Surgical Experience and Outcomes of Implantation of the ZSI 100 FtM Malleable Penile Implant in Transgender Men After Phalloplasty

Garry L.S. Pigot, Hannes Sigurjónsson, Brechje Ronkes, Muhammed Al-Tamimi, Wouter B. van der Sluis

Research output: Contribution to journalArticleAcademicpeer-review

23 Citations (Scopus)


Introduction: After free or pedicled flap phalloplasty, many transgender men need penile prosthesis implantation to successfully engage in penetrative sexual intercourse. Postoperative complications occur frequently. There is a choice between inflatable and malleable penile prostheses. Until recently, no prostheses were designed specifically for this population. Aim: The aim of this study was to describe our preliminary experience with, and surgical outcomes of, implantation of the ZSI 100 FtM Malleable Penile Implant after phalloplasty in transgender men. Methods: A retrospective chart study was conducted on surgical characteristics and postoperative complications after implantation of the ZSI Malleable Penile Implant in transgender men in 3 European centers for genital transgender surgery in Amsterdam, Stockholm, and Reykjavik. Main Outcome Measure: The main outcomes measures were surgical outcome, complications, and reason of implant failure. Results: 25 patients were retrospectively identified, with a mean age of 36 ± 9 years at implantation. The mean time between prosthesis implantation and phalloplasty was 3.6 ± 2.5 years. 10 patients previously underwent free radial forearm flap phalloplasty, 6 patients had anterolateral thigh flap phalloplasty, 2 patients had superficial circumflex iliac artery perforator phalloplasty, 1 patient had groin flap phalloplasty, and 6 patients underwent combination flap phalloplasty. With a mean follow-up of 6.3 months, prosthesis explantation because of complications was performed in 8 patients (32%), because of infection (n = 3), protrusion (n = 4), or pubic pain (n = 1). In an additional 3 patients, the prosthesis was explanted due to difficulty living with the malleable prosthesis. Of those with the prosthesis in place, 13 of 14 patients (93%) were able to engage in penetrative sexual intercourse. Clinical Implications: The current article provides advantages and disadvantages of this medical device. Strength & Limitations: This is the first study on the ZSI Malleable Penile Implant prostheses in this patient group. It also provides information on the use of malleable prostheses; whereas current literature predominantly focusses on inflatable devices. Limitations comprise the small patient population, short follow-up time, and retrospective nature of the study. Conclusion: Complication rates of the ZSI Malleable Penile Implant prosthesis seem high at the start of the learning curve. Although designed specifically for the transgender community, not all transgender patients will be eligible for this type of prosthesis. Patients need to be well counseled on specific (dis)advantages of the prosthesis. Pigot GLS, Sigurjónsson H, Ronkes B, et al. Surgical Experience and Outcomes of Implantation of the ZSI 100 FtM Malleable Penile Implant in Transgender Men After Phalloplasty. J Sex Med 2020;17:152–158.

Original languageEnglish
Pages (from-to)152-158
Number of pages7
JournalJournal of Sexual Medicine
Issue number1
Publication statusPublished - 1 Jan 2020


  • Gender Dysphoria
  • Penile Prostheses: Clinical Outcomes
  • Phalloplasty
  • Transgender

Cite this