Penuma & the Surgeon Network
The Penuma Silicone Subcutaneous Implant, Origin, Outcomes, Explantation and Litigation Context
Evidence grade 2 of 5, Thin. Read how the Atlas grades evidence.
The written rationale for this grade is still being prepared.
- FDA
- FDA-cleared (510(k)) for cosmetic correction; the only such cleared penile cosmetic device
Reference only. Not medical advice.
This is something to take to a clinician. The Atlas can tell you what is known about penuma & the surgeon network 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 medical-grade silicone implant placed subcutaneously around the penile shaft to increase flaccid and erect girth and apparent length. Developed by Dr. James Elist, it is distributed through a network of licensed surgeons and is the only FDA-cleared device marketed for penile cosmetic enhancement. Single-surgeon series reported high satisfaction with seroma and infection as the commonest complications, but more recent multi-institutional data show meaningful explantation rates and a serious complication profile after removal, and the device has been the subject of class-action / product-liability litigation.
An FDA-cleared cosmetic implant with real complication and explantation data, and litigation.
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
Unlike a medical penile prosthesis, Penuma does not enter the corpora cavernosa. It is implanted between the skin and the deep shaft structures, adding a silicone layer that increases circumference and projects the penile body forward, increasing flaccid girth and apparent length. Because it is extracorporeal to the erectile bodies, it does not create or restore rigidity and is not a treatment for erectile dysfunction.
Outcomes, explantation, and litigation context
Elist's single-center review reported the most frequent complications as seroma (~4.8%) and infection (~3.3%), with ~3% explanted for adverse events. More recent multi-institutional and independent reviews (e.g., in The Journal of Sexual Medicine, 2024-2025) describe an overall explant rate around 12%, lower with the concealed lateral scrotal approach, and, critically, severe sequelae among men who undergo explantation: in one series disabling dorsal curvature (~63%), penile shortening (~50%), sensory changes (~44%), localized infection (~38%), and de-novo erectile dysfunction (~32%). Independent authors note the literature remains limited by single-surgeon experience and incomplete follow-up, so the true explant incidence is uncertain. Penuma has also faced product-liability and class-action litigation alleging injury and inadequate warning, context a candidate should weigh.
Safety in detail
Penuma implantation is elective cosmetic surgery on healthy tissue with documented complications including seroma, infection, scarring, device migration/erosion, and the need for explantation. Explantation itself carries high rates of curvature, shortening, sensory change, and de-novo erectile dysfunction. This procedure requires a qualified surgeon and full informed consent; it is not endorsed by major sexual-medicine societies as a routine enhancement.
What people get wrong
Often saidPenuma is a penile implant like the ones used for ED
ActuallyNo, it is subcutaneous and does not touch the corpora cavernosa; it does not produce rigidity and does not treat erectile dysfunction.
Often saidFDA clearance means it is proven safe and effective for enlargement
Actually510(k) clearance reflects substantial equivalence for a cosmetic indication, not the efficacy/safety bar of a drug; independent data show real complication and explant rates.
Often saidResults are permanent and reversible
ActuallyExplantation is possible but is associated with high rates of curvature, shortening, sensory change, and de-novo ED.
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
- Material
- Medical-grade silicone, subcutaneous (not intracorporeal)
- Originator
- Dr. James Elist
- Regulatory
- Only FDA-cleared penile cosmetic device
- Reported explant rate
- ~12% in a multi-institutional series
- Common complications
- Seroma (~4.8%), infection (~3.3%)
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about Penuma & the Surgeon Network. 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.
- What can go wrong. We have not written the risk line for this one. Read the safety section below rather than treating its absence as reassurance.
- 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
Elist et al. single-center review2018-2020
Largest early series: high reported satisfaction; commonest complications seroma (~4.8%) and infection (~3.3%); ~3% explant for adverse events.
Salkowski & Levine, two-approach outcomes, Ther Adv Urol2024
Compared surgical approaches; explant rate lower after switch to concealed lateral scrotal approach (overall ~12%).
Multi-institutional update on silicone sleeve outcomes2024
Across multiple centers, erosion higher and some complications lower than the original Elist series; flagged limited long-term data.
Complications of the Penuma implant, J Sex Med2025
Detailed post-explant morbidity: high rates of curvature, shortening, sensory change, and de-novo ED after removal.