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Malleable (Semirigid) Penile Prosthesis

A malleable penile prosthesis provides bendable support without an inflatable pump or separate reservoir. It is an option for erectile dysfunction when other treatments are unsuitable or unsuccessful, or when an informed patient prefers definitive prosthetic treatment. Selection depends on anatomy, tissue health, dexterity, expectations, access and cost.[1]

This is the device hub. For implantation and salvage, see the Penile Implants atlas. Compare Inflatable Penile Prosthesis for hydraulic-device choices.

Construction and Current Models​

Malleable designs evolved from early fixed supports and silicone devices to several different flexible cores. Tactra and the older Spectra are distinct designs; their construction and outcomes should not be interchanged. Nor do all current malleable devices share one material, bending mechanism or implantation anatomy.[2][3]

DeviceVerified construction and size distinctionsPractical boundary
Tactra — Boston ScientificNitinol core with dual-layer silicone; diameters 9.5, 11 and 13 mmIt is not the articulating-segment Spectra and is not described as a Parylene-coated device.
Genesis — ColoplastSilver-wire coil and hydrophilic surface; diameters 9.5, 11 and 13 mmApply the product-specific preparation instructions; “silicone coating” omits its hydrophilic surface.
Rigi10 — RigiconStainless-steel core, titanium end caps and HydroShield hydrophilic coating; 9, 10, 11, 12, 13 and 14 mmThe manufacturer explicitly excludes the 14 mm model from US availability. A listed size is not appropriate for every corporal anatomy.
TUBE — PromedonSilver-wire core, PTFE layer and silicone constructionIt is a separate product from the Shah implant and should not be described as a Nitinol device.

Sources are the current manufacturer descriptions, not comparative clinical trials. Confirm the actual model, local authorization, available sizes and supplied instructions before selection. Products designed for a neophallus have different anchoring and tissue-support requirements from paired implantation into native corpora.[3][4][5][6][7]

What the Patient Trades Off​

Malleable rods remain firm and are positioned for intercourse or concealment. They avoid pump cycling, but the patient still needs to understand and manipulate the implant. Less complex operation can help selected patients with limited hand function; it does not eliminate the need for functional assessment. Persistent firmness and concealability are central counseling points.[1]

There are no hydraulic components to leak, but mechanical failure is still possible. Rod or shell damage, migration, erosion, pain, infection and revision remain relevant. A device is not a lifetime guarantee. Absence of a separate reservoir removes that component's placement step, not every risk of urethral, corporal, vascular or soft-tissue injury.[3][4]

Candidate Selection and Safety​

  • ED and patient preference: discuss malleable, two-piece and three-piece devices in terms of the patient's priorities. A desire for concealability is a preference to weigh, not a medical contraindication to malleable implantation.
  • Limited dexterity or difficult reservoir placement: malleable implantation may simplify operation or avoid a separate reservoir. A two-piece inflatable implant may also be relevant; previous pelvic surgery does not force one device choice.[1]
  • Infection or tissue compromise: resolve active infection and assess tissue quality before routine implantation. Salvage of an infected device is a separate specialist operation, not an exception that makes primary implantation through infection safe.
  • Device-specific exclusions: Tactra safety information contraindicates use where compromised tissue would make constant pressure harmful, in patients requiring repeated endoscopic procedures beyond routine cystoscopy, and outside its stated corporal-length range. Other models have their own exclusions.[3]

Tactra's proximal nonmalleable section must remain proximal to the penoscrotal junction. Follow its marked proximal trimming instructions and avoid bending beyond the natural U shape. Do not transfer these instructions to another rod design, cut an unapproved segment or assume that every device requires a rear-tip extender.[3]

Preparation depends on the surface and exact model. Hydrophilic devices can have specified wetting/dipping instructions; this does not establish one universal antibiotic mixture. For broader infection-prevention evidence, see the IPP hub.

Outcomes and Durability​

Malleable Versus Inflatable Devices​

A 2026 global EHR analysis of 29,385 patients reported similar recorded five-year revision/removal proportions for inflatable and semirigid implants: 13.9% versus 13.7%. Mechanical-breakdown codes were less frequent with semirigid devices (6.7% versus 9.1%), while explantation was more frequent (8.4% versus 6.5%). These are observational, code-based outcomes; selection, follow-up and unmeasured differences preclude a causal claim that either class is universally safer. The result also contradicts a blanket assertion that malleable mechanical failure is eliminated.[8]

Older comparative satisfaction studies used different questionnaires, devices and populations. Some favored inflatable implants; a nonsignificant difference in a small comparison does not prove equal satisfaction or identify a best brand. Ask specifically about concealment, rigidity, comfort and ease of use rather than quoting one combined satisfaction percentage.[9][10]

Model-Specific Reports​

The Rigi10 report included 605 patients and estimated 99.2% freedom from revision at three years, with mean follow-up of about 22 months. It used manufacturer patient-information forms and had no randomized comparator. It is an early device-surveillance estimate, not evidence that all recipients were followed for three years or that Rigi10 outperforms other brands.[11]

Length Expectations​

Habous's 133-patient study compared preimplant measurements with measurements immediately after implantation under anesthesia. It does not prove that surgery always preserves a patient's perceived length over years. Explain the limits imposed by fibrosis, prior surgery, anatomy and baseline expectations; neither malleable nor inflatable implantation guarantees length restoration.[12]

Infection Salvage​

The malleable implant salvage technique removes infected hardware, performs the salvage procedure and replaces it with a malleable implant, either definitively or with possible later conversion. In Gross's 58-patient retrospective series, 54 remained infection-free; 17 of those 54 later converted to an inflatable implant, at a mean of 6.7 months. This selected experience does not establish a 93% success probability in every infected implant or mandate later conversion.[13]

The 2026 Veterans Affairs report also found clinically important recurrent infection after salvage, reinforcing that outcomes vary by setting and patient selection. The appropriate procedure depends on infection severity, tissue viability, comorbidity, prior surgery and the patient's goals.[14]

Ischemic Priapism​

Prosthesis discussion may be appropriate after prolonged ischemia or refractory treatment, when the chance of useful erectile recovery is poor. There is no universal “insert within 48–72 hours” rule for every case. EAU 2026 specifically recommends delaying implantation after a shunt to reduce infection and erosion risk. A malleable device may later be exchanged for an inflatable one; the trade-off includes another operation. These decisions belong in the Priapism pathway, not a device-selection shortcut.[15]

Use After Phalloplasty​

A neophallus lacks normal corporal containment; fixation, sensation and soft-tissue coverage change the risk profile. Native-penis ED results should not be transferred to this setting. A 2024 meta-analysis of nine studies estimated complication rates of 37% for malleable and 38% for inflatable devices, with wide confidence intervals (18–62% and 21–59%). Similar pooled point estimates do not establish equivalence.[16]

Keep denominators explicit: Sun's single-center series implanted 40 people, but its 40% revision rate was 12/30 with follow-up, not 40% of all 40. Pigot's early ZSI 100 FTM series included 25 patients and short follow-up; its findings should not be mislabeled as the later 2026 comparative cohort. The 2026 international protocol is expert consensus, not a randomized device comparison. See the Gender-Affirming Reconstruction atlas.[17][18][19][7]

Imaging and Follow-up​

MRI eligibility is model-specific and conditional. The August 2026 Coloplast memo lists different conditions for Genesis and current Titan models; the newer Titan parameters must not be applied to Genesis or an older implant. Identify the actual implant and have MRI staff check all required field, gradient, RF and scanning-duration conditions.[20]

Provide the implant identification record and arrange ongoing device review. New pain, skin change, drainage, exposure, urinary difficulty, loss of support or difficulty positioning the device merits assessment. Persistent firmness alone is expected; progressive pressure injury or erosion is not.[3][4]

References​

1. EAU. Sexual and Reproductive Health Guidelines, 2026: erectile dysfunction, penile prosthesis section. Guideline.

2. Martinez DR, Terlecki R, Brant WO. The Evolution and Utility of the Small-Carrion Prosthesis, Its Impact, and Progression to the Modern-Day Malleable Penile Prosthesis. The Journal of Sexual Medicine. 2015;12 Suppl 7:423-430. doi:10.1111/jsm.13014

3. Boston Scientific. Tactra Malleable Penile Prosthesis: current product description and safety information, 51519609-01A. Product; safety information. Accessed September 12, 2026.

4. Coloplast. Genesis Malleable Penile Prosthesis: current product and brief safety information, PM-16954, April 2024. Manufacturer. Accessed September 12, 2026.

5. Rigicon. Rigi10 Malleable Penile Prosthesis: device construction, ordering and availability. Manufacturer. Accessed September 12, 2026.

6. Promedon. TUBE Malleable Penile Prosthesis: device construction. Manufacturer brochure. Accessed September 12, 2026.

7. Levy M, Falcone M, Bohr J, et al. Penile Implants After Phalloplasty in Transgender Individuals: A Consensus-Based Surgical Clinical Protocol. The Journal of Sexual Medicine. 2026;23(2):qdaf365. doi:10.1093/jsxmed/qdaf365

8. Kohl S, Goebel C, Kuzina A, et al. Inflatable Penile Prostheses Long-Term Revision and Removal Rates Compared to Semi-Rigid Penile Prostheses: A Real-World Analysis From a Global EHR Database. The Journal of Sexual Medicine. 2026;23(3):qdag034. doi:10.1093/jsxmed/qdag034

9. Çayan S, Aşcı R, Efesoy O, et al. Comparison of Long-Term Results and Couples' Satisfaction With Penile Implant Types and Brands. The Journal of Sexual Medicine. 2019;16(7):1092-1099. doi:10.1016/j.jsxm.2019.04.013

10. Casabé AR, Sarotto N, Gutierrez C, Bechara AJ. Satisfaction Assessment With Malleable Prosthetic Implant of Spectra (AMS) and Genesis (Coloplast) Models. International Journal of Impotence Research. 2016;28(6):228-233. doi:10.1038/ijir.2016.33

11. Wilson SK, Wen L, Carrion R, et al. Safety Outcomes of the First Rigi10™ Malleable Penile Prostheses Implanted Worldwide. International Journal of Impotence Research. 2024;36(8):833-837. doi:10.1038/s41443-023-00761-x

12. Habous M, Giona S, Tealab A, et al. Penile Length Is Preserved After Implant Surgery. BJU International. 2019;123(5):885-890. doi:10.1111/bju.14604

13. Gross MS, Phillips EA, Balen A, et al. The Malleable Implant Salvage Technique: Infection Outcomes After Mulcahy Salvage Procedure and Replacement of Infected Inflatable Penile Prosthesis With Malleable Prosthesis. The Journal of Urology. 2016;195(3):694-697. doi:10.1016/j.juro.2015.08.091

14. Angulo-Llanos L, Sandler MD, Howell NB, Williams A, Masterson TA. Outcomes of Salvage Procedures With Malleable Implants for Penile Prosthesis Infections in the Veterans Affairs National Medical System. The Journal of Sexual Medicine. 2026;23(3):qdag042. doi:10.1093/jsxmed/qdag042

15. EAU. Sexual and Reproductive Health Guidelines, 2026: priapism, immediate penile prosthesis and recommendations sections. Guideline.

16. 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

17. 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

18. 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. The Journal of Sexual Medicine. 2020;17(1):152-158. doi:10.1016/j.jsxm.2019.09.019

19. Levy M, van Abbema EL, Ronkes BL, et al. Out With the Old, in With the New? A Retrospective Comparison of Malleable Erectile Implants in Phalloplasty. BJU International. 2026. doi:10.1111/bju.70166

20. Coloplast. MRI Compatibility and Latex Content: Penile Prostheses, August 2026. Manufacturer MRI conditions.