Once you get over the initial nervousness about getting a tattoo, the process is typically smooth sailing. Sure, it’s painful—a mechanized needle digging into your skin over and over will have that effect—but temporary soreness aside, being inked by a trusted and qualified artist is usually a positive experience. But even a talented and diligent tattooist might face an issue on which the U.S. Food & Drug Administration is once again shining a light: microbial contamination in tattoo ink.
Tattoo ink is legally defined as a cosmetic and therefore falls under the regulation of the FDA, which recently released a document titled Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination. In it, the agency states that there were 15 voluntary tattoo ink recalls between 2003 and 2019, 14 of which revealed microbial contamination caused by manufacturing or distribution processes. “Eight of these recalls occurred after FDA conducted multiple surveys of tattoo inks available in the U.S. market and tested them for microbial contamination,” the document explains. “Many of these inks were heavily contaminated with a variety of microorganisms, some of which can cause serious infections.”
The report also notes that in 2012, contaminated tattoo inks caused a multi-state outbreak of skin infections.“Exposure to tattoo ink that is contaminated with microorganisms can cause skin infections, board-certified dermatologist Brendan Camp, M.D., a New York City board-certified dermatologist, confirms to Allure.
Such infections can include impetigo, abscess formation, and cellulitis; in severe cases, they can even lead to sepsis, a life-threatening reaction to infection. These types of infections “can present on the skin as painful pink or red bumps, pustules, abscesses that ooze pus, erosions and ulcers, and scars,” Dr. Camp explains. Naturally, this is not great for the tattoos themselves. “When a tattoo becomes infected, it can permanently alter the appearance of the tattoo by distorting the image through the formation of scars, uneven pigment distribution, and discoloration of the surrounding skin.”
In an effort to prevent these outcomes, the FDA issued this guidance “to help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms and thus be potentially injurious to health.” The document makes recommendations to ink manufacturers and distributors for identifying and correcting unsanitary conditions such as testing ink and components, ensuring the manufacturing process does not introduce microbial contamination by way of adequate cleaning and sanitization of equipment and providing protective equipment to employees, using appropriate sterilization methods, and doing everything possible to prevent the release of any microbially contaminated product.
