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 done 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 options.