Abstract
BACKGROUND: Adjustable continence therapy for men (ProACT(TM)) is an inflatable para-urethral balloon approved for consumer use in the United States by the Food and Drug Administration in 2015. Post-approval adverse events (AEs) have been catalogued in Manufacturer and User Facility Device Experience (MAUDE). To characterize the complication profile of the device, we systematically reviewed all publications and MAUDE narratives outlining AEs related to ProACT(TM). METHODS: Thirty-one peer-reviewed publications studying ProACT(TM) implantation in humans were identified by search of PubMed and Google Scholar using combination of keywords "ProACT", "balloon", and "continence". Eleven studies were excluded. The MAUDE database was searched for reports of AEs related to the placement of ProACT(TM) and narratives of AEs were characterized. RESULTS: Of 1,607 patients treated in published studies, 752 AEs occurred. The most common were mechanical failure (n=224, 30%), device migration/malposition (n=155, 21%), and device erosion (n=120, 16%). Devices were explanted in 24% of patients and revised or reimplanted in 28% of cases. In the MAUDE database, the AEs identified were similar, with most common complications including device erosion (n=32, 49%), surgical site infection (n=15, 19%), and urinary retention (n=9, 11%). CONCLUSIONS: Use of the ProACT(TM) device is associated with a high rate of AEs. Limitations include the lack of clinical details in the MAUDE database.