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SUFU Update on FDA meeting

posted: February 15, 2019

On February 12th 2019, the US Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Medical Device Advisory Committee in Washington, D.C. to specifically address the safety and effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse in the anterior vaginal compartment. The FDA’s objective was to solicit guidance and recommendations from the panel on the best measures to determine the safety and effectiveness of these types of devices. Notably, synthetic mesh use for posterior vaginal pelvic organ prolapse, midurethral slings, or abdominal procedures (e.g. sacrocolpopexy) was specifically excluded from the discussion during this meeting.

After initial concerns raised about the use of vaginally-placed mesh in 2008 and then in 2011, in 2016 the FDA reclassified mesh devices as Class III devices (up from Class II) based on recommendations of the panel. Previously, FDA approval for Class II devices only required 501K premarket notification review based on predicate devices. This new Class III designation requires individual devices to undergo premarket approval (PMA) studies to assess the safety and effectiveness prior to FDA approval. As part of this process, the FDA required existing devices to undergo post-market surveillance studies (known as 522 studies) to assess their safety and effectiveness in order to align with the new device classification. Currently, two companies (Boston Scientific and Coloplast) have transvaginal mesh products commercially available for treating pelvic organ prolapse of the anterior and apical compartments and are conducting post-market studies for their devices.

The intent of the FDA for this meeting was specifically stated as concerning future PMA studies. While the FDA was not asking the panel to comment or provide recommendations on the safety or effectiveness of specific devices that are commercially available, there is ongoing debate as to whether the FDA could or should act to limit currently available devices. In other countries, notably the United Kingdom and Australia, governing bodies have taken steps to halt the implantation of transvaginal synthetic mesh pending further investigations. During the public comment period, the panel heard testimonies from patients, patient advocacy groups, legal experts, professional organizations, and industry representatives. These positions varied from those staunchly opposed to the use of vaginal mesh to those opposed to any limitation on the current use of mesh.

In addition to SUFU Board of Director members, several professional organizations, including the American Urological Association (AUA), American College of Obstetrics and Gynecology (ACOG), American Urogynecologic Society (AUGS), and Society for Gynecologic Surgeons (SGS), were in attendance, many of which presented specific position statements. The AUA reaffirmed its published position statement on anterior vaginal wall mesh.

While SUFU did not make public comments at this meeting, SUFU’s position on anterior vaginal wall mesh aligns with that of the AUA. As a leader in Female Pelvic Medicine and Reconstructive Surgery, SUFU remains committed to providing the best education and training to our providers and the safest and most effective care to our patients. As more information becomes available from the FDA meeting, SUFU will continue to provide timely updates.