Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients

Abstract

Background: Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V).

Objective: To examine the occurrence of HA-V DAEs and identify patterns and characteristics.

Methods: Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed.

Results: In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident.

Limitations: The retrospective nature made it difficult to capture time to resolution or remember potential triggers.

Conclusion: In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.

Keywords: Voluma; adverse events; aesthetics; cosmetic; delayed; fillers; hyaluronic acid; late-onset; nodules.