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FDA Issues Alert to Consumers about the Adverse Effects of Permanent Makeup Inks from Premier Products

On July 2nd, 2005, the Food and Drug Administration (FDA) published a press release alerting consumers to the number of reported adverse effects in individuals who have undergone certain "micro-pigmentation procedures." This is a form of tattooing, and it's used to apply permanent makeup in the form of lip liner, eyeliner and eyebrows.

Adverse health events have been associated with certain ink shades of the Premier Pigment brand of permanent makeup ink, which are manufactured by the American Institute of Intradermal Cosmetics, doing business as Premiere Products in Arlington, TX.

To date, FDA has been made aware of more than 50 adverse events and is investigating additional reports sent to the manufacturer. Adverse reactions that have been reported include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas (chronically inflamed tissue mass associated with an infection) in the areas of the eyes and lips. In some cases, the effects reported caused serious disfigurement, resulting in difficulty in eating and talking. It is alleged that some of this disfigurement may be irreversible and/or require extensive medical intervention.

In July 2003, the manufacturer reported to FDA its intent to remove five of its ink shades from the market, based on six adverse events that had been reported. However, the FDA has obtained additional reports of adverse events involving ink shades that were not included in the firm's initial removal effort. While the investigation is ongoing, the FDA is alerting consumers about associated adverse event reports received about Premier Products ink shades identified on the FDA website.

The FDA considers intradermal tattoos (including permanent makeup) cosmetics and considers the pigments used in the inks to be color additives requiring pre-market approval under the Federal Food, Drug, and Cosmetic Act. However, FDA has not traditionally regulated tattoo inks or the pigments used in them. The actual practice of tattooing is generally regulated by local jurisdictions.

As the FDA continues its investigation, the agency urges consumers and healthcare providers to continue to report all adverse reactions from tattoos, including permanent makeup, to the FDA as well as to the appropriate state and local health authorities.

Register your Case

If you've received permanent makeup, a micro-pigmentation procedure or a tattoo and experienced adverse effects with the inks like those described above, please click the link below to submit your complaint and an attorney will review the matter for consideration in a potential legal action.

Published on Jul-7-05


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