FDA Warns of 'Permanent Makeup' ScarringJul 3, 2004 | CNN The Food and Drug Administration issued an alert Friday warning of possible disfigurements from injecting permanent ink as eyeliner, lip liner or eyebrow coloring.
The notice listed scarring and difficulty eating among the worst side effects of so-called "permanent makeup."
Only specific ink shades from the Premier Pigment brand of permanent makeup inks were associated with adverse reactions. American Institute of Intradermal Cosmetics, which does business as Premier Products, in Arlington, Texas, makes the inks.
The FDA is investigating the 50 claims it has received thus far, according to an agency statement.
Swelling, cracking, peeling, blistering, scarring and the forming of granulomas chronic swelling and infection in tissue near the eyes or lips were listed among the side effects.
"In some cases, the effects reported caused serious disfigurement, resulting in difficulty in eating and talking," the FDA statement read.
Premier Products president Sandi Hammons wrote in a statement that there are risks with all permanent procedures.
"Allergic reactions to permanent pigments can result in inflammation, itching, cracking, scarring and granuloma formation," she wrote.
Allergic reactions to pigment "can be pretty severe and treatment is difficult," said Hammons, a tattoo artist who started the company 15 years ago. Although most cases can be resolved with steroids, in some cases the pigment must be removed with lasers, she said.
"A few have resulted in really severe cases of granuloma formation," she said.
Last July, Premier Products notified the FDA that it would stop selling five ink shades. But some of the reports the FDA received about ill effects did not involve inks on that list, the regulatory agency's statement read.
Hammons added that the company sought advice from the FDA and devised a plan to resolve the problem.
Specifically, the privately held company, which has 70 percent to 80 percent of market share, recalled nearly 500 color shades that contained benzadiozole orange, which had been linked to several types of reactions, she said.
Tattoos are cosmetics and ink pigments are color additives requiring federal approval before sale, the FDA states.
But, traditionally, the FDA has not exercised oversight of tattoos or pigments. Local jurisdictions regulated tattooing.
Hammons said severe reactions occur in fewer than one in 200,000 people.