(215) Penuma® Penile Implant Adverse Events in the Manufacturer and User Facility Device Experience (MAUDE) Database

Abstract

Abstract Introduction Penuma® is an FDA-approved penile implant intended to increase flaccid penile length and girth for improved cosmesis. It is the only FDA-approved product of its kind, with reportedly thousands of implants since 2004. There is a paucity of data on the adverse events related to this procedure. Objective To describe and characterize adverse events related to Penuma® using a national database. Methods The Manufacturer and User Facility Device Experience (MAUDE) database, a voluntary-reported database of medical device complications with data since 1991, was queried. The MAUDE adverse event classification system, a validated classification system, was used as a standardized tool to classify adverse events based on severity. All adverse events related to Penuma® were identified and quantified. Results 42 reports of adverse events related to Penuma® were identified (Figure 1). Of these, 35 patients were reported to undergo device removal most commonly due to infection (n=8) or protrusion (n=8). (Table 1). The most commonly reported adverse event was deformity/disfigurement (n=27), of which 18 cases reported loss of penile length. Other adverse events included: pain (n=16), infection (n=12), decreased sensitivity (n=10), scar tissue (n=9), erectile dysfunction (n=8), seroma (n=7), and erosion (n=6). Conclusions To our knowledge, this is the first study to systematically characterize publicly reported adverse events occurring with Penuma® implantation, using the MAUDE database. Further research is warranted to delineate the incidence of adverse events related to Penuma®. Disclosure No.