Actions on Surgical Mesh Mini-Slings

April 15, 2024
FDA announced several actions that have been taken to better understand the safety and effectiveness of surgical mesh mini-slings

On April 11, the FDA announced several actions that have been taken to better understand the safety and effectiveness of surgical mesh mini-slings to treat female stress urinary incontinence (SUI) including evaluating the results of long-term follow up studies and completing an in-depth literature review to evaluate the performance of the mini-slings compared to the traditional mid-urethral slings.

The results continue to support the FDA’s conclusion that mini-slings have comparable clinical performance to traditional mid-urethral slings through at least 36 months for treating female SUI. The FDA’s recommendations have not changed.

FDA has the announcment.