If you’ve been researching penile enlargement options and come across ‘Himplant XXL,’ you’re encountering one of the most technically advanced — and most misunderstood — male enhancement procedures available today. It is a real surgical procedure with FDA clearance and published clinical evidence. It is also expensive, irreversible, and carries significant considerations that most online sources gloss over.
This guide gives you an honest, clinically grounded assessment of Himplant: what it actually is, what the evidence says, what the realistic risks and outcomes are, what it costs, and where it’s available; and—critically—what the evidence-based alternatives look like for men who aren’t surgical candidates or who want to explore non-surgical options first.
At Sandton Men’s Clinic, we believe informed decisions are better decisions. Read this before committing to anything.
1. What Is Himplant (and Himplant XXL)?
The Himplant, also known in the clinical literature as the Penuma implant, is a soft, preformed silicone implant placed surgically beneath the penile skin to increase girth (circumference) and improve the flaccid appearance of the penis. It is manufactured as a cosmetic, non-erectile device, meaning it is designed for men with normal erectile function; it is not a treatment for erectile dysfunction.
Himplant / Penuma: Key Clinical Facts
Device type: Pre-formed soft medical-grade silicone implant placed subcutaneously (under the penile skin)
Primary purpose: Cosmetic girth enhancement; may improve flaccid length appearance
Regulatory status: FDA 510(k) cleared (K181387 — ‘Pre-Formed Penile Silicone Block’). This is clearance, not approval — an important distinction
Effect on erect length: Limited and unpredictable; primarily affects flaccid appearance and girth
Effect on erect girth: Reported increases of approximately 1–2 inches in circumference
‘XXL’ designation: Refers to a larger sizing option within the implant range, contoured to individual anatomy
Suitable for: Men with normal erectile function seeking cosmetic enhancement
NOT suitable for: Men seeking ED treatment; men with active penile conditions; men who are uncircumcised (circumcision required for the procedure)
FDA Clearance vs FDA Approval: An Important Distinction
An implant is marketed as ‘FDA-cleared’, which means it has passed the FDA’s 510(k) premarket notification process, demonstrating that it is substantially equivalent to a legally marketed predicate device. This is different from FDA approval, which requires clinical trials demonstrating safety and efficacy for a specific use. FDA clearance for a device does not mean the FDA has independently verified the clinical outcomes or patient satisfaction data.
This distinction matters when evaluating outcome claims and should be part of any pre-procedure informed consent conversation.
2. The Himplant Procedure: What Actually Happens
Pre-Operative Requirements
Before a Himplant procedure is considered, surgeons require:
- Circumcision — the procedure requires circumcision, either pre-existing or performed simultaneously. Men who are uncircumcised must factor this in
- Normal erectile function — the device is not a treatment for ED. Men with erectile dysfunction are not appropriate candidates
- No active penile skin conditions or infections
- Psychological assessment — to ensure expectations are realistic and body dysmorphic disorder is not driving the request
- Comprehensive surgical consultation with a qualified urologist or plastic surgeon experienced in penile procedures
The Surgical Procedure
The Himplant procedure is performed under general or regional anaesthesia in a sterile surgical environment. The silicone implant is placed in the subcutaneous space — between the skin and the underlying erectile tissue — around the shaft of the penis. The device is contoured to the anatomy by the surgeon and secured to prevent migration.
The procedure typically takes 45–90 minutes. Post-operative dressings are applied and the patient is discharged the same day in most cases.
Recovery Timeline
- Week 1–2: Significant swelling and bruising; restricted activity; prescribed pain management
- Week 3–4: Gradual reduction in swelling; continued restriction of sexual activity
- Week 6–8: Typically cleared for sexual activity (surgeon-dependent)
- Month 3–6: Final aesthetic result becomes assessable as swelling fully resolves
- Full healing: 6–12 months for complete tissue integration
The recovery period is longer and more restrictive than many online sources suggest. Men should factor 6–8 weeks of sexual abstinence into their planning.
3. Himplant Outcomes: What the Published Evidence Shows
The most relevant peer-reviewed data on the Penuma/Himplant device comes from a study published in the Journal of Sexual Medicine by the device’s developer and associated researchers. Here is an honest summary of what that evidence shows — and what it doesn’t:
Published Reported Outcomes
- Circumference increase: Published reports indicate flaccid girth increases of approximately 1.5–2.5 cm on average; XXL sizing produces larger changes
- Erect girth: Some increase is reported but is less consistent than flaccid changes, as the device is placed outside the erectile chambers
- Flaccid length: Some improvement is commonly reported, attributable to the added volume of the device
- Erect length: Not reliably changed — the device does not affect the suspensory ligament or the tunica albuginea that limits erect length
- Patient satisfaction: The study reported high satisfaction rates — but importantly, the primary study was conducted by the device’s own developer and has not been widely replicated independently
What the Evidence Doesn’t Tell You
- The primary published study has conflicts of interest — the lead author developed the device
- Long-term outcomes (beyond 2–3 years) are not well-documented in the independent peer-reviewed literature
- Complication and revision rates in broader surgical practice (outside of the developer’s own centre) are not comprehensively reported
- The study population was relatively small; larger independent studies are limited
Important: Evidence Quality Context
FDA clearance and published data from a device developer’s own study are not the same as broad independent clinical evidence. Before considering any surgical implant procedure, patients should ask for data from multiple independent sources and discuss realistic expectations with a surgeon who is not commercially affiliated with the device manufacturer.
4. Risks and Complications: What Every Candidate Must Understand
No surgical procedure is without risk, and the Himplant procedure carries a specific profile of complications that must be fully understood before consent:
General Surgical Risks
- Infection — any subcutaneous implant carries infection risk; penile implant infections may require device removal
- Haematoma — collection of blood post-procedure requiring drainage
- Wound healing complications — particularly relevant if circumcision is performed simultaneously
- Anaesthesia risks — standard for any procedure requiring general or regional anaesthesia
Device-Specific Risks
- Implant displacement or migration — the device can move from its intended position
- Implant extrusion — in rare but serious cases, the device can erode through the skin
- Asymmetry or irregular contour — the aesthetic result may not be uniform
- Changes in sensation — temporary or permanent alteration in penile skin sensitivity
- Reduced erection quality — the added subcutaneous volume may, in some cases, affect erection dynamics; this is an important risk to discuss pre-operatively
- Dissatisfaction with the aesthetic result — outcome does not match expectation
- Revision surgery — needed if complications develop or results are unsatisfactory; adds to total cost and recovery time
Critical Consideration: Device Removal
If the Himplant device is removed — due to infection, complication, or patient dissatisfaction, the penis does not simply return to its pre-operative state. Scar tissue forms during the healing process, and the aesthetic and functional outcome after removal is not predictable. This is an irreversible surgical decision that should be made with full awareness of this reality.
5. Is Himplant XXL available in South Africa?
This is one of the most important questions for South African men researching this procedure, and it deserves a direct answer.
The Himplant/Penuma device is primarily offered in the United States, where the device’s developer and a limited network of trained surgeons perform the procedure. As of 2025/2026, the device is not widely available in South Africa through formally trained, manufacturer-affiliated surgeons. A South African clinic that offers ‘Himplant’ should be asked to specify the following:
- Whether they are using the genuine Himplant/Penuma device or a similar silicone implant product
- Whether the operating surgeon has received formal training in the specific Himplant technique
- What their individual case volume and complication rates are
- Whether the device used has SAHPRA registration or approval for surgical implantation
Men considering this procedure in South Africa should also factor in the possibility of traveling abroad for the procedure from a surgeon with documented high case volume, and weigh this against the high cost and logistical implications.
A frank pre-operative consultation at Sandton Men’s Clinic can help you navigate these questions, understand what is genuinely available locally, and assess whether surgical options are appropriate given your specific situation and goals.
6. Himplant vs Other Enlargement Options: How Does It Compare?
Primary effect:
- Himplant/Silicone Implant: Girth increase; flaccid appearance
- Best Non-Surgical Alternative: Erection quality improvement; revealed shaft length
Erect length change:
- Himplant/Silicone Implant: Minimal/unpredictable
- Best Non-Surgical Alternative: Significant for men with partial erections
Permanence:
- Himplant/Silicone Implant: Intended permanent (revision possible)
- Best Non-Surgical Alternative: Varies: lifestyle = permanent; traction = sustained
Evidence base:
- Himplant/Silicone Implant: Limited; primarily a developer study
- Best Non-Surgical Alternative: Strong (PDE5 inhibitors, exercise); moderate (traction)
Safety profile:
- Himplant/Silicone Implant: Surgical risks; irreversible decision
- Best Non-Surgical Alternative: Excellent (lifestyle); good (traction, VED)
Cost (SA):
- Himplant/Silicone Implant: Likely R70,000–R135,000+
- Best Non-Surgical Alternative: R0 (lifestyle) to R3,000 (traction device)
Recovery:
- Himplant/Silicone Implant: 6–8 weeks sexual abstinence
- Best Non-Surgical Alternative: None (lifestyle/medical); 1–2 weeks (traction adaptation)
Appropriate for:
- Himplant/Silicone Implant: Men with normal erections seeking cosmetic girth change
- Best Non-Surgical Alternative: Most men — especially those with suboptimal erections
For most men — including those with genuine concerns about size — the non-surgical pathway produces meaningful improvement at far lower cost, zero surgical risk, and without an irreversible commitment. The surgical pathway is appropriate for a narrowly defined group of men who have already optimised their non-surgical options and have a clear, cosmetically motivated goal with realistic expectations. See: how to increase penis size safely and penis enlargement results.
7. Who Is an Appropriate Candidate for Himplant — and Who Isn’t
Potentially Appropriate Candidates
- Men with circumcised anatomy and normal erectile function
- Men who have fully explored and exhausted non-surgical options
- Men with clear, stable, realistic cosmetic goals — specifically girth enhancement
- Men who have undergone thorough psychological assessment and do not have body dysmorphic disorder
- Men who can access a surgeon with demonstrable specific training and adequate case volume
- Men who fully understand and accept the risks — including the outcome of device removal
Likely Not Appropriate Candidates
- Men with untreated or poorly managed erectile dysfunction — this must be addressed first
- Men with unrealistic expectations about erect length change
- Men with body dysmorphic disorder or significant self-esteem concerns not rooted in anatomy
- Men who have not tried evidence-based non-surgical approaches
- Men seeking Himplant as an alternative to or substitute for psychological support
- Uncircumcised men who are not willing to undergo simultaneous or prior circumcision
- Men with active penile skin conditions, infections, or uncontrolled diabetes
If you’re unsure which category you fall into, a thorough consultation — not a product brochure — is the answer. Sandton Men’s Clinic provides comprehensive assessment of your specific situation before any procedure recommendation is made.
8. Questions to Ask Any Surgeon Before Committing to This Procedure
Informed consent for an irreversible surgical procedure requires clear answers to specific questions. Before committing, ask:
- How many Himplant procedures have you personally performed? High-volume surgeons have lower complication rates. Ask for specific numbers, not ranges.
- What is your individual complication rate for this procedure? Including infection, revision, and device removal.
- Are you using the genuine Himplant/Penuma device or a similar product? And is that device approved/cleared for use in South Africa?
- Have you received formal training in the Himplant technique from the manufacturer? Or equivalent structured training?
- What does my recovery look like, specifically? Including time off work, sexual abstinence, physical restrictions.
- What happens if I’m not satisfied with the result? What is the revision policy and what does removal involve?
- Am I an appropriate candidate — and why? A surgeon who validates your suitability after a brief consult without detailed assessment is a red flag.
What are the alternatives you recommend I try before surgery? A trustworthy surgeon raises this proactively.
9. The Evidence-Based Non-Surgical Pathway Worth Trying First
The majority of men who research Himplant have not yet optimised the approaches with the best value-to-evidence ratio. Before any surgical consideration:
Optimise Erection Quality
A fully engorged, firm erection is measurably and visibly larger than a partial erection. For men with any degree of erectile dysfunction or erections that aren’t hard enough, improving erection quality is the highest-value first step. Many men find this addresses their real concern without any procedure. See: how to get a very hard erection.
Reduce the Pubic Fat Pad
Abdominal fat conceals shaft length. Losing lower abdominal weight reveals this length — permanently, free, with zero risk. For men who have gained weight, this change can be dramatic.
Penile Traction Therapy
For modest length change with the best non-surgical evidence, a medical-grade traction device used consistently over 12–24 weeks has published clinical support — particularly for men with Peyronie’s disease. Cost: R800–R3,000. See: penile stretching and traction therapy.
Penile Filler (For Girth — Lower Risk Than Surgery)
If girth is specifically the concern, hyaluronic acid filler provides temporary girth enhancement without surgery or implantation. The results last 12–18 months, the cost is R15,000–R20,000 per session, and the risk profile is meaningfully lower than implant surgery. It is a viable intermediate step between non-surgical approaches and permanent implantation.
For a complete cost comparison of all South African penis enlargement options: penis enlargement costs in South Africa.
10. How Sandton Men’s Clinic Approaches This Concern
Our Approach to Penis Enlargement Consultations
✔ Assessment first — understanding what’s driving your concern before recommending any approach
✔ Erection quality evaluation — many concerns about ‘size’ are actually about erection quality
✔ Non-surgical options reviewed — traction therapy, vacuum devices, penile filler before surgical referral
✔ Honest expectation-setting — what is and isn’t achievable through each approach
✔ Surgical referral where genuinely appropriate — to qualified, experienced urological surgeons
✔ SAHPRA-compliant approach — all treatments through registered medical pathways
✔ 24/7 availability — discreet, confidential consultations every day
Find out why men across Gauteng choose Sandton Men’s Clinic for penis enlargement and men’s sexual health treatment.
Summary: Himplant XXL — The Honest Assessment
- Himplant is a real, FDA-cleared procedure — a soft silicone implant placed subcutaneously for cosmetic girth enhancement. Not an ED treatment.
- The evidence base has limitations — the primary published study was conducted by the device developer; independent long-term data is limited.
- It primarily affects flaccid girth and appearance — erect length change is minimal and unpredictable. Men seeking length gain will be disappointed.
- It carries real, irreversible risks — infection, device migration, extrusion, altered sensation, and an unpredictable post-removal outcome.
- Availability in South Africa is limited — men should verify surgeon training, device authenticity, and SAHPRA compliance before proceeding.
- Non-surgical options should come first — optimising erection quality, reducing pubic fat, traction therapy, and penile filler all offer meaningful improvement with lower risk and cost.
- A consultation is the right starting point — not a device purchase. Contact Sandton Men’s Clinic for an honest, expert assessment of your specific situation and goals.
Frequently Asked Questions
What is Himplant XXL?
Himplant (also called Penuma in the clinical literature) is a pre-formed soft medical-grade silicone implant placed surgically beneath the penile skin. ‘XXL’ refers to a larger sizing option within the implant range. It is designed for cosmetic girth enhancement in men with normal erectile function — it is not a treatment for erectile dysfunction.
Is Himplant FDA-approved?
Himplant has received FDA 510(k) clearance (K181387) as a ‘Pre-Formed Penile Silicone Block’ — not FDA approval. 510(k) clearance means the device is substantially equivalent to a predicate device; it does not mean the FDA has independently verified clinical outcomes or patient satisfaction data. This distinction is important when evaluating the device’s evidence base.
How much girth can Himplant XXL add?
Published data from the device developer’s study reports flaccid circumference increases of approximately 1.5–2.5 cm on average, with XXL sizing producing larger changes. Erect girth changes are less consistent, as the device is placed outside the erectile chambers. Results vary based on anatomy, surgeon technique, and individual healing.
Does Himplant increase erect length?
Not reliably. Himplant primarily affects flaccid appearance and girth. Some men report a perceived improvement in erect length due to changes in flaccid hang and overall appearance, but the device does not alter the structures that limit erect length (tunica albuginea or suspensory ligament). Men seeking erect length gain should explore penile traction therapy or have a frank conversation about realistic surgical options.
Is Himplant available in South Africa?
As of 2025/2026, Himplant is primarily offered in the United States through the device’s developer and affiliated surgeons. Availability in South Africa through formally trained, manufacturer-affiliated providers is limited. Men considering this procedure in South Africa should ask specific questions about device authenticity, surgeon training, SAHPRA compliance, and complication rates. A consultation at Sandton Men’s Clinic can help navigate these questions.
What are the risks of Himplant surgery?
Risks include infection (which may require device removal), haematoma, implant migration or displacement, extrusion through the skin, asymmetry, altered penile sensation, reduced erection quality in some cases, and dissatisfaction with aesthetic outcomes. Device removal does not return the penis to its pre-operative state — scar tissue forms during healing. These risks should be discussed in full before consent.
What are the alternatives to Himplant for penis enlargement?
Non-surgical alternatives with clinical evidence include: erection quality improvement through medical treatment (often the most impactful visible change); body composition change revealing concealed shaft length; penile traction therapy for modest length change (best-evidenced for Peyronie’s disease); and penile filler for temporary girth enhancement. See: how to increase penis size safely, penis enlargement tips, and penis enlargement costs in South Africa.