FDA Warns Consumers about Infection Risk from Contaminated Tattoo Inks

A Thousand Virgins Corp. in Miami (City of Industry), Florida, has recalled all lots of its tattoo grey wash inks because of microbiological contamination that could lead to infection in those who are tattooed with the inks.

The Food and Drug Administration (FDA) warns tattoo artists and consumers to avoid the contaminated tattoo inks. The inks subject to the recall were manufactured, sold and distributed by A Thousand Virgins Corp. The G1, G2 and G3 grey wash tattoo inks, labeled Lot #129, expiration date 1/16, were distributed nationwide and may be available for sale from international and online distributors.

FDA testing detected microbial contamination in the inks: Mycobacterium chelonae organisms and the molds Cryptococcus albidus and members of the Penicillium genus were found. Use of these inks may cause bacterial infection, which could lead to sepsis, a potentially life-threatening complication of an infection. Despite the recall, the FDA is concerned that artists and consumers are continuing to use these contaminated inks from their current stock.

Tattoo artists and consumers who purchase tattoo inks or individuals who are getting tattoos should check the ink bottles to see if they are included in the recall. Anyone who finds inks that are included in the recall should carefully dispose of them, first checking with local waste management authorities about safe disposal procedures. The FDA said recalled ink bottles should be placed in two plastic bags. After the first bag is sealed or tied off to prevent leakage, that bag should be placed in a second bag before disposal.

Anyone with questions about the inks may contact A Thousand Virgins at 1-866-829-4659 from Monday to Friday from 9 a.m. to 5 p.m. EST.

In July 2014, commenting on a recall of contaminated tattoo ink, Dr. Linda Katz, M.P.H., director of the FDA’s Office of Cosmetics and Colors, warned that contaminated tattoo inks could cause infection. “Tattooing poses a risk of infection to anyone, but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems,” she said. Injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo, Katz said. Symptoms of localized infection include redness, swelling, weeping wounds, blemishes, or excessive pain at the site. Anyone who has been tattooed and experiences such symptoms should seek immediate medical care. The FDA warns that even when a localized infection has healed, the area may be permanently scarred. If the infection is not treated or is inadequately treated, the infection could spread through the bloodstream—a process known as sepsis, which can be fatal.

The FDA urges consumers and tattoo artists to take precautions to avoid infections caused by tattooing. The FDA asks consumers and tattoo artists to report infections and other adverse events through the MedWatch Safety Information and Adverse Event Reporting Program so the agency can investigate and prevent further infections.

 

The post FDA Warns Consumers about Infection Risk from Contaminated Tattoo Inks appeared first on Parker Waichman -

from Parker Waichman http://www.yourlawyer.com/blog/fda-warns-consumers-about-infection-risk-from-contaminated-tattoo-inks/