Perspectives on technology: urethral slings in a post-mesh world

Area of Science:

• Urology
• Gynecology
• Surgical Innovation

Background:

• Transvaginal mesh (TVM) was once considered safe for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
• US Food and Drug Administration (FDA) 2011 safety communications and subsequent litigation negatively impacted surgeon and patient acceptance of mesh products.
• Distinguishing TVM morbidity for POP versus SUI remains challenging for patients and consumers.

Purpose of the Study:

• To review the history, efficacy, and complications of synthetic mid-urethral slings (SMUSs) and fascial slings.
• To analyze practice changes post-2011 FDA safety communication on transvaginal mesh (TVM).
• To emphasize the need for surgical registries and high-quality data for continence procedures.

Main Methods:

• Literature search of EMBASE, PubMed, and Cochrane Database of Systematic Reviews.
• Focus on articles published from 2011 onwards, following the FDA Safety Communication.
• Review of existing data on SMUSs and fascial slings, including safety and efficacy.

Main Results:

• Perceptions of mesh for SUI have been negatively affected, though SMUSs have a long safety profile.
• Lack of high-quality randomized or real-world registry data hinders definitive exclusion of SMUSs from SUI treatment.
• Significant reduction in synthetic mesh uptake due to litigation and FDA warnings.

Conclusions:

• Controversies surrounding SMUSs have altered SUI treatment paradigms.
• Despite reduced mesh use, SMUSs remain a viable option for SUI in carefully selected patients.
• Informed consent and surgical training are crucial with evolving synthetic materials.