April 15, 2024

FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence

Editor's Note

Mini-slings for stress urinary incontinence (SUI) are similarly effective to mid-urethral slings over a 36-month timeframe, according to an April 11 announcement from the US Food & Drug Administration (FDA).

FDA reached this conclusion after an in-depth, systematic literature review of post-market surveillance (“522”) studies required last year for mini-sling manufacturers.

Mini-slings are similar to mid-urethral slings in mesh design and material, but differ in length. The 522 studies assessed both objective and subjective outcomes to determine effectiveness, including 25-hour pad weight test, cough stress test (both objective), and quality-of-life (subjective, assessed via questionnaire). The agency also compared adverse events, such as mesh erosion or exposure, organ perforation, severe pain, and resurgery, finding similar event types and rates.

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