Surgical Outcomes of the ZSI475 FtM Inflatable Erectile Prosthesis Implantation After Phalloplasty.

Objective: To report the surgical outcomes and complications experienced after implantation of the ZSI475 FtM prosthesis after phalloplasty.

Methods: All consecutive patients who underwent ZSI475FtM prosthesis implantation in their neophallus between January 2016 and March 2024 in our center were included. There was no exclusion criterion. We considered the occurrence of a complication according to the date of first appearance in the medical record.

Results: A total of 89 patients, accounting for 130 implantation surgeries, were included. Among the 130 implantations, 69 (53.1%) led to a complication; the most frequent was mechanical dysfunction (52/130, 40.0%), followed by infection (8/130, 6.2%), malposition (7/130, 5.4%), and erosion (2/130, 1.5%). All cases of infection and erosion were treated by prosthesis removal. Overall, these complications led to 60 revision surgeries for replacement (41/60, 68.3%), removal (17/60, 28.3%), and refixation (2/60, 3.3%). The median follow-up was 3.9years [IQR, 2.3-5.5], and the median time to complication was 1.6years [IQR, 0.4-2.4]. The median survival time of the prosthesis was 5.4years [IQR, 4.6-5.9] and the 4-year probability of survival was 74.0% (95%CI [65.6-83.4]).

Conclusion: The ZSI475 FtM implant shows a survival probability similar to the rates reported in the literature. Future improvements are needed to increase its robustness and survival. The next step toward a better understanding of the associated complications will involve multicenter data collection of the surgical outcomes.