Use of Concomitant Stress Incontinence Surgery at Time of Pelvic Organ Prolapse Surgery since Release of the 2011 FDA Health Notification on Serious Complications Associated with Transvaginal Mesh

There is controversy regarding performing concomitant anti-incontinence procedures at the time of pelvic organ prolapse (POP) repair. Data supports improvement in stress urinary incontinence (SUI) with concomitant sling, but increased adverse events. We assessed trends in preoperative SUI evaluation, concomitant anti-incontinence procedure at POP surgery, and post-operative anti-incontinence procedures at our institution before and after the 2011 FDA Public Health Notification pertaining to vaginal mesh.

A retrospective review was performed on patients who underwent POP surgery from 2009-2015. Preoperative workup included assessment of subjective SUI and/or evaluation for leakage with reduction of POP on physical exam, urodynamics or pessary trial. Percentage of concomitant and post-operative anti-incontinence procedures were compared before and after the 2011 FDA notification.

775 women underwent POP repair. The percentage of anti-incontinence procedures at POP repair decreased from 54.8% to 38.0% after the FDA notification (p = 0.002) while the incidence of pre-operative objective SUI on exam, urodynamics and pessary trials remained constant. The incidence of post-operative anti-incontinence procedures within one year of the index surgery remained low.

We found a decrease in incidence of concomitant anti-incontinence procedures at the time of POP repair following the 2011 FDA notification despite no significant decline in subjective SUI or demonstrable SUI on preoperative evaluation. Further analysis is warranted to assess the impact of the FDA notification on management patterns of women with POP and SUI.

The Journal of urology. 2016 Nov 17 [Epub ahead of print]

Alice Drain, Aqsa Khan, Erin L Ohmann, Benjamin M Brucker, Scott Smilen, Nirit Rosenblum, Victor W Nitti

New York University Langone Medical Center, New York, NY.

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