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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.
What Risks Are Involved in Tattooing?
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.
Removal Techniques
Methods for removing tattoos 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 hypo pigmentation -- 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."
Reporting Adverse Reactions
FDA urges consumers and healthcare providers to report adverse
reactions to tattoos and permanent makeup, problems with removal, or
adverse reactions to temporary tattoos. The agency operates the
Cosmetics Adverse Reaction Monitoring (CARM) system to monitor
problems consumers experience with cosmetic products and ingredients,
including color additives. Consumers and healthcare providers can
register complaints by contacting their FDA district office (see the
blue pages of your local phone directory) or by sending written
reports of adverse reactions to: Office of Cosmetics and Colors
HFS-106
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
You also can contact CARM by telephone at (202) 401-9725.
In addition, healthcare professionals and consumers may submit
information about adverse events to MedWatch, the FDA Medical Products
Reporting Program, as follows:
By mail: Use the postage-paid MedWatch Form (PDF
format)
By phone: 1-800-FDA-1088
By fax: 1-800-FDA-0178
By Internet:
MedWatch 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 Removers
Cosmetics |
ALLERGIES & POSSIBLE RISKS OR
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