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

Abstract

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