A Single-Surgeon Retrospective and Preliminary Evaluation of the Safety and Effectiveness of the Penuma Silicone Sleeve Implant for Elective Cosmetic Correction of the Flaccid Penis

Background: Silicone blocks and sleeves are simple devices used in cosmetic surgery. They are generally viewed as safe and effective; however, there is little information on their use in the penis. Aim: This study evaluates a large single-surgeon series using a novel silicone sleeve penile implant (Penuma) to cosmetically correct the flaccid penis. Methods: 526 patients underwent elective cosmetic penile surgery using a silicone sleeve penile implant between 2009 and 2014. Institutional Review Board approval was obtained for a retrospective analysis, and study consent was obtained from 400 patients. Penile circumference was measured before surgery, immediately after surgery, and 30-90 days after the implant surgery. Using the non-validated Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in self-confidence, self-esteem, and satisfaction scores were assayed 6-8 weeks postoperatively. Scores were again assayed 2-6 years postoperatively in 77% of patients. The questionnaires rated patient self-confidence, self-esteem, and satisfaction as very low, low, medium, high, or very high. Main Outcome Measure: Outcomes include changes in penile measurements; changes in APPSSI satisfaction, self-confidence, and self-esteem scores; and incidences of adverse events. Results: In the 400 patients, the implantation of the Penuma silicone implant increased midshaft circumference from an average of 8.5 +/- 1.2 cm to 13.4 +/- 1.9 cm (56.7% increase; P < .001). A 2-category improvement in self-confidence and self-esteem was noted in 83% of patients 6-8 weeks postoperatively. On long-term follow-up (2-6 years; mean 4 years), 72% patients remained improved (2-category improvement in APPSSI scoring), and 81% of subjects reported "high" or "very high" levels of satisfaction. The most frequently reported postoperative complications were seroma (4.8%), scar formation (4.5%), and infection (3.3%). No patients reported any changes in sexual function, erections, or ejaculation. 3% experienced adverse events necessitating device removal. Clinical Implications: The Penuma silicone implant can help patients cosmetically correct the penis with increased flaccid penile girth and achieve enhanced self-confidence and self-esteem over the short- and long term. Strengths and Limitations: Strengths include the large number of subjects (400 men) and the long-term follow-up period (2-6 years). Limitations include the retrospective and single-surgeon (inventor) nature of the study; the presence of 126 non-consenting subjects, potentially impacting the complication rate; and the APPSSI's lack of validation. Conclusion: Retrospective analysis of 400 men electing to have penile cosmetic correction with the Penuma device demonstrates improvements in girth (56.7% increase) and high and sustained patient satisfaction, self-confidence, and self-esteem with minimal and manageable adverse events. Copyright (C) 2018, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.