On June 16, 2023, the FDA released draft guidance regarding potential contamination of tattoo ink. Whitney Donohue, 34, the owner of Forget Me Not Tattoo in Billings, MT, expressed no concern as she sources ink directly from the manufacturer, avoiding stores or online platforms like Amazon and eBay. She emphasized that tattoo artists themselves regulate the quality of the ink they use.
However, dermatologists warn of the real threat posed by contaminated tattoo ink. Dr. Bruce Brod, a clinical professor of dermatology at the University of Pennsylvania Health System, has seen various infections resulting from tattooing, caused by organisms commonly found in moist, liquid environments.
The FDA’s draft guidance aims to reduce the use of pathogen-contaminated tattoo ink, which can lead to persistent and difficult-to-treat infections, according to dermatologists. The guidance highlights that tattooing involves puncturing the epidermis multiple times per second, depositing ink deep into the dermis. Contaminated ink can introduce pathogens and harmful substances into the body through the bloodstream and lymphatic systems.
The release of this guidance coincides with the increasing popularity of body art. A 2019 poll showed that 30% of Americans had at least one tattoo, compared to 21% in 2012. Tattooing is common among people aged 18-34 (40%) and those aged 35-54 (36%). Despite their prevalence, doctors stress the importance of understanding the medical risks associated with tattoos.
Infections linked to tattoo ink contamination often manifest as rashes, blisters, painful nodules, or severe abscesses. One of the common bacteria found in contaminated ink is nontuberculous mycobacteria (NTM), which shares similarities with the bacteria causing tuberculosis and is present in soil and water.
The guidance outlines unsanitary manufacturing conditions that can lead to ink contamination, including packing in facilities difficult to sanitize, leaving ink or components uncovered near air ducts, unsanitary mixing practices, and inadequate staff attire.
Between 2003 and 2023, the FDA recorded 18 recalls of tattoo inks contaminated with various microorganisms. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling specific tattoo inks contaminated with microorganisms.
Reputable ink manufacturers employ gamma radiation, a process that uses high-frequency electromagnetic radiation to eliminate microorganisms in the ink and packaging. Tattoo artists are familiar with these trustworthy manufacturers, according to Donohue, who has not encountered infections in her nine years in the industry but has seen allergic reactions in customers with sensitive skin.
Dr. Teo Soleymani, an assistant clinical professor of dermatology, highlights the lack of regulatory oversight due to tattoo ink being considered a cosmetic product. Sterility and ingredient quality vary as a result. Inadvertent contamination during the application process or ink manufacturing is not uncommon.
While hepatitis and HIV transmission from unclean needles were major concerns in the past, their rates have significantly declined. The increase in infections is attributed to rare bacteria present in stagnant water, injected into parts of the body that evade the immune system. These areas have fewer associated blood vessels but are not located below the layer of skin shed every 28 days.
In some cases, antibiotics alone are insufficient, necessitating surgical tattoo removal. Soleymani warns that although tattoos can be aesthetically pleasing, they can also harbor unwanted visitors, causing months of misery and leaving behind surgical scars.
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