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DYI Botox, Botox Training in Hotel Rooms, and Importing Botox from Canada, What’s Next?

December 2, 2009 |

Jeff Russell, IAPAMWith all the recent talk about consumers buying Botox online and injecting it themselves, and physicians using illegally imported Botox from Canada, I can’t help but comment.  While looking at the FDA guidelines for cosmetic injectable procedures and chatting with medical malpractice carriers it’s very surprising how many physicians don’t realize they are going against FDA recommendations for cosmetic injectables and even breaking the law. One such FDA statement is “Botox Cosmetic should be administered in an appropriate setting using sterile instruments. Malls [hotel rooms, and conference rooms] and private homes are not medical environments and may be unsanitary.”  I’m amazed at how many Botox Training programs are being offered in hotel rooms around the country.  First the technique is wrong (since a hotel room chair is much lower than a proper practice treatment chair), and secondly with H1N1 being prevalent, who wants to be injected in a hotel room!

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 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.

In addition, I’m hearing about physicians who are buying Botox from Canada for $100 vial cheaper than here. If a physician buys Botox or any other FDA approved cosmetic injectable not only are they violating the law, they will not be covered by their medical malpractice carrier. I’m sorry I just don’t see the point is loosing any medmal coverage for saving $1/unit. 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.

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.”

The IAPAM will be releasing a series of consumer and physician oriented bulletins on the various Botox and cosmetic injectable tips and best practices.  In addition, it is important to remind physician when choosing a Botox Training program, that they choose one where the injectable portion is done in a clean medical spa or practice, not a hotel room. In keeping with FDA recommendations, all IAPAM Botox Training programs are done in a medical facility.

Well, that is my rant for today!

Cheers,   Jeff Russell
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