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FDA: Some Tattoo Ink Kits Pose Serious Infection Risk
No longer simply for sailors or bikers, tattoos have gained enormous popularity in recent years. More than one out of every four adults sports some type of permanent ink on their bodies. This has resulted not only in widespread acceptance but also in the belief that the process is safe.
However, there are many risks associated with “getting inked,” including the possibility of a severe infection. This was highlighted recently by the U.S. Food & Drug Administration’s recall of certain types of kits connected to major infections.
Our product liability lawyers understand the reportedly contaminated ink products, produced by White and Blue Lion, Inc., were recalled in mid-July. However, the FDA has expressed concern that both professional tattoo artists and consumers are still buying and using the home tattoo kits from distributors, particularly online retailers, who may not know or care that the products have been recalled.
The products are identifiable by a dragon logo on the packaging. Additionally, the manufacturer name and address is missing from the label. This is in direct violation of FDA regulations, which require such information be displayed prominently on the product label. The products were sold not just in tattoo kits, but also in sets and single units.
Federal regulators know of at least one confirmed case of a skin infection stemming from the use of these products. Other reports of serious infection have been made that appear to be connected to tattooing products with similar packaging.
When the FDA conducted independent testing of samples of the product, the federal researchers found several had dangerous bacteria known to cause infection. These types of infections would most likely require treatment with antibiotics and possibly even surgery with extended hospitalization. In some cases, people might be at risk of developing sepsis, a type of bodywide blood infection that is potentially life-threatening. Even if a person recovers from one of these infections, he or she may forever be scarred at the tattoo site.
The FDA has issued several warnings over the last month, urging tattoo artists and consumers to avoid recalled kits, as well as those products that are missing essential information.
It’s true that infection or allergic reactions are an inherent risk of tattooing. However, professional artists have ways to minimize those risks. Shops and artists who fail to abide by basic safety and cleanliness standards may increase the risk of customer infection and could be held liable. The manufacturer of the ink could also be found liable if the infection can be linked to contamination of the product.
There was a case not long ago out of New York in which a tattoo artist using distilled water and reverse osmosis to treat water used to create and dilute tattoo ink products resulted in non-tuberculous Mycobacterial skin infections in at least 18 people.
Those who may be at particular risk of infection include those with pre-existing circulatory or heart diseases, as well as those suffering from diabetes or compromised immune systems. A tattoo with contaminated products puts these individuals at greater risk of harm.
The Centers for Disease Control and Prevention recommend that consumers only patronize tattoo parlors that are approved or registered in the local jurisdiction. Customers should also specifically request the use of inks made specifically for the purpose of tattooing and ensure the artist follows appropriate hygiene standards. If a skin infection does occur, prompt medical attention is critically important.
The Ferraro Law Firm handles medical malpractice claims as a result of defective medical products or dangerous pharmaceuticals. Call (888) 554-2030 for a free and confidential consultation. Offices in Miami and Washington, D.C.
Inks Used in Certain Tattoo Kits Cause Infections, Aug. 8, 2014, U.S. Food & Drug Administration
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