Complications in Cosmetic Laser Surgery: A Review of 494 Food and Drug Administration Manufacturer and User Facility Device Experience Reports

Abstract

User error was a major factor in laser surgery complications. To improve safety and reduce errors, we propose the implementation of a procedural sequence for cosmetic laser surgery.

2018 update on dermatologic laser therapy: Part 1 – epilation, vascular lesions and pigments

“…[ 3 ] . Im Hinblick auf die hohe Komplikationsrate der Laserepilation ist das besonders wichtig [4][5][6][7] . So muss unbedingt die aktuelle Medikation des Patienten bekannt sein, damit bekannte Licht-Medikamenten-Interaktionen vermieden werden.…”

Side effects from intense pulsed light: Importance of skin pigmentation, fluence level and ultraviolet radiation—A randomized controlled trial

“…According to statistics reported by the American Society for Aesthetic Plastic Surgery, hair removal using IPL or laser was one of the most frequently performed cosmetic procedures in 2014 . Since side effects can be part of any medical treatment modality, there is a need to better understand determinants for such events in order to maximize patient safety .…”

“…Side effects can occur after IPL and the most frequently reported ones according to U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) are burns, blisters, scars, and dyspigmentation . Complications are predominantly caused by user error (30%) such as incorrect device settings, malfunction of device (20%), or patient error (4%), such as failure to avoid excessive sun exposure after treatment .…”

“…Side effects can occur after IPL and the most frequently reported ones according to U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) are burns, blisters, scars, and dyspigmentation . Complications are predominantly caused by user error (30%) such as incorrect device settings, malfunction of device (20%), or patient error (4%), such as failure to avoid excessive sun exposure after treatment . Compared to laser treatments used for the same purpose, side effects are more frequently reported after IPL, which may be explained by the polychromatic and broader spectrum of wavelengths as well as beam divergence, which reduces selectivity while lasers operate collimated, monochromatically, and target chromophores more selectively .…”

Laser (Check)Lists, Licensing, and Learning Log

“…Lasers and light-based devices have been highlighted as the most common area in which harm is caused by aesthetic practitioners, and complications of such therapy are most commonly attributable to operator error. 4 Despite recommendations in a recent independent review of the regulation of cosmetic interventions, the response of the United Kingdom government has fallen well short of mandating that all practitioners offering such therapies be medically qualified or indeed registered with any organization. 5 Tentative recommendations to formalize training of practitioners should be welcomed and built upon.…”