Tattoo infections linked to manufacturers' ink

Tattoo infections linked to manufacturers' ink - Contaminated tattoo ink caused at least 22 skin and soft tissue infections last fall in four U.S. states, according to an analysis released on Wednesday.

The infections prompted an investigation by the U.S. Centers for Disease Control and Prevention that uncovered 22 confirmed cases, 4 probable cases, and 27 possible cases of contamination-related infections in New York, Washington, Iowa and Colorado.

Products from four companies were implicated during the probe. None of the companies are identified in a CDC report, released in conjunction with a New England Journal of Medicine study of the New York cases.

A tattooed leg of a participant is pictured during the international AIDS conference at the week-long sex workers' freedom festival in Kolkata July 22, 2012. REUTERS/Rupak De Chowdhuri

"People who get tattoos must be made aware of this risk and seek medical attention" if they get a rash or other abnormalities as the site, according to a commentary in the journal from a team led by Pamela LeBlanc of the U.S. Food and Drug Administration.

The bacteria reportedly got into the containers when the manufacturer used distilled or reverse-osmosis water, which is not necessarily sterile. In the New York case, which led to a recall by the Arizona-based manufacturer, the water was used to dilute black ink into various shades of gray.

The New York cases involved infection with a bug called Mycobacterium chelonae, which caused reddish or purple raised bumps in the areas tattooed with gray. The infection can mimic an allergic reaction and be difficult to treat.

"They were not getting better" with standard care, said Dr. Byron Kennedy of the Monroe County Department of Public Health, the chief author of the New England Journal of Medicine study. "You had some folks who were on treatment for 6 months or more."

The FDA does not directly regulate tattoo ink because it is regarded as a cosmetic, but it can intervene when a product has been adulterated or is regarded as unsafe.

Currently, no FDA regulation specifically requires tattoo ink to be sterile, but some local jurisdictions, such as Los Angeles County, do require that sterile water be used when inks are diluted, according to the CDC report.

CDC is encouraging doctors to keep track of such infections and report them to the FDA.

About one in five Americans has tattoos, according to a 2012 Harris Interactive poll.

‘GRAY WASH INK'

The case surfaced in January when the Monroe County Department of Public Health received a call from a dermatologist who was treating a persistent rash on the arm of a 20-year-old man.

The infection was traced back to an unnamed artist and a new, hand-blended "gray wash" ink designed to give shading and a three-dimensional quality to the image. The ink contained no lot number and came from black ink that had been diluted.

A check of other tattoo parlors in the county found that none had used the ink or reported a similar rash.

"This is an uncommon thing," Dr. Amy Derick, a dermatologist at Northwestern University in Chicago told Reuters Health. She coauthored a 2006 study of tattoo and piercing practices that found "the complication rate was pretty low."

"It's not super-dangerous, but it requires multiple months of antibiotics" that can be very expensive, she said. "Sometimes it needs to be cut out, so it's not desirable by any stretch."

The lesson for patients, said Kennedy, is "if they notice they have a rash that's not going away, they should go to their primary care provider and not just self-care." ( Reuters Health )


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The Hidden Risks of Getting a Tattoo

The Hidden Risks of Getting a Tattoo - When a cluster of skin infections in upstate New York last fall led back to one tattoo artist, local public health officials took the usual step of investigating the artist's hygiene practices. They found that all of his equipment and methods were sanitary, but the nationally distributed ink he had been using, even in unopened bottles, wasn't.

Soon, similar investigations in Colorado, Washington and Iowa turned up harmful strains of bacteria in three other brands of ink. At least 22 skin infections across the four states were linked to contaminated ink, according to research reported Wednesday (Aug. 22) in the New England Journal of Medicine.

The offending pathogen in the New York outbreak was identified as Mycobacterium chelonae, a relative of the bacteria behind tuberculosis and leprosy that is commonly found in tap water. Though M. chelonae is usually harmless to people with normal immune systems, when it's escorted beneath the skin by a tattoo needle, it can cause a painful rash that can last for months, requiring strong antibiotic regimens and sometimes surgery to eradicate.

According to the Centers for Disease Control and Prevention (CDC), past tattoo-related Mycobacterium infections likely arose from the use of unsterile water as a diluting agent in ink. And because the ink that caused the New York outbreak was "gray wash," pre-diluted black ink used for shading, the CDC has speculated that its manufacturer may not have been using sterile water.

So should Americans, one of five of whom now reportedly sport indelible ink, be afraid to get a new tat? Is there any way to be sure that a given manufacturer's tattoo ink is sterile?

The answer to the second question is a definite no. Currently, there is no FDA regulation requiring that tattoo inks be sterile, so a consumer only has a company's or an artist's assurance to go on. It is also worth noting that although a number of the color pigments used in tattoo ink have been approved by the FDA for use in cosmetics, not a single one has ever been approved for injection into the skin.

Because reporting is voluntary, there is not good data on how often tattoo-related skin infections occur, but if one decides to play the odds and join the millions of Americans who are already inked, there are a few precautionary steps that he or she can take to decrease the chances of an infection.

Along with watch-dogging artists during tattooings to ensure that they use sterile water for dilution and cleaning, the CDC recommends that a consumer only use tattoo parlors registered by local jurisdictions and request inks that are manufactured specifically for tattoos. If an infection does occur, the CDC advises seeking medical advice and notifying the tattoo artist as well as the FDA's Medwatch program. ( LiveScience.com )


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A Trail of Ink: Tracking a Rare Tattoo-Related Infection

A Trail of Ink: Tracking a Rare Tattoo-Related Infection - The reddish-purple rash, seemingly woven into the tattoo on a 20-year-old New Yorker's forearm, was strange enough to have doctors scratching their heads.

This trail began when the man received a tattoo in Rochester, N.Y. in October 2011. A short while later, he noticed the raised, bumpy rash. He called his primary care physician.

Doctors initially treated the man's arm with topical steroids, thinking that the rash was allergic-contact dermatitis. But that only made the problem worse.

A Trail of Ink: Tracking a Rare Tattoo-Related Infection (ABC News)

By the time dermatologist Dr. Mark Goldgeier saw the patient, it was clear that this was no simple allergy.

He performed a skin biopsy so he could take a closer look at the rash under a microscope. What he saw was startling: the sample was riddled with a wormlike bacterium related to tuberculosis.

"I explained [to the patient] that he had TB, and he had a look of horror on his face," Goldgeier said.

For the patient, the finding meant a trip to an infectious disease specialist to start up to a full year of treatment.

Goldgeier, meanwhile, called the Monroe County Health Department.

"As soon as biopsy came back," he said, "I knew something in the process of tattooing was involved -- the ink, the water used for dilution, the syringes, the dressings."

And so began a nationwide medical mystery.

An article published Wednesday in the New England Journal of Medicine describes how this one dermatologist helped connect the dots in an outbreak of tattoo-related atypical skin infections.

Dr. Byron Kennedy, public health specialist at Monroe County Department of Public Health, took over the case from Goldgeier. Kennedy first confirmed the results by repeating a skin biopsy on the patient. Once again, tendrils of mycobacterium chelonae, a type of tuberculosis-related skin bacteria, showed up in the sample.

Mycobacterium chelonae is a rapidly growing bug found in soil, dust, water, animals, hospitals, and contaminated pharmaceuticals. This family of bacteria does not commonly affect healthy individuals, but in patients with suppressed immune systems -- like those with HIV or on chemotherapy -- these bacteria can cause serious disease, often resulting in death.

The finding sent Kennedy and his associates to the tattoo parlor where the patient had been inked. Everything in the clinic was sterile, which made it unlikely that the infection had arisen there. But the tattoo artist, they learned, had been using a new gray premixed ink purchased in Arizona in April 2011; he used the ink between May and December 2011.

The ingredients of the ink -- pigment, witch hazel, glycerin, and distilled water -- seemed innocuous enough. But further examination revealed that the distilled water in the pigment was the likely culprit of the contamination.

The finding raised a number of questions -- not the least of which was how the bottles of premixed ink passed U.S. Food and Drug Administration regulations.

The U.S. Centers for Disease Control and Prevention acknowledged this gap in regulations Wednesday in its Morbidity and Mortality Weekly report.

"Under the Federal Food, Drug, and Cosmetic Act, tattoo inks are considered to be cosmetics, and the pigments used in the inks are color additives requiring premarket approval," the report says.

While the pigments are subject to FDA monitoring, "no specific FDA regulatory requirement explicitly provides that tattoo inks must be sterile," they said.

Local jurisdictions can further regulate the practice of tattooing, with Los Angeles County cited by the CDC as an area where only sterile water is allowed for use with tattoo ink. This is not, however, uniform around the country.

In a perspective article published Wednesday in the New England Journal, Pamela LeBlanc of the FDA comments on this.

"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," she writes.

Kennedy had found the source of infection in this patient's case. Now, he and his colleagues focused on both treatment as well as source control.

"To make sure we weren't missing any cases, we contacted all 60 tattoo parlors in the county," Kennedy said. Luckily, none of the other parlors had been in contact with the contaminated ink. Kennedy then instructed nearby pathology labs to notify the county health department of any reported cases of this same infection. Due to these combined efforts, 19 cases of this atypical and difficult-to-treat skin infection were identified and treated, all from the same tattoo parlor. Kennedy and his team then turned the case over to the FDA.

"This case really put it on the radar of the FDA," Kennedy said.

And it was not a day too soon. CDC testing revealed that 1 out of 3 unopened bottles of the gray ink from the original distributor in Arizona contained mycobacterium chelonae. The CDC then issued a national alert for local health officials to be on the lookout for tattoo-related infections caused by this bacteria.

According to the CDC, 21 percent of adults in the U.S. report having at least one tattoo -- an increase from 14 percent in 2008. But with this burden of ink comes increased need for monitoring of safe practices and tattoo-related complications -- especially skin infections.

The CDC urges consumers to be vigilant about ensuring hygienic practices at their tattoo parlor of choice, and to alert health care providers at any sign of infection or rash.

Doctors, meanwhile, are urged to report suspected or confirmed cases to FDA's MedWatch program.

"The local dermatologist was the person to put this on our radar," said John Ricci, Senior Public Health Educator at the Monroe County Department of Health. "Without this initial case report to us, it would never have been detected." (Good Morning America )


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