PMID- 34935756
OWN - NLM
STAT- MEDLINE
DCOM- 20220425
LR  - 20230814
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 48
IP  - 2
DP  - 2022 Feb 1
TI  - Postmarket Safety Surveillance of Delayed Complications for Recent FDA-Approved 
      Hyaluronic Acid Dermal Fillers.
PG  - 220-224
LID - 10.1097/DSS.0000000000003350 [doi]
AB  - OBJECTIVE: To review postmarketing data for delayed (>/=14 days post-treatment) 
      adverse events (AEs) of interest (inflammatory and noninflammatory nodules, 
      hypersensitivity, granulomas) for newer hyaluronic acid (HA) fillers FDA-approved 
      within the last 5 years (2016-2020). METHODS: Reports from the Manufacturer and 
      User Facility Device Experience (MAUDE) database were extracted for HAREF, HADEF, 
      HAKYS, HAVER, HAVLR, HAVOB, HARH2, HARH3, and HARH4 from January 2016 to January 
      2021. Keywords from event narratives were used to identify and categorize AEs and 
      then verified through inclusion/exclusion criteria. Percentages are based on the 
      total combined events of interest to provide an overall perspective of the events 
      reported during the search period. RESULTS: Of 585 MAUDE reports, there were 195 
      (33.3%) delayed AEs of interest. Of those, 71.8% were nodules (42.1% inflammatory 
      and 29.7% noninflammatory), 21.5% hypersensitivity, and 6.7% granulomas. The 
      combined total events of interest, ordered by frequency reported, were HAVLR 
      (74.4%), HAVOB (12.3%), HADEF (5.1%), HARH4 (3.6%), HAREF (2.6%), and HARH2 
      (2.1%), with no reports for HARH3, HAVER, and HAKYS. CONCLUSION: Although delayed 
      nodules and inflammatory events are rare, reports for these events were extracted 
      from the MAUDE database from 2016 to 2020 for HAVLR, HAVOB, HADEF, HARH4, HAREF, 
      and HARH2 (most to least frequent).
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Society for Dermatologic Surgery, Inc.
FAU - Cohen, Joel L
AU  - Cohen JL
AD  - AboutSkin Dermatology and AboutSkin Research, Greenwood Village and Lone Tree, 
      Colorado.
AD  - Department of Dermatology, University of California, Irvine, CA.
FAU - Hicks, Jessica
AU  - Hicks J
AD  - Galderma Aesthetics, Medical Affairs, Fort Worth, TX.
FAU - Nogueira, Alessandra
AU  - Nogueira A
AD  - Galderma Aesthetics, Medical Affairs, Fort Worth, TX.
FAU - Lane, Vanessa
AU  - Lane V
AD  - MedSense Ltd, High Wycombe, United Kingdom.
FAU - Andriopoulos, Bill
AU  - Andriopoulos B
AD  - Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Dermal Fillers)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Databases, Factual
MH  - *Dermal Fillers/adverse effects
MH  - Humans
MH  - Hyaluronic Acid/adverse effects
MH  - *Product Surveillance, Postmarketing
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC8806034
EDAT- 2021/12/23 06:00
MHDA- 2022/04/26 06:00
PMCR- 2022/02/01
CRDT- 2021/12/22 12:37
PHST- 2021/12/23 06:00 [pubmed]
PHST- 2022/04/26 06:00 [medline]
PHST- 2021/12/22 12:37 [entrez]
PHST- 2022/02/01 00:00 [pmc-release]
AID - 00042728-202202000-00015 [pii]
AID - ds-00406-2021 [pii]
AID - 10.1097/DSS.0000000000003350 [doi]
PST - ppublish
SO  - Dermatol Surg. 2022 Feb 1;48(2):220-224. doi: 10.1097/DSS.0000000000003350.