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Mycobacterial Infections: The Link to Ink

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FDA Encourages Reporting of Adverse Events

State and local offices have long provided safety information about tattoo techniques, materials, and adverse events. But it may be time for the Food and Drug Administration to reinforce that message, Ms. Pamela M. LeBlanc and her colleagues wrote in an accompanying editorial (N. Engl. J. Med. 2012 [doi: 10.1056/NEJMp1206063]).

"In recent months, ... reported outbreaks of nontuberculous mycobaterial infections associated with contaminated tattoo ink have raised questions about the adequacy of prevention efforts implemented at the tattoo-parlor level alone," they wrote. The FDA is "reaching out to health care providers, public health officials, consumers, and the tattoo industry to improve awareness, diagnosis, and reporting (through the MedWatch program) in order to develop more effective measures for tattoo ink–related public health problems."

Since tattoo inks are considered to be in the cosmetic realm, the FDA has little control as long as the inks are marketed in accordance with intended use. Consumers should understand the inherent risks of tattooing, and patronize establishments that use techniques and inks that pose little risk for infection.

However, they wrote, "even if a person receives a tattoo at a tattoo parlor that maintains the highest standards of hygienic practice, there remains a risk of infection from the use of contaminated ink."

The MedWatch system is the most effective way to keep the FDA informed of any problems.

"The FDA encourages health care providers, public health officials, consumers, and tattoo artists to use MedWatch to report to the FDA any tattoo-related infections," as well as other adverse events related to tattooing, they noted. "The agency will continue to collaborate with other public health partners in investigating reported adverse events, identifying root causes, and taking the actions necessary to prevent future illnesses."

Ms. LeBlanc is a consumer safety officer at the FDA. She and her coauthors had no conflicts of interest to disclose.


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

Cluster 2 included two confirmed and two possible cases, both associated with the same ink, but from a different company. A sample from an unopened ink bottle grew M. chelonae. Investigators could not identify the source of contamination at either company.

The Iowa Department of Public Health reported one confirmed case. M. chelonae recovered from the ink was indistinguishable from the Washington strain, but unrelated to the New York strain.

One case was confirmed in Colorado. Artists at the tattoo parlor in question reported diluting ink and rinsing needles with distilled or reverse-osmosis water. The organism was not recovered from any sources at the manufacturing company or the tattoo parlor; however, the ink used was labeled as drawing ink, not tattoo ink.

The investigators had no relevant financial disclosures.

*Correction, 11/8/2012: An earlier version of this story misstated the location of the patient mentioned in the photo caption. The photo was taken by Dr. Matthew Mahlberg.

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