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.

Live chat by BoldChat