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.
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.
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.
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.
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.
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."
In addition, healthcare professionals and consumers may submit information about adverse events to MedWatch, the FDA Medical Products Reporting Program, as follows:
Consumers may obtain MedWatch reporting forms by calling the following FDA toll-free number: (888) 463-6332 [888-INFO-FDA]
For more information, see
Temporary Tattoos and Henna/Mehndi and
FDA's Import Alert on Tattoo
FDA Alerts Consumers About Adverse Events Associated with "Permanent Makeup" July 2, 2004
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