Journal of drugs in dermatology : JDD · 2026
Characterizing Safety Outcomes of a Dermal Filler: Injection Site and Timing Insights from the Maude Database.
СтатьяНазвание и аннотация: Перевод в очереди
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Spivak Mark, Auerbach Esther, Eisenreich Elana, Yusupov Daniel, Sebbag Shawnee, Berglas Eli, Shimanov Mark M, Musheyev David, Halaas Yael
Аннотация
BACKGROUND: Juvéderm Volbella distinguishes itself for being the only hyaluronic acid filler with dual FDA approval for perioral and infraorbital regions. Its Vycross technology formulation and use in high-risk vascular areas necessitate a comprehensive real-world safety analysis to inform clinical practice.
OBJECTIVE: To evaluate and categorize adverse events associated with Juvéderm Volbella injections using the Manufacturer and User Facility Device Experience (MAUDE) database, focusing on injection sites and the number of treated areas.
METHODS AND MATERIALS: Adverse event reports from January 2020 to January 2024 were reviewed and graded using standardized criteria. Events were grouped by injection site, number of anatomical areas injected, and time of symptom onset. Statistical analyses included chi-square and Kruskal-Wallis tests.
RESULTS: Among 315 patients, dermatologic and vascular events predominated, with higher vascular complication rates following perioral injections. Severe adverse events (CTCAE >2) occurred at a median of 75 days postinjection versus 51 days for moderate events. Perioral injections required antibiotics in 53.3% of severe cases versus 28.6% of mild cases (P=0.0003).
CONCLUSION: Perioral Volbella injections demonstrate increased vascular complication risks requiring modified clinical protocols: extended follow-up schedules (2-3 months versus standard 2 weeks), enhanced informed consent, and site-specific risk stratification. These findings provide immediate, actionable evidence for improving patient safety through evidence-based practice modifications.  .
OBJECTIVE: To evaluate and categorize adverse events associated with Juvéderm Volbella injections using the Manufacturer and User Facility Device Experience (MAUDE) database, focusing on injection sites and the number of treated areas.
METHODS AND MATERIALS: Adverse event reports from January 2020 to January 2024 were reviewed and graded using standardized criteria. Events were grouped by injection site, number of anatomical areas injected, and time of symptom onset. Statistical analyses included chi-square and Kruskal-Wallis tests.
RESULTS: Among 315 patients, dermatologic and vascular events predominated, with higher vascular complication rates following perioral injections. Severe adverse events (CTCAE >2) occurred at a median of 75 days postinjection versus 51 days for moderate events. Perioral injections required antibiotics in 53.3% of severe cases versus 28.6% of mild cases (P=0.0003).
CONCLUSION: Perioral Volbella injections demonstrate increased vascular complication risks requiring modified clinical protocols: extended follow-up schedules (2-3 months versus standard 2 weeks), enhanced informed consent, and site-specific risk stratification. These findings provide immediate, actionable evidence for improving patient safety through evidence-based practice modifications.  .