ZSI 100 FTM malleable penile implant.

01 Overview

Lasting ease of use without mechanical components.

ZSI 100 FTM, designed by the Switzerland-based Zephyr Surgical Implants for the neophallus after phalloplasty, is a malleable penile implant. The single body, manufactured predominantly from medical-grade silicone, is placed inside the neophallus and is not visible externally. Because there is no pump, reservoir or tubing system, the device's mechanical failure surface is markedly smaller.

The implant is permanently semi-rigid: with one hand the patient brings the neophallus into the straight position suitable for penetration and, after use, returns it to the bent position with one hand so that it is concealed under clothing. The silver wire core inside the body is intended to keep the implant in the position given to it and to prevent loss of shape over time.

Lisa Health provides hospitals and reconstructive urology teams with documented supply of the ZSI penile implant portfolio, version/sizing planning support and operating theatre preparation documentation. The clinical decision and determination of indication rest solely with the specialist physician.

02 Clinical indications

In which cases is it considered?

The ZSI 100 FTM is positioned for reconstructive cases in which the need for rigidity is to be met with a simple and durable construction. The headings below summarise the clinical contexts most often considered; the final indication and patient suitability are determined solely by the reconstructive urology team.

• After gender-affirming surgery: the final reconstructive step in cases where neophallus reconstruction with phalloplasty is complete and tissue healing and sensory reinnervation have been achieved.
• Penile reconstruction after trauma: provision of mechanical rigidity in cases of total/subtotal penile loss reconstructed with a flap.
• After oncological penectomy: selected cases in which phalloplasty was performed following penile cancer surgery.
• Cases unsuitable for a hydraulic system: patients for whom pump manipulation is not considered appropriate because of manual dexterity, cognitive status or patient preference.
• Priority on a simple procedure: where a shorter operating time, a single body requiring no pelvic placement and fewer components are preferred.
• Revision surgery: may be considered as an alternative in selected revision cases after a previous hydraulic implant.

Contraindications, active infection, insufficient tissue perfusion and the condition of the neourethra are addressed within the framework of the current instructions for use and clinical protocols.

03 Structure and material

Silicone body, silver core, bone anchorage.

The design combines the goals of malleability, rigidity and infection resistance in a single body. There is no separate glans segment; the rounded glans form is continuous with the body, which reduces the formation of steps or pressure points on the tissue.

• Body: medical-grade silicone elastomer; a one-piece construction that requires no component movement for inflation or deflation.
• Silver wire core: an internal wire selected to deliver good malleability together with good rigidity; it contributes to maintaining the position given to the implant.
• Rounded glans: a form continuing seamlessly from the body; there is no separate glans part.
• Proximal fixation plate: a combination of stainless steel and silicone; it allows the implant to be readily fixed to the pubic bone and aims to prevent migration.
• Surface coating: PVP + antibiotic coating is applied to contribute to protection against infection, according to the manufacturer's documentation.
• Shortenable design: the body can be shortened intraoperatively to the target length; the two versions cover different flap volumes.

04 Size chart

Standard and narrow version.

The version is selected according to the neophallus diameter and flap volume: the standard version, with its oval cross-section, is considered for fuller flaps, and the narrow version, with its slim circular profile, for flaps of more limited volume.

The dimensions are compiled from the manufacturer's catalogue; final values are confirmed with the official product documentation shared with the institution and the current instructions for use.

05 Operating principle

Single-handed use in four steps.

A malleable implant is permanently semi-rigid; use is based on mechanical positioning rather than hydraulic transfer.

• 1 — Resting position: the neophallus is in the bent position, concealed under clothing.
• 2 — Straightening: a single-handed movement brings the neophallus from the bent position into the straight position.
• 3 — Use: the neophallus remains in the erect position; the silver wire core maintains that position.
• 4 — Return: it is returned to the bent position, again with one hand.

06 Distinguishing advantages

Highlights for the operating theatre and the patient's quality of life.

• Simple, short procedure: no placement of a pelvic reservoir or scrotal pump is required; the procedure is limited to implanting a single body.
• Low mechanical failure surface: the absence of pump, valve and tubing eliminates the possibility of hydraulic failure.
• Ease of use: single-handed positioning; patient training is short and the learning curve is shallow.
• Design addressing infection risk: PVP + antibiotic coating and a reduced number of components.
• Bone fixation: secure anchorage without corpus cavernosum support by means of the proximal plate.
• Imaging and travel compatibility: designed for safe use in medical scanners; not detected by airport security scanners.
• Warranty: the manufacturer defines a warranty period of 1 year.

07 Comparison

Malleable or inflatable?

Implant selection after phalloplasty is made on the basis of patient expectation, manual dexterity, tissue quality and cosmetic priorities. The table below compares the two ZSI options for institutional assessment; the clinical preference rests with the specialist physician.

08 Technical summary

Institutional evaluation table.

09 Questions & answers

Frequently asked institutional questions.