion #694, “Management of Mesh and Graft Complications in Gynecologic Surgery,” which AUGS developed jointly with ACOG (April 2017).

AUGS readily acknowledges that women can and do experience complications related to mesh. Vigilant and attentive management of surgical complications, whether related to mesh or not, is a foundational principal of surgery. Our patients, who suffer surgical complications, deserve prompt identification and access to providers who have the necessary skills to address their needs. AUGS is dedicated to providing education to providers, to defining necessary resources for managing complications, and to promoting research to define best practice.

I recognize that our Society includes members with a spectrum of views about the use of transvaginal mesh for prolapse. Regardless, of your perspective, regulatory decisions that limit care are uncomfortable for a self-regulating profession. As a callow specialty we should reflect on the forces that led us to this awkward circumstance. However, right now, I ask that you avoid polarization and come together with your colleagues to move forward with providing excellent care for our patients.

Geoffrey Cundiff, MD
President, American Urogynecologic Society

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