Abstract Introduction Three-piece inflatable penile prosthesis (3IPP) implantation is a cornerstone in the management of chronic organic erectile dysfunction, providing the most natural patient experience. However, substantial concerns persist regarding 3IPP long-term device survival, mechanical failure rates, and complication prevalence. Objective Most available studies are not focused specifically on 3IPP, include low-volume samples or cohorts with relatively short follow-up, yielding potentially incomplete picture with likely underestimation of problem numbers. Methods In this study, we combined a systematic review of 3IPP survival, mechanical failures, and complication rates with a series of meta-analyses limited to high-volume studies (n≥200) with a mean follow-up of ≥1 year. Results Pooled estimates of overall device survival rate demonstrated a progressive decline over time. At one year post-implantation, the estimated survival rate was 94.3% (95% confidence intervals, CI 92.7–95.5%), gradually decreasing to 90.7% (CI 88.3–92.7%), 86.3% (CI 82.7–89.2%), and 72.3% (CI 68.0–76.3%) at 3, 5, and 10 years, respectively. 3IPP could have a number of mechanical failures, such as leakage in various sites, pump malfunction, and inflation/deflation difficulties. A pooled prevalence of mechanical failures accounted for 4.7% (CI 2.8–7.7%) in studies with less than 3 years of follow-up, rising to 9.4% (95% CI 6.3–13.8%) in studies with 3 or more years of follow-up. For device infections, a pooled estimate rate was 2.2% (CI 1.5–3.1%). Surgical complications encompassed hematoma (pooled prevalence 2.0%, CI 0.9-4.3%), cylinder malposition and other cylinder-related issues (0.9%, CI 0.3-2.5%), various erosions (1.0%, CI 0.5-1.9), reservoir-related complications (0.4%, CI 0.2-0.9%), and a wide range of less common issues such as intraoperative injuries and chronic pain. Conclusions Despite some advances in device design and surgical technique, complications and mechanical failures lead to a considerable decline in 3IPP survival over the first 3–10 years. These findings highlight multiple areas for improvement in 3IPP treatment, including the development of next-generation penile prosthetic devices and optimization of peri-, intra-, and postoperative strategies. Disclosure No
Sforza et al. (Mon,) studied this question.
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