Surgical · Girth enhancement · FDA-cleared · Controversial
Penuma®
Penile implant for
girth enhancement
Penuma® is an FDA-cleared soft silicone implant placed under the penile skin to increase girth and length. It is the only FDA-cleared penile girth implant and has published clinical data — but also documented complication rates and a controversy that patients should understand clearly before proceeding.
PhallusMD covers Penuma® with full transparency — including what the published data actually shows, what the complications are, and why this procedure remains controversial in the urology community despite FDA clearance.
Overview
What is Penuma® and how does it work?
Penuma® is a crescent-shaped soft medical-grade silicone implant that is inserted beneath the penile skin through a small incision near the base of the penis. It sits between the skin and the erectile cylinders (corpora cavernosa) — adding volume around the circumference of the shaft to increase girth and, to a lesser extent, flaccid length.
Unlike the Inflatable Penile Prosthesis (IPP), Penuma® does not affect erectile function — it is purely a girth implant. Men who receive Penuma® must still be able to achieve erections naturally or with medication.
The implant is available in different sizes. The surgeon selects the appropriate size during preoperative assessment. The procedure is performed under general or spinal anesthesia and typically takes 45–60 minutes.
Penuma® received FDA 510(k) clearance — not Premarket Approval (PMA). These are different regulatory pathways. 510(k) clearance means the FDA determined the device is substantially equivalent to a predicate device already on the market. It does not require the same level of clinical evidence as PMA approval.
FDA clearance means the device can be legally marketed — not that it has been rigorously proven safe and effective for this specific application through large clinical trials. This distinction matters when evaluating the strength of the evidence.
Despite FDA clearance, Penuma® is not endorsed by the AUA or SMSNA. The published data — while positive from the manufacturer’s own clinical program — has been criticized for study design limitations, industry involvement, and complication rates that some urologists consider significant for a cosmetic procedure.
Honest assessment
The real pros and cons
What the published data shows
Clinical evidence — honestly presented
The primary published study on Penuma® (Elist et al., 2018) reported on 400 men over 5 years. Key findings included meaningful increases in penile circumference and flaccid length, and high patient satisfaction rates (81% in that series).
However, the same study reported a complication rate of approximately 5.7% — including infections requiring explantation, implant-related issues, and revision procedures. For a cosmetic procedure performed in healthy men, this complication rate has been noted as a significant consideration by independent urologists reviewing the data.
The study was conducted at a single center by the device’s developer. Independent replication at other centers with unaffiliated surgeons is limited — a gap that is important for evaluating the generalizability of these results.
What is your personal complication rate with Penuma®? How many have you performed? What happens if I need it removed? Are you affiliated with the manufacturer? Can you share your revision rate independently?
A surgeon with independent experience and transparent outcomes data — not just manufacturer training — is important for this procedure. The limited network of trained surgeons means that independent verification of outcomes is particularly important.
Common questions
Frequently asked questions
Does Penuma® affect erections?
Penuma® is a girth implant — it does not improve or cause erections. Men must still be able to achieve erections naturally or with medication. The implant sits outside the erectile cylinders and should not affect erectile function when properly placed. However, men with significant ED should address it separately before considering Penuma®.
Can Penuma® be removed if I’m unhappy?
Yes — removal is surgically possible, but it is a second surgical procedure with its own risks. The penis does not necessarily return to its exact pre-implant state — scar tissue forms around the implant over time. Removal should be considered a surgical revision, not a simple undo. This is an important consideration — Penuma® should be treated as a permanent decision.
What are the most common complications?
Infection is the most serious — requiring full explantation if it occurs. Implant-related issues including migration or discomfort have been reported. Some men experience changes in sensation. Revision surgery for aesthetic issues or complications is reported in a meaningful percentage of cases. The 5.7% complication rate in the primary published study is the most referenced figure — though real-world rates at different centers may vary.
How does Penuma® compare to HA fillers?
HA fillers are reversible, non-surgical, and require no anesthesia. They last 12–24 months and can be topped up. Penuma® is permanent and surgical. For men exploring girth enhancement for the first time, HA fillers are generally the appropriate starting point — allowing you to experience enhanced girth and decide if permanent surgery is something you want before committing to it. Penuma® is more appropriate for men who have tried fillers and want a permanent solution.
Consider first
Non-surgical alternatives to explore before Penuma®
Research Penuma® carefully
This is a permanent surgical decision. Search our provider directory for vetted urologists — or join the forum to hear from men who have been through the procedure.
This page is for informational purposes only. Penuma® is FDA-cleared but not endorsed by AUA or SMSNA. Always consult a board-certified urologist with independent Penuma® experience. PhallusMD does not endorse Penuma® or International Medical Devices. Penuma® is a registered trademark of International Medical Devices, Inc.