Murad Alam1, Rohit Kakar2, Michael Nodzenski3, Omer Ibrahim4, Wareeporn Disphanurat5, Diana Bolotin6, Judy H Borovicka7, Natalie Pace3, Tina S Alster8, Kenneth A Arndt9, Kenneth R Beer10, Joshua M Berlin11, Leonard J Bernstein12, Lori A Brightman12, Kimberly Butterwick13, Sue Ellen Cox14, Vera Chotzen15, Sabrina G Fabi16, Richard E Fitzpatrick16, Roy G Geronemus12, Mitchel P Goldman16, William F Groff13, Michael S Kaminer17, Suzanne Kilmer15, Thomas E Rohrer18, Elizabeth L Tanzi19, Susan K Silva15, Simon S Yoo3, Susan H Weinkle20, John Strasswimmer21, Emily Poon3, Jeffrey S Dover22. 1. 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. 2. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois4Department of Dermatology, University of Oklahoma, West Bloomfield. 3. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 4. Department of Dermatology, Cleveland Clinic Foundation, Cleveland, Ohio. 5. Dermatology Unit, Department of Medicine, Thammasat University Rangsit Campus, Pathum Thani, Thailand. 6. Section of Dermatology, Department of Medicine, University of Chicago, Chicago, Illinois. 7. Department of Dermatology, Wayne State University, Detroit, Michigan. 8. Division of Dermatology, Department of Medicine, Georgetown University Medical Center, Washington, DC. 9. Department of Dermatology, Brown University School of Medicine, Providence, Rhode Island11Department of Dermatology, Harvard University School of Medicine, Boston, Massachusetts. 10. Department of Dermatology, University of Pennsylvania, Philadelphia. 11. currently in private practice in Boynton Beach, Florida. 12. currently in private practice in New York, New York. 13. currently in private practice in San Diego, California. 14. Department of Dermatology, University of North Carolina School of Medicine, Chapel Hill17Department of Dermatology, Duke University School of Medicine, Durham, North Carolina. 15. currently in private practice in Sacramento, California. 16. Division of Dermatology, Department of Medicine, University of California at San Diego. 17. 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. 18. Department of Dermatology, Brown University School of Medicine, Providence, Rhode Island. 19. Department of Dermatology, George Washington University Medical Center, Washington, DC. 20. Department of Dermatology, University of South Florida, Tampa. 21. Department of Biochemistry, Florida Atlantic University, Boca Raton. 22. 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.
Abstract
IMPORTANCE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. EXPOSURES: 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. MAIN OUTCOMES AND MEASURES: 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 AND RELEVANCE: 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.
IMPORTANCE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. EXPOSURES: 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. MAIN OUTCOMES AND MEASURES: 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 AND RELEVANCE: 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.
Authors: W Philip Werschler; Jacqueline M Calkin; David A Laub; Tess Mauricio; Vic A Narurkar; Phoebe Rich Journal: J Clin Aesthet Dermatol Date: 2015-10