Penile Implants Product Guide
ZSI 475 FTM Hydraulic Penile Implant
The
ZSI 475 FTM is the first-ever hydraulic penile implant designed
specifically for trans men!
Made by Zephyr Surgical Implants of Switzerland, the ZSI 475 FTM Hydraulic Penile Implant is designed to provide excellent stability and cosmetic results.
The ZSI 475 FTM is made of NUSIL silicone which is manufactured at a density that is ideal for longterm durability, malleability and providing a lifelike erection. The reinforced nickel-titanium rod interior increases the lifespan of the implant.
Important note: Zephyr penile implants are not available in the USA and ZSI is not currently seeking FDA approval. At this time, they are available in Canada, Cuba and some countries in Europe and South America.
Other features of the ZSI 475 FTM:
- One cylinder instead of two, providing excellent cosmetic results when inflated and deflated.
- Available in three sizes: 120mm, 150mm, 170mm in length.
- A 25mm wide, realistically shaped glans "stopper" is affixed to the tip of the implant. The glans is shaped with a small indentation that serves as a passage for the urethra, easing implantation.
- The proximal part of the implant has a plate made from stainless steel and silicone which is fixed securely to the pubic bone.
The implant functions like other hydraulic implants to obtain an erection:
Studies on the ZSI 475 FTM
NEW! Surgical Outcomes of the ZSI475 FtM Inflatable Erectile Prosthesis Implantation After Phalloplasty [FULL TEXT]
Marchand, Salomé et al. Urology, Volume 198, 217 - 221, April 2025.
This study looked at how well the ZSI475 FtM prosthesis worked in people who had phalloplasty as part of their gender-affirming care. Between 2016 and 2024, 89 people received the implant, with some having more than one surgery (for a total of 130 surgeries). Here's what they found:
- Over half (53%) of the surgeries resulted in some kind of complication.
- The most common issue was mechanical failure (40%), meaning the implant stopped working properly.
- Other problems included infections (6%), poor positioning (5%), and erosion (1.5%)—where the implant wears through the skin.
- Infections and erosion always led to the implant being removed.
- These complications led to 60 additional surgeries: mostly to replace the implant, but also to remove or reposition it.
- On average, it took about 1.6 years for a complication to appear, and the implant lasted about 5.4 years on average.
- After 4 years, about 74% of the implants were still working.
While the ZSI475 FtM implant is designed specifically for trans patients and offers some advantages, complications are still relatively common. The study suggests more improvements are needed, and future research should include results from multiple hospitals to better understand and reduce these issues.
Editorial Comment: "Penile implant placement after phalloplasty is wrought with complications. In order to improve patient outcomes, the ZSI475 inflatable penile prosthesis was created with phalloplasty-specific features including a wide anchor plate, a single cylinder, a testis-shaped pump, and a detachable glans implant. Pictures of this implant attract patients and surgeons as it appears to be well suited for the neophallus. The authors have the largest reported experience in placing ZSI implants. Despite their expertise and the phalloplasty-specific implant design, the overall revision rate exceeded 50%, with mechanical failure being the most common reason for surgical correction. For comparison, the average surgical revision rate for Coloplast and Boston Scientific inflatable implants is about 40%. The ZSI475 implant is therefore not ready for widespread use." — Mang L. Chen, Urology, January 15, 2025.
The
Frontier of Penile Implants in Phalloplasty: Is the ZSI 475 FTM
what we have been waiting for? [FULL TEXT]
Preto, M., Blecher, G., Timpano, M. et al. Int J Impot Res,
January 2021.
Unfortunately, the perfect prosthesis, particularly in
phalloplasty, eludes us. Ideally it would be completely inert and
remain free from infection. It would also provide perfect rigidity
and stability when erect and be easily incorporated into the
pelvis. It would remain permanently free from mechanical damage
and would never find its way eroding through local tissues. So
what is the reality for trans-males undergoing PP implantation in
a phalloplasty? The incidence of postoperative complications are
dramatically higher in phalloplasty, compared to a native phallus.
While the phalloplasty surgical community has long awaited
dedicated technologies and implants, the ZSI-475 FTM appears to
claim some benefits. However, little can be solidly concluded at
this early stage as we eagerly await further objective, well
planned trials to assess both surgical complications, implant
survival, and patient reported outcomes.
Implantation of the Zephyr ZSI 475 FTM erectile
device in cis- and transmen after phalloplasty: initial
experience and prospective analysis of surgical outcome
Wesley Verla, MD, Dept. of Urology, Ghent University Hospital. The Journal of Sexual Medicine, Volume 18, Issue 3, March 2021, Pages 615–622.
46 patients with a median (IQR) age of 35 (27-43) years were
included for analysis, comprising 7 cismen and 39 transmen. Median
(IQR) follow-up was 12 (8-18) months. Postoperative complications
comprised infection of the prosthesis in 5 patients (11%),
prosthesis malpositioning in 2 patients (4.3%), mechanical failure
in 2 patients (4.3%) and distal cilinder protrusion in 1 patient
(2.2%). All complications required revisional surgery.
Implantation of the Zephyr ZSI 475 FTM erectile device in patients
after phalloplasty is feasible and safe. Early surgical outcome is
promising, though future analyses with longer follow-up are
required to confirm these findings.
First Outcomes of the ZSI 475 FtM, a Specific
Prosthesis Designed for Phalloplasty
Paul Neuville, et al. The Journal of Sexual Medicine,
January 2019.
This is the first study to report data on the ZSI 475FtM, a new
prosthesis that has recently been specifically designed for FTM
Phalloplasty patients. It has several advantages: a large base for
pubic bone fixation, realistically shaped hard glans, and a pump
shaped like a testicle. 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). 13 of 14 patients (92.8%) who
answered a satisfaction questionnaire were satisfied or very
satisfied with the prosthesis. Preliminary results for the ZSI 475
FtM are encouraging. Safety seems to be satisfactory, and patient
satisfaction is high. Long-term studies are needed.
O.R. LIVE: Penile Implant Surgery with the ZSI 475
Here's video explaining implantation of the ZSI 475 from the team in Belgium (Lumen, Spinoit, Hoebeke.)
Zephyr also have a malleable penile implant for trans men, the ZSI 100 FTM Malleable Penile Implant.
(Images courtesy of Zephyr Surgical Implants, Switzerland.)
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Last updated: 04/16/25