Tattoos & Permanent Makeup
What the US FDA (Food and Drug Administration) Has to Say.

From the US Food and Drug Administration Center for Food Safety and Applied Nutrition — Office of Cosmetics and Colors Fact Sheet for Tattoos and Permant Makeup.

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.

However, with the growth in popularity of tattooing and permanent makeup, the 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.

Potential Complications — The FDA States These Risks: (This information is provided by the FDA) Write to them if you disagree; we just wanted people to know their stance on pigments.

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.

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.

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.

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.

Dissatisfaction The Most common problem with tattoos: 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.

Reporting Adverse Reactions

The 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 phone at 1-202 – 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 phone in the USA: 1-800-FDA-1088
By fax: 1-800-FDA-0178 Consumers may obtain reporting forms by calling the following FDA toll-free number: 888 – 463-6332 [888-INFO-FDA]

Tattoo Removal

There are various methods of tattoo removal. The removal method depends upon the pigment used, the amount of time the tattoo was on the skin, the size, location and whether or not it was done professionally. It is important to remember that it costs more to remove a tattoo than to apply one. Since it is an elective procedure it is not covered by most health insurance companies. Total removal of a tattoo is not always possible. In the U.S. dermatologist’s estimate that 400,000 people will have their tattoos removed this year.

Common Removal Methods

Surgical removal may be an option for small tattoos. Surgery also can be used for the removal of larger tattoos, but this may involve the need for multiple surgeries and skin grafting.

Dermabrasion is another removal method, which involves freezing the skin, then sanding the surface with an abrasive instrument. Because the pigments are located in the middle of the skin, pain, bleeding and or discomfort can be expected.

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

Salabrasion is a similar procedure, bur requires the application of an irritating substance prior to sanding. This position can take 30 – 60 minutes depending upon the location and size of the tattoo.

Laser treatment, whereby light is amplified by stimulated emission radiation, is a popular removal method. Its effectiveness is dependent on the targeted pigment. These instruments emit highly focused light beams that break up the pigment particles, which then evaporate.

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.

The laser beam feels as if a rubber band is being snapped against the skin. Crusting at the tattoo site results and the tattoo will gradually fade as healing takes place.

The effectiveness of this method is compromised if the person has a deep tan. In some cases the multiple treatment sessions may be required for complete removal. The average cost for complete removal can vary, but the average range for removal of a 2-square-inch tattoo is $900 -$1500.

Before You Tattoo?

If a person is considering getting a tattoo, they should know what to look for when inspecting a tattoo establishment. People need to look for basic equipment such as germicidal soap, needle buckets, proper disposal containers, packaged gauze with the sterility intact, disposable gloves. Does the studio appear to be clean?

Besides a visual inspection, ask the tattoo artist if he or she is a member of a national tattoo organization. The Alliance of Professional Tattooing is a nonprofit organization that monitors legislation and keep artists updated on safety issues.

Talking to the tattoo artist can give you an idea of the artist’s knowledge of safety, infectious disease transmission and prevention.

So, Before Getting Tattooed, (if you are of age of course)…

• Do not get a tattoo if you are sick or not feeling well. Wait until you’re feeling better before getting that tattoo.
• Make sure you’ve had food and rest. Getting tattooed on an empty stomach may cause you to feel faint, nauseated, or dizzy.
• Don’t take pain killers like aspirin, ibuprofen, and anesthetics, which may possibly cause cause problems, such as increased bleeding.
• Do not get tattooed if you are under the influence of drugs or alcohol.
• You must be over 18 years of age with a valid, government issued photo ID in most states. Call your local department of health if you are not sure of the age requirement or if you think the tattoo artist might be lying.

As I stated earlier, there is a lot of follow-up care after having a tattoo. Make sure you are informed by the tattoo artist before getting one. Antibiotic ointment must be used, you can buy it over the counter, but the tattoo artist must tell you how to care for it before you get it, otherwise leave and go somewhere else. There are sites on the web which tell you how to help the tattoo heal properly. If you do decide that you really want one, talk to your parents about the decision. Perhaps they have one or two that they wish they never got put on. Listen to their opinion and see what they have to say, they might just surprise you.

The temporary tattoos that are sold today look real and are a lot more fun because they come off as soon as you want them to. Be careful, take some time to think about this decision. And remember, many girls and guys find tattoos a turnoff!

This article is intended to provide factual information, it is not meant to encourage or discourage your choice about a tattoo if you are of age (Age 18 or older in most states in the U.S.) To read about body piercing… >>

An FYI: Scientists at the CDC are researching a possible link between tattoos and piercings and the infectious liver disease called viral hepatitis. (See our Hepatitis B section under STDs). Piercing any part of your body with a non-sterile needle may put you at risk for contracting hepatitis, which is even more contagious than HIV (the virus that causes AIDS). Like HIV, hepatitis is spread through person-to-person contact with infected blood or other body fluids and there is no cure. Just the facts, it is your body.

Thanks extended to Dr. Rob A. MD, Dermatologist – for his information on this topic .

FYI: The divisions of ‘Adolescent Medicine’ and ‘ Departments of Pediatrics’ in several major Schools of Medicine, and their Universities have been studying “Tattooing and High-Risk Behavior in Adolescents” and have concluded: “Tattooing was strongly associated with peer substance use”. And… “Adjusting for sociodemographic factors and peer substance use, tattooing in adolescents was independently and significantly associated with reported sexual intercourse, substance use, violent behaviors, and school problems.” (I am not at liberty to give this source of information at this time). I wear temporary tattoos sometimes, where do I fall in this study? 🙂

I have interviewed about 150 teenagers with tattoos and while I am NOT promoting the choice or act of tattooing, I have not found their conclusion to be true at this time.

Update, May 2003: The CDC is still concerned about the transmission of Hepatitis B and C from tattoo ‘parlors’ that do not use proper sterilization techniques. I did some research here in Florida, as we have many tattoo establishments. They all follow the state guidelines for sterilization and none that I spoke to knew of any cases of transmission from their ‘work’. If you decide to get a tattoo, check the place out first. For more on Hepatitis transmission and Hepatitis A, B, and C… see the “Hepatitis Introduction ” article and video from well-known physicians. Stay Informed. Check out “ Hepatitis C, An Epidemic Ignored”.

To “Body piercing” and healing table and Tattoo For You…