The FDA draft guidance released on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Montana. “I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use.

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said.

Commonly reported symptoms of tattoo ink-associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria (NTM), which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination including:

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Brod said.

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