Trends and incidence of postoperative reported events associated with penile prosthesis. An analysis of the food and drug administration's manufacturer and user facility device experience database

Background: Real life data on adverse events of penile prosthesis are lacking. Aim of this study is to summarize medical device reports (MDRs) related to penile prosthesis implants within the Manufacturer and User Facility Device Experience (MAUDE) database held by The Food and Drug Administration (FDA). Methods: We examined all MDRs from MAUDE database reported in the last ten years related to each FDA-approved penile implant. Event descriptions were reviewed and classified into specific event types. Outcome measures included specific penile prosthesis and reported events as detailed by the MDRs. All data is in line with the Health Insurance Portability and Accountability Act (HIPAA). Pooled Relative risk was used to compare data. Results: Overall, in 10 years, 1340 reports were sent, with the highest number of events reported between 2019 and 2022. Overall, 1240/1340 (92%) were reported as injury while 91/1340 (7%) as implant malfunction. Infection (181/1340: 14%), Erosion (144/1340: 11%), Pain (68/1340: 5%) and Perforation (47/1340: 4%) were the most frequently reported adverse events (AEs). In terms of manufacturer: 675/1340 (50%) were from Boston Scientific, 198/1340 (15%) were Coloplast and 463/1340 (35%) were AMS. When comparing different producers on disproportional analysis, Coloplast presented a higher risk of infection when compared to Boston Scientific and AMS (PRR= 1.5-2.62; P<0.05). Perforation, pain, failure to implant and erosion incidence were comparable between manufacturers. Conclusions: According to MAUDE database, the most frequent complications related to penile prosthesis are infections, erosions, pain, and perforation. Coloplast prosthesis seem to be associated with a higher risk of infection.