Testicular Prosthesis
Testicular prosthesis placement restores the scrotal envelope after orchiectomy or for congenital / acquired anorchia, with consistently high satisfaction (77–96%) when offered — yet only ~⅔ of orchiectomy patients are offered an implant and ~⅓ of those proceed.[1][6][19] The offer rate is the dominant counseling gap, not patient acceptance.
For the broader scrotal-reconstruction ladder see Scrotal Reconstruction Techniques.
History and Materials
| Era | Material |
|---|---|
| 1941 | First implant — Vitallium ball.[1] |
| 1950s–60s | Glass, polyethylene, acrylic. |
| 1970s–90s | Silicone gel-filled (Dow Corning) — worldwide standard.[1] |
| 1995 | Silicone gel manufacture discontinued in the US (breast-implant fallout) despite no evidence of systemic disease attributable to testicular silicone.[2][3] |
| 2002 | FDA approves the Torosa saline-filled prosthesis (Coloplast).[2] |
| 2020s | Rigicon Testi10™ saline — Kaplan-Meier survival 99.8% at 54 mo (n = 427).[4] |
Silicone gel remains the international standard (Nagor, Promedon, Prometel, Sebbin, Polytech, Eurosilicone).[5]
Available devices
- Saline (US). Torosa (Coloplast) — silicone-elastomer shell, intraoperatively filled with sterile saline; four sizes (XS / S / M / L); volume adjustable to match the contralateral testis.[2][6] Rigicon Testi10™ — silicone shell saline; 0.2% revision rate over 54 mo (only 1 revision from iatrogenic puncture during filling).[4]
- Silicone gel (international). More natural feel than saline; cohesive (no "sloshing"); 25–44% of patients still rate it "too firm" (texture is the unmet need regardless of material).[5][7][8]
- Other / experimental. Elliptical silastic shapes that better approximate the native ovoid testis (Ning 2011, n = 20; 100% satisfied with body image and position).[9]
Indications
| Indication | Detail |
|---|---|
| Post-orchiectomy for testicular cancer | Most common indication.[6] |
| Testicular torsion | Non-salvageable testis — intravaginal exchange at orchiectomy is feasible (Bush 2012 n = 12 adolescents: no infection / extrusion, 91.7% symmetric).[13] |
| Congenital anorchia / vanishing testis | Pediatric indication.[14] |
| Cryptorchidism with no testis found at inguinal / abdominal exploration | Pediatric indication.[14] |
| Trauma | Post-orchiectomy for unreconstructable injury.[6] |
| Atrophy (post-orchitis, post-torsion) | Selected.[6] |
| Gender-affirming masculinizing surgery | Neoscrotal augmentation as part of phalloplasty / scrotoplasty.[5] |
Contraindications. Active local infection, active malignancy at the surgical site, active rheumatological disease (per original FDA protocol).[2]
Preoperative Counseling
| Topic | Counseling point |
|---|---|
| Offer rate | 91% of orchiectomy patients consider being offered the prosthesis "extremely important" regardless of whether they accept. 42% of men without a prosthesis report never having been offered one.[8][11][19] |
| Firmness | Will feel firmer than a native testis — the most common complaint (25–70% across studies); 59.3% satisfied with "feel" vs 89.8% satisfied with "look".[4][7][8][10] |
| Position | High-riding (20–39%) is the second most common complaint.[8][10] |
| Weight | Generally lighter than a native testis.[6][9] |
| Size | Measure the contralateral testis (ultrasound or calipers); have sample sizes in clinic; intraoperative comparison.[11] |
| Timing | Simultaneous with orchiectomy is safe even when chemo / radiotherapy will follow.[12] |
| Academic-center effect | Patients at academic institutions are more likely to be offered and to receive a prosthesis (OR 2.87).[19] |
Timing
Simultaneous (at orchiectomy)
- Testicular cancer. Musi 2020 (n = 393) — no significant difference in complication rate between adjuvant ChT (4.34%), RT (6.20%), and no further treatment (6.03%).[12]
- Torsion (adolescent). Bush 2012 (n = 12) — intravaginal prosthesis at orchiectomy: no infection, no extrusion, 91.7% symmetric scrotum.[13]
Delayed
- Active infection at orchiectomy.
- Patient undecided.
- Concerns about wound healing.
- Pediatric: implantation within 1 year of orchiectomy is associated with fewer complications than later placement (p < 0.05).[14]
Surgical Approaches
| Approach | Detail |
|---|---|
| Inguinal | Standard when simultaneous with radical inguinal orchiectomy. After cord ligation and orchiectomy, prosthesis inserted through the inguinal incision into a dartos pouch, secured to dartos or distal gubernacular remnant.[6][15] |
| Scrotal | Direct scrotal incision into a dartos pouch. Higher theoretical infection / extrusion risk because of direct prosthesis–suture-line contact and thin scrotal skin.[16] |
| Suprascrotal ("Wink", Libman) | 2-cm semilunar incision 2–3 cm lateral to the penis, just above the scrotum; blunt dissection into the scrotum. Pediatric series (Osemlak n = 290) — lowest complication rate (p = 0.01); incision hidden by pubic hair; avoids prosthesis–suture-line contact.[14][16] |
| Intravaginal | Prosthesis placed under the tunica vaginalis with preplaced sutures; native tunica becomes an extra barrier layer. Animal model favors this over the tunica-albuginea position (better mobility, less chronic inflammation).[13][17] |
Technical pearls[6][11]
- Dartos pouch sized adequately — too small produces high-riding prosthesis.
- Secure to dartos / gubernacular remnant with absorbable suture to prevent migration.
- For saline devices: fill intraoperatively to the matched volume; protect against inadvertent puncture.
- Antibiotic prophylaxis; some surgeons irrigate the pocket with antibiotic solution.
- Outpatient procedure.
The fixation question
Besombes 2024 (n = 169; 146 respondents) found that fixation did not improve positioning but significantly worsened pain / discomfort (30.8% vs 9.78%, p < 0.05) — challenges the routine practice of suturing the prosthesis to dartos / gubernacular remnant. Retrospective and non-randomized.[21]
Outcomes — Satisfaction
| Series | n | Overall satisfaction | "Too firm" | High-riding | Would repeat |
|---|---|---|---|---|---|
| Clifford 2018 | 40 | 82.5% good / excellent | 44% | 20% inappropriate | 87.5%[8] |
| Araújo 2024 | 51 with prosthesis | 96.1% | 25.5% | — | —[7] |
| Yossepowitch 2011 | 86 | 77% good / excellent | 70% | 39% | —[10] |
| Adshead 2001 | 71 | 73% | — | — | —[11] |
| Incrocci 1999 | 22 | 68% improved body image | — | — | —[18] |
| Nichols 2019 | 59 with prosthesis | 89.8% satisfied with look; 59.3% with feel | — | — | —[19] |
Receiving a prosthesis is an independent positive predictor of overall genital satisfaction (OR 3.29).[19] Sexual function is not impaired — recipients more often report normal sexual activity (74% vs 50%) and none report severe ED (0% vs 16.7%; differences non-significant).[7]
Complications
Saline FDA pivotal trial (n = 149) — 19% adverse-event rate.[2]
| Complication | Rate |
|---|---|
| Device-related discomfort / pain | 3% |
| Scrotal edema | 1.3% |
| Infection | 1.3% (may require explantation) |
| Extrusion | 2.6% (requires explantation) |
| Deflation / leakage (saline only) | 0.7% |
| Pulmonary embolism | 0.7% (rare) |
| Migration / high-riding | 20–39% patient-reported |
| "Too firm" | 25–70% patient-reported |
Population-specific complication signals:
- Transgender men (neoscrotal augmentation). Pigot 2019 — overall explantation 20.8% (infection, extrusion, discomfort, leakage, urethral problems); modern technique (Hoebeke scrotoplasty) reduces this to 11.5%. Smoking is a significant risk for infection / explantation. Trend toward smaller / lighter prostheses and delayed implantation has improved outcomes.[5]
- Pediatric (Osemlak n = 290). 92.1% good outcomes; complications fewer when implantation occurred within the first 3 years of life (p = 0.002) or within 1 year of the primary operation (p < 0.05). Suprascrotal access — lowest complication rate (p = 0.01).[14]
- Post-chemo / RT. No increased complication rate.[12]
- Rigicon Testi10™. 0.2% revision rate at 54 mo (n = 427; 100% pediatric / adolescent survival in 45).[4]
- Capsular contracture. Unlike breast implants, clinically significant capsular contracture is rarely reported; a fibrous capsule does form.[17]
Saline vs Silicone Gel
| Parameter | Saline (US) | Silicone gel (international) |
|---|---|---|
| Overall satisfaction | 77–87.5% good / excellent | 73–96.1% |
| "Too firm" | 44–70% | 25.5–70% |
| Position high | 20–39% | 20–39% |
| Satisfied with look | 89.8% | ~90% |
| Satisfied with feel | 59.3% | ~58–80% |
| Body-image improvement | 68% | 68% |
| Deflation / leakage | 0.7% (unique to saline) | N/A |
| Intraoperative volume adjustment | Yes (advantage) | No (preselected sizes) |
| Feel | "Sloshes" slightly; perceived firmer | More natural / cohesive |
| Systemic disease link | None reported | None reported with up to 5+ yr follow-up |
No head-to-head RCT exists; the wide ranges reflect questionnaire / cohort heterogeneity rather than a clear material-specific signal.[1][2][5][7][8][10]
Pediatric Considerations[14][20]
- Timing. Congenital absence — implantation between 1–3 years of age; post-orchiectomy — within 1 year.
- Approach. Suprascrotal (lowest complication rate).
- Sizing. Infant-sized prostheses available; Elder 1989 reported good outcomes in 41 boys.
- Adolescent torsion. Bush 2012 — intravaginal exchange at orchiectomy; 100% survival, 91.7% symmetric scrotum.
- Adolescent Rigicon Testi10™. 100% survival in 45 patients, no revisions.[4]
Gender-Affirming Use[5]
- Largest series (n = 206; mean follow-up 11.5 yr) — overall explantation 20.8%; modern technique 11.5%.
- Multiple brands used (Nagor, Promedon, Sebbin).
- Current trend — smaller / lighter prostheses and delayed implantation (rather than at scrotoplasty) improves outcomes.
- Smoking is a significant risk for infection / explantation.
Emerging — Hormone-Eluting and Tissue-Engineered Devices
Future-direction concepts shift from passive cosmetic replacement toward endocrinologically active implants that deliver testosterone, eliminating separate hormone replacement.[11]
| Concept | Stage | Key feature |
|---|---|---|
| Poly(HEMA) testosterone-releasing prosthesis (Yoshida / Imai) | Clinical (n = 12 hypogonadal men) | Constant T release ≥ 200 ng/dL serum for 48 mo; in vitro release 5.5 ± 1.5 mg/day × 900 days; available in Japan, not FDA-approved.[22][23] |
| Double-layer silastic STPT (Chen / Ning) | Preclinical (castrated rats) | Controlled testosterone-undecanoate release via semi-permeable membranes; normalized T / LH, preserved ICPmax.[24] |
| Tissue-engineered cartilage prosthesis (Raya-Rivera / Atala) | Preclinical (castrated athymic mice) | Bioengineered cartilage shell with hollow refillable center; physiologic T sustained through 14 wk in vivo; ex vivo release > 500 ng/dL for 16 wk.[25] |
| Improved biomimetic designs | Conceptual / patent | Softer, more natural tactile properties.[11] |
Key Recommendations[6][7][8][11][14][16]
- Offer to all patients undergoing orchiectomy regardless of age.
- Simultaneous placement at orchiectomy is safe — preferred when feasible, including before chemo / RT.
- Size selection guided by contralateral measurement; sample implants in clinic.
- Counsel about firmness (the most common complaint) and high-riding risk.
- Suprascrotal approach has the lowest complication rate.
- Pediatric implantation ideally within the first 3 years of life or within 1 year of orchiectomy.
- Satisfaction is 77–96%; sexual function is not impaired.
Cross-references
- Scrotal Reconstruction Techniques — broader reconstructive ladder.
- Scrotal Primary Closure
- Scrotal Skin Grafting (STSG / FTSG)
- Testicular Thigh Pouch
- Gender-Affirming Masculinizing Procedures
References
1. Bodiwala D, Summerton DJ, Terry TR. Testicular prostheses: development and modern usage. Ann R Coll Surg Engl. 2007;89(4):349–353. doi:10.1308/003588407X183463
2. Turek PJ, Master VA; Testicular Prosthesis Study Group. Safety and effectiveness of a new saline-filled testicular prosthesis. J Urol. 2004;172(4 Pt 1):1427–1430. doi:10.1097/01.ju.0000139718.09510.a4
3. Pidutti R, Morales A. Silicone gel-filled testicular prosthesis and systemic disease. Urology. 1993;42(2):155–157. doi:10.1016/0090-4295(93)90639-r
4. Atwater BL, Kirkik D, Wilson SK, et al. Short-term revision rate of Rigicon Testi10™ testicular prosthesis in adolescents and adults: a retrospective chart review. Int J Impot Res. 2025;37(4):303–309. doi:10.1038/s41443-024-00893-8
5. Pigot GLS, Al-Tamimi M, Ronkes B, et al. Surgical outcomes of neoscrotal augmentation with testicular prostheses in transgender men. J Sex Med. 2019;16(10):1664–1671. doi:10.1016/j.jsxm.2019.07.020
6. Hayon S, Michael J, Coward RM. The modern testicular prosthesis: patient selection and counseling, surgical technique, and outcomes. Asian J Androl. 2020;22(1):64–69. doi:10.4103/aja.aja_93_19
7. Araújo AS, Anacleto S, Rodrigues R, et al. Testicular prostheses — impact on quality of life and sexual function. Asian J Androl. 2024;26(2):160–164. doi:10.4103/aja202325
8. Clifford TG, Burg ML, Hu B, et al. Satisfaction with testicular prosthesis after radical orchiectomy. Urology. 2018;114:128–132. doi:10.1016/j.urology.2017.12.006
9. Ning Y, Cai Z, Chen H, et al. Development and clinical application of a new testicular prosthesis. Asian J Androl. 2011;13(6):903–904. doi:10.1038/aja.2011.87
10. Yossepowitch O, Aviv D, Wainchwaig L, Baniel J. Testicular prostheses for testis cancer survivors: patient perspectives and predictors of long-term satisfaction. J Urol. 2011;186(6):2249–2252. doi:10.1016/j.juro.2011.07.075
11. Adshead J, Khoubehi B, Wood J, Rustin G. Testicular implants and patient satisfaction: a questionnaire-based study of men after orchidectomy for testicular cancer. BJU Int. 2001;88(6):559–562. doi:10.1046/j.1464-4096.2001.02392.x
12. Musi G, Cozzi G, Mistretta FA, et al. Insertion of a testicular prosthesis at the time of radical orchiectomy for testicular cancer is safe in patients who will subsequently undergo chemotherapy or radiotherapy. Andrologia. 2020;52(6):e13613. doi:10.1111/and.13613
13. Bush NC, Bagrodia A. Initial results for combined orchiectomy and prosthesis exchange for unsalvageable testicular torsion in adolescents: description of intravaginal prosthesis placement at orchiectomy. J Urol. 2012;188(4 Suppl):1424–1428. doi:10.1016/j.juro.2012.02.030
14. Osemlak P, Jędrzejewski G, Cielecki C, et al. The use of testicular prostheses in boys. Medicine (Baltimore). 2018;97(52):e13911. doi:10.1097/MD.0000000000013911
15. Ferro F, Caterino S, Lais A. Testicular prosthesis in children: a simplified insertion technique. Eur Urol. 1991;19(3):230–232. doi:10.1159/000473626
16. Libman JL, Pippi-Salle JL, Chan PT. The use of a suprascrotal or 'wink' incision for placing a testicular prosthesis. BJU Int. 2006;98(5):1051–1053. doi:10.1111/j.1464-410X.2006.06487.x
17. Hao TL, Chen P. Comparative experimental re-evaluation of the two implanting methods of silicone gel testicular prostheses in beagle dogs. BMC Res Notes. 2011;4:99. doi:10.1186/1756-0500-4-99
18. Incrocci L, Bosch JL, Slob AK. Testicular prostheses: body image and sexual functioning. BJU Int. 1999;84(9):1043–1045. doi:10.1046/j.1464-410x.1999.00347.x
19. Nichols PE, Harris KT, Brant A, et al. Patient decision-making and predictors of genital satisfaction associated with testicular prostheses after radical orchiectomy. Urology. 2019;124:276–281. doi:10.1016/j.urology.2018.09.021
20. Elder JS, Keating MA, Duckett JW. Infant testicular prostheses. J Urol. 1989;141(6):1413–1415. doi:10.1016/s0022-5347(17)41328-0
21. Besombes T, Suartz CV, Poinard F, et al. Should you fix testicular prosthesis? A satisfaction survey from a monocentric cohort. Urology. 2024;184:278–282. doi:10.1016/j.urology.2023.11.017
22. Yoshida M, Asano M, Kaetsu I, et al. Studies of the slow releasing of testosterone from radiation-polymerized testicular prostheses implanted subcutaneously in the back of castrated rabbits. Biomaterials. 1987;8(2):124–128. doi:10.1016/0142-9612(87)90101-3
23. Imai K, Yamanaka H, Mashimo M, Asano M, Yoshida M. Testosterone replacement therapy for male hypogonadism with a radiation-polymerized testicular prosthesis. Int J Urol. 1997;4(2):157–162. doi:10.1111/j.1442-2042.1997.tb00163.x
24. Chen HX, Yang S, Ning Y, et al. Novel double-layer silastic testicular prosthesis with controlled release of testosterone and its effects on castrated rats. Asian J Androl. 2017;19(4):433–438. doi:10.4103/1008-682X.175786
25. Raya-Rivera AM, Baez C, Atala A, Yoo JJ. Tissue-engineered testicular prostheses with prolonged testosterone release. World J Urol. 2008;26(4):351–358. doi:10.1007/s00345-008-0267-y