When I sat down with Washington D.C.-based “dermatologist to the stars” Dr. Tina Alster to discuss safety concerns surrounding wrinkle fillers and Botox, she threw me a curve ball. I was all set to delve into the FDA’s seemingly less-than-adequate oversight of these “medical devices,” when she said, “I don’t lose sleep over that. Tattoos? I lose sleep.”
“The inks are not regulated,” she said.
Really?
Surprisingly, she is correct. The Food and Drug Administration admits on its website that it is supposed to oversee them, but “because of other public health priorities and a previous lack of evidence of safety concerns, FDA has not traditionally regulated tattoo inks or the pigments used in them.”
To be clear, the inks have been approved for such use as printer ink and automobile paint, but none have been approved for injection under the skin. Since state and local authorities generally defer to the FDA on the inks and instead focus on tattoo practices, including sanitary conditions and minimum age for consumers, the inks have received little to no oversight.
On a positive note, the FDA’s Arkansas-based National Center for Toxicological Research is currently investigating tattoo inks to discover “the chemical composition of the inks and how they break down in the body, the short-term and long-term safety of pigments used in tattoo inks, and how the body responds to the interaction of light with the inks.”
Since something like 45 million Americans have at least one tattoo, this work seems like a smart idea to me.
Potential adverse reactions from tattoo inks can run the gamut from allergic rash and bumps, to cancer. In a 2011 article for the American Society for Dermatologic Surgery, Alster and co-author Arisa Ortiz, M.D.—of the Univ. of California at Irvine Department of Dermatology—state that some red and yellow pigments “decompose into known carcinogens with exposure to light and laser irradiation.”
In addition, because some inks contain metals, MRIs—which, as their name suggests, use magnets to produce images—may cause irritation, but the FDA advises that you don’t need to avoid them. However, they recommend that you inform the MRI center about your tattoo in order to take precautions.
There is one other radiology concern with tattoos. Some inks have been found to leach into the bloodstream and collect in lymph nodes. If you are being screened for breast cancer, for instance, the radiologist reading your films might not be able to distinguish between metastatic cancer and lymph nodes that are stained with ink.
Mike Martin is the president of the Alliance of Professional Tattooists, which advocates for tattoo safety. He says that the “FDA has had a kind of hands-off policy for us for many, many years.” The APT provides tattoo safety training, and according to Martin, relies on the FDA and CDC for information on the inks.
Martin says he’s personally concerned about the safety of the new black-light inks that are available and refuses to use them. “I have to be able to sleep at night,” he says. “So I’m not gonna use them.”
Last August the FDA did issue a tattoo-ink warning to consumers, tattooists and the medical community. This warning was issued in response to an outbreak of illnesses from ink contaminated with bacteria, which can cause serious conditions, including lung disease, joint infection and eye problems.
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On its website the FDA seemingly responds to critics like Alster who say that the regulatory agency is not doing enough to protect consumers: “Tattoo inks are subject to FDA regulation. FDA regulates and intervenes when a serious safety issue arises. And that’s what happened here.”
It’s great that our consumer watchdog made the public aware of an outbreak in the inks after it happened, but it could do more. The FDA has the authority to make sure tattoo inks are safe. They should use that authority before more problems occur.
2 Comments
Thanks for this article. I loathe tattoos and am glad for any research showing their are a detriment.
I actually had to have surgery to remove an inflamed lymph node a few years ago. The pathology result: speckled ink. I had gotten my 1 and only tattoo approx 12 years earlier. Never again . I also let others know about my issue due to the tattoo.