INTRODUCTION
The number of aesthetic procedures performed has risen sharply in recent years, increasing 14% from 2019 through 2022. This change is primarily due to a 23% increase in non-surgical aesthetic procedures over the same period. Among non-surgical aesthetic procedures, dermal fillers contribute 14% of the total revenue.1 With the increasing demand for dermal fillers and the large financial implications, many companies have sought to introduce new products. Juvéderm Volbella XC represents a critical case study for evidence-based safety analysis due to several unique characteristics that distinguish it from other hyaluronic acid fillers. First, it is the only FDA-approved filler with dual-site indication for both perioral (2016) and infraorbital (2021) regions, enabling direct comparison of site-specific adverse event profiles within a single product formulation.2-4 Second, its proprietary Vycross technology creates distinct cross-linking density and particle size characteristics that may influence adverse event patterns compared to conventional hyaluronic acid fillers.5,6 Third, its approved use in anatomically delicate, highly vascularized regions where serious complications like vascular occlusion can cause permanent tissue damage makes understanding its safety profile clinically relevant.7 Previous clinical trials demonstrated promising aesthetic outcomes but identified site-specific differences in adverse event rates, with perioral injections showing higher complication frequencies than infraorbital procedures.8,9 However, controlled trial conditions may not reflect real-world usage patterns, injection techniques, or patient populations, necessitating comprehensive postmarket analysis. The Manufacturer and User Facility Device Experience (MAUDE) database provides the largest available dataset for analyzing real-world adverse events, though systematic analysis using standardized severity grading has been limited.10 This study addresses these gaps by providing the first comprehensive analysis of Volbella adverse events using Common Terminology Criteria for Adverse Events (CTCAE) grading,11 enabling standardized severity assessment and clinical correlation. We hypothesize that perioral injections will demonstrate higher rates of vascular complications due to regional vascular density, and that adverse event timing patterns will inform evidence-based follow-up protocols. These findings will directly inform practice by: (1) establishing site-specific complication rates for enhanced informed consent, (2) defining evidence-based follow-up schedules based on adverse event timing, and (3) providing risk stratification frameworks for clinical decision-making.
