Iapam Aesthetic Physician Bulletin: Diy &Amp; Illegally Imported Botox

Submitted by: Leslie Marshall

The IAPAM (International Association for Physicians in Aesthetic Medicine) offers the following information for aesthetic physicians on some alarming and illegal trends dealing with cosmetic injectable treatments, specifically DIY (Do It Yourself) Botox treatments and illegally imported botulinum toxin (Dysport, Botox) product.

The Recent DIY Botox Trend

Recently, there have been several reports regarding DIY “botox-like” injectables, which can be purchased through the internet. A woman in Texas, Laurie D’Alleva, offered consumers a botox-like product called “Freeze,” complete with a “How-To” video, so consumers could administer the botulinum toxin themselves. “The Texas Attorney General is charging D’Alleva with several violations of state law. She could be fined up to $25,000 per violation per day of the Texas Food, Drug and Cosmetics Act, and up to $20,000 per violation of the Texas Deceptive Trade Practices act. The red-flags regarding this internet offering range from the unrealistically low pricing, indicating the product is not FDA approved, to her complete disregard for the potential life threatening side affects that can accompany the delivery of a neurotoxin into the body by an untrained, unlicensed administrator.

Cosmetic Injectables Must Be Purchased in US

A parallel issue with the administration of botox by non-physicians is that “Botox and Dysport and all other cosmetic injectables can only be sold legally in the US …. to physicians.” These products must be legally approved and labeled by the FDA. Depending on state law, which varies, only physicians, nurse practitioners, and nurses may inject these substances.

Dr. Russel Kridel offers his expertise and concerns regarding the issues associated with purchasing cosmetic injectables. “The products obtained must come from the US where the FDA maintains safety levels not so strictly adhered to in other countries. Importation of cosmetic injectables can be a felony, subject to one year in prison and $100,000 in fines. Recently 5 physicians, a nurse and a practice manager in New York plead guilty to such charges. Therefore patients p[and doctors, alike] 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.”

Dr. Melissa Babcock also generously shares her insights regarding the purchase of botulinum toxin products. “It is true that Allergan, the maker of Botox, sells its product to pharmacies outside the US for a much reduced price. I have received flyers in my office offering Botox for up to 30% off from Canadian pharmacies and other internet sources. I have know of physicians buying Botox from Canada. It certainly is enticing to receive a 30% discount on an expensive injectable.

I bought Botox from a Canadian pharmacy. When the product arrived it was not Botox Cosmetic but regular Botox. The two products are identical. When Allergan applied for FDA approval of their botulinum toxin to be used for cosmetic reasons the FDA approved the drug but required Allergan to add the word “Cosmetic” to the packaging. This concerned me, but my other concern it that it took 7 days for the product to arrive. Normally when I order Botox from Allergan I receive the product in less then 24 hours and on dry ice. Botox is extremely sensitive to re-warming. Re-warming would certainly decrease the efficacy of the product.

Before using the Canadian Botox I called the Georgia Drug Association to inquire. A representative told me it was illegal to dispense or to treat patients with medications from Canada. Specifically every drug manufacturer who wishes to sell medications in the state of Georgia must have a license. The Canadian companies do not. The penalties for using medications purchased from Canadian pharmacies are hefty fines and revocation of the physician’s medical license. Since that time I have only ordered Botox from Allergan and I will never order medications or even sunscreen from companies outside the US.

If you are a patient and wonder if you physician is using Botox purchased outside the US first you should ask if they are using Botox Cosmetic. The word “cosmetic” is a hologram on the bottle. Canadian Botox is usually not Botox Cosmetic. When you make your appointment, tell the staff that you want to see the bottle when you have your injection. If the office does not want to show you the bottle then go elsewhere. Additionally every bottle has a lot number. When you call for your appointment you could ask to see the lot number on the bottle. This number would identify whether the Botox was sold in the US.”

Medical Malpractice Insurance Coverage Could be at Risk

Susan Preston, President of the Professional Program Insurance Brokerage firm is very clear about the implications to a practice if a physician purchases botulium toxin products from an unlicensed distributor or another country. Many, if not most insurance carriers, including ours, only provide coverage for Botox or other injectable products bought in the United States. There have been reports of people dying when treated with an injectable product from another country. The risk is too great when buying products from other countries as no one controls drugs as well as the FDA does in the United States. Also the manufacturer might not support liability for imported products especially if they were altered in any way. Thus the person getting the injectable solution cannot be sure that it is manufactured to US specifications, backed by the manufacturer and the potential for major injury including death is much greater.

Cosmetic Treatments Should be Performed in a Medical Facility

Dr. Kridel shares that “doctors offices or other medical facilities are the safest place to have injectables administered,” either during botox training or during patient treatment….Not too many spas, peoples homes, or hotel rooms have the same standards for cleanliness and emergency care that a doctor s office does!”

The FDA agrees, and specifically states that, “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.”

Furthermore, Dr. Kridel reminds practitioners that, “all staff should be trained in sterile procedures so as to avoid contamination, re-use of needles, and infections. Plus, in the rare case of an allergic reaction, only qualified staff and physicians are trained in resuscitative measures and have emergency drugs available.

Comprehensive Botox Training Needed

Dr. Melissa Babcock reinforces for physicians and patients alike, the importance of having a skilled professional involved in product preparation. “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. 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.

Dr. Thomas Sterry also champions the importance of being trained in a product’s preparation and dilution. “Botox comes in 100 unit vials that need to be diluted by the physician. Some doctors are accustomed to diluting it with 10 cc s of saline, making the concentration weak, but they inject more volume. Some make a very concentrated solution to give more pin point results. It s a style point with no generally accepted right way to do it, but the more concentrated solution does tend to hurt less.”

The Patient Consultation Is Central to a Successful Outcome

After training, managing patient expectations is the next most critical success factor in a good outcome with botox. Dr. Sterry offers these tips for physicians to discuss with their patients:

a. Ensure that you discuss with the patient, “what they are paying for.” Some physicians will charge per area (e.g. forehead) while others will charge based on how much product is being injected. b. Ensure the patient understands the office policy for touch ups before beginning the treatments. Some offices charge, while others will not. Typically, when patients pay by the unit, touch-ups are not “included.” c. Council patients that they should wait at least three months between injections to avoid the risk of developing antibodies to the botox, which will counteract the effects of injections.

Conclusion

Dr. Sterry provides these final thoughts. “People love Botox – patients and doctors – because of how accessible it is and for how minimally invasive it is, [but] the ease that people perceive it’s administered with has become exaggerated. In order to administer injectables with the best results, one must know very well the layout of facial muscles and understand well the product being injected. Finally, a huge part of injectables is artistic flair – you are using these products to literally fine tune the physical appearance of the face in a manner that is semi-permanent. Whatever the result is, it’ll be there for some time.”

“The most important thing for both patients and physicians to keep in mind is that injecting the skin with Botox, Dysport, Juvederm or any other product is not ‘easy’ and even otherwise trained professionals have seen far less than stellar results. A colleague of mine let me know that even after undergoing some training with Botox injections, he was still unable to generate the results he wanted. In one case, he very unfortunately had some trouble with the muscles around the eye. Certainly after more Botox training and practice he’s honed his skill but it just goes to show that these injections must not be taken lightly [just] because they are far less invasive and less expensive than other facial cosmetic procedures.”

About the International Association for Physicians in Aesthetic Medicine (IAPAM)

The International Association for Physicians in Aesthetic Medicine is a voluntary association of physicians and supporters, which sets standards for the aesthetic medical profession. The goal of the association is to offer education, ethical standards, credentialing, and member benefits. IAPAM membership is open to all licensed medical doctors (MDs) and doctors of osteopathic medicine (DOs). Information about the association, or about physician certification, can be accessed by contacting:

Jeff Russell, Executive-Director International Association for Physicians in Aesthetic Medicine (IAPAM) 1-800-219-5108 x705 e-mail: info@theiapam.com

Botox and Juvederm is a trademark of Allergan, Inc. Dysport, Restylane, anb Perlane is a trademark of Medicis, Inc.

About the Author: The IAPAM was founded to unite licensed physicians who practice aesthetic medicine and their supporters. IAPAM membership is open to licensed medical doctors (MDs), doctors of osteopathic medicine (DOs) and the medical students studying for those degrees. Website

iapam.com

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isnare.com

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