Lombardo Riccardo, Zammitti Filippo, Nacchia Antonio, Guercio Alessandro, Turchi Beatrice, Romagnoli Matteo, Santoro Giuseppe, Franco Antonio, Tema Giorgia, Cicione Antonio, Fuschi Andrea, Al Salhi Yazan, Pastore Antonio L, Tubaro Andrea, DE Nunzio Cosimo
Department of Urology, Sapienza University, Rome, Italy -
Department of Urology, Sapienza University, Rome, Italy.
Minerva Urol Nephrol. 2025 Aug;77(4):546-552. doi: 10.23736/S2724-6051.25.06309-8.
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).
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.
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.
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.
缺乏阴茎假体不良事件的真实生活数据。本研究的目的是总结美国食品药品监督管理局（FDA）维护的制造商和用户设施设备经验（MAUDE）数据库中与阴茎假体植入相关的医疗器械报告（MDR）。
我们检查了MAUDE数据库中过去十年报告的所有与每种FDA批准的阴茎植入物相关的MDR。对事件描述进行审查并分类为特定的事件类型。结果指标包括特定的阴茎假体和MDR详细报告的事件。所有数据均符合《健康保险流通与责任法案》（HIPAA）。采用合并相对风险来比较数据。
总体而言，在10年中，共发送了1340份报告，2019年至2022年期间报告的事件数量最多。总体而言，1240/1340（92%）报告为伤害，而91/1340（7%）为植入故障。感染（181/1340：14%）、侵蚀（144/1340：11%）、疼痛（68/1340：5%）和穿孔（47/1340：4%）是报告最频繁的不良事件（AE）。在制造商方面：675/1340（50%）来自波士顿科学公司，198/1340（15%）来自康乐保公司，463/1340（35%）来自美国医疗系统公司（AMS）。在不成比例分析中比较不同生产商时，与波士顿科学公司和美国医疗系统公司相比，康乐保公司出现感染的风险更高（PRR = 1.5 - 2.62；P < 0.05）。各制造商之间穿孔、疼痛、植入失败和侵蚀的发生率相当。
根据MAUDE数据库，与阴茎假体相关的最常见并发症是感染、侵蚀、疼痛和穿孔。康乐保公司的假体似乎与更高的感染风险相关。
