Your Botox May Be Counterfeit!
Recent FDA investigations have found counterfeit versions of Botox in doctors’ offices and medical clinics nationwide. Counterfeit versions of Botox Cosmetic have been sold by unlicensed suppliers who are not authorized to ship or distribute medical products or medications in the United States.
This could be dangerous for patients because of the potential contamination of these unregulated toxins. In an alert issued, the FDA stated, “Medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer counterfeit, illegal, and unapproved medications from unlicensed or foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.[1]”
While Allergan, the manufacturer for Botox cosmetic, believes this has not affected Botox distributed in the U.S., patients should still be aware. As a plastic surgeon, board certified by the American Board of Plastic Surgery, I took an oath to act in an ethical manner and protect patients. Purchasing unregulated medications, like toxins or dermal fillers, falls out the realm of acting ethically, in my opinion.
The American Society of Plastic Surgeons showed that over 6.7 million Botox injections were performed last year by board certified plastic surgeons. This doesn’t even include injections by other specialties, like dermatology, facial plastic surgery, or by other practitioners, such as nurse injectors or aestheticians. Unscrupulous physician offices or medi-spas may have purchased this counterfeit Botox in order to increase profit margins because this is typically purchased for a decreased price per vial. Often these “clinics” are unable to purchase the FDA approved toxins like Botox or Dysport, because they lack a medical director or someone with the appropriate degrees and training. These “clinics” are often the punchline for “Plastic Surgery Gone Wrong” stories that have been popular in this reality TV show era.
Trusting your beauty to a non-core physician (Plastic Surgery, Facial Plastic Surgery, Dermatology) who are not board certified in their respective fields is risky. This likely means that the practitioner does not have the stringent training needed to perform these procedures safely and successfully. Intimate familiarity with facial anatomy is a must. Often Cosmetic Surgeons are not board certified in Plastic Surgery, but may, in fact be certified in other specialties, like family medicine or OB/GYN. Unfortunately, these specialties do not have a strong focus on anatomy. While going after a surface wrinkle with a toxin like Botox or Dysport may not seem all that technically difficult, it is what lies underneath that is most important. Oftentimes, a blood vessel or nerve can be involved in the errant poking of needles by the untrained.
For those unfamiliar with facial anatomy, the risk of having a complication may approach greater than 50%. An intimate understanding of anatomy is paramount when using these substances and medications. The risk of having an injector with questionable qualifications is scary enough. Now add to that the possibility of introducing counterfeit Botox into your face or body and the situation is truly frightening.
One way to ensure that the Botox being used on you is regulated by the FDA involves the labeling of the product. The counterfeit product can be identified by one or more of the following:
the vial is missing the lot number the outer carton does not have any entries next to the LOT: MFG: EXP: the outer carton and vial display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”[2]
For patients receiving Botox treatments, it will be difficult to check this. However, you are well within your rights to question the source of the toxin and to ask to “see” the bottle and packaging. If you do this and stick to treatment from a plastic surgeon board certified by the American Board of Plastic Surgery, you can be confident in your safety being maintained.
[1] 1. US Food and Drug Administration. Counterfeit version of BOTOX® found in the United States. US Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/ucm443217.htm. Published April 17, 2015. Accessed April 17, 2015.
