Continence Procedures in a Post-Mesh World: The Role of Surgical Registries

What is it about?

The article discusses the history and controversies surrounding synthetic mid-urethral slings (SMUSs) and fascial slings used to treat stress urinary incontinence (SUI) in women. The use of these slings was considered safe before the 2011 US Food and Drug Administration (FDA) Safety Communication statement on transvaginal mesh (TVM). However, the issuing of the 2011 FDA Safety Communication and subsequent litigation against TVM manufacturers have shifted both surgeon and patient acceptance of mesh products. The controversies surrounding SMUSs have changed the treatment landscape of SUI, with a significant reduction in the uptake of synthetic mesh products in Australia. Although there are ample data related to surgical outcomes and safety for both autologous fascial and retropubic SMUSs in carefully selected patients, informed consent and surgical training will be of paramount importance as newer synthetic materials reach clinical maturity.

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Why is it important?

This research is important because it highlights the controversies surrounding synthetic mid-urethral slings (SMUSs) and their association with stress urinary incontinence (SUI) treatment. The study emphasizes the need for surgical registries and high-quality randomized controlled data to guide recommendations for continence procedures. The research provides insight into the history of SMUSs, their efficacy, associated complications, and changes to practice that have occurred after the 2011 US Food and Drug Administration (FDA) Safety Communication statement on transvaginal mesh (TVM). Key Takeaways: 1. SMUSs have a long and established safety profile but have been negatively affected by the controversies surrounding TVM morbidity for POP vs SUI. 2. There remains a lack of high-quality randomized or real-world registry data to definitively exclude SMUS from the SUI treatment algorithm. 3. Informed consent and surgical training will be crucial as newer synthetic materials reach clinical maturity. 4. The Australasian Pelvic Floor Procedure Registry is an example of efforts to establish ways to monitor the surgical outcomes and safety of mesh products.