29, 2000; Updated June
FDA considers the inks used in
intradermal tattoos, including
permanent makeup, to be cosmetics and considers the pigments used in
the inks to be color additives requiring premarket approval under the
Federal Food, Drug, and Cosmetic Act. However, because of other public
health priorities and a previous lack of evidence of safety concerns,
FDA traditionally has not exercised its regulatory authority over
tattoo inks or the pigments used in them. The actual practice of
tattooing is regulated by local jurisdictions.
FDA is aware of more than 150 reports of
adverse reactions in
consumers to certain permanent make-up ink shades, and it is possible
that the actual number of women affected was greater. In addition,
concerns raised by the scientific community regarding the pigments used
in these inks have prompted FDA to investigate the safe use of tattoo
inks. FDA continues to evaluate the extent and severity of adverse
events associated with tattooing and is conducting research on inks. As
new information is assessed, the agency will consider whether
additional actions are necessary to protect public health.
In addition to the reported adverse reactions, areas of concern include
tattoo removal, infections that result from tattooing, and the
increasing variety of pigments and diluents being used in tattooing.
More than fifty different pigments and shades are in use, 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.
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 and skin infections caused by Staphylococcus aureus
Tattoos received at facilities not regulated by your state or at
facilities that use unsterile equipment (or re-use ink) may prevent you
from being accepted as a blood or plasma donor for twelve months.
- 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.
- Allergic reactions.
Although FDA has received
reports of numerous adverse ractions associated with certain shades of
ink in permanent makeup, marketed by a particular manufacturer, reports
of allergic reactions to tattoo pigments have been rare. However, 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. 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
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
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 and avoid
A Common Problem: Dissatisfaction
common problem that may develop with
tattoos is the desire to
remove them. Removing tattoos and permanent makeup can be very
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
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.
your healthcare provider about
the best removal techniques for you.