Mycobacterium Tattoo-associated Outbreaks

In January 2012, FDA responded to reports of infections associated with recently acquired tattoos. Reports described raised red, sometimes crusty papules, occurring in the grey areas of a newly acquired tattoo, typical of cutaneous Mycobacterial infection. In this outbreak, the individuals had all been tattooed by the same tattoo artist, using the same brand and color of ink. Culture of skin biopsies confirmed Mycobacteria chelonae, all with the same Pulsed Field Gel Electrophoresis (PFGE) fingerprint. FDA became concerned about the possibility that the outbreak was caused by the intact ink itself when it was reported that the tattoo parlor did not dilute the ink. FDA investigated the ink manufacturer, who voluntarily recalled the product to prevent additional cases of infection.

FDA investigated ink suppliers and manufacturers in outbreaks occurring across the country where ink dilution at the parlor did not appear to be a confounding factor. Investigational efforts involved collaboration among many agencies including but not limited to CDC, Monroe County Health Department, Seattle King County Health Department, and Wadsworth laboratory. It became clear that contaminated intact tattoo ink, in addition to ink diluted with non-sterile water, can cause Mycobacterium outbreaks. FDA concluded that the pathogen may have been introduced into the ink during the manufacture of the ink from either; the use of contaminated ingredients, the inadequate preservation of contaminated ingredients, or during processing or packaging of the ink. Furthermore, it became apparent that these infections are not usually being reported to the FDA and these infections are poorly recognized by consumers and the healthcare community. Additionally, infections may not be treated in a timely or appropriate manner.

As a result, FDA realized there was an urgent need for outreach to the tattoo industry, physicians, and consumers to increase awareness and knowledge of the risk of infection associated with tattoos. FDA encourages the reporting of illnesses to the FDA and tattoo parlors by departments of health, healthcare providers and consumers in order to prevent further infections.