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
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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

 

New Trends in Anti-Aging Procedures: “Vampire” Facelift and Ultherapy March 7, 2011

I recently read with great interest two articles about new in office anti-aging procedures.  The first article was in Harper’s Bazaar, and it was about a new nonsurgical browlift called Ultherapy.  The second article was in The New York Times Skin Deep series about a new trend in facelifts called the “vampire facelift”.    Neither of these procedures are surgical or invasive.  The so-called vampire facelift falls under the category of “liquid facelifts” which is a facial rejuvenation procedure that normally means fillers and Botox are used to create a temporary change in the appearance of one’s face without surgery.   Ultherapy uses ultrasound technology and heat to lift the brows and rejuvenate one’s appearance.

I’ll begin by discussing the vampire facelift.   Let me quote The New York Times article in order to further explain the vampire facelift:

[this procedure] entails having blood drawn from your arm, then spun in a centrifuge to separate out the platelets. They are then injected into your face, with the hope of stimulating new collagen production. Selphyl, as the system is called, arrived on the booming facial-rejuvenation market in 2009, and is now used by roughly 300 doctors nationwide in the name of beauty, said Sanjay Batra, the chief executive of Aesthetic Factors, which manufactures the Selphyl system.

Why would someone choose to pursue this procedure as opposed to having Botox and fillers injected into their face? 

Ghoulish as the procedure sounds, some patients prefer the idea of using their own blood rather than a neurotoxin or synthetic filler to rejuvenate their faces. “We all want to look better,” said Joan Sarlo, 56, who underwent a Selphyl “vamp-lift” performed by Dr. Lisa A. Zdinak, a Manhattan-based doctor whose specialty is ophthalmic plastic surgery. But the “less unnatural the better,” Ms. Sarlo said. “What could be better than your own blood?”

Some doctors say that fillers taken from one’s body are less likely to cause irregularities and bumps in thin-skinned areas than synthetic ones like Sculptra Aesthetic. But at this point, it’s hard to tell whether “platelet-rich fibrin matrix,” or P.R.F.M. (the medical term for the golden-hued platelets that Selphyl extracts), is an effective filler for hollowed-out cheeks and wrinkles.

But for me the crux of any cosmetic procedure comes down to safety and proof that the procedure is safe through FDA approval as opposed to testimonials and heresy.  And here is where things get messy, excuse the pun, with the vampire facelift:

What’s more, doctors and consumers aren’t clear on where Selphyl stands with the F.D.A. In a YouTube video featuring Dr. John Argerson, a board-certified family medicine doctor who works out of Refine MediSpa in Johnson City, Tenn., tells consumers that Selphyl is a “newly F.D.A.-approved filler” for nose-to-lip folds. And in a December 2009 article in Dermatology Times, a trade publication, Dr. Ranella Hirsch, a board-certified dermatologist, said Selphyl is “a new F.D.A. approved dermal filler.” This week, Dr. Hirsch, who doesn’t use Selphyl in her practice, said that she couldn’t explain why she misspoke, adding in an e-mail that “the lack of clarity between F.D.A. approval versus F.D.A. clearance to market is a key point.”

Indeed. The F.D.A. has not approved or cleared P.R.F.M. derived in a Selphyl centrifuge to be marketed for facial rejuvenation. In 2002, the agency cleared a blood-collection system called Fibrinet, whose platelet-rich byproducts orthopedic doctors then used to speed tissue repair. In 2009, this same machine was born again as Selphyl, and since then, the company promoted it as a way to “reverse the natural aging process.” This week, Shelly Burgess, an F.D.A. spokeswoman, said that Selphyl’s maker would have to file an amendment to get clearance to market its blood collection system in a new way, and no such amendment could be found at this writing.

Asked whether Aesthetic Factors’ marketing of Selphyl for cosmetic rejuvenation violated any F.D.A. policy, Ms. Burgess simply wrote, “As a regulatory agency we would not discuss whether a firm’s claims violate our regulations.”

In light of the fact that there is little to no clinical data that this procedure works as claimed, and furthermore since the FDA has neither cleared nor approved this procedure I would steer clear of doing it until there is such approval.  There are so many safe options for liquid facelifts that there is really no need to try something that is still in trial stages.  Who knows?  Maybe 15 years from now a vampire facelift will be the norm but until then I would suggest that you proceed with caution.

 

 

Ultherapy is very different from the vampire facelift described above.  This procedure uses ultrasound heat on your forehead in order to greatly increase collagen production beneath the skin’s surface.  As collagen production increases in that area of your face your brow firms.  Immediately after getting the treatment you will see a smoothing effect, and as your collagen production increases over time your results will improve in the months to come.  And what might be the best news of all, these results are pretty much permanent though some patients may need a touch up in a year.  Ultherapy costs somewhere between $1,000 to $4,000 and has been cleared by the FDA for use on the forehead (according to the Harper’s Bazaar article).  If the machine is used incorrectly a burn could result because of the intense heat generated by the machine.  That heat can also make the procedure less than comfortable. 

According to an article in the April, 2011 issue of Vogue (which I can’t find online unfortunately) Ultherapy can be used on both the face and the neck not just the forehead.  The article explains how Ultherapy works thusly:

Thermal energy bypasses the upper layers of the skin (those conventionally targeted by Fraxel and Thermage), safely heating the underlying connective tissue that lines the facial muscles.  That tissue contracts, resulting in an immediate tighting and, ultimately, a tangible lift.  …  In an attempt to target multiple layers of tissue, doctors then set the device to a shallower depth and make a second pass with the hand piece, this time intentionally aiming its heat at the skin’s upper layers in order to stimulate line-smoothing collagen production.

Furthermore, according to the Vogue article it takes about an hour to complete both the neck and the face using ultrasonic imaging so the doctor performing the procedure can view each layer of the muscle and skin as they work on the patient.  Risks include some swelling and bruising and a feeling of tightness for a few days following the procedure.  And one more thing, the procedure doesn’t feel so great.  It can feel like a hot prickling sensation to intense and short bursts of pain.  

Overall as an option for slowing down the aging process Ultherapy sounds promising.  You can try it out if you feel that your face needs a lift but you aren’t ready for a facelift yet.

One more note – it turns out both of these procedures have been featured on The Rachael Ray Show , How to Look 10 Years Younger,  which has made me wonder – do I need to start watching The Rachael Ray Show in order to keep up with cosmetic procedure trends?  I always thought her show was all about cooking. 

 

 
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