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The inks used in tattoos and permanent makeup (also known as micropigmentation) and the pigments in these inks are subject to FDA regulation as cosmetics and color additives. However, FDA has not attempted to regulate the use of tattoo inks and the pigments used in them and does not control the actual practice of tattooing. Rather, such matters have been handled through local laws and by local jurisdictions.

But with the growth in popularity of tattooing and permanent makeup, FDA has begun taking a closer look at related safety questions. Among the issues under consideration are tattoo removal, adverse reactions to tattoo colors, and infections that result from tattooing.

Another concern is the increasing variety of pigments and diluents being used in tattooing — more than fifty different pigments and shades, and the list continues to grow. Although a number of color additives are approved for use in cosmetics, none is approved for injection into the skin. Using an unapproved color additive in a tattoo ink makes the ink adulterated. Many pigments used in tattoo inks are not approved for skin contact at all. Some are industrial grade colors that are suitable for printers’ ink or automobile paint.

Nevertheless, many individuals choose to undergo tattooing in its various forms. For some, it is an aesthetic choice or an initiation rite. Some choose permanent makeup as a time saver or because they have physical difficulty applying regular, temporary makeup. For others, tattooing is an adjunct to reconstructive surgery, particularly of the face or breast, to simulate natural pigmentation. People who have lost their eyebrows due to alopecia (a form of hair loss) may choose to have “eyebrows” tattooed on, while people with vitiligo (a lack of pigmentation in areas of the skin) may try tattooing to help camouflage the condition.

Whatever their reason, consumers should be aware of the risks involved in order to make an informed decision.

 The following are the primary complications that can result from tattooing:

Infection . Unsterile tattooing equipment and needles can transmit infectious diseases,such as hepatitis. The risk of infection is the reason the American Association of Blood Banks requires a one-year wait between getting a tattoo and donating blood.

It is extremely important to make sure that all tattooing equipment is clean and sterilized before use. Even if the needles are sterilized or never have been used, it is important to understand that in some cases the equipment that holds the needles cannot be sterilized reliably due to its design. In addition, the person who receives a tattoo must be sure to care for the tattooed area properly during the first week or so after the pigments are injected.

Removal problems . Despite advances in laser technology, removing a tattoo is a painstaking process, usually involving several treatments and considerable expense. Complete removal without scarring may be impossible. See “The Most Common Problem: Dissatisfaction” and “Removal Techniques,” below.

Allergic reactions .Although allergic reactions to tattoo pigments are rare, when they happen they may be particularly troublesome because the pigments can be hard to remove. Occasionally, people may develop an allergic reaction to tattoos they have had for years.

Granulomas .These are nodules that may form around material that the body perceives as foreign, such as particles of tattoo pigment.

Keloid formation . If you are prone to developing keloids — scars that grow beyond normal boundaries — you are at risk of keloid formation from a tattoo. Keloids may form any time you injure or traumatize your skin, and according to Office of Cosmetics and Colors (OCAC) dermatologist Ella Toombs, M.D., tattooing or micropigmentation is a form of trauma. Micropigmentation: State of the Art, a book written by Charles Zwerling, M.D., Annette Walker, R.N., and Norman Goldstein, M.D., states that keloids occur more frequently as a consequence of tattoo removal.

MRI complications . There have been reports of people with tattoos or permanent makeup who experienced swelling or burning in the affected areas when they underwent magnetic resonance imaging (MRI). This seems to occur only rarely and apparently without lasting effects.

There also have been reports of tattoo pigments interfering with the quality of the image. This seems to occur mainly when a person with permanent eyeliner undergoes MRI of the eyes. Mascara may produce a similar effect. The difference is that mascara is easily removable.

The cause of these complications is uncertain. Some have theorized that they result from an interaction with the metallic components of some pigments.

However, the risks of avoiding an MRI when your doctor has recommended one are likely to be much greater than the risks of complications from an interaction between the MRI and tattoo or permanent makeup. Instead of avoiding an MRI, individuals who have tattoos or permanent makeup should inform the radiologist or technician of this fact in order to take appropriate precautions, avoid complications, and assure the best results.

The Most Common Problem: Dissatisfaction

According to Dr. Toombs, the most common problem that develops with tattoos is the desire to remove them. Removing tattoos and permanent makeup can be very difficult.

Skill levels vary widely among people who perform tattooing. According to an article by J.K. Chiang, S. Barsky, and D.M. Bronson in the June 1999 issue of the Journal of the American Academy of Dermatology, the main complication with eyelid tattooing is improperly placed pigment. You may want to ask the person performing the procedure for references and ask yourself how willing you are to risk permanently wearing someone else’s mistake.

Although tattoos may be satisfactory at first, they sometimes fade. Also, if the tattooist injects the pigments too deeply into the skin, the pigments may migrate beyond the original sites, resulting in a blurred appearance.

Another cause of dissatisfaction is that the human body changes over time, and styles change with the season. The permanent makeup that may have looked flattering when first injected may later clash with changing skin tones and facial or body contours. People who plan to have facial cosmetic surgery are advised that the appearance of their permanent makeup may become distorted. The tattoo that seemed stylish at first may become dated and embarrassing. And changing tattoos or permanent makeup is not as easy as changing your mind.

 Methods for Tattoo Removal include laser treatments, abrasion, scarification, and surgery. Some people attempt to camouflage an objectionable tattoo with a new one. Each approach has drawbacks:

Laser treatments can lighten many tattoos, some more easily and effectively than others. Generally, several visits are necessary over a span or weeks or months, and the treatments can be expensive. Some individuals experience hypopigmentation — a lightening of the natural skin coloring — in the affected area. Laser treatments also can cause some tattoo pigments to change to a less desirable shade.

Unfortunately, knowing what pigments are in your tattoo or permanent makeup has always been difficult and has become more so as the variety of tattoo inks has multiplied. Inks are often sold by brand name only, not by chemical composition. Because the pigments are sold to tattoo parlors and salons, not on a retail basis to consumers, manufacturers are not required by law to list the ingredients on the labels. Furthermore, because manufacturers may consider the identity and grade of their pigments “proprietary,” neither the tattooist nor the customer may be able to obtain this information.

There also have been reports of individuals suffering allergic reactions after laser treatments to remove tattoos, apparently because the laser caused allergenic substances in the tattoo ink to be released into the body.

Dermabrasion involves abrading layers of skin with a wire brush or diamond fraise (a type of sanding disc). This process itself may leave a scar.

Salabrasion, in which a salt solution is used to remove the pigment, is sometimes used in conjunction with dermabrasion, but has become less common.

Scarification involves removing the tattoo with an acid solution and creating a scar in its place.

Surgical removal sometimes involves the use of tissue expanders (balloons inserted under the skin, so that when the tattoo is cut away, there is less scarring). Larger tattoos may require repeated surgery for complete removal.

Camouflaging a tattoo entails the injection of new pigments either to form a new pattern or cover a tattoo with skin-toned pigments. Dr. Toombs notes, however, that injected pigments tend not to look natural because they lack the skin’s natural translucence.

What About Temporary Tattoos?

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Most contain color additives approved for cosmetic use on the skin. However, the agency has issued an import alert for several foreign-made temporary tattoos.

According to OCAC Consumer Safety Officer Allen Halper, the temporary tattoos subject to the import alert are not allowed into the United States because they don’t carry the FDA-mandated ingredient labels or they contain colors not permitted by FDA for use in cosmetics applied to the skin. FDA has received reports of allergic reactions to temporary tattoos.

In a similar action, FDA has issued an import alert for henna intended for use on the skin. Henna is approved only for use as a hair dye, not for direct application to the skin. Also, henna typically produces a reddish brown tint, raising questions about what ingredients are added to produce the varieties of colors labeled as “henna,” such as “black henna” and “blue henna.”

 FDA has received reports of adverse reactions to some temporary skin-staining products. The following information is intended to respond to questions about the safety and legality of such products.

What about “decal”-type temporary tattoos?

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Many contain color additives approved for cosmetic use on the skin. However, FDA has received reports of allergic reactions to some temporary tattoos.

An import alert is in effect for several foreign-made temporary tattoos. According to Consumer Safety Officer Allen Halper of FDA’s Office of Cosmetics and Colors, the temporary tattoos subject to the import alert are not allowed into the United States because they don’t have the required ingredient declaration on the label or they contain colors not permitted for use in cosmetics applied to the skin.

What about henna, or mehndi?

Henna, a coloring made from a plant, is approved only for use as a hair dye, not for direct application to the skin, as in the body-decorating process known as mehndi. This unapproved use of a color additive makes these products adulterated and therefore illegal. An import alert is in effect for henna intended for use on the skin. FDA has received reports of injuries to the skin from products marketed as henna.

Since henna typically produces a brown, orange-brown, or reddish-brown tint, other ingredients must be added to produce other colors, such as those marketed as “black henna” and “blue henna.” So-called “black henna” may contain the “coal tar” color p-phenylenediamine, also known as PPD. This ingredient may cause allergic reactions in some individuals. The only legal use of PPD in cosmetics is as a hair dye. It is not approved for direct application to the skin. Even brown shades of products marketed as henna may contain other ingredients intended to make them darker or make the stain last longer.

In addition to color additives, these skin-decorating products may contain other ingredients, such as solvents.

How do I know what’s in a temporary tattoo or henna/mehndi product?

Cosmetics including temporary skin-staining products that are sold on a retail basis to consumers must have their ingredients listed on the label. Without such an ingredient declaration, they are considered misbranded and are illegal in interstate commerce. FDA requires the ingredient declaration under the authority of the Fair Packaging and Labeling Act (FPLA).

Because the FPLA does not apply to cosmetic samples and products used exclusively by professionals–for example, for application at a salon, or a booth at a fair or boardwalk–the requirement for an ingredient declaration does not apply to these products.

Does FDA approve color additives?

By law, except for coal tar colors used in hair dyes, color additives used in cosmetics must be approved by FDA for their intended uses. Some may not be used unless FDA has certified in its own labs that the composition of each batch meets the regulatory requirements. Cosmetics–including temporary tattoo products–that do not comply with restrictions on color additives are considered adulterated and are illegal in interstate commerce.

Does FDA approve other cosmetic ingredients?

Except for color additives, FDA does not have the authority to approve cosmetic products or ingredients, although the use of several substances in cosmetics is prohibited or restricted due to safety concerns. However, if the safety of the product or its ingredients has not been substantiated, the product is misbranded–and therefore illegal in interstate commerce–if it does not have this warning on the label:

“Warning-The safety of this product has not been determined.”

How do I report an adverse reaction to a temporary tattoo or other cosmetic?

FDA encourages consumers to report any adverse reactions to cosmetics either to their nearest FDA district office or to FDA’s Office of Cosmetics and Colors. Here’s how:

• To contact your nearest FDA district office, you can find their phone numbers on FDA’s Web site. These phone numbers also are included in the U.S. Government listings in the Blue Pages of the phone book under United States Government/Health and Human Services.
• To contact FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), call (301) 436-2405 or email CAERS@cfsan.fda.gov.

Tattoo Removal and Prisoners

National’s Law & Order spokesman, Simon Power, says the Corrections Department’s tattoo removal scheme has proved to be a waste of $278,000 of taxpayers’ money.

He is commenting on replies from the Corrections Minister to questions regarding the scheme, which was designed to see if removing prisoners’ visible tattoos reduced serious offending.

In one reply the department admits ‘The re-offending rate was not significantly different from that of a control group of prisoners.’

Mr Power says this supports what had long been suspected: “The scheme is a waste of money.”

“It has cost an average of $891 for each of the 312 prisoners who have taken part since 1999 and has achieved virtually nothing. The department admits that.”

“Its own figures cite some serious re-offending by prisoners despite having their tattoos removed – crimes like assaults on females, kidnapping and aggravated robbery, burglaries, and breach of parole.”

“It is time to ditch the scheme and spend the money on something more useful. Corrections’ resources are really stretched right now so there are plenty of things to choose from,” says Mr Power.

Oral Piercing

Body piercing is popular today in the United States and other western societies. One common type of body piercing is tongue piercing, which involves placing a “barbell”-type stud through the tongue. But wearing a tongue stud puts people at risk for chipped teeth, recessed gums, and nerve damage, warns the Academy of General Dentistry (AGD).

However, most people don’t realize that getting an oral piercing also places them at risk for developing a fatal infection or, in some cases, a mini-tongue, according to a report in the January/February 2006 issue of General Dentistry, the AGD’s clinical, peer-reviewed journal.

In the report, a young woman’s pierced tongue developed a large, round lump adjacent to the piercing. The lump, which she called her “second tongue,” didn’t hurt, nor was it infected, but it was growing. This mass was determined to be a scar tissue formation. Improvement was noted after oral hygiene was increased (frequent use of mouthwash and hydrogen peroxide mouthwash) and the tongue stud was replaced with a shorter shaft.

“Keep the wound clean. Make sure the bar is short so food and bacteria won’t enter the site,” advises Ellis Neiburger, DDS, lead author of the study. “Replace the metal barbell heads with plastic ones.”

The number of adults between ages 21 and 31 who have their tongue pierced continues to increase, notes Melvin K. Pierson, DDS, FAGD, AGD spokesperson, despite his efforts to educate his patients about the dangers.

Although this article cited an extreme case, there are some very common dangers associated with tongue piercing. Unclean piercing equipment can cause other infections, such as bloodborne hepatitis. Also, if a patient is not instructed to avoid touching the piercing, they might spread infections with their own fingers.

“I see a lot of damage caused by piercing: tooth fractures, tooth chips. Patients don’t see the relation between them and piercing, which weakens the tooth. The damage is almost always in the pre-molars, the middle teeth, almost parallel to the piercing,” says Dr. Pierson. “The best way to prevent damage is to not get your tongue pierced.”

“I don’t recommend piercing,” says Dr. Pierson. “Because of the risks associated with this unregulated procedure, if someone is considering an oral piercing, he or she should discuss it with their medical or dental professional.”

Hazards of tongue piercing:

• Infection due to unsterile instruments.

• Pierced blood vessel or artery.

• Development of scar tissue.

• Tooth fractures and chips.

Getting Tattoo

In recent years, many have said that white collar professionals, college students and celebrities getting tattooed, pumping iron or riding motorcycles democratize or blur distinctions between rich and poor. However, a Penn State researcher claims just the opposite in a study including fads and fashions such as body sculpting at expensive health clubs, rich urban biking, the art of the chopper and modern primitive tattooing.

“The object is not to get chummy with the poor. These are artistic practices that reconstruct class boundaries and ultimately relegate the poor to the hardcore,” says Karen Bettez Halnon, associate professor of sociology at Penn State’s Abington Campus near Philadelphia.

Signature tattoos, custom choppers, expensive health club fitness programs and the like represent a new form of gentrification, or middle class takeover of lower class communities, Halnon notes.

Her findings are published in an article, “Muscles, Motorcycles and Tattoos: Gentrification in a New Frontier,” in the current issue of the international Journal of Consumer Culture.

Halnon’s study explains how a “compelling symbolic triplet of lower class masculinity” has been glorified with a range of class distinguishing qualities such as: discussing the practices in esoteric language; locating the practices deep in history; treating the practices as optional and autonomous indulgences; gaining the sponsorship of elite institutions; and establishing professional skills and knowledge that provide social distance from the lower classes.

The researcher examined the content of coffee table books, conference proceedings, museum exhibits, and the techniques of various artists and experts who sculpt customized bodies and machines, such as on the television shows “American Chopper” and “Miami Ink.” The Penn State professor says her findings are troubling because “gentrifying muscles, motorcycles and tattoos, like all cases of gentrification, ultimately displaces the lower classes from their communities.”

Providing an example of the harm that may be done through symbolic gentrification, Halnon cited Wooden and Blazak’s study of San Francisco gutter punks who took drastic measures to defend against “frat boys and pro athletes” who invaded their “symbolic turf” by appropriating body piercing as a style. One group of gutter-punks responded by cutting off their pinky fingers.

“The extremity of such action may be understood as measure of the extreme value of symbolic territory for the socially and economically disenfranchised,” notes Halnon.

Tattoo Removal

If you didn’t believe your mom when she said that you would regret getting your beloved’s name tattooed on your arm - you are not alone.

Tattoos are an ancient tradition. In some cultures, tattooing was done for prestige and was very sacred. Today, people get tattoos in memory of loved ones, as a sign of rebellion or just to be cool.

However, tattoos can carry a number of health risks.

“If not done properly, the most common health risks are scarring, allergic reactions, and Hepatitis C,” said Dr. Ramsey Markus, an assistant professor of dermatology and director of the dermatology laser center at Baylor College of Medicine in Houston. “Allergic reactions are particularly bothersome as they are often chronic, itchy and difficult to treat. Red inks are the most likely to cause allergic reactions.”

There’s no cure for Hepatitis C, which is a liver disease caused by the Hepatitis C virus. Infections can occur in new tattoos, especially without appropriate after care.

A tattoo is a puncture wound, made deep in your skin, that’s filled with ink. Tattoos are long-lasting because they are injected into the dermis, the second layer of skin where the cells are stable and do not shed.

Unfortunately, it’s often more expensive to remove a tattoo than it is to get one. Dermatologists at Baylor College of Medicine are using the Medlite C6 laser, one of the safest and fastest tattoo removal lasers.

“Before the latest laser technology, the only way to remove a tattoo was surgically,” Markus said. “The tattoo would be cut out, burned off or sanded away. Salabrasion, or sanding the skin and rubbing in salt, was also effective.”

The Medlite C6 laser produces a beam of laser light that passes through the skin to break up the ink. The ink particles that are small enough are removed gradually for up to three months by the immune system. The treatment takes a few minutes depending on the size and color of the tattoo.

The number of sessions depends on the color of the ink, its density and how deep the tattoo is placed. Amateur tattoos take two to four sessions, while professional tattoos require six to 10 sessions. Black, blue and red inks are the easiest to remove, and green and yellow are the most difficult.

“Before getting a tattoo people should think about whether or not it’s worth it in the long run,” Markus said. “Some people keep their tattoos for ever, but others regret that they acted on impulse and decide to get it removed.”

Ear Piercing and Infection

My daughter is 4-months-old and I would like to have her ears pierced, but I want to make sure she is not too young for that. Are there any risks associated with piercing at this age?

Women, children and even men have worn earrings dating back to Biblical times and while ear piercing used to be considered a “rite of passage” into adulthood, we now see young children and even babies with pierced ears.  Even if it is quite common to see infants with earrings, there are some health issues parents should consider before proceeding with the piercing.

The major concern is infection.  Piercing should be done by a reputable expert who follows aseptic technique (wears gloves, sterilizes equipment and uses alcohol or other antiseptic on the skin).  Earring posts should be hypo-allergenic stainless steel or gold to reduce the chances of an allergic reaction which also can lead to infection.  The initial posts should stay in place for six weeks.  The pierced area of the ear should be cleaned, front and back, with alcohol several times a day. You should try to keep the babies hands away from her newly pierced ears.

Second to infection, it is very important that the piercing not be done before infants have completed their DPT shots.

Infants should only wear stud earrings, or earrings that lie close to the skin. Loops or dangling earrings can get caught in clothing or on objects and tear the ear lobe. Children also are much more prone to play with and pull on dangling earrings. With any earring, parents should make sure the back of the earring is secure and does not become loose or fall off, creating the risk of swallowing the earring.

Parents may also be confronted by older children who not only want to pierce their ear lobes, but the cartilage on the outer ear. I strongly advise against this since cartilage is easily injured, easily infected and has such poor blood supply that it will heal very poorly. There are known instances where cartilage piercing has lead to severe infection and ultimate disfiguration of the ear itself.

Some people, regardless of age, are prone to form keloids. These growths, such as scar tissue, occur after tissue injury and become large, unsightly growths that are difficult to correct. If there is any family history of keloid formation, it is advisable not to pierce your daughter’s ears until she is much older, such as a teenager or young adult. It may make good sense not to pierce your child’s ear until she is old enough to make the personal decision herself.

In our society, ear piercing is considered a fashion statement and is popular among boys and girls, men and women. If you do consider ear piercing for your child, no matter what their age, you should discuss the pros and cons with your child and your physician, making sure you take the necessary steps to prevent infection or injury.  There is no reason to risk a serious health problem for a cosmetic effect.

Nipple Piercing and Breastfeeding

Until recently, the option to breastfeed after birth was not offered to women with nipple piercings. While there may have been assumed implications to breastfeeding when pierced, limited documentation exists.

Now, there exist organizations that promote breast-feeding for those women and teach nurses how to deal with them on an individual basis. “The challenge for perinatal nurses becomes how to intervene to maximize opportunities for breastfeeding success in women with nipple piercings,” says Dr. Armstrong. While nurses are now encouraged to offer breastfeeding as an option, there are still reservations regarding the results.

In the past, breastfeeding supporters have said it is safe for pierced women to breastfeed, but noted there could be serious risks involved in doing so. Infants can aspirate on the jewelry and the metal of the jewelry can cause trauma to an infant’s lips, palate, tongue and gums, according to an article in the June/July issue of AWHONN Lifelines presenting findings from research about women’s breastfeeding success when the nipple is pierced.

“Careful history taking and physical assessment of the breasts a {prenatal} time affords the opportunity for nurses to provide pierced women with factual information about nipple piercing and breastfeeding,” says lead author Myrna L. Armstrong.  By considering the piercing as an integral part of the breastfeeding decision process, prenatal nurses can help foster breastfeeding success.