(435) Multi-institutional Safety and Efficacy Outcomes with the Penuma Penile Implant

Abstract Introduction Penuma is a novel soft silicone penile sleeve implant that FDA cleared for cosmetic augmentation of the penis, including enhancing girth and length flaccid correction deformities such as retractile penis mid-shaft indentations. Since its clearance, approximately 5,000 devices have been implanted. The increasing popularity accompanied by concerns over patient safety. Possible risks complications include infection or erosion requiring removal implant, hematoma, seroma, prosthesis displacement, persistent flaring proximal to coronal sulcus necessitating revision. Over time, surgical method has evolved, most notably with use scrotal lateral incision in lieu an infrapubic incision. Objective Our objective provide recent multi-institutional data on safety efficacy outcomes patients undergoing surgery across multiple high volume surgeons at tertiary care centers. Methods We performed retrospective analysis men implants between November 2020 March 2022 three surgeons, each working separate large academic hospital. Adverse events unsatisfactory revision determined physician follow up questionnaires were recorded. Outcomes measurements incidents peri post-operative adverse pre- post-operatively (Figure 1). Results 169 male underwent surgery. Mean age was 42.3 +/− 9.8 years. BMI 28.7 4.1. population very healthy (3% tobacco smokers, 2% diabetes, 1% cardiovascular disease). Pre-operative mean 7.6 1.9 cm. Post-operative 11.2 Patients added average 3.8 cm their length, 50% increase (p < 0.001). 9.1 1.4 12.5 1.2 3.4 1.1 girth, 37% Complications rates were: 0.6%, seroma 1.2%, 3.6% 2). Complication found be lower than those reported previously published, IRB-approved review outcomes. Ten (5.9%) results - all had sulcus; but one opted 3). Based questionnaires, revisions satisfactory One completed under local anesthesia time scrotoplasty. Conclusions can used safely enhance other forms augmentation. Should occur, they are mainly cosmetic. Their easily low risk. Disclosure No