Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients.
Adult
Aged
Cosmetic Techniques
/ adverse effects
Dermal Fillers
/ adverse effects
Edema
/ chemically induced
Erythema
/ chemically induced
Facial Dermatoses
/ chemically induced
Female
Humans
Hyaluronic Acid
/ adverse effects
Male
Middle Aged
Pain
/ chemically induced
Retrospective Studies
Skin
/ pathology
Time Factors
Voluma
adverse events
aesthetics
cosmetic
delayed
fillers
hyaluronic acid
late-onset
nodules
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
received:
11
04
2019
revised:
15
01
2020
accepted:
29
01
2020
pubmed:
9
2
2020
medline:
20
1
2021
entrez:
9
2
2020
Statut:
ppublish
Résumé
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). To examine the occurrence of HA-V DAEs and identify patterns and characteristics. Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed. 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. The retrospective nature made it difficult to capture time to resolution or remember potential triggers. 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.
Sections du résumé
BACKGROUND
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
OBJECTIVE
To examine the occurrence of HA-V DAEs and identify patterns and characteristics.
METHODS
METHODS
Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed.
RESULTS
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
CONCLUSIONS
The retrospective nature made it difficult to capture time to resolution or remember potential triggers.
CONCLUSION
CONCLUSIONS
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.
Identifiants
pubmed: 32035107
pii: S0190-9622(20)30152-3
doi: 10.1016/j.jaad.2020.01.066
pii:
doi:
Substances chimiques
Dermal Fillers
0
Juvederm VOLUMA
0
Hyaluronic Acid
9004-61-9
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
86-95Informations de copyright
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.