What is the Science Behind the Penuma® Implant?
We invented the implant in the early 2000s and subsequently received 510(k) clearance. A large clinical study and several case studies have demonstrated the safety and effectiveness of the Penuma® implant. Our most recent, IRB-approved clinical study over a five year period found very high levels of satisfaction with the implant over the short and long-term and significant improvements in patient self-confidence. Adverse events were found to be low and on par with other silicone implant.
Where is the Surgery Performed?
Currently, it is available in Los Angeles and on a limited basis in Chicago, Houston, New York, and the Washington, DC area with other geographies emerging soon. All pre-op consultations can be done by phone and online. Patients should expect to stay in the area for 3-4 days after the surgery.
What size is the Penuma® Implant?
The implant is contoured by the physician to your individual shape. Our physicians will determine the appropriate size for you.
What is the Penuma® Implant Made of?
The Penuma® implant is made of a soft, medical-grade silicone to provide a natural feel. The implant contains no liquid or gels.
Where is the Penuma® Implant Manufactured?
The Penuma® implant is manufactured in the United States at an ISO-certified, FDA-registered facility.
What are the Benefits and Risks of the Implant?
As with any surgery, there are potential benefits and potential risks. Our IRB-approved, retrospective clinical study found that patients experienced high levels of satisfaction with the implant and increased levels of self-confidence as a result of the implant. There were a small number of adverse events reported (e.g., infection in 3% of cases and seroma in 5% of cases) and often due to patient non-compliance with post-operative instructions; therefore, it is imperative that patients follow all post-operative instructions. You can read more about this clinical study in this medical journal article here. The medical staff will discuss all possible risks, complications, benefits, and alternatives, including no surgery, with patients prior to the procedure.
So How Much Does the Penuma® Implant Cost?
Pricing is based on the individual circumstances of potential patients. Patients consider the implant to be a long-term investment in their well being. Please note that we work with several financing companies to ensure that the implant can be cost-effective.
Does the Penuma Implant Affect My Ability to Get/Sustain an Erection, Sensitivity During Sex and Ejaculation?
Based on an IRB-approved clinical review of 400 patients over 5 years, there were NO cases of changes to penile function, ability to get or sustain an erection, ejaculation, or sensation during sex. As with any surgical procedure, individual results may vary.