Impact of United States Food and Drug Administration Position Statements on Complication Rates Within 30 Days After Stress Urinary Incontinence Sling Surgery.

INTRODUCTION: The US Food and Drug Administration (FDA) has issued 3 notices regarding the use of synthetic material in stress urinary incontinence (SUI) sling surgeries. In 2011, the FDA published a 15-page report on the use of mesh in SUI procedures, reviewing nearly 4000 cases of adverse events including erosion, infection, pain, and difficulty urinating. This study investigated the impact of these notices on sling placement patterns and their complication rates.

METHODS: This was a retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database from 2008 to 2020 with Current Procedural Terminology code 57288. Exclusion criteria included male sex, American Society of Anesthesiology class IV-V, primary surgical specialty other than urology or gynecology, or concurrent major operations (hysterectomy, colpocleisis, rectocele repair, etc).

RESULTS: Of the 79,536 surgical cases of SUI slings, 41,856 met the study criteria and were included in analysis. In the examined timeframe (2012-2014) following the 2011 FDA statement, there was a significant decline in complications after SUI sling placement and a significant increase in the number of fascial slings. Cases performed after the statement had 18% decreased odds of any complications. Cases performed by urologists had 41% reduced odds of complications compared with those performed by gynecologists. Fascial slings had 4-fold increased odds of complications.

CONCLUSIONS: FDA monitoring and communication regarding implantable synthetics may influence surgical practice and outcomes. Additional study is needed to investigate whether the FDA should have more frequent communication regarding procedures with synthetic implantation.