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Introduction: The AdVance and Virtue male slings are treatment options for post-prostatectomy incontinence (PPI), with the goal of reducing urinary incontinence without affecting voiding parameters. A concern of any procedure in treating men with PPI is the presence of significant complications. The purpose of this study was to report the presentation and treatment of complications from this minimally invasive treatment to a tertiary referral practice and to highlight complications reported in the food and drug administration (FDA) device failure database.
Materials & Methods: From January 2008 through March 2011, we reviewed all cases of AdVance and Virtue sling complications that presented to our institutions. The FDA manufacturer and user facility device experience (MAUDE) database was queried for self-reported complications.
Results: A total of 5 patients were referred to the Lahey Clinic and Penn Presbyterian Medical Center with complications following a male perineal sling. Treatments required a combination of surgical exploration, drainage and irrigation with antibiotics, mesh excision, and further surgery to treat the incontinence. The MAUDE database contained 11 major complications out of a total of 61 complications that were reported for the AdVance and Virtue male slings. There were significantly more major complications reported in MAUDE than in published literature.
Conclusions: Although rare, major complications of the male perineal slings are more common than they appear in the literature. Many of these cases may require additional reconstructive surgery and subsequent procedures for treatment of underlying incontinence.