Penuma Silicone Implant
Subcutaneous Silicone Penile Implant for Cosmetic Augmentation
Evidence grade 2 of 5, Thin. Read how the Atlas grades evidence.
The written rationale for this grade is still being prepared.
- FDA
- FDA 510(k) cleared (2004 for cosmetic correction of soft-tissue penile deformity; 2022 for cosmetic penile enhancement), the only FDA-cleared device of its kind
Reference only. Not medical advice.
What can go wrong
As a surgical implant, documented complications occur at a meaningful rate (commonly cited 10-30%) and include infection, seroma/hematoma, scarring and scar contracture, implant migration or buckling, skin erosion, pain, and the need for surgical removal (explantation). Outcomes depend heavily on surgical technique and patient selection; dissatisfaction and revision are documented.
This is something to take to a clinician. The Atlas can tell you what is known about penuma silicone implant in general. It cannot tell you what is happening in your body, and the difference matters most for exactly the symptoms that bring people to this page.
Penuma is a crescent-shaped soft silicone implant surgically placed under the penile skin to increase girth (and some flaccid length). It is the only FDA-cleared device of its kind: it received 510(k) clearance in 2004 for cosmetic correction of soft-tissue penile deformity, and a separate 510(k) clearance in 2022 for cosmetic penile enhancement. Unlike injectables, the implant is a fixed, removable object, but it is a surgical procedure with documented complications; published case series report meaningful complication and explantation rates (overall figures up to roughly 10-30% in some series), with device erosion the most frequent serious complication and infection and the need for implant removal also reported.
The only FDA-cleared cosmetic augmentation device, and even FDA clearance does not mean low risk.
What people take it for
These are the reasons people give for taking it. They are not effects it has been shown to have.
How it is supposed to work
A custom-sized silicone implant is inserted through an incision near the base of the penis and positioned in the subcutaneous plane over the tunica albuginea (outside the erectile bodies), increasing circumference and, to a degree, flaccid length. The implant adds bulk mechanically; it does not interact with the erectile mechanism, and it can be surgically removed if complications occur.
Safety in detail
This is a surgical implant procedure with a documented complication rate commonly cited at 10-30%, including infection and explantation. It requires evaluation, informed consent, and follow-up with a qualified surgeon; self-selection without thorough psychological and surgical assessment is discouraged.
What people get wrong
Often saidFDA clearance means it is risk-free
ActuallyFDA 510(k) clearance establishes a regulatory pathway (via substantial equivalence to a predicate device), not the absence of risk and not a demonstration of efficacy. Penuma carries documented surgical complications, including erosion, infection, and the need for implant removal.
Often saidIt enlarges the erect penis from the inside
ActuallyThe implant sits outside the erectile bodies in the subcutaneous plane and primarily adds girth and some flaccid length; it does not augment the erectile tissue itself.
Who profits, and who pushes back
Nobody is named here yet, because we have not done that work on this entry. Read that as unfinished. Somebody almost certainly sells this, and somebody almost certainly disputes it. Assume both until we have checked.
At a glance
- Device type
- Crescent-shaped soft silicone subcutaneous implant
- FDA status
- 510(k) cleared 2004 (soft-tissue deformity) and 2022 (cosmetic enhancement); only FDA-cleared device of its kind
- Primary effect
- Increased girth; some flaccid length
- Reported complication rate
- Variable; up to ~10-30% in some series, erosion most common serious event
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about Penuma Silicone Implant. A short entry is not a safe entry.
- Timeline. We have not built the dated record of research and regulatory events.
- Cost and market. We have not documented what it sells for or who sells it.
- Supply chain. We have not mapped where it is made.
- Who uses it. We have not documented the user groups.
- What could change. No forward-looking summary yet.
- How it compares. We have not set it against the alternatives.
- Children and teenagers. We have not checked what is known about younger people.
- Where we land. We have not taken a position on this yet.
Sources
The studies below are named and described, but not linked. You cannot open them from here and check our reading against them, which means this page is our summary of the literature rather than a document you can verify. Weigh it accordingly until the links exist.
The studies that matter
Penuma implant case series and manufacturer-reported outcomes2010s-2020s
Report increases in girth and patient-reported satisfaction in selected patients, alongside complications including device erosion (the most frequent serious event, reported roughly 3-7% in larger multi-institutional series), infection, seroma, scarring, implant migration, and explantation; overall complication figures up to ~10-30% appear in some smaller series.
Sexual Medicine Reviews on augmentation2019
Cautions that cosmetic augmentation evidence is generally low-quality and that procedures can harm physical and mental health; the Penuma device is the regulatory exception as the only FDA-cleared option.