Midurethral slings: evidence-based medicine vs the medicolegal system.
Midurethral sling procedures are minimally invasive surgeries for stress urinary incontinence that use a trocar system to place a narrow ribbon of polypropylene mesh under the midurethra. The peer-reviewed scientific literature on these procedures is abundant and midurethral slings are the most well-studied incontinence procedure ever. Systematic reviews of the literature demonstrate that midurethral slings are safer and more (or equally) effective as traditional procedures. The midurethral sling is the worldwide standard for the treatment of female stress urinary incontinence and >3 million procedures have been performed. The Food and Drug Administration and international scientific review agencies have consistently differentiated transvaginal mesh for stress urinary incontinence from transvaginal mesh for prolapse. In the recruitment of patients to participate in transvaginal mesh litigation, plaintiff lawyers have not made the distinction between stress urinary incontinence and prolapse procedures because more women have received midurethral slings than transvaginal mesh for prolapse by an order of magnitude. The litigation costs of defending their products have forced several companies that manufactured midurethral slings to leave the marketplace. It is not inconceivable that midurethral slings could become absent from the US market. If that happens, then US women with stress urinary incontinence will be harmed because they will not have access in this country to the best and safest stress urinary incontinence surgical procedure ever developed. It may be time for the Institute of Medicine or another comparable national agency to provide evidence-based recommendations on the midurethral sling.
Department of Reproductive Medicine, University of California San Diego School of Medicine, San Diego, CA. Electronic address: cnager@ucsd.edu.
Charles W
CW
Nager
D000329:Advertising; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008318:Malpractice / Q000331:legislation & jurisprudence*; D019060:Minimally Invasive Surgical Procedures / Q000331:legislation & jurisprudence; D056887:Pelvic Organ Prolapse / Q000601:surgery; D053825:Suburethral Slings; D013526:Surgical Mesh; D014481:United States; D014486:United States Food and Drug Administration; D014550:Urinary Incontinence, Stress / Q000601:surgery
evidence-based medicine; litigation; midurethral slings; stress urinary incontinence; surgery; systematic review; transvaginal mesh