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Adverse Events Associated with Male Urethral Sling Placements: A Review of the Manufacturer and User Facility Device Experience Database (MAUDE)

Elyaguov J1, Ballinger Z1, Passarelli R1, Phillips J1

1. New York Medical College, Westchester Medical Center

KEYWORDS: Male, Pelvic Floor, Stress Urinary Incontinence, Quality of Life (QoL), Surgery

Several therapies involving medical devices exist to treat male stress urinary incontinence (SUI), most commonly a result of sphincteric incompetence following radical prostatectomy. An earlier development in surgical correction for male SUI, the artificial urinary sphincter (AUS) has been dubbed the gold standard implant, particularly in moderate to severe cases. Alternatively, the male urethral sling was designed to buttress the bulbar urethra via ventral compression and elevation, often reserved for patients with milder cases and diminished dexterity. In the United States, three perineal male sling systems have been popularized: the AMS AdVance™ (trans-obturator), the AMS InVance™ (bone-anchored), and the Coloplast Virtue™ (quadratic) slings. Few studies have investigated long-term outcomes of such devices, with a recent review reporting median follow-up ranging from 12 to 58 months [1]. In light of recent heightened scrutiny and regulatory changes in mesh therapy for female pelvic floor surgery, we decided to analyze adverse events reported for male urethral slings to the United States Food and Drug Administration (FDA) [2]. We aimed to review this publicly available federal database for unfavorable outcomes associated with these devices as well as evaluate trends in salvage therapy after sling failure.

Read the full abstract text here: https://www.ics.org/2020/abstract/133