June 16, 2022

unregulated botox

Have you ever wondered why it really matters where you purchase the botulinum toxin that you use in clinic on your patients – whether that is direct from the manufacturer, from a recognised pharmacy, or from “Botox Dave” on Instagram? Have you thought about the dangers if it is a parallel import or an unlicensed product or maybe just something that someone ‘knocked up’ in a lab somewhere and sold online?

In this blog, Dr Tim Pearce will explore the risks involved in the different avenues that exist for the procurement of botulinum toxin products for use in aesthetic practice, and why you should not be buying from unreliable or unregulated sources.

Do you feel anxious about causing complications? Many clinicians feel so overwhelmed with the thought of causing a vascular occlusion that it stops them growing their aesthetics business. Dr Tim is currently hosting a webinar series to help you overcome your fear of complications so that you can uplevel your knowledge, and increase your CPD-certified learning to build a successful aesthetics business. Sign up here >>

Dr Bach McComb caused botulism by using fake ‘Botox’

Source: U.S. FDA Consumer Health Information
Source: U.S. FDA Consumer Health Information

Dr Tim recollects that when he first started his career in aesthetic practice, there was a high profile and infamous case in America that made him think about how important it was to purchase the right botulinum toxin products.

The case involved Dr Bach McComb in Florida who acquired research-grade botulinum toxin type A (clearly labelled for ‘research purposes only, not for human use’ according to the U.S. FDA) at a reduced price and used it on himself, his girlfriend and two others. All four of them ended up close to death in a hospital ITU with paralysis and botulism due to a massive overdose of botulinum toxin.

Having survived, Dr McComb was prosecuted in 2006 and sentenced to three years in prison for botulism poisoning. Later, two other doctors in Arizona, Dr Chad Livdahl and his wife Dr Zahra Karim were also sentenced to jail for selling the bootleg botulinum toxin to hundreds of physicians across the USA. Reports at the time stated that they sold over 3,000 vials of the research-grade botulinum toxin cashing in well over $1million.

Of course, you might wonder how this could happen to a doctor, aside from trying to save money. It is almost impossible to see the amount of botulinum toxin that you need to achieve an effective treatment – this is because it is impossible to see in the vial whether you have the right amount, or if you have ten or one hundred times the amount, you simply cannot tell by looking at it. The only way you would find out how strong your botulinum toxin is would be at the point of treatment, which could have devastating consequences as Dr McComb discovered.

On a recent trip to the IMCAS conference in Paris, Dr Tim recalls hearing a speaker who had analysed the contents of different ‘fake’ botulinum toxin products they had been able to buy. The products were tested in a laboratory to see how effective they were, and surprisingly, it wasn’t that the ‘fake’ toxins were weaker, on the contrary, many of the concoctions were stronger – one of them being twice as strong as the description on the vial.

This again draws parallels with Dr McComb, because this scenario makes them much worse for you as a practitioner than if you treated a patient with a product that was weaker. If it was weaker, it may not work, or need a top-up and more product to achieve a result, but with a stronger product, there is unlimited risk including death from botulism poisoning.

Thankfully, with normal cosmetic doses, we are nowhere near using enough botulinum toxin to cause botulism symptoms, but if you treat a patient with an unknown product that has several hundred times more in the vial than the amount you think, the risks are significant.

You really need to think about how you buy your botulinum toxin products.

What are the risks of buying botulinum toxin from an unreliable source?

It might be tempting to buy your botulinum toxin from ‘Botox Dave’ on Instagram because he has got something that looks very similar, or a product that has a different brand name but comes from a country where it is used routinely, and his prices are attractive. But what are the risks?

It is important to understand then when you are purchasing botulinum toxin, you are not simply buying a vial of a drug, you are buying into a system that supports the product.

The production of botulinum neurotoxin products is one of the most sophisticated manufacturing and distribution processes available to produce a medicine – botulinum toxin is both a bioweapon and a wonder drug!

It is extremely difficult and dangerous to manufacture it from the bacterium Clostridium Botulinum, it needs to be made accurately and consistently, and tested, so it is the same in every vial of the millions made. When you buy it, you are not just paying for the toxin, you are paying for all the skill and technology that it takes to accurately distribute just the right (tiny) amount of botulinum toxin into individual vials so that as a practitioner, you get predictable results. Value comes from the validation of this consistency.

Don’t buy botulinum toxin from Instagram, online importers, or fake pharmacies

botox scam fraud fake

It is this consistency that will be missing if you consider purchasing cheaper or imported products from unknown and unregulated sources via social media and the Internet. You will be purchasing a product that has no validation – you have no idea how it was transported and managed through the supply chain, if it was a dodgy batch that someone wanted to get rid of, or whether the batch was falsely made in a different laboratory and labelled up differently, making it counterfeit and of unknown quantity.

This lack of validation is the main risk when it comes to using botulinum toxin products that have not come through legitimate sources such as via the manufacturer or regulated pharmacies. Other avenues including online purchasing through accounts on Instagram, online sites, or operations claiming to be online pharmacies (which often do not ask for a prescription) are likely to be providing parallel imported products, including drugs that do not have a license for use in the UK, with much less validation in place.

Dr Tim recommends that you do not consider buying from these businesses and only purchase licensed botulinum toxins direct from the manufacturer or via a regulated and approved pharmacy distributor.

The take home message from Dr Tim is that when it comes to the procurement of botulinum toxin products, you are looking for the validation and certainly surrounding the product. If you buy a vial of toxin over the Internet that works once, that does not mean that it is going to work next time, or that it will not overdose someone another time, you just got lucky.

The reassurance that comes with purchasing certainty around what you use on your patients, and that your patients know that you are prepared to spend more for the certainly of legitimate products for their safety is paramount. Make sure you let your patients know that you are ensuring this level of best practice to keep them safe.

To learn more about botulinum toxins and the licensed products available in the UK, why not enrol in Dr Tim Pearce’s eLearning Foundation Course on Botox® in Aesthetic Medicine.

You can find Dr Tim Pearce on Instagram if you have a question on Botox treatments that you want him to answer, or if you have any other burning questions or comments about aesthetic practice.

Aesthetics Mastery Show

The Dangers of Black Market Botox

Unlicensed and Unregulated Botox Dangers

To find out more, watch the Aesthetics Mastery Show, where Dr Tim shares the dangers of buying your botulinum toxin from an unreliable or unregulated source over the internet.

Response from Botox® Practitioners

The show has had thousands of views and has prompted response and debate from aesthetics professionals. Some of the latest comments include:

“Absolutely terrifying that any licensed medical professional would ever take this unnecessary risk and pass it onto their patients. Thankfully most would never do anything like that, but the more on alert and educated that patients are, the better. Great topic! DIY airplane? haha never!”

Nurse Carla TV

“I get messages almost weekly from sales reps selling these products. I report every single Instagram page that follows me or messages me. It’s everywhere and so accessible.”

Marisa Amechi R.N. C.A.N.S.

Read more and join in the debate on our YouTube channel.

BOTOX® / Botulinum Toxin eLearning

One way in which practitioners can improve their skills is to invest in training. If you’re a medically qualified aesthetic clinician, then eLearning courses could be a great way to support your learning. Dr Tim Pearce has created a pair of courses which provide foundation knowledge and complications training for botulinum toxin. Find out more about the courses together with a list of modules at:

In addition, browse our FREE downloadable resources and access FREE eLearning by following Dr Tim on social media.

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Dr Tim Pearce eLearning

Dr Tim Pearce MBChB BSc (Hons) MRCGP founded his eLearning concept in 2016 in order to provide readily accessible BOTOX® and dermal filler online courses for fellow Medical Aesthetics practitioners. His objective was to raise standards within the industry – a principle which remains just as relevant today.

Our exclusive video-led courses are designed to build confidence, knowledge and technique at every stage, working from foundation level to advanced treatments and management of complications.

Thousands of delegates have benefited from the courses and we’re highly rated on Trustpilot. For more information or to discuss which course is right for you, please get in touch with our friendly team.

 

Botox® is a registered trademark of Allergan Aesthetics plc.

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