Characterizing Safety Outcomes of a Dermal Filler: Injection Site and Timing Insights from the Maude Database

Area of Science:

• Dermatology
• Aesthetic Medicine
• Medical Device Safety

Background:

• Juvéderm Volbella is the sole hyaluronic acid filler with dual FDA approval for perioral and infraorbital regions.
• Its Vycross technology and use in vascular areas necessitate safety analysis.
• Real-world data is crucial for informing clinical practice regarding Volbella safety.

Purpose of the Study:

• To evaluate and categorize adverse events associated with Juvéderm Volbella.
• Focus on injection site and number of treated areas.
• Analyze safety data from the MAUDE database.

Main Methods:

• Reviewed 315 adverse event reports from January 2020 to January 2024.
• Events were graded and grouped by injection site and symptom onset.
• Statistical analyses included chi-square and Kruskal-Wallis tests.

Main Results:

• Dermatologic and vascular events were most common, with higher vascular risks in perioral injections.
• Severe adverse events occurred later (median 75 days) than moderate events (median 51 days).
• Perioral injections led to higher antibiotic use in severe cases (53.3%) compared to mild cases (28.6%).

Conclusions:

• Perioral Volbella injections present increased vascular complication risks.
• Modified clinical protocols are needed, including extended follow-up (2-3 months) and enhanced informed consent.
• Site-specific risk stratification is essential for improving patient safety in aesthetic procedures.