Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance
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Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance. / Hattersley, Anne M.; Kiernan, Michael; Goldberg, David; Dierickx, Christine; Sliney, David H.; Haedersdal, Merete; Nash, J. Frank.
I: Lasers in Surgery and Medicine, Bind 55, Nr. 4, 2023, s. 414-422.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance
AU - Hattersley, Anne M.
AU - Kiernan, Michael
AU - Goldberg, David
AU - Dierickx, Christine
AU - Sliney, David H.
AU - Haedersdal, Merete
AU - Nash, J. Frank
N1 - Publisher Copyright: © 2023 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.
PY - 2023
Y1 - 2023
N2 - 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.
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.
KW - adverse events
KW - home-use device
KW - intense pulsed light (IPL)
KW - postmarketing surveillance
U2 - 10.1002/lsm.23650
DO - 10.1002/lsm.23650
M3 - Journal article
C2 - 36883997
AN - SCOPUS:85150477235
VL - 55
SP - 414
EP - 422
JO - Lasers in Surgery and Medicine
JF - Lasers in Surgery and Medicine
SN - 0196-8092
IS - 4
ER -
ID: 366265778