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Penuma® & Himplant — Subcutaneous Silicone Penile Sleeve

The Penuma® is an FDA-cleared subcutaneous silicone penile implant used for cosmetic augmentation; FDA has also cleared the distinct Augmenta penile implant for cosmetic correction of soft-tissue deformities.[16][17] It received FDA 510(k) clearance as a Class II medical device[23] and is a medical-grade soft-silicone crescent-shaped sleeve placed in the subcutaneous space around the penile shaft to increase girth and flaccid length. Published series report a 56.7% increase in midshaft circumference (single-surgeon series) and a 52% increase in flaccid length (single-center series).[1][2][3]

Penuma and Himplant: same device family.

Himplant is described by its developer as a contemporary iteration of the Penuma silicone-sleeve concept with refined sizing, built on the same subcutaneous-shaft mechanism, silicone-elastomer material and implantation principle (manufacturer description). The SMSNA 2024 statement addresses Penuma and Himplant together.[6] The SMSNA identifies Himplant as a rebranding of Penuma but notes changes in device materials and implantation technique.[6] The published outcome data come almost entirely from the original Penuma device, because the foundational and later 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 with embedded polyester mesh in the FDA-cleared device; this solid implant is distinct from injected liquid silicone.[16] The SMSNA strongly recommends against permanent penile fillers, including liquid silicone.[16][6]
  • Sizes. FDA K220760 specifies Large (L) (12 cm length, 0.5 cm maximum thickness, 2 cm height), XL (15 cm length, 0.8 cm maximum thickness, 3 cm height), and XXL (18 cm length, 1.1 cm maximum thickness, 3.5 cm height). The surgeon selects and may trim the sleeve to fit the patient's penile dimensions.[16]
  • 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 or aesthetic. The sleeve does not treat erectile dysfunction. It lies outside the corpora, but selected referrals after genital enlargement procedures including subcutaneous implants have reported sexual dysfunction; the incidence among Penuma recipients is unknown.[9] 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 Pre-Formed Penile Silicone Block has FDA clearance for cosmetic penile augmentation;[18] the distinct Augmenta penile implant has clearance for cosmetic correction of penile soft-tissue deformities.[20] Both received 510(k) clearance, a different regulatory pathway from PMA approval, which requires more rigorous clinical evidence.[1]
  • The Penuma has FDA clearance for cosmetic penile augmentation; the distinct Augmenta implant is cleared for cosmetic correction of penile soft-tissue deformities.[19][20] Erectile penile prostheses are cleared for the treatment of ED, a separate regulatory and clinical category.[1]

Indications and Patient Selection​

Society guidance before selection. EAU 2026 strongly recommends against subcutaneous penile implants (Penuma) for girth enhancement as experimental.[26] SMSNA 2024 recommends silicone-sleeve surgery only with IRB oversight, long-term safety endpoints, no patient cost, an experienced surgeon, and counseling about potentially severe complications.[26][6]

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.
  • Current tobacco use (the multicenter silicone-sleeve cohort authors advise avoiding implantation; 2% of their 299 patients were smokers).[15]
  • Pre-existing intracorporeal penile prosthesis (IPP).
  • Significant penile curvature (Peyronie's disease).
  • Additional exclusions in the 92-patient series: stretched penile length <6 cm, anticoagulation that could not be stopped, erectile dysfunction refractory to oral medication, and recurrent urinary tract infection.[13]
  • Exclusions in the 299-patient multicenter series: uncircumcised status (circumcision was offered at least 3 months before implantation) and previous penile enhancement surgery or injections, which can create subdartos scarring and threaten skin integrity.[15]
  • Unrealistic expectations or undiagnosed penile dysmorphic disorder (PDD). The SMSNA 2024 statement requires that body dysmorphic disorder be ruled out before invasive treatment, using structured assessment such as the BDD Questionnaire together with psychological evaluation.[6]

Patient demographics in the 49-patient single-center 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. In the original Elist technique, make a 6-cm incision 2–3 cm above the pubic symphysis, releasing adjacent tissue while preserving the suspensory ligament.[2]
  2. Penile-skin degloving in the subcutaneous plane between the dartos fascia and Buck's fascia.
  3. Pocket creation along the dorsal and lateral shaft, extending toward the corona. Preserve fibroareolar tissue on the dartos side to protect skin blood supply; inspect the skin throughout and before closure, avoid crushing or penetrating retraction, and size the sleeve to avoid pressure points. In the 92-case series, two early operations were aborted after distal shaft skin perforation.[13][15]
  4. Implant insertion with sizing trial; the appropriately sized device is positioned to wrap around the dorsal and lateral shaft.
  5. Distal fixation. In the four-center technique, nonabsorbable suture fixes the sleeve to the subcoronal tunica albuginea to limit migration; its proximal end remains unfixed in a pocket approximately 2 cm distal to the suspensory ligament to accommodate changes in penile size with erection.[15]
  6. Drain and layered closure. The original Elist protocol placed a 19F closed-suction drain and removed it when output was below 20 mL/day.[2] A later 92-case series used a #10 JP drain through a separate scrotal stab incision, removed on postoperative days 3–4, and closed the incision in three layers; 11/92 patients still required seroma drainage.[2][13]
  7. Non-constricting postoperative wrap. In the four-center series, patients used a mesh-tube wrap to protect the skin without pressure and were warned against constriction from penile rings; the original report described compression as seroma treatment, not as a routine dressing.[15][2]

Operative time approximately 45–60 minutes.

"Concealed" scrotal approach (Wilson 2022 update)​

A newer technique reaches the same subdartos space through an approximately 4-cm lateral scrotal-fold incision; dissection stays close to the penoscrotal junction to avoid scrotal contents.[1][13][15] Early findings suggest:

  • Less visible scarring (incision concealed in scrotal rugae).
  • Shorter operative time.
  • A 2024 single-surgeon retrospective comparison found seroma requiring drainage in 11/92 patients (4/39 infrapubic versus 7/53 lateral scrotal; p = 0.690), revision in 5/39 versus 1/53, and removal in 8/39 versus 3/53. Its nonvalidated satisfaction survey was completed by 43 of 92 patients at least 6 months after surgery; only patients with the implant still in place were surveyed.[13]

A 92-patient single-surgeon retrospective series compared the lateral scrotal with the infrapubic approach.[13]

Postoperative protocol in the four-center cohort. Patients were told to avoid regular activity for 1 week, masturbation and vigorous activity for 4–6 weeks, intercourse for 6 weeks, and practices that impose sustained shaft pressure, especially penile rings.[15]

Efficacy Data​

StudynFollow-upGirth gainLength gainSatisfactionRemoval rate
Elist 2018 (single-surgeon, inventor)[2]400Girth: immediate and 30–90 d; APPSSI: 2–6 yr (mean 4 yr) in 77%+4.9 cm circumference (8.5 → 13.4 cm; +56.7%, p < 0.001)Not primary endpoint81% "high" or "very high" at 2–6 yr among follow-up respondents; 83% improved self-confidence at 6–8 wk; 72% sustained at 2–6 yr among follow-up respondents3%
Siegal 2023 (single center)[3]496 mo (mean)Not separately reportedReported mean individual gain +4.9 ± 2.9 cm (+52%, p < 0.01); published group means were 8.1 → 12.3 cm (a 4.2-cm difference), an unresolved source discrepancyNot formally assessedNot reported (7 AEs total)
Wilson & Picazo 2022 (multicenter developer-group update; unpublished data reported in an invited article)[1][6]100/234 responded (42.7%)[28]Not specifiedNot specifiedNot specifiedHigh patient and partner satisfaction on a five-question telephone survey among respondentsAdverse outcomes described as similar to the single-surgeon series
Siegal 2024 (four-center retrospective cohort)[15]299Median safety follow-up 11.6 mo (IQR 6.5–17.9); size measured before emergence from anesthesia+3.4 ± 1.5 cm flaccid girth (+36.9%), immediate+4.1 ± 1.5 cm flaccid length (+50%), immediateNot formally assessed21/299 (7.0%) explanted for grade IIIb events; no durability of size gain established

Efficacy observations.

  • Girth enhancement is the primary outcome; the original series reported a 56.7% increase in midshaft circumference (8.5 to 13.4 cm), at the top of the 16–56% flaccid girth gains reported across augmentation phalloplasty techniques in a systematic review of generally poor-quality studies.[2][7]
  • Length enhancement in the single-center series was 52% in flaccid length (8.1 to 12.3 cm) at a mean follow-up of 6 months. A scaffolding effect that prevents retraction is the proposed mechanism.[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]
  • Erectile function. No patients in the original series reported changes in sexual function, erections or ejaculation. The implant lies external to the tunica albuginea.[2]
  • Psychological outcomes. 83% of patients demonstrated a 2-category improvement in self-confidence and self-esteem at 6–8 weeks; among the 77% reassessed at 2–6 years, 72% maintained this improvement.[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%
Capsular fibrosis14/400 (3.5%)
Suture detachment or breakage6/400 (1.5%; two removals, four revisions)
Temporary skin sensitivity loss6/400 (1.5%)
Superficial penile skin ulcer5/400 (1.3%)
Hematoma4/400 (1.0%; one removal)
Sexual function / erection / ejaculation change0% reported

Single-center 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 49-patient Siegal report describes its complications as mainly cosmetic, but the subsequent four-center series found erosion in 15/299 (5.0%), infection in 4/299 (1.3%), distal-flaring revision in 17/299 (5.7%), and grade IIIb explantation in 21/299 (7.0%) over median 11.6-month follow-up. All erosions and infections led to explantation; these risks warrant explicit counseling.[3][15]

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]
  • In a separate Penuma-specific referral cohort selected for removal or complications (n = 16), 10 developed disabling dorsal curvature, 8 had penile shortening, and 5 reported de novo erectile dysfunction after explantation.[28] Ten underwent scar revision, yet none reported return to preimplant status.[28]

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.
  • Reimplantation after removal. None of the 21 explanted patients in the four-center cohort underwent reimplantation; the authors generally discourage replacement after infection because fibrosis makes the subcutaneous compartment difficult to recreate safely.[15]
  • Pilot result. Wilson and Picazo described a 12-patient, six-month rehabilitation pilot after removal for dissatisfaction and reported a favorable result in this selected group; its outcomes after removal for infection or other medical reasons were still being evaluated.[1]
  • The program is currently being evaluated for patients requiring removal for medical reasons (infection, suture-related issues).
  • A separate four-center cohort reported daily traction and PDE5 inhibitors after erosion or infection explantation, without comparative evidence of benefit.[15]

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]

  • The SMSNA recommends that silicone-sleeve surgery be performed only under IRB oversight, with long-term safety endpoints and without cost to the patient.[6]
  • The statement gives distinct, therapy-specific recommendations based on the literature through December 2023.
  • The 2026 Fifth ICSM consensus separately advises that subcutaneous penile implants such as Himplant be offered only with caution in an experimental setting.[29]
  • Body dysmorphic disorder must be ruled out before invasive treatment, using structured assessment and professional psychological evaluation.[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 gainElist 2018: +56.7% (+4.9 cm midshaft circumference)[2]Yang 2020: +2.50 cm mean girth at 1 month; +1.41 cm at 18 months[14]Yang 2020: +2.30 cm mean girth at 1 month; +1.79 cm at 18 months[14]Variable
OnsetImmediate (surgical)ImmediateGradual (weeks–months)Immediate
DurabilityPermanent while implant in situYang 2020: HA girth gain declined from its 1-month peak but remained +1.41 cm at 18 months; 46/67 participants overall had 18-month data[14]In one RCT, 18-month data were available for 46/67 participants overall; PLA gain declined 22.1% from its 1-month peak[14]Variable (fat resorption)
ReversibilityRemovable, but post-explant deformity or shortening may persist[6]Reversible with hyaluronidaseNot reversibleNot easily reversible
InvasivenessSurgical (general anesthesia)Office injectionOffice injectionSurgical
Complication rateElist 2018: removal 3%, seroma 4.8%, infection 3.3%; Siegal 2023: infection 1/49 (2%); Siegal 2024: erosion 15/299 (5.0%), grade IIIb explant 21/299 (7.0%) at median 11.6 months; Salkowski 2024: all-cause removal 11/92 (12%) in a nonrandomized series[2][3][15][13]Yang 2020: injection-related adverse events 3/33 (9.1%), mild[14]Yang 2020: injection-related adverse events 2/34 (5.9%), mild[14]No graft-specific rate established here; Manfredi reported skin necrosis/ulcers, wound infection, or reoperation in 8/15 studies across surgical procedures[10]
Effect on erectionNo erection or ejaculation change reported in the inventor cohort; sexual dysfunction reported among selected complication referrals after varied genital enlargement procedures, including subcutaneous implants (Penuma-recipient incidence unknown)[2][9]No changeNo changeVariable
FDA status510(k) cleared for cosmetic penile augmentation[16]Off-labelOff-labelNot established for this mixed graft/fat category
SatisfactionElist 2018: 72% retained a two-category self-confidence/self-esteem improvement and 81% rated satisfaction high/very high at 2–6 years among follow-up respondents (77% reassessed)[2]Yang 2020: satisfaction improved from baseline at 18 months; Manfredi: 75–100% across injection studies, not HA alone[14][10]Yang 2020: satisfaction improved from baseline at 18 months, comparable to HA[14]Manfredi: 60–100% across surgical studies, not graft-specific[10]

Strengths​

  • FDA-cleared device for cosmetic penile augmentation. The distinct Augmenta implant is also FDA-cleared for cosmetic correction of penile soft-tissue deformities.[1][21][22]
  • Large girth gain. The 56.7% increase is at the top of the reported range for augmentation techniques.[2][7]
  • Removable device; tissue recovery varies. Augmentation persists while the implant remains in place, and the sleeve can be explanted.[1][2] The four-center cohort describes fibrosis of the subcutaneous compartment after explantation; selected referrals after various genital-enlargement procedures, including subcutaneous implants, reported shortening, curvature and sexual dysfunction. Their frequency among all Penuma recipients is unknown.[9][15]
  • Erectile function. The implant lies external to the tunica albuginea. In the 400-man retrospective inventor series, no patient reported a change in erections, ejaculation or sexual function.[2][6]
  • Later independent cohorts include 49-, 92-, and 299-patient retrospective series. They report flaccid size gains measured at differing time points and differing complication and explant rates; the Wilson telephone survey was developer-reported.[1][3][13][15]
  • Post-explant rehabilitation has been described by the developer group in 12 patients followed for six months after elective removal for dissatisfaction; outcomes after medically indicated removal remained under evaluation.[1]

Limitations and Concerns​

  • Limited comparative evidence. The foundational 400-patient single-surgeon inventor series was retrospective and used a nonvalidated outcome instrument, raising potential bias concerns. Later 49-, 92-, and 299-patient cohorts are observational; the 49-patient series had mean follow-up of six months, and longer-term safety and patient-reported outcomes remain limited. A 2026 device-specific systematic review identified 12 publications, with four cohorts eligible for its primary single-arm meta-analysis (pooled explantation/removal 7.08%; erosion/exposure 5.12%).[2][3][13][15][27]
  • 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 rates depend on cohort and endpoint. The inventor series reported 3% explantation for adverse events, and a narrative review described removal rates up to 10%. The four-center cohort reported 21/299 (7.0%) explants for grade IIIb events at median 11.6 months; a single-surgeon approach comparison reported 11/92 (12%) removals for any reason, including 8/39 (21%) infrapubic and 3/53 (6%) lateral scrotal. The approach comparison was nonrandomized.[2][8][15][13]
  • 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. Clearance rested on substantial equivalence and did not require a prospective efficacy trial.[4][24] The K220760 dossier included retrospective clinical testing from 526 implantations, with outcomes analyzed in 400 consenting patients.[4][16]

Distinction From Non-Medical Silicone Implants and Injectables​

Penuma and Himplant must be distinguished 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 or 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 iteration Himplant, is a subcutaneous silicone sleeve for penile girth enhancement that is permanent but removable. Its FDA 510(k) clearance covers cosmetic penile augmentation; the distinct Augmenta penile implant also has FDA 510(k) clearance for cosmetic correction of soft-tissue deformities.[24][25] The evidence includes the 400-patient inventor series with a nonvalidated outcome instrument, a 49-patient single-center series, a 92-patient single-surgeon approach comparison, and a 299-patient four-center cohort, plus a developer-reported survey; all procedural cohorts are observational and long-term outcomes remain limited.[1][2][3][13][15] The EAU 2026 penile-girth recommendation table advises against subcutaneous penile implants (Penuma) as experimental (Strong).[26] Separately, the SMSNA 2024 statement recommends silicone-sleeve surgery only under IRB oversight and body-dysmorphic-disorder screening before invasive treatment.[26][6] The inventor series reported 3% adverse-event explantation; a broader narrative review described removal rates up to 10%. Separate cohorts reported 21/299 (7.0%) grade IIIb explants at median 11.6 months and 11/92 (12%) all-cause removals in a single-surgeon comparison; selected referral patients have had severe complications after several forms of genital enlargement surgery.[2][8][15][13][9] Patient selection, BDD screening and informed consent address these risks. Concurrent suspensory ligament division adds its own risk of penile instability.[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, Khera M, Köhler T, 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

13. Salkowski M, Levine LA. "Outcomes and patient satisfaction after Penuma silicone implant surgery via two surgical approaches." Ther Adv Urol. 2024;16:17562872241280021. doi:10.1177/17562872241280021

14. Yang DY, Jeong HC, Ko K, et al. "Comparison of clinical outcomes between hyaluronic and polylactic acid filler injections for penile augmentation in men reporting a small penis: a multicenter, patient-blinded/evaluator-blinded, non-inferiority, randomized comparative trial with 18 months of follow-up." J Clin Med. 2020;9(4):1024. doi:10.3390/jcm9041024

15. Siegal AR, Celtik KE, Razdan S, et al. "A multi-institutional update on surgical outcomes after penile silicone sleeve implantation." Ther Adv Urol. 2024;16:17562872241241858. doi:10.1177/17562872241241858

16. U.S. Food and Drug Administration. "Pre-Formed Penile Silicone Block: 510(k) K220760." 2022. FDA clearance

17. U.S. Food and Drug Administration. "Augmenta Penile Implant: 510(k) K200073." 2022. FDA clearance

18. U.S. Food and Drug Administration. "Pre-Formed Penile Silicone Block: 510(k) K220760." 2022. FDA clearance

19. U.S. Food and Drug Administration. "Pre-Formed Penile Silicone Block: 510(k) K220760." 2022. FDA clearance

20. U.S. Food and Drug Administration. "Augmenta Penile Implant: 510(k) K200073." 2022. FDA clearance

21. U.S. Food and Drug Administration. "Pre-Formed Penile Silicone Block: 510(k) K220760." 2022. FDA clearance

22. U.S. Food and Drug Administration. "Augmenta Penile Implant: 510(k) K200073." 2022. FDA clearance

23. U.S. Food and Drug Administration. "Pre-Formed Penile Silicone Block: 510(k) K220760." 2022. FDA clearance

24. U.S. Food and Drug Administration. "Pre-Formed Penile Silicone Block: 510(k) K220760." 2022. FDA clearance

25. U.S. Food and Drug Administration. "Augmenta Penile Implant: 510(k) K200073." 2022. FDA clearance

26. European Association of Urology. "EAU Guidelines on Sexual and Reproductive Health: Penile Size Abnormalities and Dysmorphophobia." 2026. Guideline

27. Yang H, Xiao W, Wang H, et al. "Subcutaneous penile silicone sleeve implants for penile augmentation: a systematic review and meta-analysis." Int J Impot Res. 2026. doi:10.1038/s41443-026-01368-8

28. Barham DW, Lee J, Ghaziyar H, Gelman J. "Complications of the Penuma penile implant for genital enhancement." J Sex Med. 2025;22(5):975–977. doi:10.1093/jsxmed/qdaf055

29. Chung E, Jenkins L, Moon DG, et al. "Penile augmentation and cosmetic surgery: recommendations from the Fifth International Consultation on Sexual Medicine (ICSM 2024)." Sex Med Rev. 2026;14(1):qeaf067. doi:10.1093/sxmrev/qeaf067