Skip to main content

Penuma® & Himplant — Subcutaneous Silicone Penile Sleeve

The Penuma® is the only FDA-cleared subcutaneous silicone penile implant designed specifically for cosmetic enhancement of the flaccid penis. It received FDA 510(k) clearance as a Class II medical device and is a medical-grade soft-silicone crescent-shaped sleeve placed in the subcutaneous space around the penile shaft to increase both girth (~ +56.7%) and apparent flaccid length (~ +52%).[1][2][3]

Penuma vs Himplant — same device family

Himplant is a contemporary rebrand / next-generation iteration of the Penuma silicone-sleeve concept, marketed under different commercial naming and refined sizing but built on the same subcutaneous-shaft mechanism, the same silicone-elastomer material, and the same surgical-implantation principle. Reconstructive urologists and urogynecologists should treat Penuma and Himplant as a single device category for indications, complication profile, salvage, and explant counseling. Differences in published outcome data overwhelmingly reflect the original device (Penuma) because the foundational and multicenter series were performed under that name.[1][2][3]

For the broader male cosmetic-genital-surgery decision framework see the Male Cosmetic Genital Surgery atlas page. For the clinical-conditions framework on small-penis syndrome / penile dysmorphic disorder see Small Penis Syndrome. For the unrelated and dangerous category of non-medical injected silicone, see Free Silicone Injection and Penile Pearls.

Device Design and Specifications​

The Penuma is a custom-shaped, soft, solid silicone-elastomer implant.[1][2][3]

  • Shape — crescent-shaped (C-shaped) sleeve that wraps the dorsal and lateral aspects of the penile shaft and leaves the ventral surface (urethral side) open to avoid urethral compression and preserve erectile function.
  • Material — medical-grade silicone elastomer (the same biocompatible cured-elastomer family used in breast implants, testicular prostheses, and chin implants). Fundamentally distinct from injected liquid silicone, which is unrelated and contraindicated.
  • Sizes — three principal sizes: Long (L), Extra-Long (XL), and Extra-Extra-Long (XXL); selected intraoperatively based on the patient's penile dimensions. Himplant offers a refined size matrix marketed as more granular shaft-by-shaft fit.
  • Placement — positioned in the subcutaneous space between the dartos fascia and Buck's fascia, external to the tunica albuginea. This is fundamentally different from erectile penile prostheses (AMS 700, Coloplast Titan), which are placed intracorporeally within the corpora cavernosa.
  • Function — purely cosmetic / aesthetic. The Penuma does not treat erectile dysfunction and does not affect the erectile mechanism. It enhances the appearance of the flaccid penis.[1][2]

FDA Regulatory Status​

The Penuma received FDA 510(k) clearance — the regulatory pathway for Class II medical devices that demonstrate "substantial equivalence" to a previously marketed predicate device.[1][4]

  • The 510(k) pathway requires demonstration of substantial equivalence in materials, design, and intended use to a predicate device. It does not require prospective clinical-trial data for clearance.[4]
  • The device is cleared specifically for cosmetic correction of the flaccid penis — distinct from FDA "approval" via the PMA pathway, which requires more rigorous clinical evidence.[1]
  • The Penuma is the only penile implant with FDA clearance for aesthetic enhancement. Erectile penile prostheses are cleared for the treatment of ED, a separate regulatory and clinical category.[1]
  • Counseling note: 510(k) clearance does not imply the same level of clinical evidence as PMA approval, and the device label and marketing position should be communicated honestly to the patient before consent.

Indications and Patient Selection​

Indications described in the published literature.[1][2][3][5]

  • Cosmetic enhancement of the flaccid penis in men dissatisfied with penile appearance.
  • Adult-acquired retractile penis — the Penuma has been specifically described as a treatment for retractile penis where the shaft retracts into the prepubic space.[5]
  • Cosmetic deformities of the penile shaft.

Reported contraindications and exclusions from the published series.[2][3]

  • Active infection or skin disease of the penis.
  • Uncontrolled diabetes mellitus.
  • Immunosuppression.
  • Active smoking (relative contraindication — nearly all patients in the multicenter series were non-smokers).
  • Pre-existing intracorporeal penile prosthesis (IPP).
  • Significant penile curvature (Peyronie's disease).
  • Unrealistic expectations or undiagnosed penile dysmorphic disorder (PDD) — formal psychological screening (BDDQ-AS or BDD-YBOCS) is recommended at the front of every consultation.[6]

Typical patient demographics from the multicenter series.[3]

  • Mean age 40.2 ± 8.9 years.
  • Mean BMI 28.2 ± 4.5.
  • Predominantly non-smokers with minimal comorbidities.

Surgical Technique​

Classic infrapubic approach (original technique)​

Performed under general anesthesia as an outpatient procedure.[2][3]

  1. Transverse infrapubic incision (~ 3–4 cm) at the penopubic junction.
  2. Penile-skin degloving in the subcutaneous plane between the dartos fascia and Buck's fascia.
  3. Pocket creation along the dorsal and lateral aspects of the penile shaft, extending distally toward the corona.
  4. Implant insertion with sizing trial; the appropriately sized device is positioned to wrap around the dorsal and lateral shaft.
  5. Suture fixation to prevent migration.
  6. Layered closure of the infrapubic incision.
  7. Compressive dressing.

Operative time approximately 45–60 minutes.

"Concealed" scrotal approach (Wilson 2022 update)​

A newer technique implants the device through a scrotal incision.[1] Early findings suggest:

  • Less visible scarring (incision concealed in scrotal rugae).
  • Shorter operative time.
  • Less seroma formation than the classic infrapubic approach.

This approach is still emerging and has not been fully characterized in peer-reviewed publications outside the Wilson 2022 update.

Efficacy Data​

StudynFollow-upGirth gainLength gainSatisfactionRemoval rate
Elist 2018 (single-surgeon, inventor)[2]4002–6 yr (mean 4 yr)+4.9 cm circumference (8.5 → 13.4 cm; +56.7%, p < 0.001)Not primary endpoint81% "high" or "very high"; 83% improved self-confidence at 6–8 wk; 72% sustained at 2–6 yr3%
Siegal 2023 (multicenter, non-inventor)[3]496 mo (mean)Not separately reported+4.9 ± 2.9 cm flaccid length (8.1 → 12.3 cm; +52%, p < 0.01)Not formally assessedNot reported (7 AEs total)
Wilson & Picazo 2022 (multicenter update)[1]Not specifiedNot specifiedConsistent with original seriesConsistent with original seriesHigh patient and partner satisfaction (multicenter confirmation)Similar to original single-surgeon series

Key efficacy observations.

  • Girth enhancement is the primary outcome — the original series demonstrated a 56.7% increase in midshaft circumference (8.5 → 13.4 cm), the largest girth gain reported for any penile-augmentation technique in the literature.[2][7]
  • Length enhancement in the multicenter series was 52% flaccid length (8.1 → 12.3 cm), attributed to the implant's scaffolding effect preventing retraction.[3]
  • Retractile-penis correction — in 3 patients with adult-acquired retractile penis, Penuma (with concurrent suprapubic-fat-pad removal in 2 of 3) produced visible penile shaft and glans at > 1 year follow-up with improved self-confidence and self-esteem.[5]
  • No effect on erectile function — no patients in the original series reported any changes in sexual function, erections, or ejaculation. The implant lies external to the tunica albuginea and does not interfere with the erectile mechanism.[2]
  • Psychological outcomes — 83% of patients demonstrated a 2-category improvement in self-confidence and self-esteem at 6–8 weeks; 72% maintained this improvement at 2–6 years.[2]

Complications and Safety Profile​

Original single-surgeon series (n = 400)[2]​

ComplicationRate
Seroma (most common; usually self-resolving or aspirated)4.8%
Scar formation (visible / hypertrophic at infrapubic incision)4.5%
Infection (often requiring device removal)3.3%
Device removal for adverse events3%
Sexual function / erection / ejaculation change0% reported

Multicenter non-inventor series (n = 49)[3]​

ComplicationRate
Infection1 case (2%)
Erosion (implant through penile skin)2 cases (4.1%)
Persistent distal flaring (visible "ridge" near corona)4 cases (8.2%) — 3 of 4 required revision, all with good cosmetic outcome

The Siegal multicenter cohort framed complications as "mainly cosmetic and easily corrected with low risk."

Broader penile-augmentation / referral-center literature​

  • A 2026 narrative review of silicone-implant complications described risks of infection, erosion, seroma, and necrosis, with cases resulting in severe penile deformities and a removal rate of up to 10%.[8]
  • The Furr 2018 referral-center series documented severe complications from various genital-enlargement procedures including subcutaneous penile implants. All patients who had undergone subcutaneous penile-implant placement had the device removed prior to presentation at the referral center, with adverse changes including sexually disabling penile deformity, severe shortening, curvature, edema, subcutaneous masses, infection, non-healing wounds, and sexual dysfunction. 10 of 11 required corrective surgery, 3 with split-thickness skin grafting.[9]
  • The Furr series included multiple types of subcutaneous implants and injections, not exclusively the Penuma device, and the true incidence cannot be calculated because the denominator of procedures performed is unknown.[9]

Penile Rehabilitation Program After Device Removal​

A novel penile-rehabilitation program has been described specifically for patients who undergo Penuma removal.[1]

  • Purpose — restore the penis to its pre-operative appearance after device removal.
  • Pilot data — 12 patients followed for 6 months while participating in the program.
  • Result — effective in patients who underwent removal for dissatisfaction; the penis returned to its pre-operative state.
  • The program is currently being evaluated for patients requiring removal for medical reasons (infection, suture-related issues).
  • Specific protocol details (use of penile-traction therapy, vacuum erection device, topical or systemic medications) have not been fully published.[1]

SMSNA Position Statement (2024)​

The Sexual Medicine Society of North America (SMSNA) addressed silicone-sleeve implants as one of five distinct categories in the 2024 position statement on cosmetic penile-enhancement procedures.[6]

  • Silicone-sleeve implants were included among procedures considered investigational with limited data.
  • The SMSNA issued distinct, therapy-specific recommendations based on the current literature.
  • A multidisciplinary approach including psychiatric / psychological evaluation was recommended to identify patients with penile dysmorphic disorder who should not be offered surgical intervention.
  • Further studies — particularly from non-inventor surgeons — were emphasized as needed to validate safety and efficacy.[6]

Comparison: Penuma vs Other Girth-Enhancement Approaches​

FeaturePenuma silicone sleeveHA filler injectionPLA filler injectionDermal / fat grafts
MechanismStructural implant (subcutaneous sleeve)Volumetric filler (subcutaneous)Biostimulatory (neocollagenesis)Tissue augmentation
Girth gain+56.7% (+4.9 cm circumference)+1.7–3.9 cm circumference+1.3–2.7 cm circumference+16–30%
OnsetImmediate (surgical)ImmediateGradual (weeks–months)Immediate
DurabilityPermanent while implant in situ12–18 months (resorption)18+ months (stable)Variable (fat resorption 20–80%)
ReversibilityReversible (device removal)Reversible (hyaluronidase)Not reversibleNot easily reversible
InvasivenessSurgical (general anesthesia)Office injectionOffice injectionSurgical
Complication rate3–10% removal; seroma 4.8%, infection 2–3.3%5–14% (mild)6–14% (mild)Skin necrosis, infection, reoperation up to ~ 53% in some series
Effect on erectionNo change reportedNo changeNo changeVariable
FDA status510(k) cleared for cosmetic correctionOff-labelOff-labelOff-label
Satisfaction72–81%75–100%Comparable to HA60–100%

Strengths​

  • Only FDA-cleared device for cosmetic penile enhancement — provides a regulatory framework other approaches lack.[1]
  • Largest girth gains of any penile-augmentation technique in the literature (+56.7%).[2][7]
  • Permanent but reversible — the implant gives durable augmentation while in place yet can be removed if complications arise or the patient is dissatisfied.[1][2]
  • No effect on erectile function — subcutaneous placement external to the tunica albuginea preserves the erectile mechanism.[2]
  • Multicenter validation from non-inventor surgeons confirms the original single-surgeon findings.[1][3]
  • Rehabilitation program available for patients requiring device removal.[1]

Limitations and Concerns​

  • Limited independent data. The foundational study (n = 400) was conducted by the device inventor (Dr James Elist) as a single-surgeon retrospective analysis, raising potential bias concerns. The only non-inventor multicenter study (n = 49) has only 6 months of follow-up.[2][3]
  • Non-validated outcome instrument. The APPSSI (Augmentation Phalloplasty Patient Selection and Satisfaction Inventory) used to measure satisfaction has not been validated.[2]
  • Excluded subjects. 126 non-consenting subjects were excluded from the original analysis, potentially affecting the reported complication rate.[2]
  • Removal rate up to 10%. While the original series reported 3%, a broader silicone-implant complications review reported up to 10%.[2][8]
  • Severe complications at referral centers. Sexually disabling penile deformity, severe shortening, and need for skin grafting have been documented after subcutaneous-silicone-implant removal, though some referral-center series include non-Penuma devices.[9]
  • No randomized controlled trials comparing Penuma to sham surgery, other augmentation techniques, or no treatment.[10][11]
  • Cost. The procedure is typically not covered by insurance; pricing is approximately $15,000–$20,000 (publicly available pricing).
  • Limited long-term data. The longest published follow-up is 2–6 years from a single surgeon. Very-long-term outcomes (> 10 years) including implant durability, capsular contracture, and late complications remain unknown.[2]
  • 510(k) regulatory limit. The 510(k) pathway does not require prospective clinical-trial data — clearance was based on substantial equivalence to a predicate device rather than on safety- and efficacy-trial evidence.[4]

Distinction From Non-Medical Silicone Implants and Injectables​

It is critical to distinguish Penuma / Himplant from non-medical subcutaneous penile implants and injections, which represent a separate and far more dangerous category.[8][9][12]

  • Non-medical foreign-body implantation (beads, balls, rods of various materials) inserted for sexual-pleasure enhancement carries devastating complication rates including pain, erosion, inflammation, nodules, skin ulcers, necrosis, penile deformity, gangrene, and even death.[8] See Penile Pearls.
  • Non-medical liquid-silicone injection (silicone oil injected in non-sterile conditions) causes sclerosing lipogranuloma requiring complex tissue excision and skin transplantation.[8][12] See Free Silicone Injection.
  • The Penuma / Himplant is a manufactured, FDA-cleared, medical-grade cured-elastomer device implanted by trained surgeons in sterile conditions — fundamentally different from these non-medical practices.[1][2]

Clinical Summary​

The Penuma — and its contemporary rebrand Himplant — represents the most structurally robust approach to penile girth enhancement, producing the largest girth gains in the literature (+56.7%) with a permanent but reversible mechanism. FDA 510(k) clearance provides a regulatory distinction from every other cosmetic penile-augmentation approach. The evidence base, however, remains limited — dominated by a single-surgeon inventor series with a non-validated outcome instrument and supplemented by a single small multicenter study with short follow-up. The SMSNA considers the procedure investigational, and a multidisciplinary approach with formal psychological screening is recommended. The 3–10% device-removal rate and reports of severe complications at referral centers underscore the importance of careful patient selection, BDD screening, and rigorous informed consent. Concurrent SLD is generally not recommended because of instability risk.[1][2][3][6][8][9]

See Also​

References​

1. Wilson SK, Picazo AL. Update on the Penuma — an FDA-cleared penile implant for aesthetic enhancement of the flaccid penis. Int J Impot Res. 2022;34(4):369–374. doi:10.1038/s41443-021-00510-y

2. Elist JJ, Valenzuela R, Hillelsohn J, Feng T, Hosseini A. A single-surgeon retrospective and preliminary evaluation of the safety and effectiveness of the Penuma silicone-sleeve implant for elective cosmetic correction of the flaccid penis. J Sex Med. 2018;15(9):1216–1223. doi:10.1016/j.jsxm.2018.07.006

3. Siegal AR, Zisman A, Sljivich M, Razdan S, Valenzuela RJ. Outcomes of a single center's initial experience with the Penuma penile implant. Urology. 2023;171:236–243. doi:10.1016/j.urology.2022.07.066

4. Darrow JJ, Avorn J, Kesselheim AS. FDA regulation and approval of medical devices: 1976–2020. JAMA. 2021;326(5):420–432. doi:10.1001/jama.2021.11171

5. Elist JJ, Baniqued M, Hosseini A, Wilson SK. Correction of retractile penis with subcutaneous soft-silicone penile implant. Int J Impot Res. 2020;32(3):317–322. doi:10.1038/s41443-019-0174-3

6. Trost L, Watter DN, Carrier S, et al. Cosmetic penile-enhancement procedures: an SMSNA position statement. J Sex Med. 2024;21(6):573–578. doi:10.1093/jsxmed/qdae045

7. Vyas KS, Abu-Ghname A, Banuelos J, Morrison SD, Manrique O. Aesthetic augmentation phalloplasty: a systematic review of techniques and outcomes. Plast Reconstr Surg. 2020;146(5):995–1006. doi:10.1097/PRS.0000000000007249

8. Ramazan M, Øbro LF, Wiborg MH, et al. Complications of penile augmentation: a narrative review of injectables, implants, and surgical grafts. Int J Impot Res. 2026;38(3):238–246. doi:10.1038/s41443-025-01190-8

9. Furr J, Hebert K, Wisenbaugh E, Gelman J. Complications of genital-enlargement surgery. J Sex Med. 2018;15(12):1811–1817. doi:10.1016/j.jsxm.2018.10.007

10. Manfredi C, Romero Otero J, Djinovic R. Penile girth-enhancement procedures for aesthetic purposes. Int J Impot Res. 2022;34(4):337–342. doi:10.1038/s41443-021-00459-y

11. Romero-Otero J, Manfredi C, Ralph D, et al. Non-invasive and surgical penile-enhancement interventions for aesthetic or therapeutic purposes: a systematic review. BJU Int. 2021;127(3):269–291. doi:10.1111/bju.15145

12. Pang KH, Randhawa K, Tang S, et al. Complications and outcomes following injection of foreign material into the male external genitalia for augmentation: a single-centre experience and systematic review. Int J Impot Res. 2024;36(5):498–508. doi:10.1038/s41443-023-00675-8