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.

We queried the Manufacturer and User Facility Device Experience Database (MAUDE) for event types classified as “injury”, “malfunction” or “death” with relation to male urethral sling systems from July 1, 2009 to June 30, 2019. We also searched the commercially available devices by brand name—AMS AdVance, AMS InVance and Coloplast Virtue—to ensure we captured all associated reports. Our search generated a raw tally of 776 reports. After filtering duplicated entries and applying our exclusion criteria for insufficient information, we identified 429 total remaining reports. A minority of the reports required reclassification of the event types based on the event description provided.

The AMS products accounted for 420/429 (98%) reports, including 326/429 (76%) AdVance and 68/429 (16%) InVance slings; an additional 26/429 (6%) AMS slings were unspecified. There were otherwise only 9/429 (2%) total reports for the Coloplast Virtue sling. Notably, 51/68 (75%) of the InVance reports were submitted prior to 2014, while 25/26 (96%) of the unspecified AMS slings were reported in 2018-2019 (Figure 1).

Overall, no deaths were recorded. Of the event types, there were 406/429 (94.6%) injuries and 23/429 (5.4%) malfunctions observed (Table 1). Time to presentation was not consistently noted, however, 38/429 (9%) were described as intra-operative events, of which 20/38 (53%) were classified as malfunctions. Persistent SUI was by far the most common primary complication reported at 209/406 (51%), followed by erosion at 37/406 (9%) and infection at 32/406 (8%). The most common intra-operative injury described was a urethral or bladder perforation and accounted for 19/406 (4.7%) reports, all of which involved the trans-obturator AdVance sling. The most common device malfunction, 10/23 (43%), involved either the sheath or plastic connector of the AdVance sling being inadvertently left in situ. A break in the mesh product was the second most common malfunction, reported 7/23 (30%) times. The only malfunctions seen for InVance slings were 3/23 (13%) cases in which the anchoring bone screws were displaced. 

Of the 409 injury reports, 335 (82%) described a necessary surgical intervention for the unfavorable outcome. The remaining 74 (18%) reports either managed the complication conservatively or did not note an operative treatment in the event description. Overall, new continence devices were implanted in 275/429 (64%) cases. An AUS was implanted in 118/275 (43%), and an additional 137/275 (50%) noted placing an “alternative continence device” but did not identify the specific product. Only 20/275 (7%) cases noted a new sling was implanted, 6/20 (30%) of which were replaced at the time the original sling malfunctioned. A majority of the malfunctions, 16/23 (70%), otherwise did not require a new device. At least 91/429 (21%) slings required removal, 41/91 (45%) of which had a new device implanted concurrently. All 53/406 (13%) reports that detailed a salvage procedure but could not specify an injury described an AUS placed in managing the adverse event.

The general distribution of adverse events per sling device is consistent with prior literature noting AdVance slings to be most popularly implanted followed by InVance and Virtue [3]. The observation that InVance reports were predominately submitted earlier in the cohort may be reflective of the device no longer being available on the market by the latter half of the decade. Persistent SUI, which can be considered a marker of sling failure, was the most common reason why additional surgery was required. Device malfunctions accounted for a minor fraction of all reports in this current study, the bulk of which can be attributed to user error. Though the incidence of complications and success rates for male slings in the literature may vary, it is important to acknowledge this report's surgical outcomes information as it is publicly available to our patients.

As male urethral slings are implantable synthetic products, medical device safety should be considered in their use. An array of adverse events has been reported in the publicly available MAUDE database for the three popular fixed male slings. The majority of these events necessitated surgical intervention and a considerable amount involved implanting secondary continence devices.

Meisterhofer K, Herzog S, Strini KA, et al. Male slings for postprostatectomy incontinence: a systematic review and meta-analysis. Eur Urol. 2019;01:008.
Sandberg JM, Gray I, Pearlman A, Terlecki RP. An evaluation of the Manufacturer and User Facility Device Experience database that inspired the United States Food and Drug administration’s reclassification of transvaginal mesh. Investig Clin Urol. 2018 Mar;59(2):126-132.
Doudt AD and Zuckerman JM. Male slings for post-prostatectomy Incontinence. Rev Urol 2018; 20(4): 158-169