Penuma Silicone Implant
Subcutaneous Silicone Sleeve (Penuma / Himplant)
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 for cosmetic correction of the flaccid penis (2022)
Reference only. Not medical advice.
What can go wrong
Documented complications include pain, seroma, device erosion, infection, cosmetic dissatisfaction, and device migration or malposition, with published single-center series reporting device removal in roughly 11-12% of patients. Multi-institutional data report lower rates of some specific complications but still non-trivial explant for non-cosmetic reasons. As a permanent implant, complications can require revision or removal surgery.
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 (also marketed as Himplant) is a soft silicone implant placed subcutaneously along the penile shaft to increase flaccid girth and length. It holds an FDA 510(k) clearance obtained in 2022 for aesthetic/cosmetic correction of the flaccid penis in men with normal erections - a narrower scope than the broad 'enlargement' framing in much marketing. Published series report meaningful cosmetic girth and flaccid-length gains but also a notable device removal (explant) rate: single-center series have reported roughly 11-12% explant for reasons including pain, dissatisfaction, erosion, and infection.
FDA-cleared for cosmetic correction of the flaccid penis - marketed as enlargement, with a real explant rate.
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
The implant is a pre-formed silicone sleeve tunneled under the penile skin over the shaft, adding a permanent volume layer that increases flaccid girth and forward projection. It is not erectile tissue and does not participate in erection; the effect is primarily cosmetic and most evident in the flaccid state.
Cleared scope vs marketing
The gap here is regulatory framing versus advertising. The 510(k) clearance is for aesthetic correction of the flaccid penis in men with normal erections; marketing frequently presents Penuma as a broad 'enlargement' solution. 510(k) clearance denotes substantial equivalence to a predicate device, not a demonstration of enlargement efficacy through pivotal RCTs. The published explant rate is the number that anchors realistic expectations.
Safety in detail
This is an elective surgical implant with a documented explant/revision rate (~11-12% in published series) and requires evaluation by a qualified surgeon. Its FDA 510(k) clearance is for cosmetic correction of the flaccid penis, not a general enlargement indication.
What people get wrong
Often saidFDA clearance means Penuma is proven to enlarge the penis
Actually510(k) clearance denotes cosmetic correction of the flaccid penis by substantial equivalence, not a pivotal-RCT demonstration of enlargement; marketing often overstates the cleared scope.
Often saidBeing an implant, results are trouble-free and permanent
ActuallyPublished series report ~11-12% device removal for pain, dissatisfaction, erosion, or infection; permanence includes the possibility of revision or explant.
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.
A high-ticket cash-pay implant sold through a licensed-surgeon network; the model depends on premium per-case fees, and explants/revisions add downstream surgical volume.
Set against the alternatives
Penuma is the most formally regulated cosmetic enlargement device (a genuine FDA 510(k) clearance), which distinguishes it from pills, jelqing, and off-label fillers. But its clearance is cosmetic and narrow, its effect is chiefly on the flaccid penis, and its explant rate is a real, published cost that separates it from lower-commitment temporary options.
At a glance
- FDA status
- 510(k) cleared 2022, cosmetic scope
- Explant rate (series)
- ~11-12%
- Effect
- Flaccid girth/length cosmetic gain
- Explant reasons
- Pain, dissatisfaction, erosion, infection
- Marketed as
- Enlargement (broader than cleared scope)
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.
- 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
Levine et al., update on the Penuma FDA-cleared implant (Int J Impot Res)2022
Described technique and outcomes; reported cosmetic gains alongside a device explant rate on the order of ~11-12% for pain/dissatisfaction/erosion
Complications of the Penuma implant for genital enhancement (JSM)2023-2025
Explant ~12% in a cohort; reasons included dissatisfaction, erosion, and infection
Multi-institutional outcomes after penile silicone sleeve implantation2024
Reported specific complication rates (infection ~1.3%, seroma ~2%, erosion ~5%) with several percent explanted for non-cosmetic complications