PMID- 36883997
OWN - NLM
STAT- MEDLINE
DCOM- 20230413
LR  - 20230523
IS  - 1096-9101 (Electronic)
IS  - 0196-8092 (Linking)
VI  - 55
IP  - 4
DP  - 2023 Apr
TI  - Assessment of adverse events for a home-use intense pulsed light hair removal 
      device using postmarketing surveillance.
PG  - 414-422
LID - 10.1002/lsm.23650 [doi]
AB  - BACKGROUND AND OBJECTIVES: Home-use intense pulsed light (IPL) hair removal 
      devices are convenient for consumers. Consumer safety associated with home-use 
      IPL devices, however, remains a subject of interest. In this descriptive 
      analysis, we assessed the most commonly reported adverse events (AEs) for a 
      home-use IPL device from postmarketing surveillance and qualitatively compared 
      these with AEs from clinical studies and medical device reports of home-use IPL 
      treatments. MATERIALS AND METHODS: For this analysis of voluntary reports, we 
      queried a distributor's postmarketing database for IPL devices for the period 
      beginning January 1, 2016, to December 31, 2021. All sources of comments, for 
      example, phone, e-mail, company-sponsored web sites, were included in the 
      analysis. AE data were coded according to the Medical Dictionary for Regulatory 
      Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify 
      AE profiles from existing literature on home-use IPL devices and we searched the 
      Manufacturer and User Facility Device Experience (MAUDE) database for reports on 
      home-use IPL devices. These results were qualitatively compared to the data in 
      the postmarketing surveillance database. RESULTS: A total of 1692 cases involving 
      IPL were identified from voluntary reports of AEs between 2016 and 2021. The 
      shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped 
      IPL devices) was 67/100,000 during this 6-year period. The most commonly reported 
      AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and 
      erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health 
      events were observed. The reported AEs were qualitatively similar to the pattern 
      seen in clinical studies and the MAUDE database associated with such home-use IPL 
      treatments. CONCLUSION: This is the first such report documenting AEs for 
      home-use IPL hair removal from a postmarketing surveillance program. These data 
      are supportive of the safety of such home-use low-fluence IPL technology.
CI  - (c) 2023 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals 
      LLC.
FAU - Hattersley, Anne M
AU  - Hattersley AM
AD  - Procter & Gamble, Mason, Ohio, USA.
FAU - Kiernan, Michael
AU  - Kiernan M
AD  - CyDen Ltd., Swansea, Wales, UK.
FAU - Goldberg, David
AU  - Goldberg D
AD  - Skin Laser & Surgery Specialists of NY and NJ, Hackensack, New Jersey, USA.
FAU - Dierickx, Christine
AU  - Dierickx C
AD  - Skinperium Clinic, Luxembourg, Luxembourg.
FAU - Sliney, David H
AU  - Sliney DH
AD  - Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, 
      USA.
FAU - Haedersdal, Merete
AU  - Haedersdal M
AD  - Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.
FAU - Nash, J Frank
AU  - Nash JF
AUID- ORCID: 0000-0001-6133-9639
AD  - Procter & Gamble, Mason, Ohio, USA.
LA  - eng
PT  - Journal Article
DEP - 20230308
PL  - United States
TA  - Lasers Surg Med
JT  - Lasers in surgery and medicine
JID - 8007168
SB  - IM
MH  - Humans
MH  - *Hair Removal/adverse effects
MH  - Skin
MH  - Erythema/etiology
MH  - *Intense Pulsed Light Therapy/methods
MH  - Pain
OTO - NOTNLM
OT  - adverse events
OT  - home-use device
OT  - intense pulsed light (IPL)
OT  - postmarketing surveillance
EDAT- 2023/03/09 06:00
MHDA- 2023/04/13 06:42
CRDT- 2023/03/08 10:43
PHST- 2023/02/18 00:00 [revised]
PHST- 2022/10/20 00:00 [received]
PHST- 2023/02/23 00:00 [accepted]
PHST- 2023/04/13 06:42 [medline]
PHST- 2023/03/09 06:00 [pubmed]
PHST- 2023/03/08 10:43 [entrez]
AID - 10.1002/lsm.23650 [doi]
PST - ppublish
SO  - Lasers Surg Med. 2023 Apr;55(4):414-422. doi: 10.1002/lsm.23650. Epub 2023 Mar 8.