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Transcorporal Artificial Urinary Sphincter Cuff Placement in a Case Requiring Revision for Urethral Atrophy
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Impact of United States Food and Drug Administration Position Statements on Complication Rates Within 30 Days After

Arshia Aalami Harandi1, Natalie Braun2, Jason Kim1

  • 1Department of Urology, Stony Brook University Medical Center, Stony Brook, New York.

Urology Practice
|June 27, 2025
PubMed
Abstract

Insights

The US Food and Drug Administration

Area of Science:

  • Urology
  • Gynecology
  • Surgical Quality Improvement

Background:

  • US Food and Drug Administration (FDA) issued notices on synthetic mesh for stress urinary incontinence (SUI) surgery.
  • A 2011 FDA report detailed adverse events like erosion, infection, and pain from SUI mesh procedures.

Purpose of the Study:

  • To investigate the impact of FDA notices on SUI sling placement and complication rates.
  • To analyze changes in surgical practice and patient outcomes following FDA communications.

Main Methods:

  • Retrospective analysis of the National Surgical Quality Improvement Program (NSQIP) database (2008-2020).
  • Included 41,856 SUI sling procedures (CPT code 57288), excluding specific patient and surgical criteria.

Main Results:

  • A significant decline in SUI sling complications was observed post-2011 FDA statement.
  • An increase in fascial slings and a decrease in overall complications (18%) occurred.
  • Urologist-performed procedures had 41% fewer complications; fascial slings showed 4-fold increased complication odds.

Conclusions:

  • FDA monitoring and communication influence surgical practices and outcomes for synthetic implants.
  • Further research is needed on the frequency and impact of FDA communication for implantable synthetics.
Keywords:
meshmid-urethral slingslingstress incontinenceurinary incontinence

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