The U.S. Food and Drug Administration is ramping up warnings for hospital and physician providers to be alert for hard-to-treat raised skin rashes stemming from contaminated tattoo inks after a 19-person outbreak in New York, the fourth state to be impacted in recent years.
The alert, issued in Thursday's New England Journal of Medicine, stems from an article in the same issue by public health officials in Rochester, NY. Officials discovered 19 tattoo parlor patrons were infected with Mycobacterium chelonae infections after receiving tattoos from a single shop in that city last fall.
Public health officials were alerted to the problem by a local dermatologist who said one of his patients had first sought care for the rash on his arm through another physician, who treated him unsuccessfully with a corticosteroid, and then referred him. The dermatologist did a skin biopsy to determine the infection.
Public health officials were then able to track back to the manufacturer of the batches of ink, purchased from a supplier in Arizona, and found that unopened bottles of ink contained the M. chelonae. The tattoo artist relinquished his client list, and 18 more customers were discovered to have similar rashes.
"Had this link not been established, you would still have this particular index case as well as others with infections that persisted," Byron S. Kennedy, MD, deputy director of the Monroe County Health Department, said in an interview Wednesday.
Unlike previous reports of tattoo infections that may have resulted from the use by tattoo artists of contaminated water to dilute the inks they had already purchased, this outbreak appears to have been caused by contaminants that went into the ink before it was shipped from its manufacturer's supply in Arizona.
Additionally, this strain of bacteria is hard to diagnose, and therefore health officials said, many tattoo recipients may have mysterious rashes that are going without treatment. Even after the infections are identified, they can be difficult to resolve, often requiring a course of antibiotics for several months.
Kennedy says he submitted the article to the NEJM because "it was clear this is a potentially a growing problem, and because tattooing has become more popular," with an estimated one in five U.S. adults now sporting skin ink.
Previous outbreaks involving infected tattoo inks have been reported in Washington, Iowa, and Colorado.
John Ricci, spokesman for the Monroe County Health Department in Rochester, says health officials "suspect that there are a lot of people who get tattoos who think that those ink products are being tightly regulated and tested. As a result of this investigation, we have learned that is not the case."
Added Kennedy, "from our perspective at the local level, what this suggests is that even if you go to a parlor and witness practices that meet recommended guidelines, it still does not remove the potential risk, and this is a case in point."
"An environmental health assessment suggested that best practices were generally observed at the parlor where the index patient received his tattoo, and no concerns about hygiene were noted," Kennedy and colleagues wrote in their NEJM article.
"In particular, the artists used sterile instruments, wore clean disposable gloves, poured ink into single-use containers, and provided appropriate aftercare to the tattooed site," they wrote.
"Importantly, no dilution or mixing of inks at the parlor occurred and the artist avoided contamination of ink from tap water at the facility."
The FDA officials said in the accompanying Perspective article that while tattoo inks are considered cosmetics, the FDA does not have the authority to require premarketing submission of safety data from manufacturers, distributors or marketers of cosmetic products.
However, the FDA "can request that a manufacturer recall violative products and issue advisory letters." It also can ask the Department of Justice to conduct seizures, enjoin a firm or person from manufacturing or distributing products, or file criminal charges against a firm or responsible person on behalf of the FDA.
Thursday's Morbidity and Mortality Weekly Report contains further information and background about the problem of infectious microbes in tattoo inks.