for “Bargain” Injectables, Says ASAPS

January 3, 2000

NEW YORK, NY (December 3, 2004) — Patients may pay with their health and even their lives if they mistakenly choose unqualified and sometimes unscrupulous practitioners to administer wrinkle-fighting injectable treatments, says the American Society for Aesthetic Plastic Surgery (ASAPS). ASAPS, the nation’s leading society of board-certified plastic surgeons who specialize in cosmetic surgery, says that four seriously ill people who were hospitalized following injections of an unidentified substance at a Fort Lauderdale clinic could be the latest victims of what has become an increasingly common problem — illegal and unsafe drugs administered as cosmetic treatments by practitioners without appropriate training and credentials. Original reports of the incident suggested that the individuals might be suffering from botulism, but this has not yet been confirmed. “No one yet has all the facts about these particular cases, so it would be imprudent to jump to any conclusions about the cause of their illness,” says ASAPS President Peter Fodor, MD, of Los Angeles .

Early in the investigation, reports had suggested a possible association with BOTOX®, the popular wrinkle treatment that contains a very small, and proven safe, dose of botulinum toxin type A. However, later reports on the Fort Lauderdale case have suggested that the individuals may have been injected with an unapproved substance, perhaps containing botulinum toxin or some other agent. “More than 15 years of experience with therapeutic applications of botulinum toxin (type A) to millions of patients worldwide has never produced this type of response when used at the doses recommended in the product labeling and administered in clinical practice,” says Dr. Fodor.

Botulism is very rare. According to infectious disease experts, the systemic illness is contracted only by ingesting or being intravenously inoculated with living spores from the botulinum bacteria. This might occur through consuming unpasteurized food products or through a contaminated wound.

The popularity of injectable treatments including BOTOX® and a host of soft tissue fillers, such as those containing hyaluronic acid (Restylane®, Hylaform), has encouraged their promotion by inadequately trained or non-medical practitioners, some of whom may obtain illegal substances and perform procedures under nonsterile conditions. Past incidents have been documented in which patients were seriously harmed by injections of non-medical grade materials. “Unfortunately, patients sometimes are lured by promises of less expensive treatments, or they simply fail to check the qualifications of the person administering the treatments,” says Dr. Fodor. “In such cases, patients may be unnecessarily risking their health and safety.”

Treatments such as skin resurfacing and BOTOX® injections are medical procedures that require appropriate training and sound judgment in order to help ensure safety. ASAPS recommends that such procedures should be performed in appropriate facilities by a properly qualified physician who has received specific training in the particular procedure.

BOTOX® temporarily blocks the transmission of impulses from the nerve cells to the muscles that cause frown lines and other dynamic wrinkles, smoothing out existing lines over time and helping to prevent the further development of wrinkles. BOTOX® treatments must be repeated periodically to maintain the results. According to statistics from ASAPS, nearly 2.3 million BOTOX® procedures were performed in 2003, making it the nation’s most popular nonsurgical procedure. The number of BOTOX® procedures has increased an incredible 3387 percent since 1997, more than any other cosmetic procedure.



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