The U.S. Food and Drug Administration Friday said more than 50 adverse events have been reported by people who have Premier Pigment brand permanent makeup.
Permanent makeup is applied using a micropigmentation procedure a form of tattooing to add lip liner, eyeliner or eyebrow color to the face. It has been linked to adverse events associated with certain ink shades of the Premier Pigment brand. The manufacturer is American Institute of Intradermal Cosmetics, doing business as Premier Products, in Arlington, Texas.
The FDA said it has data on more than 50 events and is investigating additional complaints including reports of swelling, cracking, peeling, blistering and scarring, as well as formation of granulomas or inflamed tissue from infection around the eyes and lips.
The agency said some cases included reports of serious disfigurement that resulted in patients have difficulty eating and talking.
The manufacturer said in 2003 it would remove five of its ink shades from the market but FDA said its reports cover other shades as well.