Chicago, IL—The American Board of Cosmetic Surgery (ABCS) warned about the dangers of counterfeit Botox® products used in anti-wrinkle injections and offered guidance on how to avoid these potentially harmful products in response to a recent public warning issued by the Food and Drug Administration (FDA). In April 2024, the FDA reported that counterfeit Botox was found to have been used in multiple states across the U.S. from November 4, 2023 to March 31, 2024, leading to serious patient complications.
“We are deeply disturbed by these events and will continue to advocate for patients to choose treatments provided by, or under the supervision of, an ABCS board-certified cosmetic surgeon or other physician with appropriate experience and training,” says ABCS President Jeffrey A. Swetnam, MD, FACS, FAACS. “American Board of Cosmetic Surgery Diplomates adhere to the strictest safety standards and only purchase botulinum toxin products directly from the manufacturers and authorized suppliers to protect their patients’ health and well-being.”
The FDA’s alert came after several patients in multiple states suffered severe complications from injections of counterfeit botulinum toxin products. These adverse reactions include blurred or double vision, droopy eyelids, slurred speech, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, muscle weakness, fatigue, and difficulty lifting one’s head.
The investigation, which is still open at this time, noted these dangerous effects occurred in individuals who received counterfeit botulinum toxin administered by unlicensed or under-trained injectors. The counterfeit neurotoxin injections additionally occurred outside of licensed medical facilities; in some cases, injections were being administered from private residences.
Recognizing genuine Botox® packaging: Legitimate Botox products are manufactured by Allergan Aesthetics (an AbbVie company) and feature distinctive packaging that includes an “Allergan” hologram over the label and the name "OnabotulinumtoxinA" in a purple banner across the top. In contrast, counterfeit botulinum toxin products recently identified in the FDA’s investigation had packaging with a firework-pattern hologram and a lot number of C3709C3, without any hologram on the vial.
Guidance for medical providers: The American Board of Cosmetic Surgery encourages all injectors to remain vigilant in monitoring for potential negative reactions associated with botulinum toxin injections, particularly if symptoms suggesting botulism appear near the area of injection. In cases where systemic botulism is a concern, contact one's local health department immediately for the next steps and to facilitate antitoxin release. Follow the local protocols for reporting any adverse effects.
Guidance for patients: The American Board of Cosmetic Surgery advises patients seeking Botox-type injectables to verify the credentials of their providers and to ensure that any botulinum toxin product used is sourced from reputable suppliers. Injectors should be licensed according to individual state laws and have received proper training in administering FDA-approved botulinum toxin products. This includes utilizing the correct dosage and placement techniques to achieve safe, natural-looking results.
Patients should also be aware of which brand of neuromodulator their injector uses, as multiple FDA-approved options are available, including Botox®, Dysport®, Jeuveau®, Xeomin®, and Daxxify™. The ABCS urges patients to receive treatments exclusively in licensed healthcare settings, under the supervision of a physician (MD or DO). Physicians overseeing cosmetic injectables help ensure the highest standards of care are met to significantly reduce the risk of encountering counterfeit products.
Many cosmetic surgeons certified by the American Board of Cosmetic Surgery offer non-surgical treatments, including Botox-type injectables, at medical spas integrated within their cosmetic surgery practices, where they often perform injections themselves or work closely with qualified injectors under their supervision.
If any unexpected side effects develop after one receives a neurotoxin injection, particularly changes in vision, drooping eyelids, unexplained muscle weakness, or trouble breathing or swallowing, go to the emergency room immediately and inform them of the treatment, including the injection site and the number of units received if known.
For those considering cosmetic injectables, the ABCS invites readers to visit their website at www.americanboardcosmeticsurgery.org to learn more about treatment options and to find a board-certified cosmetic surgeon in the area who either performs injectables or oversees licensed injectors.
###
For more information about American Board of Cosmetic Surgery, contact the company here:
American Board of Cosmetic Surgery
Dr. Jeffrey Swetnam
(425) 689-5665
press@americanboardcosmeticsurgery.org
8840 Calumet Ave Ste 205, Munster, IN 46321
