How Safe Is Permanent Makeup?
Adding permanent makeup to your skin may sound easy and convenient, but like any surgical procedure, there are risks.
By Leanna Skarnulis
Reviewed By Brunilda Nazario
Lovely red lips, perfectly shaped eyebrows, and flattering eyeliner. Permanent makeup holds the promise you'll work all day, go to the gym, dance all night, and wake up in the morning with makeup in place. Nothing, it seems, will phase these cosmetic tattoos.
In the hands of a skilled person, the procedures are generally safe. But state regulatory agencies haven't kept pace with the growth of the permanent makeup industry, and there are lots of unqualified people wielding needles.
Permanent makeup is considered micropigmentation, similar to tattoos. It involves using a needle to place pigmented granules beneath the upper layers of the skin. Tattooing and medical restoration, which corrects imperfections from scars and vitiligo (lack of natural pigmentation in the skin), are similar procedures. "They're the same procedures but used for different purposes," says ophthalmologist Charles S. Zwerling, MD, who coined the term micropigmentation.
Permanent makeup for eyeliner is the most popular cosmetic enhancement, followed by eyebrows and lip color. Some practitioners offer blush and eye shadow, but Zwerling, chairman of the American Academy of Micropigmentation (AAM) in Goldsboro, N.C., says he's totally opposed. "What I've seen has been very poorly done. You can't be sure what the color is going to do, and if you get an allergic reaction, you're dealing with a large surface area. You're talking about major reconstructive face surgery."
Most procedures are done after applying an anesthetic to the skin. Zwerling says after the initial procedure, touch-up might be required but no sooner than one month and as much as three months later. Practitioners include dermatologists, cosmetologists, aestheticians, nurses, and tattooists. Before you rush to the Yellow Pages to find a practitioner, experts advise doing your homework.
"Allergic reactions to pigments are reasonably rare, but it's difficult to remove the irritant," says FDA spokesman Stanley Milstein, PhD, in Washington, D. C. "Anytime you implant a foreign body into the skin, it has the potential for results not anticipated. The reaction could occur years later as a rash or an immune system allergic reaction."
Zwerling says pigments, like iron oxide, rarely cause allergic reactions. "Iron oxide has been shown to be the safest pigment," he says. "Anything that is vegetable based, organic, or natural is the most risky. It's the natural products in vegetables and herbs that can cause horrible allergic reactions."
Two more possible adverse reactions are granulomas, which are masses that form inside tissue around a foreign substance, and keloids, which are overgrowths of scar tissue or a raised scar. Keloids appear more often with removal of permanent makeup than with its application.
In July 2004, the FDA alerted the public to a number of reported adverse events in individuals who had undergone certain micropigmentation procedures. The adverse events are associated with certain ink shades of the Premier Pigment brand of permanent makeup inks, which are manufactured by the American Institute of Intradermal Cosmetics, doing business as Premier Products, in Arlington, Texas.
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As of July, the FDA had been made aware of more than 50 adverse events and is investigating additional reports sent to the manufacturer. Reactions that have been reported include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas in the areas of the eyes and lips. In some cases, the effects reported caused serious disfigurement, resulting in difficulty in eating and talking.
In December 2003, a jury in San Antonio found the owner of a permanent makeup salon guilty of infecting a woman with hepatitis C during a series of touch-ups to her lip color. They awarded the woman more than half a million dollars.
"I know of about 10 cases of hepatitis transmission from permanent makeup and in Canada a case of AIDS," says Zwerling. "The majority of practitioners were tattooists." Unsterile tattooing equipment and needles can transmit infectious diseases such as hepatitis.
'FDA-Approved Colors' -- a Red Flag
Don't be lured by ads claiming a practitioner uses FDA-approved colors. "Stay away," says Zwerling. "They're misrepresenting themselves and the profession." FDA approves colors only for specified end uses. When someone says "FDA-approved colors," you have no way of knowing whether the approval applies to cosmetics, food, or automotive paint, but one thing is certain: no color additive has ever been FDA-approved for injecting under the skin.
"FDA is certainly looking at some health and safety consequences," says Milstein. Complicating the issue is the fact that some pigments are mixtures of materials and are not required to have ingredients labeled because they're not sold to consumers. "These mixtures can be so complex it is very difficult for tattooists to know what they're using," he says.
Through its Cosmetics Adverse Reaction Monitoring program (CARM), the FDA urges consumers and health-care providers to report adverse reactions to tattoos and permanent makeup and problems with removal. Contact your FDA district office listed in the blue pages of your phone book.
"An issue you should be most concerned about is what happens some years down the road and you have an MRI," says Milstein. "There will be swelling or burning in the pigmented area due to interactions between the magnetic field and the pigment, and it may interfere with the quality of the MRI image."
Zwerling acknowledges that people will experience redness or inflammation following an MRI but says it's not a reason to avoid permanent makeup. "There's a magnetic reaction with the iron oxide in the pigment. It vibrates and sets up a mild inflammatory action that can be controlled by a topical steroid cream or Benadryl." He adds that the reaction from the permanent make up won't compromise the quality of the imaging as long as the radiologist is aware of the permanent makeup. "You have to tell them so they won't misread it."
How Permanent Is Permanent?
"Think of permanent makeup as permanent," says Zwerling. "Be absolutely sure, because it's not likely it can be changed."
Everybody is different, but he says in the vast majority of cases a significant amount of fading occurs each year. "Some people I did 20 years ago look great today, and some I did a year ago need another procedure."
Over time, some colors can migrate, and the result can be pretty creepy. Zwerling says this is most likely to happen if a practitioner uses black India ink, which should not be used in micropigmentation. "It has a very small particle size, so it's almost like staining the skin," he says. "Iron oxide pigments are inert, meaning they don't react metabolically. There's just a miniscule amount of migration with iron oxide."
He adds there's an unexpected benefit from permanent makeup in that it seems to help wrinkling and also helps break down scar bands so that scars are flattened somewhat. "But you can't always guarantee that," he says.
What if you walk into a salon wanting Jennifer Lopez's eyebrows and come out with Ben Affleck's? "The biggest risk in any cosmetic operation is disappointing results," says Zwerling. "Get it right the first time because the chance of getting it right the second time is complicated, and it gets progressively more complicated after that. You may have to travel. I know of only a handful of masters in the U.S. who can fix mistakes."
"Most people think laser treatments can remove tattoos or permanent makeup, but they can leave their own side effects, such as lighter skin color," says Milstein. Other removal methods include dermabrasion, surgical removal, and sometimes further tattooing to camouflage the problem. "Some techniques will leave a scar where the makeup was," he says.
Do It With Your Eyes Wide Open
Is it legal for someone to inject pigment into your skin whose only training was a correspondence course? Or no training? Absolutely. "Some states have no regulations at all, and that's frightening," says Zwerling. "Anyone can set up shop."
So what's a consumer to do?
Make sure the salon has a business license and a certificate showing it's been inspected by the local board of health.
Find out if the practitioner has been tested and found competent. The AAM is an accrediting body that requires a written, oral, and practical exam for certification. "Some states have chosen us as their certifying body," says Zwerling. "We try to be sure practitioners are at least competent in knowing the right procedures, how to sterilize, etc."
How many procedures has the practitioner performed and how long have they been doing it?
Ask to meet people the practitioner has performed procedures on. "Don't rely on a bunch of testimonials or pictures," says Zwerling. "Anybody can create a portfolio by stealing pictures from a web site."
Consider aesthetics, safety, and comfort. "Physicians may not be the best practitioners," says Zwerling. "They may know the science but not the artistry." The best choice might be a practice in which a nurse or cosmetologist works under the auspices of a physician. And if comfort is high on your agenda, be aware that the topical anesthetics a cosmetologist or tattooist uses are not as effective as injections in the hands of a medical professional.
To avoid infection, make sure you see the practitioner remove a fresh needle from a package and open a fresh bottle of pigment. And follow instructions for caring for the treated area in the days and weeks following the procedure.
Remember: Cosmetic styles change. Don't adopt a trendy look that could look dated in five, 10, or 20 years.
A final piece of advice. "Ask yourself how willing you are to wear someone else's mistake," says Milstein. "Changing tattoos or permanent makeup is not as easy as changing your mind."
Published June 21, 2004.
SOURCES: Micropigmentation: State of the Art, by Charles S. Zwerling, MD, Annette C. Walker, RN and Norman F. Goldstein, MD. "Tattoos and Permanent Makeup Fact Sheet," FDA/CFSAN Office of Cosmetics and Colors. Stanley Milstein, PhD, special assistant to the director, Office of Cosmetics and Colors, FDA/CFSAN, Washington, D.C. Charles S. Zwerling, MD, chairman, American Academy of Micropigmentation, Goldsboro, N. C. FDA.
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