Introduction: Penuma®, a penile silicone sleeve implant, first developed in 2004, is the first FDA-cleared penile implant for cosmetic enhancement. The company endorses that on average, girth and flaccid length are increased by one to two inches. Given the novelty of the device and the scarcity of surgeons trained in placement, data regarding surgical outcomes as well as patient satisfaction are limited. It is thought that patient selection is a critical contributor to the ultimate success of the surgery. Post-operative complications have previously been described and can include seroma, infection, and erosion.
Methods: Retrospective chart review was performed on patients that were six months or greater from initial date of surgery. Progress notes from follow up appointments as well as telephone encounters were reviewed to look for patient complaints, post-operative physical exams, and post operative procedures. Subsequent operative reports apart from initial implant were also reviewed. An electronic survey assessing various aspects of penile satisfaction before and after the implant was sent to patients who were six months or greater from surgery and still had the device in place.
Results: From April 2019 to February 2021, 70 patients underwent insertion of subcutaneous soft silicone penile implant (Penuma®) with two surgeons. Post operatively, flaccid penile length base to tip increased on average 4.0-6.0 cm, mid-shaft girth increased 2.5-5.0 cm, and there was no increase in erect length. 8 of these patients (11%) subsequently underwent removal of the device, reasons for which included pain (2), dissatisfaction with the device (1), erosion (4), and loss of skin after frostbite (1). 19 patients (27%) experienced postoperative seromas, of which 14 required drainage. Four patients (6%) required operative revision for edge protrusion (2), proximal dislodgement (1) and improved placement (1). A follow up survey was sent to two surgeons’ patient populations of 66 patients, for which we had a 40% response rate. With regards to patient satisfaction, 65% of patients self-reported being “dissatisfied” or “very dissatisfied” with the appearance of their penis before the implant compared to 96% who reported being “satisfied” or “very satisfied” after the implant. 85% of patients reported being “satisfied” or “very satisfied” with how natural their penis looks after the implant, with 4% reporting being “very dissatisfied.” 65% reported feeling “very dissatisfied” with self-confidence with regards to their penis prior to surgery, while 92% felt “satisfied” or “very satisfied” regarding the same after surgery. Overall, 85% of responders “agreed” or “somewhat agreed” that they would opt to undergo surgery again.
Conclusions: The Penuma® penile sleeve implant can improve patient self-satisfaction and self-confidence with regards to the appearance of their penis while maintaining a natural feel. Post operative complications, including need for re-operation, are low but not negligible. The number of surgeons that currently offer the Penuma® implant surgery in the United States is quite small, and this study suggests that it may be a successful potential option for men with penile dysmorphic disorder.
Source of Funding: No funding was needed for this study
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