Removed: The Augmenta Implant: A Cadaver Model of a Novel Anatomic Subdermal Implant for Cosmetic Penile Enhancement

Abstract

Introduction: There are limited options for cosmetic penile enhancement and the correction of structural penile deformities. Aim: We present the Augmenta, an innovative, technologically advanced subcutaneous elastomer-silicone cosmetic penile implant (CPI), as evaluated by objective structural changes in a cadaveric model. Methods: Five fresh male cadaver pelves were utilized in this preclinical setting. Placement of a subcutaneous elastomer-silicone CPI was performed via a penoscrotal approach. Penile circumference was measured at the base and distal shaft before and after implant placement. Penile length was measured from the pubic bone to the tip of the glans penis before and after implantation of Augmenta. Main Outcome Measure: Objective outcomes included changes in penile circumference and shaft length in both the flaccid and erect state, both before and after CPI placement. Results: In 5 cadaver models, implantation of the Augmenta CPI increased flaccid penile shaft base circumference from an average of 8.7 cm to 12.0 cm after implantation (39.1% increase, P < .001). Flaccid distal circumference increased from 7.3 cm to 10.3 cm (41.8% increase, P = .020). During the erect state, penile base circumference increased from an average of 12.5 cm to 13.7 cm (6.3% increase, P = .273), while distal erect circumference changed from an average of 11.3 cm to 12.4 cm (9.7% increase, P = .298). Nonstretched flaccid shaft length increased from an average of 12.1 cm to 14 cm (15.2% increase, P = .073). Clinical Implications: The Augmenta CPI could serve as alternative option for men seeking cosmetic penile enhancement. Strengths and Limitations: Limitations include a small number of cadavers which do not completely reproduce living physiologic function and the use of a single technical approach. However, a consistent and standardized surgical approach reduces operator-dependent outcomes. Another strength is the use of fresh human cadavers that most closely represent live models. Conclusion: In a cadaveric model, the Augmenta CPI demonstrates enhancements in penile girth in both the flaccid and erect state. The unique honeycomb technology, the embedded polyester mesh, and the antimicrobial hydrophilic coating of the Augmenta CPI may provide an advantage to currently available CPIs. Clinical trials will be needed to demonstrate both the safety and feasibility.