(Phoenix, AZ) – The hCG Ultimate Fat Burning Diet has received significant publicity based on impressive weight-loss results. However, this diet is extremely sensitive and must be monitored by a medical professional to assure desired results are achieved.
“Many unqualified businesses and on-line companies have recently advertised their version of the hCG diet,” said Dr. Ann Watwood, Medical Director at Derma Health Institute of Ahwatukee. “It’s important for consumers to realize this is a specialized program that requires the close supervision of a doctor. At Derma Health Institute, patients are seen weekly to ensure they’re achieving a positive outcome without medical complications.”
The Ultimate Fat Burning Diet involves the hormone hCG, or human chorionic gonadotropin, to assist in weight loss. This natural hormone is found in both men and women and increases significantly during the early stages of pregnancy. Clinically, it has been shown that using this hormone in combination with a very specific low calorie diet will stimulate the body to mobilize and burn extra fat cells for energy.
When administered properly, patients can see a weight loss average of 10-25 pounds over the three week hCG program. When used incorrectly, consumers reported feeling faint and weak, dizziness, extreme hunger attributed to improper hormone administration and no weight loss at all.
“This type of extreme diet can be dangerous if a patient is not correctly monitored,” Watwood added. “At Derma Health Institute, blood samples are taken before the diet begins to confirm there are no underlying health problems like diabetes, high blood pressure, hyperthyroidism or issues with kidneys or liver that could adversely affect the patients overall health. Patients are then monitored by physicians in weekly meeting to ensure that there are no complications that could affect their health or success on the diet."
Consumers need to remember it’s illegal to purchase any drug without a prescription from a licensed practitioner and medications sold in other countries are not held to the same safety standards of those sold in the United States. Therefore, there is nothing in place to confirm a substance ordered on-line is really hCG.
For more information on the hCG diet contact Derma Health Institute at (480) 539-0777 Mesa/Gilbert, (480) 730-9000 Chandler/Tempe, (480) 460-1505 Ahwatukee/Phoenix or (480) 991-7900 Paradise Valley/Scottsdale.
http://www.dermahealthinstitute.com
Showing posts with label safety. Show all posts
Showing posts with label safety. Show all posts
Wednesday, February 17, 2010
Wednesday, January 6, 2010
Botox and Dysport Safety/Danger Information You Should Know
We’ve all heard of DIY home repairs, but DIY Botox and laser treatments? Yes, in this economy many people are looking at cutting costs, but before you start injecting yourself with cosmetic injectables or using a laser on yourself, you need to evaluate the potential life threatening risks.
Injecting foam insulation around a drafty electrical socket is one thing, but injecting oneself with a botulinum toxin product is quite another. Consumers need to be aware that engaging in DIY laser treatments or cosmetic injectables carry with it a great deal of risk vs. reward. Consumers interested in cosmetic injectable procedures should always engage a professionally-trained physician to administer these treatments. Patients should choose doctors who have completed a comprehensive Botox Training program.
The International Association of Physicians for Aesthetic Medicine (IAPAM) (http://www.iapam.com), offers consumers the following 4 “tips” on how to ensure their aesthetic medicine treatment is both safe and effective.
Tip One: Botox buyer beware
Recently, there have been several reports regarding DIY “botox-like” injectables, which can be purchased through the internet. A woman in Texas offered consumers a botox-like product called “Freeze,” complete with a “How-To” video, so consumers could administer the botulinum toxin themselves. The red-flags regarding this internet offering range from her unrealistically low pricing to her lack of knowledge regarding the potential side affects that can accompany the administration of a neurotoxin into the body.
In this instance, the vendor was offering 100 unit vial of “Freeze” for $139, where the physician cost for a 100 unit vial of Botox Cosmetic® is over $500. Equally, for Dysport, she was quoting $169 US for a 500 unit vial, where a 300 unit vial in the US is sold to physicians for $475. “As the saying goes if its too good to be true, than it probably is,” says IAPAM Executive-Director Jeff Russell. “If you see someone selling a cosmetic injectable on the internet for a quarter of the cost to physicians, then the product is most likely counterfeit and you have no idea what is actually in it,” continues Russell.
Furthermore, “it’s important to ensure the vial being used is not counterfeit, look for the 3-d hologram to ensure its is the FDA approved product,” says Jeff Russell. Single-use vials of BOTOX Cosmetic® have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. To see the hologram, rotate the vial back and forth between your fingers under a desk lamp or fluorescent light.
The FDA offers these salient “tips” to consumers considering botulinum toxin injectables:
* Know what you are being injected with and make sure your health care professional is using only an FDA-approved product, purchased within the United States. Patients and doctors alike can verify that the product they are receiving is an FDA-approved and licensed botulinum toxin type A medical product.
* If your doctor refuses to give you this information, look for another health care professional.
As well, if your vial is not in English, this is another red flag. Some physicians buy their cosmetic injectables from Mexico and Canada where they often originate in China and Eastern Europe. These vials are not FDA approved, and therefore you have no idea what is actually in the vial. You should ask your provider if they purchased their injectable products directly from the US distributor.
Dr. Russ Kridel, respected Houston facial plastic surgeon, and member of The American Medical Association Council on Science and Public Health agrees. “Patients need to be cautious when injectables are offered at bargain prices, because they may have been obtained through web sites or offshore; they may be counterfeit and there’s no one to assure purity or content! Serious injury or personal harm may result when unknown substances are injected.”
Such was the case in 2004 in Florida, where the Office of Criminal Investigations of the FDA found that the resulting cases of botulism in four patients, who became ill after cosmetic injectable treatments, were a product of the illegal administration of enormous amounts of unlicensed and unapproved botulinum toxin by an unlicensed physician.
Tip Two: Cosmetic injectables need to be prescribed by a physician
Botox Cosmetic and Dysport are FDA controlled substances, and can only be sold to licensed physicians for administration.
Dr. Melissa Babcock, board-certified dermatologist and Mohs Surgeon practicing in the Atlanta area, offers this sage advice to consumers: “If you are not a trained medical professional, botulinum toxin (Botox or Dysport) can be very dangerous to use. Medical professionals are trained to dilute the concentrated product correctly, inject it correctly into appropriate muscles and use the correct concentration for each muscle they are injecting. As a physician with a lot of experience injecting Botox, I am very concerned for a patient that may try to buy and inject their own Botox.”
Also, reputable physicians only buy their cosmetic injectable product directly from the US division of the pharmaceutical company (i.e. Botox Cosmetic and Juvederm are only available from Allergan, Inc. in Irvine, CA; and Dysport, Restylane, Perlane are only available for purchase from Medicis, Inc. in Scottsdale, AZ).
Tip Three: Know the Risks
The FDA offers additional tips to consumers regarding understanding the risks associated with botulinum toxin:
* Make sure the benefits and risks are fully explained to you in a patient consultation.
* Fully disclose any medical conditions you might have and medications you are taking, including vitamins and over-the-counter drugs.
* Botulinum toxin products should be administered in an appropriate setting using sterile instruments. Malls, private homes, [hotel rooms, and conference rooms] are not medical environments and may be unsanitary.
Dr. Kridel also comments on the risks associated with neurotoxin injectables. “Doctors’ offices are probably the safest place to have such injectables administered. Not too many spas, peoples’ homes, or hotel rooms have the same standards for cleanliness and emergency care that a doctor’s office does!”
Dr. Babcock offers equally potent advice to patients regarding the real dangers associated with self-injecting botulinum toxin. “An untrained person injecting Botox would certainly experience side effects such as drooping eyelids, and other facial distortions resembling a person who suffered a stroke. My message to patients: Botox is a powerful medication that when used correctly can make beautiful results. When used incorrectly the results can be disastrous. Save your money, go to a medical professional and don’t try Botox at home!”
Tip Four: Choose a physician who is comprehensively trained in all cosmetic injectable outcomes
Dr. Kridel emphasizes the importance of engaging a trained and experienced physician in the administration of injectables. “The practice of medicine is defined by the diagnosis and treatment of a problem. Is an aesthetician or nurse deciding on their own what injectable is appropriate for you and how much you should get? Or is the physician first seeing you, discussing the options and then deciding, based on your medical history and his exam, what should be done—the preferable route—and is that doctor relaying on alternatives to that injectable? And what kind of physician is doing the injecting or the supervision? Is the physician one who routinely treats such conditions?
Furthermore, Dr. Kridel encourages patients to seek out medical practices where, “staff are trained in sterile procedures so as to avoid contamination, re-use of needles, and infections. Plus, in the rare case of an allergic reaction, [ensure] staff and physicians are trained in resuscitative measures and have emergency drugs available.”
The FDA also cautions that there is a possibility of experiencing potentially life-threatening distant spread of toxin effect from the injection site after local injection. However, distant spread of BOTOX cosmeitc resulting in serious side effects has never been reported to the FDA.
Also, doctors administering botulinum toxin understand that products are not interchangeable, and that clinical doses expressed in units are not comparable from one botulinum toxin product to the next (e.g. Botox Cosmetic® vs. Dysport®). Units of one product cannot be converted into units of another product.
Given these risks, patients should insist on engaging physicians who have completed comprehensive, clinical training programs like the IAPAM’s Aesthetic Medicine Symposium or Advanced Botox /Dermal Filler Bootcamp.” For the patient, this translates into ensuring that their physician is trained in the latest injection techniques, is comfortable with dealing with a possible adverse event due to the procedure and is a member of a internationally recognized aesthetic association.
The Last Word
Dr. Brian R. Buinewicz offers these closing thoughts to consumers foolishly considering DIY cosmetic injectables.
“This is incredibly concerning that someone would be so short sighted [as to consider] DIY Botox. Botulinum toxin A is a drug that, if administered incorrectly, can have serious and potentially fatal side effects. To take the chance of a serious or fatal reaction to save a few bucks and for convenience is beyond reason. Would someone perform their own appendectomy or Cesarean section because it was convenient for them and they could save on anesthesia and hospital costs?”
Understandably, consumers will continue to look for opportunities to forgo expensive professional services, ranging from a basic handyman to an accountant. However, in every instance where a consumer chooses the DIY option over the “do it for me” option, the key question has to be: risk vs. reward, and the issues of risk associated with the DIY applications in aesthetic medicine are significant.
Dr. Kridel reminds patients that “what is exciting now are all the FDA approved injectables that we now have,” giving many choices to doctors and patients to individualize the right treatment. It’s just wise to have the right physician examining and guiding you to the optimal result!” Ultimately, the wisest consumers will opt to save money through DIY home decorating, and not aesthetic medicine procedures.
-compiled by Leslie Marshall, Online Media and Research Specialist, The IAPAM.
More more information:
Jeff Russell, Executive-Director
International Association for Physicians in Aesthetic Medicine (IAPAM)
1-800-219-5108 x705
e-mail: info@theiapam.com
web: http://www.iapam.com
Injecting foam insulation around a drafty electrical socket is one thing, but injecting oneself with a botulinum toxin product is quite another. Consumers need to be aware that engaging in DIY laser treatments or cosmetic injectables carry with it a great deal of risk vs. reward. Consumers interested in cosmetic injectable procedures should always engage a professionally-trained physician to administer these treatments. Patients should choose doctors who have completed a comprehensive Botox Training program.
The International Association of Physicians for Aesthetic Medicine (IAPAM) (http://www.iapam.com), offers consumers the following 4 “tips” on how to ensure their aesthetic medicine treatment is both safe and effective.
Tip One: Botox buyer beware
Recently, there have been several reports regarding DIY “botox-like” injectables, which can be purchased through the internet. A woman in Texas offered consumers a botox-like product called “Freeze,” complete with a “How-To” video, so consumers could administer the botulinum toxin themselves. The red-flags regarding this internet offering range from her unrealistically low pricing to her lack of knowledge regarding the potential side affects that can accompany the administration of a neurotoxin into the body.
In this instance, the vendor was offering 100 unit vial of “Freeze” for $139, where the physician cost for a 100 unit vial of Botox Cosmetic® is over $500. Equally, for Dysport, she was quoting $169 US for a 500 unit vial, where a 300 unit vial in the US is sold to physicians for $475. “As the saying goes if its too good to be true, than it probably is,” says IAPAM Executive-Director Jeff Russell. “If you see someone selling a cosmetic injectable on the internet for a quarter of the cost to physicians, then the product is most likely counterfeit and you have no idea what is actually in it,” continues Russell.
Furthermore, “it’s important to ensure the vial being used is not counterfeit, look for the 3-d hologram to ensure its is the FDA approved product,” says Jeff Russell. Single-use vials of BOTOX Cosmetic® have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. To see the hologram, rotate the vial back and forth between your fingers under a desk lamp or fluorescent light.
The FDA offers these salient “tips” to consumers considering botulinum toxin injectables:
* Know what you are being injected with and make sure your health care professional is using only an FDA-approved product, purchased within the United States. Patients and doctors alike can verify that the product they are receiving is an FDA-approved and licensed botulinum toxin type A medical product.
* If your doctor refuses to give you this information, look for another health care professional.
As well, if your vial is not in English, this is another red flag. Some physicians buy their cosmetic injectables from Mexico and Canada where they often originate in China and Eastern Europe. These vials are not FDA approved, and therefore you have no idea what is actually in the vial. You should ask your provider if they purchased their injectable products directly from the US distributor.
Dr. Russ Kridel, respected Houston facial plastic surgeon, and member of The American Medical Association Council on Science and Public Health agrees. “Patients need to be cautious when injectables are offered at bargain prices, because they may have been obtained through web sites or offshore; they may be counterfeit and there’s no one to assure purity or content! Serious injury or personal harm may result when unknown substances are injected.”
Such was the case in 2004 in Florida, where the Office of Criminal Investigations of the FDA found that the resulting cases of botulism in four patients, who became ill after cosmetic injectable treatments, were a product of the illegal administration of enormous amounts of unlicensed and unapproved botulinum toxin by an unlicensed physician.
Tip Two: Cosmetic injectables need to be prescribed by a physician
Botox Cosmetic and Dysport are FDA controlled substances, and can only be sold to licensed physicians for administration.
Dr. Melissa Babcock, board-certified dermatologist and Mohs Surgeon practicing in the Atlanta area, offers this sage advice to consumers: “If you are not a trained medical professional, botulinum toxin (Botox or Dysport) can be very dangerous to use. Medical professionals are trained to dilute the concentrated product correctly, inject it correctly into appropriate muscles and use the correct concentration for each muscle they are injecting. As a physician with a lot of experience injecting Botox, I am very concerned for a patient that may try to buy and inject their own Botox.”
Also, reputable physicians only buy their cosmetic injectable product directly from the US division of the pharmaceutical company (i.e. Botox Cosmetic and Juvederm are only available from Allergan, Inc. in Irvine, CA; and Dysport, Restylane, Perlane are only available for purchase from Medicis, Inc. in Scottsdale, AZ).
Tip Three: Know the Risks
The FDA offers additional tips to consumers regarding understanding the risks associated with botulinum toxin:
* Make sure the benefits and risks are fully explained to you in a patient consultation.
* Fully disclose any medical conditions you might have and medications you are taking, including vitamins and over-the-counter drugs.
* Botulinum toxin products should be administered in an appropriate setting using sterile instruments. Malls, private homes, [hotel rooms, and conference rooms] are not medical environments and may be unsanitary.
Dr. Kridel also comments on the risks associated with neurotoxin injectables. “Doctors’ offices are probably the safest place to have such injectables administered. Not too many spas, peoples’ homes, or hotel rooms have the same standards for cleanliness and emergency care that a doctor’s office does!”
Dr. Babcock offers equally potent advice to patients regarding the real dangers associated with self-injecting botulinum toxin. “An untrained person injecting Botox would certainly experience side effects such as drooping eyelids, and other facial distortions resembling a person who suffered a stroke. My message to patients: Botox is a powerful medication that when used correctly can make beautiful results. When used incorrectly the results can be disastrous. Save your money, go to a medical professional and don’t try Botox at home!”
Tip Four: Choose a physician who is comprehensively trained in all cosmetic injectable outcomes
Dr. Kridel emphasizes the importance of engaging a trained and experienced physician in the administration of injectables. “The practice of medicine is defined by the diagnosis and treatment of a problem. Is an aesthetician or nurse deciding on their own what injectable is appropriate for you and how much you should get? Or is the physician first seeing you, discussing the options and then deciding, based on your medical history and his exam, what should be done—the preferable route—and is that doctor relaying on alternatives to that injectable? And what kind of physician is doing the injecting or the supervision? Is the physician one who routinely treats such conditions?
Furthermore, Dr. Kridel encourages patients to seek out medical practices where, “staff are trained in sterile procedures so as to avoid contamination, re-use of needles, and infections. Plus, in the rare case of an allergic reaction, [ensure] staff and physicians are trained in resuscitative measures and have emergency drugs available.”
The FDA also cautions that there is a possibility of experiencing potentially life-threatening distant spread of toxin effect from the injection site after local injection. However, distant spread of BOTOX cosmeitc resulting in serious side effects has never been reported to the FDA.
Also, doctors administering botulinum toxin understand that products are not interchangeable, and that clinical doses expressed in units are not comparable from one botulinum toxin product to the next (e.g. Botox Cosmetic® vs. Dysport®). Units of one product cannot be converted into units of another product.
Given these risks, patients should insist on engaging physicians who have completed comprehensive, clinical training programs like the IAPAM’s Aesthetic Medicine Symposium or Advanced Botox /Dermal Filler Bootcamp.” For the patient, this translates into ensuring that their physician is trained in the latest injection techniques, is comfortable with dealing with a possible adverse event due to the procedure and is a member of a internationally recognized aesthetic association.
The Last Word
Dr. Brian R. Buinewicz offers these closing thoughts to consumers foolishly considering DIY cosmetic injectables.
“This is incredibly concerning that someone would be so short sighted [as to consider] DIY Botox. Botulinum toxin A is a drug that, if administered incorrectly, can have serious and potentially fatal side effects. To take the chance of a serious or fatal reaction to save a few bucks and for convenience is beyond reason. Would someone perform their own appendectomy or Cesarean section because it was convenient for them and they could save on anesthesia and hospital costs?”
Understandably, consumers will continue to look for opportunities to forgo expensive professional services, ranging from a basic handyman to an accountant. However, in every instance where a consumer chooses the DIY option over the “do it for me” option, the key question has to be: risk vs. reward, and the issues of risk associated with the DIY applications in aesthetic medicine are significant.
Dr. Kridel reminds patients that “what is exciting now are all the FDA approved injectables that we now have,” giving many choices to doctors and patients to individualize the right treatment. It’s just wise to have the right physician examining and guiding you to the optimal result!” Ultimately, the wisest consumers will opt to save money through DIY home decorating, and not aesthetic medicine procedures.
-compiled by Leslie Marshall, Online Media and Research Specialist, The IAPAM.
More more information:
Jeff Russell, Executive-Director
International Association for Physicians in Aesthetic Medicine (IAPAM)
1-800-219-5108 x705
e-mail: info@theiapam.com
web: http://www.iapam.com
Friday, May 22, 2009
Think Before You Ink: Are Tattoos Safe?
Think Before You Ink: Are Tattoos Safe?
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.
For more information about the Laser Tattoo Removal at Derma Health Institute.com, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=179
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.
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 ultravioloet (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 Surgery can help you find a doctor experienced in tattoo removal.
For more information about the Laser Tattoo Removal at Derma Health Institute.com, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=179
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.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
Protect Your Health
Joint FDA/WebMD resource
www.webmd.com/fda
www.fda.gov/oc/opacom/hottopics/tattoos.html
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.
For more information about the Laser Tattoo Removal at Derma Health Institute.com, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=179
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.
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 ultravioloet (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 Surgery can help you find a doctor experienced in tattoo removal.
For more information about the Laser Tattoo Removal at Derma Health Institute.com, go to:
http://www.dermahealthinstitute.com/catalog/product_info.php?products_id=179
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.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
Protect Your Health
Joint FDA/WebMD resource
www.webmd.com/fda
www.fda.gov/oc/opacom/hottopics/tattoos.html
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