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Erectile Prosthesis (Penile Implant) After Gender-Affirming Phalloplasty

Penile implant placement after gender-affirming phalloplasty is a complex, high-risk procedure that enables transmasculine individuals to achieve neophallus rigidity for penetrative intercourse — the final stage of masculinizing genital reconstruction, performed 9–12 months after phalloplasty once the flap has healed, sensation has returned, and vascular pedicle integrity and reliable micturition have been confirmed.[1][2][3] Across the Rooker 2019 systematic review (n = 1,056 phalloplasty patients), 75% (792) received a penile prosthesis; 83.9% achieved penetration with satisfaction rates comparable to cisgender men despite substantially higher complication rates.[4]

This is the dedicated atlas page covering all prosthesis types and variants. For the cohort-level framework, see Masculinizing Gender-Affirming Surgery. For the prerequisite procedure, see Gender-Affirming Hysterectomy and the phalloplasty pages in 04k.

Indication and Context​

The neophallus constructed during phalloplasty lacks corpora cavernosa and therefore has no intrinsic erectile capacity. A penile prosthesis is the only method to achieve rigidity sufficient for penetrative intercourse without an external device.[4][5]

Timing and Prerequisites​

Per the Levy 2026 Delphi consensus protocol (21 international experts) and ACOG guidance, insertion should occur no earlier than 9–12 months after phalloplasty to allow:[6][3][7]

  • Complete flap healing and maturation.
  • Verification of vascular pedicle anatomy (Doppler ultrasound or angiography).
  • Establishment of reliable micturition (if urethral lengthening was performed).
  • Adequate neophallus sensation — some surgeons advocate waiting until protective sensation returns.[8]
  • Resolution of any urethral complications (fistula, stricture).

Prosthesis Types​

TypeExamplesCylinder configurationKey features
Three-piece inflatable (IPP)AMS 700, Coloplast TitanSingle or dualMost common (83.6%); most natural erection/flaccidity cycle; requires reservoir + pump[1][2]
Two-piece inflatableAMS AmbicorSingle or dualSelf-contained pump / reservoir; simpler but less rigidity[3]
Malleable (semirigid)Coloplast Genesis, AMS SpectraSingle or dualAlways semirigid; simpler surgery; no mechanical parts; permanently firm[3][4]
ZSI 475 FtM (hydraulic)ZSI 475 FtMSinglePurpose-designed for neophallus; large base for pubic fixation; testicle-shaped pump; realistic hard glans[9][6]
ZSI 100 FtM (malleable)ZSI 100 FtMSinglePurpose-designed malleable for neophallus; specific anchoring[9][10]

Single vs dual cylinder: 61% single, 39% dual. Single-cylinder is more common because neophallus girth often cannot accommodate two cylinders and there is no native septum to separate them.[4][11]

Surgical Technique​

Implantation in a neophallus differs fundamentally from native penile-prosthesis surgery due to the absence of corpora cavernosa, tunica albuginea, and native crura. Three critical technical steps:[1][5]

1. Cylinder-channel creation​

A space is carefully dissected within the neophallus by blunt and sharp dissection through flap tissue. Care to avoid injury to the vascular pedicle and the neourethra (if present).

2. Proximal fixation to the pubic bone​

No crura for rear-tip anchoring → prosthesis must be fixed to the pubic symphysis. Techniques:[12][11]

  • Bone anchoring — corticotomy in the pubic symphysis with bone drill; rear-tip extender seated with anchoring sutures through bone.[12]
  • Infrapubic approach — horizontal incision anterior to the pubic symphysis allows direct neophallus-tract dissection and anchor-site creation.[13][7]
  • Neoscrotal approach — advocated by some surgeons for better access.[11]

3. Cylinder wrapping (neotunica construction)​

To prevent distal erosion and provide structural support, cylinders are wrapped to create a neotunica albuginea:[1][14][15]

  • Gore-Tex (PTFE) sleeve — Zuckerman / Baylor series 81% sexual-activity rate.[14]
  • Dacron vascular graft — Falcone / London series; fitted around proximal and distal cylinder to anchor the device and prevent apical protrusion.[11][15][16]
  • Allografts (acellular dermal matrix) — alternative biologic wrapping.[1]

A distal "sock" or cap is placed over the cylinder tip to distribute pressure and reduce distal-erosion risk through thin neophallus skin.[5] For inflatable prostheses, the reservoir is placed extraperitoneally (typically during a staged first procedure) and the pump is positioned in the neoscrotum.[16]

Staged vs single-stage approach​

Some centres use a two-stage approach for inflatable prostheses:[16]

  • Stage 1 — extraperitoneal reservoir placement + glans sculpture + testicular implant insertion.
  • Stage 2 — cylinder(s) and pump placement.

May reduce operative time and complication risk at each individual surgery.

Outcomes​

Functional​

  • Penetrative intercourse achieved: 77–93% with a functioning prosthesis.[4][17][16][9]
  • Patient satisfaction: 85–93% across series; comparable to cisgender men.[1][16][9]
  • IIEF-5: Mean 20.2/25 in the ZSI 475 FtM series.[9]
  • Self-Esteem and Relationship score: mean 84.5/100.[9]

Device survival​

SeriesDeviceFollow-upSurvival / retention
Falcone 2018 (n = 247)[16]Inflatable (Dacron-modified)20 mo mean5-yr survival 78%
Kocjancic review[1]IPP (various)5 yr42–78% retention
Rooker SR (n = 792)[4]Mixed3 yr mean60% original implant present
ZSI FtM (Amsterdam)[18]Hydraulic + malleable26–32 mo3-yr explantation-free survival 31–39%
ZSI 475 FtM (Lyon)[9]Hydraulic3.9 yr medianMedian survival 5.4 yr; 4-yr 74%
Chen infrapubic (n = 107)[7]Modified commercial79.8 wk16% revision rate

Complications​

Complication rates are substantially higher than cisgender penile-prosthesis surgery, driven by absence of native corporal tissue, thin flap coverage, and the need for bone anchoring.[4][19]

Fraiman 2024 meta-analysis:[19]

  • Inflatable: 38% (95% CI 21–59%).
  • Malleable: 37% (95% CI 18–62%).
  • No significant difference between types.
ComplicationInflatableMalleable
Infection8.5–20%7.7–11.2%[1][2][4]
Mechanical dysfunction12.9–40%9.1%[1][18]
Dislocation / detachment5.7%14.9%[1][9]
Erosion / extrusionVariable7.6%[1][10]
Malposition5.4%5.4%[18][9]
Explantation rate19% (95% CI 9–38%)13% (95% CI 4–33%)[19]
Revision rate36–43%32–40%[2][4][9][18]

Risk factors for complications​

  • Secondary (revision) implantation: OR 3.5 (p = 0.03) vs primary procedures.[18]
  • Urethral lengthening: HR 2.6 (95% CI 1.3–5.0, p = 0.01) for late complications.[18]
  • Phalloplasty flap type — significantly affects infection risk (p = 0.013).[16]
  • Surgeon experience — probability of infection decreases significantly with case volume.[20]

Purpose-Designed (ZSI FtM) vs Modified Cisgender Prostheses​

A key debate: do purpose-designed FtM prostheses (ZSI 475 FtM, ZSI 100 FtM) outperform modified cisgender devices (AMS 700, Coloplast Titan / Genesis with Dacron wrapping)?[15][9]

  • ZSI 475 FtM features a large base plate for pubic fixation, a realistic hard glans, and a testicle-shaped pump — eliminating the need for Dacron wrapping and bone drilling.[9]
  • Falcone 2026 comparative study — shorter OR time with ZSI FtM (85 vs 105 min, p < .05).[15]
  • ZSI FtM showed poor 3-yr complication-free survival (31–39%) despite being purpose-designed; late complication rates 56–58%.[18]
  • No clearly superior device — the field continues to evolve.[4][15]

Penile Implants in AMAB Individuals After Phalloplasty​

Penile prostheses are also implanted in AMAB individuals undergoing phalloplasty for penile inadequacy (bladder exstrophy–epispadias complex, penile cancer, trauma, micropenis). Pang 2025 SR (n = 184): complication rates up to 64.3%, explantation up to 40% for erosion, but 80–100% satisfaction.[21]

Emerging Approaches​

  • Osteointegrated penile epithesis — external prosthetic phallus anchored to the pubic bone via osseointegrated implants; alternative to traditional phalloplasty + internal prosthesis.[3]
  • Continued refinement of purpose-designed devices with improved anchoring and materials.
  • Standardised consensus protocols for perioperative care (Levy 2026 Delphi).[6]

Key Counselling Points​

Patients must be thoroughly counselled that:[1][4][16]

  1. Multiple revisions are expected over lifetime — revision rates 36–43% are standard.
  2. Complication rates are significantly higher than cisgender penile prosthesis surgery.
  3. Despite complications, satisfaction remains high (85–93%) and most achieve penetrative intercourse.
  4. Inflatable vs malleable trade-offs — inflatable provides more natural cycling but more mechanical failure; malleable is simpler but permanently semirigid.
  5. No ideal prosthesis specifically designed for the neophallus exists yet — purpose-built devices are improving.

Evidence Limitations​

  • Rooker 2019 SR (n = 1,056 phalloplasty patients, 792 with prosthesis) is the largest aggregate; component series heterogeneous in device, technique, follow-up.[4]
  • Fraiman 2024 meta-analysis establishes complication-rate parity between inflatable and malleable but quality of underlying evidence is low.[19]
  • Levy 2026 Delphi consensus standardises perioperative care but no universally accepted guideline yet exists.[6]
  • No RCTs comparing device types or anchoring techniques.
  • Long-term outcomes beyond 5 yr poorly characterised — most series report 3-yr survival.
  • Validated PROMs for transmasculine implant outcomes are lacking; IIEF-5 and Self-Esteem-and-Relationship scores adapted from cisgender populations.[9]

References​

1. Kocjancic E, Jaunarena JH, Schechter L, Acar Ö. Inflatable penile prosthesis implantation after gender-affirming phalloplasty with radial forearm free flap. Int J Impot Res. 2020;32(1):99–106. doi:10.1038/s41443-019-0153-8

2. Committee on Gynecologic Practice and Committee on Health Care for Underserved Women. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, Number 823. Obstet Gynecol. 2021;137(3):e75–e88. doi:10.1097/AOG.0000000000004294

3. Berli JU, Knudson G, Fraser L, et al. What surgeons need to know about gender confirmation surgery when providing care for transgender individuals: a review. JAMA Surg. 2017;152(4):394–400. doi:10.1001/jamasurg.2016.5549

4. Rooker SA, Vyas KS, DiFilippo EC, et al. The rise of the neophallus: a systematic review of penile prosthetic outcomes and complications in gender-affirming surgery. J Sex Med. 2019;16(5):661–672. doi:10.1016/j.jsxm.2019.03.009

5. Blecher GA, Christopher N, Ralph DJ. Prosthetic placement after phalloplasty. Urol Clin North Am. 2019;46(4):591–603. doi:10.1016/j.ucl.2019.07.013

6. Levy M, Falcone M, Bohr J, et al. Penile implants after phalloplasty in transgender individuals: a consensus-based surgical clinical protocol concerning pre-, peri-, and postoperative care. J Sex Med. 2026;23(2):qdaf365. doi:10.1093/jsxmed/qdaf365

7. Chen ML, Patel DP, Moses RA, et al. Infrapubic insertion of penile implants in transmen after phalloplasty. Urology. 2021;152:79–83. doi:10.1016/j.urology.2021.01.026

8. Hage JJ. Dynaflex prosthesis in total phalloplasty. Plast Reconstr Surg. 1997;99(2):479–485. doi:10.1097/00006534-199702000-00025

9. Neuville P, Morel-Journel N, Cabelguenne D, et al. First outcomes of the ZSI 475 FtM, a specific prosthesis designed for phalloplasty. J Sex Med. 2019;16(2):316–322. doi:10.1016/j.jsxm.2018.11.013

10. Pigot GLS, Sigurjónsson H, Ronkes B, Al-Tamimi M, van der Sluis WB. Surgical experience and outcomes of implantation of the ZSI 100 FtM malleable penile implant in transgender men after phalloplasty. J Sex Med. 2020;17(1):152–158. doi:10.1016/j.jsxm.2019.09.019

11. van der Sluis WB, Pigot GLS, Al-Tamimi M, et al. A retrospective cohort study on surgical outcomes of penile prosthesis implantation surgery in transgender men after phalloplasty. Urology. 2019;132:195–201. doi:10.1016/j.urology.2019.06.010

12. Cohen AJ, Bhanvadia RR, Pariser JJ, et al. Novel technique for proximal bone anchoring of penile prosthesis after radial forearm free flap neophallus. Urology. 2017;105:2–5. doi:10.1016/j.urology.2017.01.016

13. Sun HH, Isali I, Mishra K, et al. Surgical outcomes at a single institution of infrapubic insertion of malleable penile prosthesis in transmen. Urology. 2023;173:209–214. doi:10.1016/j.urology.2023.01.001

14. Zuckerman JM, Smentkowski K, Gilbert D, et al. Penile prosthesis implantation in patients with a history of total phallic construction. J Sex Med. 2015;12(12):2485–2491. doi:10.1111/jsm.13067

15. Falcone M, Peretti F, Preto M, et al. The outcomes of inflatable penile prosthesis implantation in the context of genital gender-affirming surgery in assigned female-at-birth patients: a comparative study between cis-male Dacron-modified and Zephyr Surgical Implants 475 female-to-male penile prosthesis. Int J Impot Res. 2026;38(4):344–349. doi:10.1038/s41443-025-01137-z

16. Falcone M, Garaffa G, Gillo A, et al. Outcomes of inflatable penile prosthesis insertion in 247 patients completing female-to-male gender reassignment surgery. BJU Int. 2018;121(1):139–144. doi:10.1111/bju.14027

17. Marchand S, Morel-Journel N, Carnicelli D, et al. Surgical outcomes of the ZSI475 FtM inflatable erectile prosthesis implantation after phalloplasty. Urology. 2025;198:217–221. doi:10.1016/j.urology.2025.01.002

18. Levy M, van der Sluis WB, van Abbema EL, et al. Hydraulic and malleable female-to-male penile implants after phalloplasty in transgender individuals: a retrospective cohort analysis. BJU Int. 2025. doi:10.1111/bju.16911

19. Fraiman E, Nandwana D, Loria M, et al. Complication and explantation rates of penile prostheses in transmasculine patients: a meta-analysis. Urology. 2024;194:260–268. doi:10.1016/j.urology.2024.08.022

20. Briles BL, Middleton RY, Celtik KE, et al. Penile prosthesis placement by a dedicated transgender surgery unit: a retrospective analysis of complications. J Sex Med. 2022;19(4):641–649. doi:10.1016/j.jsxm.2022.01.518

21. Pang KH, Christopher N, Ralph DJ, Lee WG. Insertion of erectile device following phalloplasty in individuals assigned male at birth: a systematic review. J Sex Med. 2025:qdaf019. doi:10.1093/jsxmed/qdaf019