Opinion: No

Urinary incontinence is a highly prevalent condition affecting up to half of all women, most of whom have a component of stress urinary incontinence (SUI) (1). Approximately 10% of these women will undergo surgical treatment. While for decades the standard of care was the Burch colposuspension or autologous fascial pubovaginal sling, rapid advances in the development of augmented polypropylene products (APM) for medical use led to the widespread adoption of synthetic midurethral slings (SMUS) for the treatment of SUI. SMUS are now the standard of care and the most commonly performed procedure for the treatment of SUI worldwide. Multiple level one randomized trials have demonstrated equivalent outcomes for SMUS to Burch colposuspension and autologous fascial slings (2). In addition to their ease of use, SMUS provide faster operative times, reduced post-operative morbidity, faster resumption of normal activity, and reduced cost (3). Patient satisfaction with the procedures has been quite high (4) with comparable durability to the older techniques. As seen for slings, the adoption of APM products for the treatment of pelvic organ prolapse (POP) gained rapid acceptance due to perceived safety, efficacy, and durability. With increasing use, however, a growing number of severe complications came to light, prompting the FDA to release its first black box warning in 2008 (5). Such concerns continue to grow; after an expanded warning reissued in 2011 (6), the past year has seen the FDA upgrade of transvaginal mesh for the treatment of POP to a class III (“high-risk”) device (7). Transvaginally-placed mesh used in the treatment of incontinence, however, remains exempt from these warnings, despite the fact that more than half of the tens of thousands of lawsuits brought against mesh manufacturers have been from patients implanted with retropubic or transobturator SMUS (8). Of the nearly one thousand patients seen at our center over the past five years for transvaginal mesh complications, 77% (n=747) were related to SMUS placement. The last FDA safety communication from 2011 notes that almost half of the Medical Device Reports (MDRs) for urogynecological meshes in the Manufacturer and User Device Experience (MAUDE) database were associated DIffERENCE Of OpINION