Presentation Authors: Alexandra Siegal*, Anh Nguyen, Zhenyue Huang, William Berg, Sina Mehraban-Far, Michael Gross, Stephen Eng, Steven Weissbart, Jason Kim, Stony Brook, NY
Introduction: The Food and Drug Administration (FDA) issued a 2011 warning on serious complications of surgical mesh in urogynecological procedures. There is limited data on the impact of the FDA warning on urethral sling placement for stress urinary incontinence (SUI). We sought to determine insertion and revision rates of urethral sling across time and among general gynecologists, urologists, and female pelvic medicine and reconstructive surgery (FPMRS) trained physicians using a statewide database.
Methods: The New York Statewide Planning and Research Cooperative System (SPARCS) is an all payer reporting system that collects physician and patient data. Data on sling implantations for SUI performed by NY physicians from 2005 to 2015 were extracted using CPT codes. Physician board certification data was collected based on NY license numbers. Pre-2011 was defined as 2007-2010 and post-2011 was defined as 2012-2015.
Results: 54,151 sling operations were identified, of which 2,472 were revisions. Total urethral sling placements decreased by 40.9% from 2011 to 2015. After 2011, the proportion of slings placed by non-FPMRS physicians decreased (70.2% to 58.3%).The total number of sling revisions remained relatively stable from 2011 to 2015. In this time, FPMRS providers began to perform the majority of revisions (46.8% to 57.8%). Since the FDA warning, average time between sling implant and revision decreased for both non-FPMRS and FPMRS providers (non-FPMRS: 72 mo. to 24 mo., FPMRS: 64 mo. to 23 mo., p < 0.001).
Conclusions: Since the FDA warning, utilization of the urethral sling by non-FPMRS physicians for SUI has greatly decreased, with an increasing proportion of procedures by FPMRS physicians. Similarly, the proportion of sling revisions by FPMRS physicians has increased. Decreased time between sling implant and revision may reflect more aggressive surveillance of patients in response to the FDA and/or patient driven concerns.