The Food and Drug Administration has warned consumers about certain inks used in permanent makeup, which have been blamed for more than 50 adverse reactions nationwide -- some quite serious. The tattoo procedure, also known as micropigmentation, involves the injection of inks into the skin to make it appear as if the consumer has applied lip liner, eyeliner or color for eyebrows or other parts of the body.
The FDA reported swelling, cracking, peeling, blistering, scarring and granulomas -- inflamed tissue masses associated with infection -- around the eyes and lips. The agency said some consumers suffered disfigurement and difficulty eating and talking.
The inks the FDA pointed to were distributed by Premier Pigments, a Texas firm that says it makes most of the world's permanent makeup pigments and that they have been used safely by "millions" of consumers, mostly in the United States and Asia. Premier says the offending inks are in orange hues and were recalled a year ago. In some cases, they are still being used by technicians who didn't get the word or are mixing them with other firms' products, the firm said.
Linda M. Katz, an internist who heads the FDA's Office of Cosmetics and Colors, talked to staff writer Avram Goldstein about the warning.
Q How many people are using permanent makeup?
AWe don't actually keep track of the amount of product sold to consumers. I can't give you an exact number. . . . But it is gaining in popularity. There seem to be more articles in fashion magazines about permanent makeup.
What kind of adverse reactions have you seen?
Obviously, reports of scarring, rashes, swelling and keloid formation around the face is something we get concerned about.
What is causing these allergic reactions?
We don't know all of the inks that may be in either permanent makeup or in tattoos. It may be different ink pigments that cause different kinds of reactions. . . . We're not sure what people are allergic to. They are not all allergic reactions, but some look like they are allergic in nature.
When did you first start getting reports of adverse reactions?
Maybe about 10 months ago. From what we've seen at this point, it looks like only this product is involved.
Does that mean other injectable ink products are acceptable?
Not necessarily. We don't know what actual problems might happen from using these inks. We cannot attest to the safety of any of them. There is no FDA-sanctioned ink for dermal injection. . . . Local authorities have jurisdiction in the art of tattooing and how they are used. We have the regulation over the ink that gets used. None of the inks used for tattoos has been approved for color additives.
What type of technician is the best qualified to apply permanent makeup?
I'm not aware of whether that matters. Some are trained tattoo artists. Some physicians may do it.
Is the FDA telling consumers not to have permanent makeup?
I'm not saying that no one should have that. We're just trying to make consumers aware of the public health risk. . . . People who are considering it should at least be well informed about the potential risks from tattoos. If they do have a problem, they should make sure that they see a physician to help them with an adverse event that might occur.