As the popularity of tattoos continues to grow, so does the concern about potential risks. Some risks, such as the spread of infections through the use of unsterilized needles, have long been known. But what isn’t clear is the safety of tattoo inks.

Permanent tattoos are made by using needles to inject colored ink below the skin’s surface. Permanent make-up is considered a permanent tattoo that mimics the results of cosmetic products such as an eyebrow pencil, lip liner, eyeliner, or blush.

While state and local authorities oversee the practice of tattooing, ink and ink colorings (pigments) used in tattoos are subject to FDA regulation as cosmetics and color additives. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA has not traditionally regulated tattoo inks or the pigments used in them.

FDA has received reports of bad reactions to tattoo inks right after tattooing or even years later. Some people report itchy or inflamed skin around their tattoos in the summer when they’ve been out in the sun. Recent reports associated with permanent make-up inks have prompted FDA to study tattoo ink safety.

“Our hope is to get a better understanding of the body’s response to tattoos and their impact on human health, and to identify products at greatest risk,” says Linda Katz, M.D., M.P.H., Director of FDA’s Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition.

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What are the Risks?

• Infection – Dirty needles can pass infections, like hepatitis and HIV, from one person to another.
• Allergies – Allergies to various ink pigments in both permanent and temporary tattoos have been reported and can cause problems.
• Scarring – Unwanted scar tissue may form when getting or removing a tattoo.
• Granulomas – These small knots or bumps may form around material that the body perceives as foreign, such as particles of tattoo pigment.
• MRI complications – People may have swelling or burning in the tattoo when they have magnetic resonance imaging (MRI). This happens rarely and does not last long.

Tattoo Ink Research

In a laboratory within FDA’s Arkansas-based National Center for Toxicological Research (NCTR), research chemist Paul Howard, Ph.D., and his team are investigating tattoo inks to find out

• the chemical composition of the inks and how they break down (metabolize) in the body;
• the short-term and long-term safety of pigments used in tattoo inks;
• how the body responds to the interaction of light with the inks.

“There have been no systematic studies of the safety of tattoo inks,” says Howard, “so we are trying to ask—and answer—some fundamental questions.” For example, some tattoos fade over time or fade when they are exposed to sunlight. And laser light is used to remove tattoos. “We want to know what happens to the ink,” says Howard. “Where does the pigment go?”

NCTR researchers are exploring several possibilities:

• The body cells may digest and destroy the ink, just as they rid the body of bacteria and other foreign matter as a defense against infection. NCTR studies show that a common pigment used in yellow tattoo inks, Pigment Yellow 74, may be broken down by enzymes, or metabolized. “Just like the body metabolizes and excretes other substances, the body may metabolize small amounts of the tattoo pigment to make it more water soluble, and out it goes,” says Howard.
• Sunlight may cause the ink to break down so it is less visible. NCTR researchers have found that Pigment Yellow 74 decomposes in sunlight, breaking down into components that are colorless. The pigment components may still be there, says Howard, and we don’t know if these are potentially toxic.
• The skin cells containing the ink may be killed by sunlight or laser light and ink breakdown products may disperse through the body.

Research has also shown that some pigment migrates from the tattoo site to the body’s lymph nodes, says Howard. Lymph nodes are part of the lymphatic system, a collection of fluid-carrying vessels in the body that filter out disease-causing organisms. Whether the migration of tattoo ink has health consequences or not is still unknown. NCTR is doing further research to answer this and other questions about the safety of tattoo inks.

Tattoo Tips for Consumers

Ink:

• FDA has not approved any tattoo pigments for injection into the skin. This applies to all tattoo pigments, including those used for ultraviolet (UV) and glow-in-the-dark tattoos. Many pigments used in tattoo inks are industrial-grade colors suitable for printers’ ink or automobile paint.
• The use of henna in temporary tattoos has not been approved by FDA. Henna is approved only for use as a hair dye.

Permanence:

• Consider tattoos permanent. Removal is time-consuming, costly, and doesn’t always work. The most common method of tattoo removal is by laser treatment, which delivers short flashes of light at very high intensities to the skin to break down the tattoo ink. FDA allows several types of lasers to be marketed for tattoo removal. Some color inks are harder to remove than others. Many repeat visits every several weeks may be required to remove a tattoo, and it may never be entirely gone.
• Do not buy or order online do-it-yourself tattoo removal products. These acid-based products are not FDA-approved and can cause bad skin reactions.
• Consult your health care provider—not a tattoo parlor—if you want a tattoo removed. The American Society for Laser Medicine and Surgery³ can help you find a doctor experienced in tattoo removal.

Don’t Avoid an MRI:

• If you need to have an MRI done, don’t avoid it. Inform the radiologist or technician that you have a tattoo so appropriate precautions can be taken.

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 the condition.
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 (“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 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 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 and avoid complications.

A Common Problem: Dissatisfaction

A common problem that may develop with tattoos is the desire to remove them. Removing tattoos and permanent makeup can be very difficult.

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.

Consult your healthcare provider about the best removal techniques for you.

What About Temporary Tattoos?

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Most contain color additives approved for cosmetic use on the skin. However, the agency has issued an import alert for certain foreign-made temporary tattoos¹.

The temporary tattoos subject to the import alert are not allowed into the United States because they don’t carry the FDA-mandated ingredient labels or they contain colors not permitted by FDA for use in cosmetics applied to the skin. FDA has received reports of allergic reactions to temporary tattoos.

In a similar action, FDA has issued an import alert for henna intended for use on the skin². Henna is approved only for use as a hair dye, not for direct application to the skin. Also, henna typically produces a reddish brown tint, raising questions about what ingredients are added to produce the varieties of colors labeled as “henna,” such as “black henna” and “blue henna.” FDA has also received reports of allergic reactions to products applied to the skin that contain henna.

Reporting Adverse Reactions

FDA urges consumers and healthcare providers to report adverse reactions to tattoos and permanent makeup, problems with removal, or adverse reactions to temporary tattoos. Consumers and healthcare providers can register complaints using the contact information in Your Guide to Reporting Problems to FDA³.

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Goldsmith’s lawsuit alleges that doctors can only make a profit using Botox if they reuse the single-use vials that the drug comes in.

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Body shaping through circumferential reduction treatment by SyneronTM exposed as celebrity beauty secret

Khloe Kardashian, celebrity and star of the E show Keeping up with the Kardashians, receives the VelaShapeTM http://velashape.com treatment for cellulite reduction and body contouring through circumferential reduction during the March 22 episode airing at 10/9c.

In the episode, Khloe prepares her body for an upcoming photo shoot for a charity ad campaign. Khloe visits Dr. Shalini Kapoor-Grover of REVIVE: Beverly Hills Medical Institute and receives VelaShape treatments on her stomach.

VelaShape, clinically proven to take inches off the thighs, is a celebrity beauty secret that has been embraced by not only Khloe but also her sister, Kim Kardashian.

“For women already in great shape, like Khloe Kardashian, VelaShape helps smooth and contour curves,” said Dr. Shalini. “My VelaShape patients include men and women looking to not only smooth the top layer of the skin but also to even out stubborn pockets of fat on the thighs, buttocks, stomach, back and arms that are not reduced with diet and exercise alone.”

VelaShape, developed by SyneronTM Medical Ltd. NASDAQ: ELOS , tightens and tones flabby skin through heat, vacuum and massage to reduce or shrink the size of the actual fat cells and fat chambers. In four to six treatments, each spaced one week apart, the non-invasive VelaShape dramatically improves the appearance of problem areas including the arms, love handles, buttocks, stomach and thighs.

In a recent poll of 195 VelaShape treatment providers, more than 84 percent reported VelaShape resulted in an average circumferential reduction of one to two inches, 14 percent reported an average of two to four inches and two percent reported an average reduction of five inches or more.

To find a VelaShape treatment provider near you or for more information, please visit http://www.velashape.com. Catch new episodes of Keeping up with the Kardashians Sundays at 10/9c.

Read full via PRNewswire Syneron Medical Ltd

The target is toenail fungus — an infection in an estimated 10 percent of American adults, or 23 million people — that causes toenails to become thick, yellow and fetid.

If these lasers, which recently completed small clinical trials, work, they will represent a new way to treat nail infection by selectively irradiating fungi while leaving the nail and surrounding tissue intact.

Right now, there is no sure cure. The fungi are so hardy that popular antifungal pills, which carry a small risk of liver damage, are completely successful less than half of the time. And a prescription lacquer, painted on the toenails daily for 48 weeks, has a complete cure rate of less than 10 percent.

Pharmaceutical giants like Schering-Plough and Novartis are developing new lacquers, pills and ointments to battle the fungi. But some podiatrists and patients are pinning their hopes on the experimental laser treatments.

Nomir Medical Technologies in Waltham, Mass., is developing a laser called Noveon for diseases like antibiotic-resistant staph infections as well as nail afflictions.

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With more and more people looking for non-invasive ways to reduce wrinkles or other unsightly facial problems, researchers and surgeons continue to bring cutting edge treatments to the forefront.

Local surgeon, Dr. Steve Weiner, MD of Aesthetic Clinque, was selected to do a one-year study for Fraxel Repair, a non-invasive laser treatment used for the reduction of fine to moderate wrinkles on the face, neck and chest.

The study began after Weiner formed a relationship with Solta Medical Inc., which included several nationwide webinars in which three of Weiner’s patients were featured.

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According to documents filed with the FDA, this technology generates UHF ultrahigh frequency energy which converts Nitrogen gas into plasma. The plasma emerges from a specialized hand-piece and is directed onto the skin to be treated.

Rapid heating of the skin occurs as the excited gas gives up energy to the skin.

Through the combination within the hand-piece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that are intended to heat different layers of the skin, depending on the desired outcome, in order to rejuvenate the skin or tighten the tissue.

This procedure is intended to be relatively pain-free, but a topical anesthetic can be applied. The procedure can take less than 30 minutes. Shedding of skin likely will occur, and patients may experience redness, swelling and some oozing.

FDA approved for treatment of the following conditions:

• Wrinkles or fine lines
• Superficial skin lesions
• Actinic and seborrheic keratosis colored, textured patches of the skin
• Viral papillomata benign tumor such as a wart

News brief via Technology Brief: Plasma Skin Resurfacing.