PMID- 30235374
OWN - NLM
STAT- MEDLINE
DCOM- 20190103
LR  - 20190103
IS  - 2326-6929 (Electronic)
IS  - 0011-4162 (Linking)
VI  - 102
IP  - 2
DP  - 2018 Aug
TI  - Learning curves: historical trends of FDA-reported adverse events for dermal 
      fillers.
PG  - E20-E23
AB  - Dermal fillers are medical devices regulated by the US Food and Drug 
      Administration (FDA); therefore, reported adverse events (AEs) are publicly 
      available via OpenFDA. Evaluation of historical AE data trends may help 
      distinguish between AEs related to expected learning curves associated with a new 
      type of filler from AEs related to inherent characteristics of a product. In this 
      study, the full history of AE data was evaluated to establish reproducible 
      learning curves for FDA-approved dermal fillers. Reactions to AEs for new fillers 
      that garner FDA approval or are awarded new indications should be in response to 
      analysis of AE rate data and determination of whether they fit on a historically 
      normal learning curve.
FAU - Chandawarkar, Akash A
AU  - Chandawarkar AA
AD  - Department of Plastic and Reconstructive Surgery, Johns Hopkins University School 
      of Medicine, Baltimore, Maryland, USA.
FAU - Provenzano, Destie J
AU  - Provenzano DJ
AD  - Georgetown University School of Medicine, Washington, DC, USA.
FAU - Rad, Ariel N
AU  - Rad AN
AD  - Department of Plastic and Reconstructive Surgery, Johns Hopkins University School 
      of Medicine, Baltimore, Maryland, USA.
FAU - Sherber, Noelle S
AU  - Sherber NS
AD  - Department of Dermatology, George Washington University School of Medicine & 
      Health Sciences, Washington, USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Dermal Fillers)
SB  - IM
MH  - Dermal Fillers/administration & dosage/*adverse effects
MH  - *Device Approval
MH  - Humans
MH  - *Learning Curve
MH  - Reproducibility of Results
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2018/09/21 06:00
MHDA- 2019/01/04 06:00
CRDT- 2018/09/21 06:00
PHST- 2018/09/21 06:00 [entrez]
PHST- 2018/09/21 06:00 [pubmed]
PHST- 2019/01/04 06:00 [medline]
PST - ppublish
SO  - Cutis. 2018 Aug;102(2):E20-E23.