June 16, 2023 – The FDA’s draft guidance released this week on possible contamination in tattoo ink didn’t worry Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, MT.
“I get our ink directly from the manufacturer – not in the store or on Amazon or eBay,” she said. “You never know if it's going to be repackaged.”
She said tattoo artists regulate the standard of the ink they use.
Still, the danger is real, says Dr. Bruce Brod, clinical professor of dermatology on the University of Pennsylvania Health System. “I've seen several different infections from tattoos, and they come from organisms that tend to contaminate things in moist, liquid environments.”
The FDA published the brand new draft Orientation aid The aim of the study, published on Monday, is to cut back using tattoo ink contaminated with pathogens, as these could cause persistent infections which might be particularly difficult to treat, dermatologists said.
“Tattooing involves piercing the epidermis with needles approximately 100 times per second, and ink is injected deep into the dermis, 1.5 to 2 millimeters below the skin's surface,” the instructions state. “Contaminated tattoo ink can cause infection and serious injury. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site to other parts of the body via the blood and lymphatic systems.”
The guidelines come as body art is becoming increasingly popular. According to a 2019 study Opinion pollThirty percent of Americans had at the least one tattoo, up from just 21 percent in 2012. Forty percent of 18- to 34-year-olds and 36 percent of 35- to 54-year-olds had at the least one tattoo. And while tattoos are common, they carry medical risks that folks should pay attention to beforehand, doctors said.
The commonest symptoms of tattoo ink infections include rashes, blisters, painful nodules and severe abscesses. One of probably the most common bacteria present in contaminated tattoo ink is nontuberculous mycobacteria (NTM)which is said to the tuberculosis pathogens and is present in soil and water.
The guidelines list several unsanitary manufacturing conditions that may result in ink contamination, including:
- Preparing or packing tattoo inks in facilities which might be difficult to disinfect, akin to carpeted areas
- Uncovered ink or ink components, especially near open air ducts
- Unhygienic mixing of tattoo inks, including with unclean utensils or containers
- Lack of appropriate clothing of staff, lack of use of hair nets, lab coats, aprons, gowns, masks or gloves
“Infections often spread along the drainage channels in the skin, forming squiggly, uneven lines with large, red, lumpy nodules,” Brod said.
Between 2003 and 2023, the FDA reported 18 recalls of tattoo inks contaminated with various microorganisms. In May 2019, the FDA issued a Security alarm Consumers, tattoo artists and retailers are advised to avoid using or selling certain tattoo inks contaminated with microorganisms.
Reputable ink manufacturers use a process called Gamma radiationwhere high frequency electromagnetic radiation is used to kill microorganisms within the ink and its packaging.
Most trusted manufacturers of high-quality ink are well-known amongst tattoo artists, Donohue said.
Although she has experienced allergic reactions in clients with sensitive skin, within the nine years she has worked within the tattoo industry she has never had anyone come back with an infection.
Because tattoo ink is taken into account a cosmetic product, there isn't much regulatory oversight, meaning sterility and quality of ingredients vary, says Teo Soleymani, MD, assistant professor of dermatology and dermatologic surgery on the UCLA David Geffen School of Medicine.
“Cosmeceuticals are not subject to FDA control like prescription drugs,” he said. “We have often observed unintentional contamination during the application or manufacturing of the inks.”
In recent years, the spread of hepatitis and HIV through unclean needles has been a serious problem, but these numbers have declined significantly, Soleymani said.
The increased infections are as a result of rare bacteria present in stagnant water. And they’re injected into an element of the body that enables them to evade the immune system, he said: shallow enough that there aren't many blood vessels, but not under the layer of skin that’s shed every 28 days.
Sometimes antibiotics alone don’t help and the tattoo should be surgically removed.
“Not only does the aesthetic you wanted to achieve have to be removed, but you're also left with a surgical scar,” Soleymani said. “Tattoos can be beautiful, but they can bring with them uninvited guests that can cause months of suffering.”