Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.
OBJECTIVE
Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date.


OBJECTIVE
To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers.


METHODS
A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation.


METHODS
Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form.


METHODS
The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination.


RESULTS
Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors.


CONCLUSIONS
Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois2Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois3Department of Surgery, Feinberg School of Medicine, No.
Murad
M
Alam
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois4Department of Dermatology, University of Oklahoma, West Bloomfield.
Rohit
R
Kakar
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Michael
M
Nodzenski
Department of Dermatology, Cleveland Clinic Foundation, Cleveland, Ohio.
Omer
O
Ibrahim
Dermatology Unit, Department of Medicine, Thammasat University Rangsit Campus, Pathum Thani, Thailand.
Wareeporn
W
Disphanurat
Section of Dermatology, Department of Medicine, University of Chicago, Chicago, Illinois.
Diana
D
Bolotin
Department of Dermatology, Wayne State University, Detroit, Michigan.
Judy H
JH
Borovicka
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Natalie
N
Pace
Division of Dermatology, Department of Medicine, Georgetown University Medical Center, Washington, DC.
Tina S
TS
Alster
Department of Dermatology, Brown University School of Medicine, Providence, Rhode Island11Department of Dermatology, Harvard University School of Medicine, Boston, Massachusetts.
Kenneth A
KA
Arndt
Department of Dermatology, University of Pennsylvania, Philadelphia.
Kenneth R
KR
Beer
currently in private practice in Boynton Beach, Florida.
Joshua M
JM
Berlin
currently in private practice in New York, New York.
Leonard J
LJ
Bernstein
currently in private practice in New York, New York.
Lori A
LA
Brightman
currently in private practice in San Diego, California.
Kimberly
K
Butterwick
Department of Dermatology, University of North Carolina School of Medicine, Chapel Hill17Department of Dermatology, Duke University School of Medicine, Durham, North Carolina.
Sue Ellen
SE
Cox
currently in private practice in Sacramento, California.
Vera
V
Chotzen
Division of Dermatology, Department of Medicine, University of California at San Diego.
Sabrina G
SG
Fabi
Division of Dermatology, Department of Medicine, University of California at San Diego.
Richard E
RE
Fitzpatrick
currently in private practice in New York, New York.
Roy G
RG
Geronemus
Division of Dermatology, Department of Medicine, University of California at San Diego.
Mitchel P
MP
Goldman
currently in private practice in San Diego, California.
William F
WF
Groff
Department of Dermatology, Brown University School of Medicine, Providence, Rhode Island20Department of Dermatology, Yale School of Medicine, New Haven, Connecticut21Department of Dermatology, Dartmouth Medical School, Hanover, New Hampshire.
Michael S
MS
Kaminer
currently in private practice in Sacramento, California.
Suzanne
S
Kilmer
Department of Dermatology, Brown University School of Medicine, Providence, Rhode Island.
Thomas E
TE
Rohrer
Department of Dermatology, George Washington University Medical Center, Washington, DC.
Elizabeth L
EL
Tanzi
currently in private practice in Sacramento, California.
Susan K
SK
Silva
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Simon S
SS
Yoo
Department of Dermatology, University of South Florida, Tampa.
Susan H
SH
Weinkle
Department of Biochemistry, Florida Atlantic University, Boca Raton.
John
J
Strasswimmer
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Emily
E
Poon
Department of Dermatology, Brown University School of Medicine, Providence, Rhode Island11Department of Dermatology, Harvard University School of Medicine, Boston, Massachusetts20Department of Dermatology, Yale School of Medicine, New Haven, Connecticut21.
Jeffrey S
JS
Dover
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D003357:Cosmetic Techniques / Q000009:adverse effects*; D003880:Dermatology / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007267:Injections; D053685:Laser Therapy / Q000009:adverse effects* / Q000379:methods; D008297:Male; D008875:Middle Aged; D009498:Neurotoxins / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies
D009498:Neurotoxins