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
Whatever their reason, consumers
should be aware of the risks involved in order to make an informed decision.
Risks Are Involved in Tattooing?
The following are the
primary complications that can result from tattooing:
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.
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
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.
are nodules that may form around material that the body perceives as foreign,
such as particles of tattoo pigment.
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.
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.
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 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 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.
involves abrading layers of skin with a wire brush or diamond fraise (a
type of sanding disc). This process itself may leave a scar.
in which a salt solution is used to remove the pigment, is sometimes used
in conjunction with dermabrasion, but has become less common.
involves removing the tattoo with an acid solution and creating a scar
in its place.
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
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.