Source pages last reviewed: June 9, 2026. Always confirm current information at himplant.com.

Regulatory status (per the manufacturer)

Himplant® is described as FDA-cleared for penile augmentation and is the first FDA-cleared cosmetic penile implant. Source — FDA/HIPAA Regulatory Disclosure.
The device received its initial FDA clearance in 2004; the brand was renamed to Himplant® in 2024 with a reinforced sheeting update and a scrotal-incision approach. Source — About / History.
Implantation is restricted to "trained and qualified healthcare providers" in the manufacturer's network. Source.

Device description (per the manufacturer)

A subcutaneous, 270-degree silicone sleeve made of "soft, medical-grade silicone." It contains no gel core and no liquid. Source — FAQ.
Placed beneath the skin of the shaft through a small scrotal incision; secured with stitches behind the head of the penis and reinforced with surgical mesh. Source — About.
A Jackson-Pratt drain is typically used for 2–3 days post-op. Source.

Candidacy criteria (per the manufacturer)

Age 21+, in good general health, able to undergo anesthesia.
Must refrain from tobacco and illicit drugs for a minimum of 30 days before and 3 months after the procedure.
Realistic expectations and willingness to follow all pre- and post-operative instructions.
Diabetes screening: A1C ≤ 7.5 required, with recent (within 3 months) blood work; higher rates are deferred until controlled.
Excessive suprapubic fat may affect eligibility.

Source — Eligibility FAQ.

Recovery timeline (per the manufacturer)

Sexual activity: typically cleared at 6–8 weeks; condom use advised for the first 6–8 weeks of activity.
Light upper-body exercise: typically ~4 weeks.
Light lower-body exercise: typically 4–6 weeks.
Regular exercise: typically 6–8 weeks; UroWrap compression sleeve recommended for up to 6 months.
Capsule formation: generally takes 4–8 months to fully develop.
Avoid hot tubs, saunas, and submersion until cleared (typically 6–8 weeks).

Source — FAQ.

Risks and outcomes (per the manufacturer)

Listed risks include: infection, seroma, hematoma, implant-related complications, discomfort, and dissatisfaction with aesthetic results. Source — FDA/HIPAA Disclosure.
Per a manufacturer-cited 2021 study, removal of the implant for adverse events or personal preference occurred in less than 10% of cases. Source — FAQ.
Per a manufacturer-cited 5-year, 400-patient clinical review, no cases of changes to penile function, ability to get or sustain an erection, or ejaculation were observed. Sensation changes (increased or decreased) may occur and are generally temporary. Source — FAQ.
The device is described as removable if needed, with a rehabilitation process required after removal. Source.
The manufacturer published study referenced as the source of the "+1 to 2 inches in girth and flaccid length on average" figure is PD52-07 (AUA Journals). Per the manufacturer: "The company endorses that on average, girth and flaccid length are increased by one to two inches." Individual results vary.

Pricing (per the manufacturer)

The manufacturer states most patients pay $10,500–$19,000 depending on location, surgeon, and add-ons (e.g., circumcision, lipectomy, travel). Source — Pricing · Source — FAQ.
The manufacturer notes that many clinics offer financing, including zero-interest options.

Our internal cost guide and any partner-clinic pricing we publish are independent of the manufacturer. See our cost guide.

Warranty (per the manufacturer)

The manufacturer offers a limited lifetime warranty that "includes one replacement of the device." The manufacturer covers only the device cost; surgeon, facility, and procedure fees are not included. Source — Warranty · Full warranty policy.
Restrictions apply; the warranty is offered at the manufacturer's sole discretion.

Peer-reviewed studies the manufacturer cites

The following studies are listed by the manufacturer on its Clinical Research page. Methodology, sample sizes, and follow-up vary; readers are encouraged to read the originals.

Trained-surgeon directory

The manufacturer maintains an authorized-provider directory. Patients should verify any surgeon's listing directly: himplant.com Find-a-Physician.

Manufacturer disclaimers (reproduced)

"The information provided on this website is intended for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. Individual results may vary."

Source — Himplant Disclaimer · Source — FDA/HIPAA Disclosure.

How we use this information

We summarize manufacturer-stated facts on this page so readers can distinguish between (a) what the device-maker itself publishes and (b) our independent editorial content. We do not guarantee outcomes, do not present manufacturer figures as our own findings, and do not receive marketing payments from the manufacturer in exchange for editorial coverage. See our editorial policy and content review process.

Device disclosure & risks

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.

Himplant® — Manufacturer-Stated Facts