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Not medical advice. The Atlas is not a substitute for a clinician who can examine you.

Penuma Implant

Subcutaneous Soft Silicone Penile Implant for Cosmetic Girth/Length

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 (2022) for aesthetic correction of soft-tissue deformities of the penis

Reference only. Not medical advice.

What can go wrong

Reported complications include distal/lateral protrusion of the implant at the coronal margin causing patient and partner discomfort, skin erosion, infection, seroma, penile shortening, ventral or dorsal curvature, and implant migration. Following explant, published case series report disabling dorsal curvature, penile shortening, infection, and de novo sensory changes in a substantial fraction of patients. Explant can leave the penis worse than baseline.

This is something to take to a clinician. The Atlas can tell you what is known about penuma 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 medical-grade silicone implant placed in the subcutaneous (dartos) plane of the penile shaft to increase flaccid and erect girth and apparent length. It received an FDA 510(k) clearance in 2022, but the marketed indication (cosmetic enlargement) is broader than the cleared indication (aesthetic correction of soft-tissue deformities). It is distinct from an erectile prosthesis, it does not produce or improve erections. The published complication record is non-trivial and the device has been the subject of litigation against its principal developer, Dr. James Elist, and the Elist clinic in Beverly Hills.

The only FDA-cleared cosmetic penile implant, and the most litigated.

What people take it for

These are the reasons people give for taking it. They are not effects it has been shown to have.

  • Cosmetic flaccid girth increase
  • Cosmetic apparent length increase
  • Marketed for 'aesthetic enhancement of the flaccid penis'

How it is supposed to work

The implant is a silicone sleeve sutured into the loose subcutaneous tissue between Buck's fascia and the dartos, wrapping the shaft to add bulk. It is anchored proximally; girth gain is mechanical and persistent only while the implant remains in place. It has no role in rigidity, the corpora cavernosa are not entered.

What 'FDA cleared' actually means here

A 510(k) clearance certifies substantial equivalence to a predicate device for a stated indication, it is NOT the premarket approval (PMA) that erectile prostheses or new high-risk implants undergo, and it does not establish efficacy for cosmetic enlargement. Penuma's clearance language concerns aesthetic correction of soft-tissue deformities; consumer marketing of 'enlargement' outruns that wording. Clearance is frequently miscommunicated to patients as an efficacy endorsement.

Safety in detail

This is an elective cosmetic surgical implant with documented complication and explant rates and potential for permanent deformity. It does not treat erectile dysfunction. Evaluation should include screening for penile dysmorphic disorder. Self-referral to high-volume cosmetic clinics without independent counseling carries documented risk.

What people get wrong

  • Often saidFDA cleared means FDA proved it works for enlargement

    Actually510(k) clearance certifies equivalence for soft-tissue aesthetic correction, not RCT-level proof of cosmetic enlargement benefit.

  • Often saidIt is reversible

    ActuallyExplant is possible but frequently leaves curvature, shortening, scarring, or sensory change; reversal is not a clean return to baseline.

Who profits, and who pushes back

  • Independent academic urologists

    Pushes backSexual medicine specialists

    Cosmetic enlargement claims rest on developer-reported data; complication and explant rates from outside series are higher, and explant can cause permanent deformity.

How we got here

Developed over years by Dr. James J. Elist, a Los Angeles urologist; earlier iterations were marketed before the 2022 510(k) clearance under International Medical Devices. The device and clinic have drawn lawsuits alleging deformity, undisclosed risk, and dissatisfaction, plus regulatory and media scrutiny of how 'FDA cleared' is presented to prospective patients.

  1. 2000sEarly subcutaneous silicone shaft implant concepts developed by Elist
  2. 2016-2021Penuma marketed; developer case series published
  3. 2022FDA 510(k) clearance granted for aesthetic soft-tissue correction
  4. 2022-2025Independent series report higher explant rates; litigation against Elist/clinic publicized

What we do not know

  • What are long-term (5-10 year) explant and revision rates outside the developer's center?
  • How often is the cleared indication conflated with cosmetic enlargement in informed consent?

At a glance

FDA pathway
510(k) clearance, 2022
Plane
Subcutaneous / dartos, not intracorporal
Material
Soft medical-grade silicone
Treats ED?
No

What this entry does not yet cover

What follows is unfinished work on our side, not a finding about Penuma Implant. A short entry is not a safe entry.

  • 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.

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. (largest single-center PPI series), Urology / J Sex Med2022

    Reported complication rate near 19% with explant around 3% in the developer's own cohort

  • Salkowski & Levine, outcomes by two surgical approaches2024

    Independent center reported an overall explant rate around 12%, lower after switching to a concealed lateral scrotal approach

  • Post-explant outcomes case series2024-2025

    Majority of explanted patients developed dorsal curvature and shortening; subsets had infection and sensory loss