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Consumer Cosmetic Injectable Safety Tips

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 cosmetic injectable 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 (www.drbrianbuinewicz.com) 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.

For more information about physician certification, contact Jeff Russell, Executive Director of the IAPAM at www.iapam.com or 1-800-219-5108 or info@theiapam.com

-compiled by Leslie Marshall, Online Media and Research Specialist, The IAPAM. 

Online Media and Research Specialist, The IAPAM ~ Leslie Marshall

Leslie is responsible for crafting and managing the IAPAM’s (www.iapam.com) internal and external communications including: producing our member newsletter (www.aestheticmedicinenews.com), creating association press releases, augmenting website content, writing industry articles, managing our online reputation, partnering on social networking strategies, and developing varied means to effectively keep members, industry professionals, and the media informed about the association and the industry. Additional responsibilities include: verifying industry facts and information and making the results available to our members.

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