* Infections prompted CDC probe
* FDA does not directly regulate tattoo inks
By Gene Emery
Aug 22 (Reuters Health) - Contaminated tattoo ink caused at
least 22 skin and soft tissue infections last fall in four U.S.
states, according to an analysis released on Wednesday.
The infections prompted an investigation by the U.S. Centers
for Disease Control and Prevention that uncovered 22 confirmed
cases, 4 probable cases and 27 possible cases of
contamination-related infections in New York, Washington, Iowa
Products from four companies were implicated during the
probe. None of the companies is identified in a CDC report,
released in conjunction with a New England Journal of Medicine
study of the New York cases.
"People who get tattoos must be made aware of this risk and
seek medical attention" if they get a rash or other
abnormalities at the site, according to a commentary in the
journal from a team led by Pamela LeBlanc of the U.S. Food and
The bacteria got into the containers when the manufacturer
used distilled or reverse-osmosis water, which is not
necessarily sterile. In the New York cases, which led to a
recall by the Arizona-based manufacturer, the water was used to
dilute black ink into various shades of gray.
The New York cases involved infection with a bug called
Mycobacterium chelonae, which caused reddish or purple raised
bumps in the areas tattooed with gray. The infection can mimic
an allergic reaction and be difficult to treat.
"They were not getting better" with standard care, said Dr.
Byron Kennedy of the Monroe County Department of Public Health
in New York, the chief author of the New England Journal of
Medicine study. "You had some folks who were on treatment for 6
months or more."
The FDA does not directly regulate tattoo ink because it is
regarded as a cosmetic, but it can intervene when a product has
been adulterated or is regarded as unsafe.
Currently, no FDA regulation specifically requires tattoo
ink to be sterile, but some local jurisdictions, such as Los
Angeles County, do require that sterile water be used when inks
are diluted, according to the CDC report.
CDC is encouraging doctors to keep track of such infections
and report them to the FDA.
About one in five Americans has tattoos, according to a 2012
Harris Interactive poll.
SOURCES: bit.ly/PwHriF New England Journal of Medicine,
August 23, 2012, and 1.usa.gov/10AZNP MMWR, August 22,
(Reporting by Gene Emery in Providence, Rhode Island; Editing
by Ivan Oransky and Cynthia Osterman)