The American Society for Aesthetic Plastic Surgery (ASAPS) , the nation's leading society of board-certified plastic surgeons who specialize in cosmetic surgery, announced today that patients need to be wary of “bargain” injectables or other treatments that are not approved by the United States Food and Drug Administration (FDA). Unregulated injectables or treatments can compromise patient health and put patient lives at risk. “Some practitioners buy products that have not been approved for use in the United States, often from foreign discount vendors, which is a dangerous and illegal practice,” said Mark Jewell, MD, ASAPS President. “Patients can, however, take some easy steps to make sure their plastic surgeon is qualified and has purchased FDA-approved treatments.”
Injectable treatments are medical procedures that require appropriate training and sound judgment in order to help protect patient safety. ASAPS recommends that patients avoid discounts that seem extreme and make sure their surgeon or doctor is credentialed. In addition, the Society recommends that all medical procedures be performed in appropriate facilities by a properly qualified clinician who has received specific training in the particular procedure. Patients should be wary of procedures offered in non-clinical settings such as shopping malls, private homes, office parties, and group social gatherings.
Only drugs that are labeled and approved by the U.S. Food and Drug Administration (FDA) can be legally marketed or sold within this country. For example, currently Botox® is the only type of botulinum toxin approved in the U.S. Botulinum toxin (type A), can be used as an injectable to temporarily reduce or eliminate the appearance of wrinkles . Earlier this month a doctor was indicted on Federal charges for injecting patients with a form of botulinum toxin that has not been approved for use on humans by the FDA. The doctor and his nurse face multiple charges including misbranding of drugs. Other cases of practitioners obtaining illegal, non-medical grade substances have been documented, as have cases of injectable treatments being administered by inadequately trained or non-medical practitioners. This can lead to serious patient harm, including death.
“Physicians who buy or use non-FDA approved products risk significant liability exposure, invalidation of professional liability insurance coverage, criminal penalties and action by regulatory agencies. Often these physicians think they are buying product that is FDA approved because packaging, including package inserts, are identical. To be safe, doctors should only buy from approved state-side suppliers" said Dr. Jewell.
Neither patients nor physicians should buy or use non-FDA approved injectables. Drugs purchased from foreign sources may be counterfeit versions of FDA-approved drugs, contaminated, outdated or improperly packaged and labeled. Physicians who directly obtain or assist their patients in obtaining prescription drugs from foreign sources may risk increased professional liability exposure.
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