- WASHINGTON (Reuters) - A
type of ink used to apply permanent makeup has been linked to cases of
serious disfigurement from swelling, scarring and other reactions, U.S.
regulators said on Friday.
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- The Food and Drug Administration said it had received
more than 50 reports of reactions to certain ink shades made by the American
Institute of Intradermal Cosmetics. The company in Arlington, Texas, also
does business under the name Premier Products, and the inks were sold under
the Premier Pigments brand.
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- Permanent makeup is a form of tattooing used to apply
lip liner, eyeliner or eyebrow color.
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- Reactions reported to the FDA include swelling, cracking,
peeling, blistering and scarring around the eyes and lips, as well as granulomas,
which are lumps of inflamed tissue, the agency said in a statement.
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- In some cases, the reactions caused serious disfigurement
that resulted in difficulty eating and talking, the FDA said.
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- Premier Pigments said allergic reactions were a risk
with all permanent cosmetic and tattoo procedures.
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- The company recalled some pigment products in 2003 because
of the reactions, and had asked the FDA to investigate, a statement said.
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- "Premier Pigments will continue to work in unison
with the FDA to do everything necessary to inform and maintain the safety
of the public," Sandi Hammons, president of Premier Pigments, said
in a statement.
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- The company recalled five ink shades in July 2003, the
FDA said. The agency continued to receive reports of reactions involving
shades not subject to the recall, the FDA said.
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- The agency urged consumers and health-care providers
to report reactions from tattoos and permanent makeup to the FDA as well
as state and local health authorities.
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