Correspondence

Adverse Reactions after Permanent-Makeup Procedures

N Engl J Med 2007; 356:2753June 28, 2007

Article

To the Editor:

Permanent makeup, used to enhance facial appearance (most commonly the eyebrows, eyelids, and lips), is administered by intradermally injecting inks containing various pigments and suspending agents. The number of people receiving permanent makeup is unknown.

From 1988 to 2003, the Food and Drug Administration (FDA) received only five reports of adverse reactions after permanent-makeup procedures. Beginning in 2003, the FDA received more than 150 reports of adverse reactions in persons who had undergone permanent-makeup procedures.1

We identified 101 patients who had had adverse reactions to permanent-makeup procedures (Figure 1Figure 1Allergic Contact Dermatitis That Developed after the Application of Permanent Makeup on the Eyebrows.) through adverse-event reports and another 8 such patients through referrals from already-identified patients. Oral consent was obtained from 99 patients; 92 of these patients, who were from 27 states, met the inclusion criteria: living in the United States and having local signs and symptoms of inflammation lasting for more than 7 days after a permanent-makeup procedure performed between June 1, 2002, and August 31, 2004.

Telephone interviews of the 92 patients were conducted. The most commonly reported reactions were tenderness (in 87 patients [95%]), swelling (in 84 patients [91%]), itching (in 81 patients [88%]), and bumps (in 76 patients [83%]). In 63 patients (68%), the reactions had not completely resolved at the time of the interview; the duration of symptoms ranged from 5.5 months to more than 3 years. Healing occurred more rapidly in patients without a self-reported history of allergy than in those with such a history (hazard ratio for delayed healing, 0.49; 95% confidence interval, 0.25 to 0.94). We attempted to obtain approval for a review of medical records from all 89 patients (97%) who had seen a physician for the reactions. Medical records were obtained for 33 of the patients; the records indicated a clinical diagnosis of an allergic or granulomatous reaction in 27 patients (82%). These findings are consistent with those in previous case reports.1-4

Of the 92 patients, 21 (23%) — whose permanent-makeup procedures involved a total of 53 facial sites — had at least one site tattooed without an adverse reaction. Of the 53 sites, 34 sites were injected with a single product line of ink, and 22 of the 34 sites (65%) had adverse reactions. Of the 19 sites that were injected with a different product line of ink, 6 (32%) had an adverse reaction (P=0.03, assuming independence among the 53 sites), suggesting a possibly increased risk with the specific product line of ink.

Our findings show that application of permanent makeup can result in serious, long-term disfiguring reactions. The product line of ink associated with most of the reactions was recalled in September 27, 2004. Consumers and medical professionals should report adverse reactions to permanent-makeup procedures to the FDA.5

Masja Straetemans, Ph.D.
Centers for Disease Control and Prevention, Chamblee, GA 30341
straetemansm@rki.de

Linda M. Katz, M.D., M.P.H.
Food and Drug Administration, College Park, MD 20740

Martin Belson, M.D.
Centers for Disease Control and Prevention, Chamblee, GA 30341

5 References

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   Duke D, Urioste SS, Dover JS, Anderson RR. A reaction to a red lip cosmetic tattoo. J Am Acad Dermatol 1998;39:488-490
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   Yang DS, Kim SC, Lee S, Chung Y. Foreign body epithelioid granuloma after cosmetic eyebrow tattooing. Cutis 1989;43:244-247
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   Tattoos and permanent makeup. Rockville, MD: Food and Drug Administration, 2006. (Accessed June 7, 2007, at http://www.cfsan.fda.gov/~dms/cos-204.html.)
   

Citing Articles (2)

Citing Articles

1. 1

   Arisa E. Ortiz, Tina S. Alster. (2011) Rising Concern over Cosmetic Tattoos. Dermatologic Surgeryn/a-n/a
   CrossRef

2. 2

   Sabrina M. Wenzel, Julia Welzel, Christian Hafner, Michael Landthaler, Wolfgang Bäumler. (2010) Permanent make-up colorants may cause severe skin reactions. Contact Dermatitis 63:4, 223-227
   CrossRef