What regulatory changes are needed to improve safety and reduce complications of permanent makeup?
Clinical Applications
Dr. Schwarzenberger is the former physician editor of DermWorld. She interviews the author of a recent study each month.
By Kathryn Schwarzenberger, MD, FAAD, January 1, 2025
In this month’s Clinical Applications column, DermWorld Physician Editor Kathryn Schwarzenberger, MD, FAAD, talks with Jack Newcomer, MD, and Walter Liszewski, MD, FAAD, about their JAAD paper, ‘Permanent makeup: A review of its technique, regulation, and complications.’
DermWorld: Your paper offers an overview of permanent makeup (PMU), focusing specifically on its uses, the variation in regulations governing its application, and the complications that may arise from the procedure. Why did you choose to study this topic?
DermWorld: Given the lack of federal oversight and uniform training requirements for PMU artists in the U.S., what regulatory changes do you believe are most urgently needed to improve safety and reduce complications?
Drs. Newcomer and Liszewski: First, we feel that all permanent makeup artists should receive appropriate training in both hygiene and blood-borne pathogens. Ideally, this would consist of more standardized regulatory guidelines on a federal level to ensure that all PMU artists are adequately trained in proper sterile technique to reduce the risk of infection. Currently, there is too much variability in training, with some artists able to receive certification through training courses that are as short as four hours, whereas others engage in apprenticeships for as long as two years.
In addition, there should be increased regulation of permanent makeup inks given that many inks currently contain hazardous substances linked to allergic reactions and even potential malignancy (see below). For example, the European Union’s REACH regulation restricts the use of certain constituents in tattoo and PMU inks, and could serve as a model for the U.S.
We also feel that there should be a system in place requiring mandatory reporting of adverse reactions to permanent makeup, which would help to identify the risks associated with PMU inks.
DermWorld: Based on your research, what specific pigments or ingredients raise the most concern for adverse reactions?
Drs. Newcomer and Liszewski: In terms of specific constituents, azo pigments, particularly those used in red inks such as Pigment Red 22 or Pigment Red 181, are common culprits in allergic reactions to red tattoos and permanent makeup. Quinacridone or anthraquinone dyes are also associated with allergic contact dermatitis. In addition, permanent makeup often contains metallic contaminants such as nickel and chromium, which can elicit allergic contact dermatitis.
Although there is no clear relationship between PMU and skin cancer, polycyclic aromatic hydrocarbons, which are well-known carcinogens, are often found in black tattoo inks and can remain in the skin and regional lymph nodes which could theoretically lead to systemic exposure and subsequently increase the risk of cancer. Additionally, 2-anisidine is found in some red tattoo inks and has been shown to accelerate the growth rate of squamous cell carcinomas in mice exposed to ultraviolet radiation.
DermWorld: What recommendations would you give dermatologists for managing PMU-related complications, especially in cases of granulomatous reactions or infections caused by improper hygiene?
Drs. Newcomer and Liszewski: Of course, the best treatment is prevention of the complication itself, although even if more standardized regulations are implemented, there will always be complications as with any procedure. For granulomatous reactions, dermatologists can consider topical steroids for more mild cases and intralesional triamcinolone for more severe cases. Infectious complications related to improper hygiene during PMU procedures should be treated similarly to other infections, with antibiotic therapy tailored based on culture and sensitivity results. Infections are most often caused by Staphylococcus aureus or Streptococcus pyogenes, so empiric antibiotic therapy should target those organisms. For the rarer cases involving atypical mycobacterial infections, a combination of macrolides, rifamycins, and ethambutol should be considered.
DermWorld: Considering that dissatisfaction and regret are common complications, how would you suggest improving patient education to set more realistic expectations prior to PMU procedures?
Drs. Newcomer and Liszewski: Patient dissatisfaction and regret are often a result of unmet expectations and procedural complications. One way to help set realistic expectations about a PMU procedure is using visual aids. For example, before-and-after photos can help illustrate potential outcomes to patients and help them understand the variability in results, while helping to temper unrealistic expectations. In addition, proper counseling prior to the procedure should include a discussion of potential complications, including the possibility of needing repeat procedures or corrections and the financial aspects associated.
DermWorld: What areas of PMU research do you think are currently under-explored but critical for better understanding and mitigating risks associated with permanent makeup procedures?
Drs. Newcomer and Liszewski: We currently have a very limited understanding of the safety of many of the products incorporated in PMU pigments. More research is needed surrounding the biokinetics and safety of complex ink formulations, as well as the degradation products of PMU pigments, especially given the concern that various degradation products could be carcinogenic. Further research on the safety of these compounds could help to establish standardized safety and regulatory guidelines, particularly surrounding appropriate concentrations of individual constituents and evaluation of potentially hazardous substances. Additionally, further research is needed to improve diagnosis of hypersensitivity to PMU inks, as current patch testing methods are largely inadequate with unavailability of pigments as test allergens.
Jack Newcomer, MD, is a dermatology resident at the Mayo Clinic in Minnesota. Dr. Newcomer does not have any relevant financial and/or commercial conflicts of interest.
Walter Liszewski, MD, FAAD, is a dermatologist at Northwestern University. Dr. Liszewski does not have any relevant financial and/or commercial conflicts of interest.
Disclaimer: The views and opinions expressed in this article do not necessarily reflect those of DermWorld.
Want to read more?
Check out the most popular Clinical Applications columns.
