Tattoo Ink: Is it Safe & Regulated?

The art of tattooing is generally considered safe and has improved over the past two decades. Complications as a result of tattoo ink or tattooing are typically minor and rare. There are risks, however, and anyone considering a tattoo should highly consider discussing their options and the procedure with a professional and reputable tattoo artist, as well as other individuals who have had the procedure done. Researching the safety of tattoo inks is also a great way to gain a greater understanding of tattoo art.

Does the FDA regulate tattoo ink?

The FDA does regulate the color additives used in tattoos, and occasional restrictions are placed on some chemicals. However, by and large, the tattoo industry is highly unregulated and most chemicals used are not regulated by the FDA. The tattoo industry is vast, and many inks and chemicals are used without much testing. The FDA currently has delegated tattoo industry regulation to state or county jurisdiction.

Does the FDA approve other cosmetic products?

Except for color additives, the FDA does not regulate cosmetic products or color inks, although the use of several chemicals used in cosmetics is prohibited or restricted due to safety concerns. Still, numerous chemicals used in the tattoo industry are not evaluated for safety. Many tattoo ink manufacturers may attach a disclaimer: "Warning-The safety of this product has not been determined."

It is up to consumers to monitor the ingredients in cosmetic products, seeking out information from non-profit organizations such as the Skin Deep Cosmetic Safety Database.

Are there any side effects associated with tattoo ink?

Adverse side effects have been reported, though millions of individuals get tattoos each year and experience little to no complications. That said, side effects associated with tattoo ink and other cosmetic products may not be apparent because they involve chemical and hormonal reactions within the body.

Can tattoos cause infections?

The vast number of inks, chemicals and pigments used when tattooing may cause an infection. Antiseptics used when caring for tattoo machines and needles are important in the prevention of infection. It is important to note that no tattoo ink has ever been approved by the FDA for use on human skin, so selecting a professional and reputable tattoo artist is a very important part in the prevention of infection. There is no guarantee that adverse reactions, whether visible or not, will not occur, regardless of the tattoo artist. Nevertheless, all consumers should be aware of the risks involved in order to make an informed decision.

Can tattoo ink cause allergic reactions?

There are several reports of allergic reactions to tattoo inks; however, allergies to specific ingredients in any given cosmetic product exist prior to exposure and may not necessarily mean anything about the safety of the specific ingredient that caused the reaction. When considering the millions of individuals who are tattooed, reports of allergic reactions are relatively low. There is no definitive database where individuals may report such complications, so any available statistics may be misleading.

What other medical risks are associated with tattoo ink or tattooing?

After the procedure, a painless thickening or inflammation of the skin around the tattoo may occur. This thickening is called a granuloma and is usually a minor problem that occurs as a reaction to the ink or pigment used. The majority of such reactions subside in a few months, or even years.

For individuals with darker skin tones, or those with a strong tendency to develop elevated scar tissue, developing a keloid scar is another risk to consider. Keloid scars appear as an unsightly thickening of the skin and are typically a cosmetic problem. Individuals who are prone to keloid scars should consider how a tattoo may permanently alter the appearance of their skin in an unsightly way. Once a keloid scar occurs, removal may be challenging, as the scar tissue may return.

Additionally, researchers released a report saying that the metals in tattoo ink may be cancer causing. As opposed to tattooing of the past, today techniques, tools and chemicals have changed significantly. "Many of today's tattoo inks contain metallic salts, oxides, sulphides and selenides," according to a study done by the Institute for Health and Consumer Protection on permanent tattoo inks in Europe. "Many of the chemicals found were originally intended for use in writing, automobile paints and printer inks."

Also, because the ingredients found in tattoo ink are considered trade secrets, "tattoo inks may contain chemicals known to cause mutations, birth defects or cancer, though these symptoms may take years to appear."

Does tattoo ink affect X-ray imaging?

There have been reports of individuals with tattoos or permanent makeup who have experienced swelling or burning in the affected areas after undergoing a magnetic resonance imaging (MRI) scan. This has been related to the ink pigments and is a rare complication. Therefore, individuals who have tattoos or permanent makeup should inform the radiologist or technician of this fact in order to take appropriate precautions and avoid complications.

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