The use of surgical mesh in urology has long been the subject of debate and scrutiny, with particular concern raised about its safety in the treatment of pelvic organ prolapse. On April 16, after years of escalating actions, the FDA ordered an immediate halt to the sale and distribution of surgical mesh kit products indicated for the transvaginal pelvic organ prolapse repair. The announcement generated widespread reaction and coverage in the lay press, including The New York Times and USA Today. In this interview, Eric S. Rovner, MD, discusses the FDA’s announcement, the status of midurethral slings for the treatment of stress urinary incontinence, and how he expects his treatment of prolapse to change in the wake of the FDA’s announcement. Dr. Rovner is professor of urology at the Medical University of South Carolina, Charleston. Dr. Rovner was interviewed by Urology Times Editorial Consultant Gopal H. Badlani, MD, professor of urology at Wake Forest Baptist Medical Center, Winston-Salem, NC.
Please discuss the recent FDA announcement regarding surgical mesh products.
The FDA’s April 16 statement was limited to pelvic organ prolapse mesh, specifically for the indication of anterior vaginal wall reconstruction through a transvaginal approach. This statement did not pertain to posterior vaginal wall mesh or apical vaginal mesh used for abdominal sacral colpopexy. Posterior mesh products have not been available in the United States since 2016. In fact, at the time of the FDA statement, the only remaining products that were being commercially marketed for vaginal pelvic organ prolapse repair were for anterior vaginal wall reconstruction. In essence, the FDA gave a cease-and-desist order to the remaining two manufacturers of pelvic organ prolapse mesh—Boston Scientific and Coloplast—directing them to discontinue all sales and distribution and have a plan to do so within 10 days.
This FDA directive also did not apply to currently available transobturator and retropubic midurethral slings. Those slings currently on the market are unaffected by this FDA directive. In addition, currently used transabdominal mesh products such as those used for abdominal sacrocolpopexy, either through an open approach or through a robotic or laparoscopic approach, are not affected by this statement.
To reiterate, it is still permissible to use mesh for slings if providers are trained to do so?
That is essentially correct. The mesh used for laparoscopic, robotic, and open abdominal sacrocolpopexy was not specifically mentioned in the FDA statement. In addition, the mesh specifically used for midurethral slings such as transobturator slings and retropubic slings was not mentioned by the FDA in this particular statement.
Was the FDA’s April 16 announcement premature, given that the agency’s request for 522 postmarket surveillance data had a due date of December 2019?
The results of the FDA-mandated 522 studies have not been published in journal or abstract form to my knowledge. It is conceivable therefore that the FDA made this decision prior to the final results of these studies. The data upon which the FDA made this decision is unclear. Furthermore, whether the FDA decision is final or potentially reversible when the 522 studies are completed is speculative.