Tattoos and permanent makeup can lead to a lasting headache for patients

Washington -- Take a look around. Butterflies and flowers adorn patients' shoulders and ankles, wolves and dragons are spread across their chests and backs. Even feet are fair game for the tattoo pen.

Nearly one-quarter of adults in the United States have at least one tattoo, and its close associate, permanent makeup, is gaining in popularity.

Such markings are not only fashion statements, they can also help improve a patient's appearance after reconstructive surgery, or disguise a lack of skin pigmentation or the loss of eyebrows due to alopecia. Some women might choose permanent makeup to save time in the morning.

But warnings are in order before a trip to the tattoo parlor, and primary care physicians could be called upon to deliver them.

Before 2003, there were few complaints about tattoos and permanent makeup, said Linda Katz, MD, MPH, director of the Food and Drug Administration's Office of Colors and Cosmetics. But since then, the FDA has received many reports of adverse reactions, particularly from women who have had their lips, eyes and eyebrows color-enhanced.

Some of those complaints resulted in a 2004 FDA alert to consumers to avoid certain shades of ink manufactured by Premier Pigments, a Texas manufacturer of permanent cosmetic pigments. The company since has taken those inks off the market. But the increasing number of available pigments and shades continue to raise concern, Dr. Katz said. Although some color additives are approved for use in cosmetics, none is approved for injection into the skin, she said.

Some of the pigments used in tattoos are not approved for skin contact at all. Some are industrial grade and are suitable for printers' ink or automobile paint. Dr. Katz spoke at the FDA's 2006 Science Forum held in Washington, D.C., April 18-20.

Among the problems that could bring recipients of permanent markings to a physician's office are infections from unsterile tattooing equipment -- including such serious infections as hepatitis. The risk of infection is one reason the American Assn. of Blood Banks requires a one-year wait between getting a tattoo and donating blood.

Allergic reactions, though rare, do occur, and they are hard to treat given the difficulty in removing such markings. People also might develop allergies years after receiving a tattoo, according to FDA information. Other skin problems include the formation of granulomas and keloids surrounding the tattoo or makeup.

Reports even give details of people with body markings who experience swelling or burning in the affected areas when they undergo magnetic resonance imaging, according to the FDA, although this seems to occur only rarely and is without lasting effects.

Removal difficulties

Attempts to remove an unwanted marking raise a host of additional problems, said R. Rox Anderson, MD, a professor of dermatology at Harvard Medical School in Boston, who has removed many tattoos. He also spoke at the FDA forum.

Despite the gains made during recent years in laser removal, only 75% of the inks on the market can be removed, and certain colors, such as a particular shade of green, are impossible to get rid of, he said. Plus, the process is lengthy, painful and costly. In other words, what seemed like a real buy at the start -- a lifetime tattoo for only $50 -- can turn into an expensive debacle, Dr. Anderson added.

More than half of the ink implanted into the dermis by the tattoo artist makes its way into the body's lymphatic system and, when blasted by a laser in an attempt to remove the tattoo, more ink is dispersed into the lymph nodes. The presence of multicolored pigment could pose a problem when and if an examination of the lymphatic system is called for in a future diagnostic procedure, he said.

He would like to see inks developed that can be safely applied and also relatively easily removed.

The FDA traditionally has not regulated tattoo inks or the pigments used in them, Dr. Katz said, because there had not been many reports of problems. But the agency is encouraging physicians to report any adverse events among patients.

To date, the agency has been made aware of more than 50 reactions from permanent makeup that include swelling, cracking, peeling, blistering and scarring in the areas of the eyes and lips. In some cases, the effects reported caused serious disfigurement that led to difficulty in eating and talking, according to agency information. Swelling can occur as long as one month after a procedure, Dr. Katz said.