Complications in cosmetic laser surgery: a review of 494 Food and Drug Administration Manufacturer and User Facility Device Experience Reports.
BACKGROUND
Complications in cosmetic laser and energy based surgery affect a number of patients every year and may cause scars, burns, blisters, and pigmentation damage.


OBJECTIVE
To evaluate documented complications in cosmetic laser- and energy-based surgeries, determine the most common errors, and recommend a simple procedural sequence to reduce patient complications.


METHODS
U.S. Food and Drug Administration Manufacturer and User Facility Device Experience Adverse Event Reports after cosmetic laser- and energy-based procedures with varied devices were reviewed (N = 494). The laser manufacturer, device used, event type, injury type, cause, operator, and indication for treatment for each case were identified.


RESULTS
In the 494 cases reviewed between 2006 and 2011, the most common complications were burns, scarring, blistering, pigmentation damage, and infection. The most common cause of these complications was user error by a healthcare provider (30%), followed by laser device malfunction (20%) and patient error (4%). Indications for treatment were unknown for 69% of cases, and 38% of the cases were an unknown cause of complication.


CONCLUSIONS
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.
Zachary
Z
Zelickson
Sarah
S
Schram
Brian
B
Zelickson
D001768:Blister / Q000209:etiology; D002056:Burns / Q000209:etiology; D002921:Cicatrix / Q000209:etiology; D003357:Cosmetic Techniques / Q000009:adverse effects* / Q000295:instrumentation; D004868:Equipment Failure; D006801:Humans; D053685:Laser Therapy / Q000009:adverse effects* / Q000295:instrumentation; D019300:Medical Errors / Q000009:adverse effects / Q000517:prevention & control; D010043:Outcome and Process Assessment, Health Care; D010349:Patient Compliance; D010859:Pigmentation Disorders / Q000209:etiology; D058996:Quality Improvement; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration