Tattoo Health Concerns Spark FDA Warning, as Agency Announces New Tattoo StudyDec 10, 2007 | Parker Waichman LLP
Tattoos carry serious health risks, the U.S. Food and Drug Administration (FDA) warned on Friday, and it urged consumers to think about health and safety before getting tattoos. For its part, the FDA announced that it is implementing its own study of issues involved in the ancient art. The potential to transmit infections through unsterilized needles has been known for years; however, few investigations have reviewed health effects linked to tattoo inks and pigments, which is now an agency focus.
Some wonder why the FDA has developed an interest in tattoos and feel the FDA should be investigating physicians infecting people, such as the Dix Hills Doctor-Harvey Finkelstein-whose shoddy practices infected at least one patient with hepatitis C and placed thousands at risk. Twelve of Finkelstein's patients have tested positive for either hepatitis C or B since the investigation into his practice began last month.
State and local authorities oversee the practice of tattooing ink and ink colorings (pigments) used in tattoos which are subject to FDA regulation as cosmetics and color additives; however, because of other public health priorities and a previous lack of evidence of safety concerns, the FDA has not traditionally regulated these inks or pigments. Tattoo enterprises are supervised by either county or state health authorities and are required to follow a set of health and safety guidelines. The FDA's Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition said it hopes to better understand the body's response to tattoos and their impact on human health and to identify products at greatest risk.
Allergies linked to pigments are not news given that people can be allergic to anything and some people developed allergies to older inks due to their ingredients; however, some tattoo artists are using 100 percent organic ingredients today, lowering allergic responses. The FDA noted that risks linked to tattoos can be formidable: Dirty needles can transmit HIV, hepatitis B and C, and other bacterial contaminants; scar tissue formation from receiving or removing tattoos, granulomas (small knots or bumps); and MRI complications-some people develop swelling or burning at the tattoo site when undergoing magnetic resonance imaging because of the iron oxide in tattoo pigments. Research has shown that some pigment migrates from the tattoo site to the body's lymph nodes, part of the lymphatic system, a collection of fluid-carrying vessels in the body that filter out disease-causing organisms.
Generally, the notion that tattoo shops can be a source of infection is not the norm as reputable enterprises pride themselves on infection control; however, the FDA issued its alert about the potential health risks of tattooing last week.
The FDA says there have been no systematic studies of the safety of tattoo inks, so they are looking at some of the basics: Some tattoos fade over time, some fade when exposed to sunlight; laser light is used to remove tattoos. What happens to the ink? The FDA has not approved any tattoo inks for injection into the skin and many ink pigments used are industrial strength colors suitable for printers' ink or automobile paint.