Full medical risks, complications & disclaimer

Himplant^® (formerly Penuma) holds FDA 510(k) clearance for cosmetic girth enhancement and correction of soft-tissue deformities. 510(k) clearance is a regulatory pathway that determines a device is substantially equivalent to a previously cleared predicate device.

• Clearance is not the same as FDA "approval", which is a higher-evidence pathway typically reserved for Class III, life-sustaining devices.
• Clearance applies to the device — not to your individual surgical outcome, the surgeon performing your procedure, or the clinic you choose.
• Clearance does not guarantee results, eliminate complications, or insulate patients from adverse events.
• International clinics (including Tijuana) may operate outside direct U.S. FDA jurisdiction — verify the device used is the authentic Himplant^®/Penuma device, not a copy.

All implant surgery carries risk. Reported complications in published Himplant^®/Penuma series and in male enhancement surgery generally include — but are not limited to:

• Infection — superficial or deep, sometimes requiring device removal.
• Seroma or hematoma — fluid or blood collection, may require drainage.
• Implant exposure or extrusion — skin breakdown over the device.
• Implant migration — shift in device position requiring revision.
• Contour irregularity, lumps, or asymmetry.
• Sensory changes — numbness, hypersensitivity, or altered sensation.
• Scarring, keloid formation, wound dehiscence.
• Pain — short-term post-operative and, rarely, chronic.
• Erectile or ejaculatory changes — uncommon but reported.
• Anesthesia-related risks — including allergic reaction, cardiopulmonary events.
• Dissatisfaction with aesthetic outcome, sometimes requiring revision or removal.
• Rare serious events: deep vein thrombosis, pulmonary embolism, sepsis.

Smoking, diabetes, obesity, bleeding disorders, immunosuppression, and non-compliance with post-operative care significantly increase risk.

Himplant^® and similar procedures are not appropriate for everyone. You should generally not proceed if you have:

• Active urologic, genital, or systemic infection.
• Uncontrolled diabetes, bleeding disorders, or immunosuppression.
• Untreated Peyronie's disease or significant penile curvature without prior evaluation.
• Active smoking or nicotine use (typically must cease weeks before and after).
• Unrealistic expectations or body dysmorphic concerns.
• History of poor wound healing or keloid scarring.
• Age under 21 or anatomy that is still developing.

Himplant^® primarily increases girth and flaccid length. It is not a treatment for erectile dysfunction and does not substantially increase erect length. A board-certified urologist must evaluate you in person.

• The device is reversible — it can be surgically removed, though some scarring or tissue thinning may remain.
• Revision or removal involves additional cost, recovery, and surgical risk.
• The manufacturer's limited lifetime warranty covers device defects but typically does not cover surgical fees for revision or removal.
• Long-term durability data beyond ~5 years remains limited.
• Reported satisfaction (≈70–80%+ "high/very high") is meaningful but not universal; a minority of patients are dissatisfied or experience complications requiring further surgery.

• Limited recourse for complications after returning home.
• Travel-associated risk of DVT/PE in the early post-op period.
• Variable regulatory oversight outside the U.S.; verify surgeon credentials and facility accreditation.
• Confirm authentic FDA-cleared device — counterfeit silicone implants exist on the global market.
• Ensure clear written follow-up, revision, and complication policies before traveling.