The gold standard
Himplant® — the first & only FDA-cleared penile implant
A soft, medical-grade silicone sleeve designed for permanent, natural-feeling girth enhancement. Built in the U.S. under ISO-certified quality controls, with published multi-year safety data.
FDA 510(k) cleared
The only penile implant with specific U.S. FDA clearance for cosmetic enhancement and correction of soft-tissue deformities.
Outpatient procedure
Performed by a board-certified urologist in roughly 45–60 minutes. Reversible — the device can be removed if desired.
Built in the USA
Manufactured under ISO-certified quality controls. Limited lifetime warranty on the device itself.
Comparison
Himplant® vs. fillers, fat transfer, and unregulated implants
A clear, side-by-side comparison of the most common male enhancement options — focused on permanence, typical results, risk profile, and regulatory oversight.
| Option | Permanence | Typical girth | Risk profile | Regulatory status |
|---|---|---|---|---|
| Himplant® (FDA-cleared) Top pick | Permanent | +1–2 inches | Standard surgical risks; published outcomes data | FDA 510(k) cleared |
| HA Fillers (PhalloFILL / UroFill) | 12–24 months | +0.5–1.5 inches | Lower-risk; repeat sessions required; can be uneven | Off-label use of approved filler |
| Fat transfer (lipofilling) | Partial — fat reabsorbs | +0.75–1.5 inches | Lumps, irregular absorption, asymmetry | Surgeon-dependent; no specific device clearance |
| Other silicone implants (e.g., Peniflex) | Permanent | +1.5–2 inches | Variable; limited published peer-reviewed data | Not FDA-cleared in the US |
| AlloDerm / dermal grafts | Variable | +0.5–1 inch | Graft resorption; less predictable | Tissue product — not a device clearance |
Avoid pills, pumps, and back-room injections — those products have no FDA approval for cosmetic enhancement and can cause serious harm. Always verify your surgeon's board certification and the facility's accreditation.
Clinical evidence
What the data shows
Multi-year safety & satisfaction data
Published case series report 70–80%+ patient satisfaction at 12+ months, with no reported changes in erectile function, urination, or penile sensation in primary cohorts.
Low explant rate
Published explant/revision rates compare favorably to other cosmetic genital procedures when performed by high-volume, board-certified urologists.
FDA 510(k) clearance
Cleared by the U.S. FDA for cosmetic penile enhancement and correction of soft-tissue deformities — the only penile augmentation device with this specific clearance.
Independent study summaries. Confirm current data and your individual risk profile directly with a board-certified urologist. Visit himplant.com for the official manufacturer eligibility tool.
Candidacy
Who is Himplant® for?
- Adult men (typically 22+) in good general health
- Realistic expectations about cosmetic girth enhancement
- No active urological infection or untreated ED
- Willingness to follow the 6–8 week recovery and post-op protocol
- Non-smoker or able to abstain through the recovery window
Tijuana pricing — 2026
$8,000 – $15,000 all-inclusive
Covers surgery, Himplant® device, recovery hotel, ground transport, and follow-up. Comparable US pricing typically runs $16,000 – $25,000+.
Manufacturer-attributed facts
For a full reference of facts as published by the device manufacturer — FDA clearance, candidacy criteria, recovery timeline, risks, warranty, and the peer-reviewed studies they cite — see our dedicated citation page. Statements are sourced and clearly attributed.
View manufacturer facts & citationsSources & Medical Literature
Key claims are based on peer-reviewed studies, FDA documents, and verified third-party sources.
20 minutes from San Diego. Board-certified urologists. Half the US price.
Our top-ranked Himplant® network clinic is a short SENTRI lane crossing from San Diego — with a fully bilingual coordinator handling transport, lodging, and follow-up.
- Board-certified urologists, 12+ years specialty experience
- JCI-affiliated facility, strict infection-control protocol
- Surgery + 5-night recovery, return home day 6–7
Himplant® — manufacturer attribution & risk disclosure
Manufacturer
Himplant® (also marketed in some markets as Penuma®) is a medical-grade silicone subcutaneous penile implant developed and distributed by International Medical Devices, Inc. (IMD) / Augmenta. Surgeons must be trained and authorized by the manufacturer to perform the procedure. Patients should confirm directly with the manufacturer or treating surgeon whether a given clinician is a trained provider.
Regulatory status
Penuma® received U.S. FDA 510(k) clearance for cosmetic correction of soft-tissue deformities of the penis. 510(k) clearance is not the same as FDA approval and does not certify clinical efficacy for cosmetic enhancement. Regulatory status of Himplant® varies by country; patients receiving care outside the United States should confirm local regulatory clearance directly with their surgeon.
Material risks patients should understand before consenting
- Infection, including implant infection that may require removal.
- Seroma (fluid collection) and hematoma in the first weeks post-op.
- Implant migration, palpability, contour irregularity, or asymmetry.
- Penile sensory changes — temporary or, less commonly, persistent.
- Erectile or ejaculatory function changes; the implant does not treat erectile dysfunction.
- Scar tissue (capsular contracture-type response) and skin-related complications.
- Implant explantation, revision surgery, or reoperation.
- Outcome variability — published satisfaction data reflect selected cohorts, not all patients.
This site does not represent the manufacturer and is not a substitute for the manufacturer's Patient Information Booklet or the informed-consent process performed by a trained surgeon. Patients should request the manufacturer's official patient information, review it with their surgeon, and verify the surgeon's authorization to perform the procedure before consenting.
Important disclaimer
This page is part of an independent editorial guide and does not provide medical advice. Cost ranges shown are 2026 estimates compiled from public clinic disclosures, Bookimed, and third-party sources, and may change. Surgical results vary by patient. Every procedure carries risks including but not limited to seroma, infection, implant migration, scarring, sensory change, and revision surgery. Always consult a board-certified urologist before making any decision and verify accreditations and outcomes directly with each provider.