Introduction: Penuma is a soft silicone penile sleeve implant FDA cleared for cosmetic augmentation and correction of penile deformities. 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 proximal to the coronal sulcus requiring 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. Our objective is to provide the first set of multi-institutional data on safety and efficacy outcomes in patients undergoing Penuma penile implant surgery across multiple high implant surgeons. Methods: We performed a retrospective analysis of men undergoing Penuma implant between November 2020 and October 2022 with four surgeons, each from a separate geographically diverse academic hospital. Peri- and post-operative adverse events such as unsatisfactory cosmetic outcomes requiring revision as determined by physician follow up and patient questionnaires were noted. Penile length and girth measurements were made pre- and post-operatively. Results: 228 male patients underwent Penuma implant surgery. Mean age was 42.2 +/- 10.2 years. Mean BMI was 28.7 +/- 4.1. Our patient population was very healthy (4% hyperlipidemia, 2% smokers, 1% diabetes, 1% cardiovascular disease). Patients added an average of 4.4 +/- 2.3 cm to their penile length (54% increase) and an average of 3.6 +/- 1.3 cm to their girth (39% increase) (p < 0.01). Complications rates were: infection 0.8%, seroma 2.3%, and erosion 6.6%. Complication rates of infection and seroma were lower and erosion rates were higher than those previously reported in a single-center review. 5.7% reported unsatisfactory cosmetic results that resulted in revision – all had persistent flaring of the Penuma at the coronal sulcus. These cases may be revised under local anesthesia. Based on questionnaires, all revisions had satisfactory outcomes. Conclusions: This is the first study to characterize the long-term safety of the Penuma penile implant across multiple surgeons and institutions. The Penuma can be used to safely enhance flaccid penile length and girth in patients who desire cosmetic augmentation or with retractile penis and other deformities. When cosmetic complications occur, corrections may be completed easily and with low risk. SOURCE OF Funding: None
