Seth Matarasso, MD, Addresses Counterfeit Botox News and How to Move Forward

On April 16, 2024, the US Food and Drug Administration (FDA)issued an urgent alert to health care professionals and consumers regarding counterfeit botulinum toxin products in several states. The counterfeit products were administered for cosmetic purposes, leading to adverse events, including hospitalizations. Patients who received the counterfeit botulinum toxin reported symptoms such as blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness, and difficulty lifting their head. These symptoms mirror those observed when botulinum toxin spreads beyond the intended injection site.¹

To better understand the significance of counterfeit Botox products and what dermatologists need to be on the lookout for, Dermatology Times spoke to its Editorial Advisory Board member, Seth Matarasso, MD. Matarasso, a board-certified dermatologist practicing in San Francisco, California, is the president of the American Society for Dermatologic Surgery (ASDS). He has been in practice for more than 30 years and continuously advocates for increased vigilance regarding the safe administration of aesthetic procedures.

Interview with Seth Matarasso, MD

Seth Matarasso, MD

Dermatology Times: As an established physician who practices and teaches safe and ethical aesthetic procedures, what was your initial reaction to the recent news of counterfeit Botox?

Matarasso: Unfortunately, it's not unexpected. This issue occurs every few years and physicians, the public, and regulatory boards get very concerned about it and then, the notoriety rapidly dissipates. I've seen this before, not only with toxins, but with fillers as well. So, I'm not surprised. I'm frustrated and disappointed because people's lives and health are put in jeopardy and it's unacceptable.

Dermatology Times: Have you seen an increase in your patients asking more questions about Botox, labels, and where these treatments are coming from?

Matarasso: I think most of my patients are seasoned and know when they go to a physician that they're comfortable with and have had a history with, their degree of suspicion is not raised. However, I have a few patients who have said, “I do not want to do my injectable procedure today until there is more information about the extent of this current issue and the safety of the toxin has been toxin re-established.”

Ultimately, I think in the long run this will be beneficial for patients; they will become more educated, and they will know to ask, “Who's holding this syringe? Are you licensed? Are you trained? Do you know facial anatomy and potential risks” Or are you somebody that is going to go from location to location without any supervision?” I'm hoping this will be a call for increasing patient safety and education.

Dermatology Times: With your involvement with ASDS/A and being a leading member, how is this society continuing to respond to the news and provide updates or education to its members?

Matarasso: ASDS/A has been very proactive. We put out a statement and notified all members of the ASDS/A that these counterfeit toxins are readily available. It is really crucial for physicians to reach out to patients to educate them and alleviate their concerns. I believe that those using non-FDA approved, and not medical grade, counterfeit toxins were not well-trained personnel. They are profiting from unsuspecting patients. Just because you're wearing a white coat does not mean that you are a physician nor appropriately or adequately trained to do these procedures. I think as a society, we've become immune to the fact that these are medical procedures. With these popular “TikTok docs,” patients see these procedures on social media and think they are risk-free and simple. These are the medical procedures that should be performed by appropriately trained personnel. In general, patients do not ask “You're going to be injecting this toxin into my face, where did you get the toxin from? Can I see the label to make sure that it's valid? Can I see your training credentials?” This has become such a routine and mundane procedure that I don't think patients appreciate the adverse consequences profile.

Dermatology Times: What should physicians be on the lookout for regarding botulism poisoning in patients?

Matarasso: When you have an adverse event from an FDA-approved toxin, they are localized anatomic concerns and are temporary and gradually improve. There are certain site-specific anatomic adverse events that one can see with toxins: such as facial asymmetries from muscle weakness. But, when a patient presents with blurred vision or is having difficulty speaking or swallowing, those are more consistent with systemic complications. When you have symptoms or signs of botulism poisoning, they are more systemic and not isolated to just one area.

Dermatology Times: What further work is needed in regulating cosmetic procedure certifications and training?

Matarasso: I realize that patients are cost-conscious and that offering toxin injections can be lucrative and consequently there is a lot of potential for fraud. Patients shouldn’t have a medical procedure, or something done where there is no recourse if a complication arises. I routinely get questions, and I can tell my patients “I've been treating patients with botulinum toxin for close to 30 years and I am one of the largest dispensers of toxin in the country and if you have questions, I or one of my staff is here every day to address your concerns.” 

A phrase that is appropriate in this scenario is “caveat emptor,” -buyer beware. If a procedure seems too inexpensive, patients should raise some questions. The problem that I see many times is these are pop-ups. If there's a complication or if a patient has botulism poisoning, when they go back to have their complication addressed, the “injector” is gone and has moved elsewhere. This is out of the hands of physicians, and until there is more governance of these non-medical personnel by local, state, and national governments, this is going to happen again.”

What is so upsetting is that the unsuspecting patient is the victim and needs to be educated. Injection of botulinum toxin is a deceptively simple procedure, and it is costly, so I realize that those with questionable ethics are trying to cut costs by using non-medical grade toxins, but ultimately, they are putting the patient's well-being and health and safety in jeopardy. I suspect that that this is only the tip of the iceberg and we're only seeing the cases that have been reported. Patients are often too embarrassed to admit that they sought treatment by unlicensed personnel, so I believe that more cases have not been reported.

There's only so much the ASDS/A can do. We can educate and alert our members and encourage them to only purchase products that are FDA-approved and from reputable manufacturers. And we can educate and advocate for patient safety. We simply cannot police those outside of our specialty. I know at the ASDS/A we are doing the best that we can. Our members and our physicians have risen to a higher level, but it is the outliers that we do not have any control over.

Dermatology Times: Do you have any experience with trying to work with state or government representatives for legislative change?

Matarasso: The ASDS/A has been very proactive. There was one bill proposed that would allow personnel who are not qualified to perform these procedures and that bill was not successful. Every state has different guidelines so it's hard to do something universal. It’s also difficult because many of those who are in regulatory power don't see this issue as a health concern but rather as a vanity concern. The second thing is that the state regulations vary so dramatically from state to state, that it's hard to make any significant changes. And as I said before, those who are using counterfeit products are hard to track down, and by the time that a problem arises, they cannot be located. There's no way to press charges against those injectors who are using fake products because they are very mobile. 

What's also concerning is that this is not an isolated event; this will continue to happen. I've been in practice for over 30 years and offhand, I can think of similar prior scenarios. In Florida, people died from the use of veterinary-grade toxin. There was an outcry and there was a call for more regulation, and then the concerns rapidly faded away. In California, people were crossing the border and using adulterated silicone and patients were disfigured. In fact, one woman was so irreparably harmed that she took her life. These consequences are significant. Botulism is significant.

Dermatology Times: Do you have any closing thoughts about counterfeit Botox?

Matarasso: I often see patients who have a neurotoxin complication from an ill-trained provider at a reduced cost and they are left without a solution. It is important for patients to remain alert and ask a few important questions, “What's your educational background? What's your training? Do you know anatomy? If something unusual happens, are you available?” I don't think as physicians we can regulate that, and I am not sure that the government can either.

The bottom line is yes, the use of botulinum toxin is an aesthetic procedure. But it is a medical procedure with medical consequences and not something to be taken lightly.

Reference

1. Counterfeit version of Botox found in multiple states. News release. US Food and Drug Administration. April 16, 2024. Accessed June 19, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states?utm_medium=email&utm_source=govdelivery