An epidemiologic assessment of FDA-reported complications of cosmetic injections, 2020-2024

Summary: Abstract Body: The objective of this study was to examine the data surrounding patient adverse experiences to cosmetic injections using a national database. Data were taken from reports by the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. All entries over a 5-year period (1/1/2020 to 12/31/2024) were included for the following brands: Restylane, Juvéderm, and Sculptra. General etiology (contamination; device failure; off-label use, or user error) of the reported event were assessed. Among specific Juvéderm and Restylane products (when named), G’, a measure of elasticity that can be assessed across brand/product, was included along an ordinal scale and analyzed for impact on specific patient outcomes of interest (infection, occlusion, vision-related events, skin necrosis, and anaphylaxis). A total of 2,351 entries were reported and occurred during the specified time period. Overall, the most common brand-specific events were infection (Juvéderm, 37% of all brand-specific adverse events), swelling/edema (Restylane, 38%), and nodules (Sculptra, 47%). The majority of cases of user error occurred among Juvéderm injectors (98%). Among logistic regression analyses, G’ level remained negatively associated with infection risk after controlling for brand (p<0.001); G’ level was similarly positively and significantly associated with likelihood of obstruction event reporting (p<0.001) as was the interaction term between G’ and brand (p=0.002). Product rheology and proprietary, brand specific factors are both implicated in adverse outcomes of cosmetic injections, particularly for risk of infection and vascular obstruction. Given that over 2.5 million soft tissue filler injections are performed annually across the United States and this number continues to rise, vigilant epidemiologic assessment is critical to identify risks of branded product lines in order to ensure safety in dermatologic care. Kaylin Beiter¹, Joseph F. Sobanko¹ 1. Dermatology, University of Pennsylvania, Philadelphia, PA, United States. Clinical Research: Epidemiology and Observational Research