The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS), the largest association of facial plastic surgeons in the world, is urging consumers to remain vigilant as counterfeit and unapproved neuromodulators continue to enter the market. Following recent FDA warning letters issued to more than a dozen companies across the U.S. and internationally for selling unauthorized versions of botulinum toxin type A – the neurotoxin used to temporarily relax facial muscles and smooth wrinkles – the AAFPRS warns that these counterfeit products pose serious health risks.
“As counterfeit injectable products continue to surface, it’s imperative for patients to prioritize their safety,” says Anthony E. Brissett, MD, FACS, President of the AAFPRS. “Anyone considering cosmetic treatments should take care to seek out medically trained professionals who use only properly handled, FDA-approved medications."
WHY THIS MATTERS
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Counterfeit products may be contaminated, incorrectly formulated, or ineffective, exposing patients to dangerous chemicals and unpredictable effects.
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Even when the product is legitimate, injections performed by individuals without proper medical training can lead to irreversible complications including nerve damage, drooping of eyelids or facial muscles, severe asymmetry, breathing difficulties, and blindness.
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At-home Do-It-Yourself (DIY) injections are especially hazardous, even with “real” product. A misplaced injection can injure a nerve, puncture a blood vessel, or affect muscles that control critical functions such as blinking, swallowing, or speech.
WHAT CONSUMERS SHOULD DO
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Always verify the credentials of the treating provider. Only professionals certified in facial plastic surgery, dermatology, or other relevant medical specialties should perform cosmetic injections.
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Request to see the medication vial and its packaging. Legitimate neuromodulator products have proper labeling and expiration dates on the packaging that matches the vial—and come from licensed pharmaceutical distributors.
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Never purchase neuromodulators over the internet for at-home use. The price may seem attractive, but the effects of counterfeit toxins are simply not worth the risk.
WHAT THE AAFPRS RECOMMENDS
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Seek injectable care from a licensed, board-certified physician trained in facial anatomy and injectables, specializing in plastic surgery of the face, head and neck—or under the direct supervision of such a physician. These treatments should never be performed outside a medical setting or by an untrained individual.
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Report suspicious injectable products or unlicensed providers to your state medical board—and the FDA (via the FDA MedWatch Online Voluntary Reporting Form).
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Seek medical attention right away for any unusual symptoms after an injection. Acting quickly can prevent serious complications and prevent others from harm.