On This Page:
to get a tattoo? Today, people from all walks of life have tattoos,
which might lead you to believe that tattoos are completely safe.
there are health risks that can result in the need for medical care.
The Food and Drug Administration (FDA) is particularly concerned about a
family of bacteria called nontuberculous Mycobacteria (NTM) that has been found in a recent outbreak of illnesses linked to contaminated tattoo inks.
one of several disease-causing NTM species, can cause lung disease,
joint infection, eye problems and other organ infections. These
infections can be difficult to diagnose and can require treatment
lasting six months or more.
Some of these contaminated inks have
caused serious infections in at least four states in late 2011 and early
2012. FDA is reaching out to tattoo artists, ink and pigment
manufacturers, public health officials, health care professionals, and
consumers to warn them of the potential for infection.
warns that tattoo inks, and the pigments used to color them, can become
contaminated by other bacteria, mold and fungi. To raise awareness and
make diagnoses more accurate, FDA strongly encourages reporting of
tattoo-associated complications to its MedWatch program, says Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors.
the word out to tattoo artists is particularly critical. Even when they
diligently follow hygienic practices, they may not know that an ink
itself may be contaminated. Contamination is not always visible in the
inks, Katz says.
FDA’s goal is to encourage these artists to take
certain precautions in their practice and to urge potentially infected
clients to seek medical care. “Reporting an infection to FDA and the
artist is important. Once the problem is reported, FDA can investigate,
and the artist can take steps to prevent others from being infected,”
says epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office
of Cosmetics and Colors.
back to top
A Challenging Investigation
inks are subject to FDA regulation. FDA investigates and intervenes
when a serious safety issue arises. And that’s what happened here.
CORE (Coordinated Outbreak Response and Evaluation) Network initiated
and coordinated the investigation with state and local health
departments and laboratories, the Centers for Disease Control and
Prevention (CDC), and FDA investigators working in numerous district
The investigation began in January 2012 when FDA, through
its MedWatch reporting program, learned about seven people in Monroe
County, New York who had NTM infections. They’d all gotten tattoos from
the same artist, who used the same brand of ink on all of them. The
infections occurred on the newly acquired tattoos, with red bumps
appearing soon after the tattoo had healed.
FDA later learned of
12 more people with an NTM infection who were also clients of this same
tattoo artist. The same brand of ink was also used on them. Of these 19
people, 14 were confirmed to have the same type of NTM infection. An NTM
sample from a sealed container of the same type of ink used to tattoo
the affected individuals was a perfect match to the NTM linked to these
Meanwhile, FDA learned of outbreaks of NTM infections
in other states, including but not limited to Washington, Iowa, and
Colorado. The cases in these states involved different NTM species or
different ink manufacturers than those in New York. While the infections
in Washington, Iowa, and Colorado were not linked to the New York
infections, there was a link identified between the M. chelonae infections in Washington and Iowa.
the New York outbreak alone, FDA investigators visited the tattoo ink
supplier and manufacturer. These were located as far away as California.
These investigations resulted in a recall of the implicated ink.
back to top
Strategies for Controlling Risks of Infection
artists can minimize the risk of infection by using inks that have been
formulated or processed to ensure they are free from disease-causing
bacteria, and avoiding the use of non-sterile water to dilute the inks
or wash the skin. Non-sterile water includes tap, bottled, filtered or
Consumers should know that the ointments often
provided by tattoo parlors are not effective against these infections.
NTM infections may look similar to allergic reactions, which means they
might be easily misdiagnosed and treated ineffectively.
infection is diagnosed, health care providers will prescribe appropriate
antibiotic treatment according to Katz. Such treatment might have
uncomfortable side effects, such as nausea or gastrointestinal problems.
However, without prompt and proper treatment an infection could spread
beyond the tattoo or become complicated by a secondary infection.
If you suspect you may have a tattoo-related infection, FDA recommends the following:
your health care professional if you see a red rash with swelling,
possibly accompanied by itching or pain in the tattooed area, usually
appearing 2-3 weeks after tattooing.
- Report the problem to the tattoo artist.
- Report the problem to MedWatch, on the Web or at 1-800-332-1088; or contact FDA’s consumer complaint coordinator in your area.
back to top
Why Tattoo Inks Go Bad
Inks and pigments can be contaminated through:
- use of contaminated ingredients to make inks,
- use of manufacturing processes that introduce contaminants or allow contaminants to survive,
- use of unhygienic practices that contaminate ink bottles or mixing with contaminated colors,
- use of non-sterile water to dilute the inks, and
- using tattoo inks past their expiration date.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
August 22, 2012
Related Consumer Updates
Share This Page