First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty

Abstract

Introduction The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle. Aim To assess the safety, feasibility, and patient satisfaction of the ZSI 475 FtM. Methods Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon). Patients were then asked to answer a satisfaction questionnaire that included the International Index of Erectile Function–5, Erectile Dysfunction Inventory of Treatment Satisfaction, and Self-Esteem and Relationship, as well as other non-validated questions. Main Outcome Measure Complication rates and the scores of the different questionnaires were reviewed. Results 20 patients who had gender dysphoria and underwent operation for a female-to-male procedure were included. The mean age was 37.9 years. Complications after 21 implantations included 2 (9.5%) infections that were medically treated (Clavien II), 1 (4.7%) infection treated by explantation (Clavien IIIb), 2 (9.5%) mechanical failures (Clavien IIIb), and 1 (4.7%) malpositioning (Clavien IIIb). The mean follow-up was 8.9 months (SD 4.0), with 50% of the implanted patients having >12 months of follow-up. 14 patients (70%) answered the satisfaction questionnaire. 12 patients (85.7%) had regular penetrative sexual intercourse. The mean International Index of Erectile Function–5 score was 20.2 of 25 (standard deviation [SD] 7.9), the mean Self-Esteem and Relationship score was 84.5 of 100 (SD 9.9), and the mean Erectile Dysfunction Inventory of Treatment Satisfaction score was 82 of 100 (SD 17.5). 13 patients (92.8%) were satisfied or very satisfied with the prosthesis. Clinical Implications This new innovative prosthesis could better answer the challenges faced by the implantation of an erectile device by phalloplasty. Strength & Limitations Our study is the first to report data on this new prosthesis. The main limitation is the small number of patients and the short follow-up. Conclusion Preliminary results for the ZSI 475 FtM are encouraging. Safety seems to be satisfactory, and patient satisfaction is high. Long-term studies are needed for further analysis.

Narrative review of penile prosthetic implant technology and surgical results, including transgender patients

“…Despite this study being one of the most recent publications in the field of penile prosthetics on gender reassignment surgeries, it lacks data from more recent two and three-piece prosthesis models. Table 5 presents important post-operative metrics by prosthesis type and model from all available published studies on penile implants in female to male neophallus prosthesis implantation (90,(95)(96)(97)(98)(99)(100).…”

Methods for managing erectile function in cis- and trans-male patients after neophallus reconstruction

“…Table 1. Complication rates for patients who required additional surgical intervention after penile prosthesis insertion [12] Patients, % (n ) As for the ZSI 475 FtM prosthesis, the data from a series of 20 patients show that two patients experienced mechanical failure, one experienced implant infection, and one had cylinder mispositioning, for which all had revision procedures [20] .…”

Penile implant infection factors: a contemporary narrative review of literature

“…Infection rates range from 4.7% to 33% in patients receiving phalloplasty (62)(63)(64)(65)(66). Most studies of prosthesis after phalloplasty are in the transgender population.…”