Askanesthetician's Blog

An esthetician explores skincare issues and concerns

Is Permanent Make-up Worth the Risks? March 14, 2011

Filed under: beauty,make-up — askanesthetician @ 7:29 am
Tags: , , , , ,

Ever wonder what it would be like to wake-up in the morning already wearing your make-up?  There is a solution if you never want to have to apply your make-up again.  That solution is permanent make-up which is a tattoo done on areas that women (or men) traditionally use cosmetics.  For instance you could tattoo on your eyeliner, your lipliner, and define your eyebrows with permanent make-up.  While permanent make-up has worked out well for some for others permanent make-up has turned into a disaster.

Before considering if permanent make-up is right for you first and foremost you should know what the FDA regulates when it comes to tattoos and permanent make-up and what risks are involved when you seek this type of service:

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.

During 2003 and 2004, FDA became aware of more than 150 reports of adverse reactions in consumers to certain permanent makeup ink shades, and it is possible that the actual number of women affected was greater. The inks associated with this outbreak were voluntarily recalled by the company that marketed them in 2004. 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 the condition.
Whatever their reason, consumers should be aware of the risks involved in order to make an informed decision.

 A few other things, besides what was mentioned above, should be noted about permanent make-up.  One is that it isn’t entirely permanent; it can begin to fade over time.  Another thing are the risks involved with getting any sort of tattoo.  The FDA website explains the risks as follows:

  • Infection. Unsterile tattooing equipment and needles can transmit infectious diseases, such as hepatitis and skin infections caused by Staphylococcus aureus (“staph”) bacteria*. 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 reactions 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 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.

Another very important thing to consider before having permanent make-up done is the amount of training and experience the person you are going to has had.  That is where things can get tricky.  Neither the federal government nor the FDA regulates or mandates the training or practice of permanent make-up, that is left up to each individual state to determine.  If you really want permanent make-up done be sure to thoroughly check-out the place you do it at.  Ask about training and experience.  I would also ask to speak to past clients.  Make sure the place is clean and sterile.  So many health issues can arise from an unclean environment or instruments.  Make sure you do not put yourself at risk unnecessarily.

**The FDA is hosting a webinar on tattoos and permanent make-up March 15.  If this topic interests you this would be a great way to learn more.**


Sources and Further Reading


3 Responses to “Is Permanent Make-up Worth the Risks?”

  1. Pam Says:

    I’ve had permanent eyeliner since 2005 without any complications. I made sure that I went to a trusted technician with 10+ years of experience, per my mom’s recommendation and encouragement, and referred several friends, all of whom also had successful results. Mine initially looked like liquid eyeliner and now looks more natural. The color is not as vibrant before, and I anticipated needing a touch-up every 10 or so years.

    Is the FDA concerned with only ink for permanent makeup or for all tattoos? I’ll try to catch the webinar. Thanks for the post!

    • Thanks so much for sharing your experience! Much appreciated. That adds a lot to my post. Thanks!

      The FDA is concerned with ink for both permanent make-up and all types of tattoos including temporary tattoos.

  2. My life professional since 1993 has been permanent cosmetics. Great info

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