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This study evaluates the surgical outcomes and long-term complications of ZSI 475 FtM penile implants following phalloplasty across multiple centers.

June 6, 2026

(080) An International Multicentre Retrospective Cohort Analysis of ZSI 475 FTM Penile Implants Following Phalloplasty

Key Points

This study evaluates the surgical outcomes and long-term complications of ZSI 475 FtM penile implants following phalloplasty across multiple centers.
Data collected from medical records across five international centers.
Included individuals who underwent phalloplasty followed by ZSI 475 FtM penile implant insertion.
Analyzed complications like infection, mechanical dysfunction, malposition, and erosion.
245 procedures were included, with a complication rate of 9% for infections requiring removal.
Mechanical dysfunction occurred in 37% of procedures, leading to 74 revisions and 6 removals.
Overall complication-free survival rates at 1, 3, and 5 years were 69%, 35%, and 12%, respectively.

Abstract

Abstract Introduction Penile prosthesis implantation in transgender individuals following phalloplasty is a delicate procedure necessary to provide rigidity within the neophallus. The Zephyr Surgical Implants (ZSI) 475 FtM inflatable implant features design attributes aimed at facilitating implantation within the neophallus. Current literature on the ZSI 475 FtM consists of single-centre studies with small sample sizes, limiting generalisability. Objective The objective of this first multicentre study of its kind was to evaluate surgical outcomes and long-term complications associated with penile implants in phalloplasty. Methods Data were collected from medical records across five international centres. Individuals who underwent phalloplasty followed by ZSI 475 FtM penile implant insertion were included. Data was comprised of patient demographics, surgical details, postoperative complications and follow-up outcomes. Complications were classified as infection, mechanical dysfunction, malposition or erosion. Results A total of 155 patients were included across five centres: Hôpital Lyon Sud (n=82), Amsterdam UMC (n=52), Molinette Hospital (n=19), Guemes Hospital (n=7), and Belgrade Center for Genital Reconstructive Surgery (n=6). The mean age at implantation across all centres was 38 ± 10 years, with a mean BMI of 25 ± 4 kg/m2. The phalloplasty flap types which occurred were free radial forearm (74/166), abdominal (39/166), anterolateral thigh (23/166), superficial circumflex iliac perforator (20/166), latissimus dorsi (8/166) and unknown (2/166). A total of 245 procedures were included (110 primary implantations and 135 reimplantations), with a mean follow-up of 2.5 ± 2 years. Prosthesis infection requiring removal occurred in 9% of procedures (22/245). The most common complication was mechanical dysfunction (37%, 91/245), which resulted in 74 implant revisions and 6 implant removals. In 51 cases the area of dysfunction was identifiable: the cylinder (55%, 28/51), the tubing (43%, 22/51) or the pump (2%, 1/51). This was followed by malposition (7%, 16/245), which required repositioning of the implant in 6 cases and removal in 9. Lastly, erosion occurred as the least common complication (2%, 4/245) and required removal in all cases. There was no significant difference between centres in overall complication rates (X2 = 22.3, p = 0.32). Complication-free survival rates over time did not differ significantly between centres (log-rank p = 0.08), with an overall complication-free survival rate of 69% at 1 year, 35% at 3 years and 12% at 5 years postoperatively. Conclusions This study demonstrated consistent surgical outcomes for the ZSI 475 FtM penile implant across participating centres. However, the observed complication rate underscores the need to optimize implant survival. Achieving this goal requires standardizing clinical practices and establishing global cooperation for the shared reporting of knowledge and outcomes. Disclosure No

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