News Special: Reporting Botulinum Toxin Complications

By Holly Carver / 01 Nov 2021

Aesthetics looks at a recent study which indicates botulinum toxin complications are being underreported

Botulinum toxin is the bread and butter of aesthetics and has always been considered a generally safe procedure. However, new research has revealed that one in six patients suffer complications after having botulinum toxin injections.1 The research was undertaken by four doctors at the Royal Free and St Thomas’ hospitals in London; three were plastic surgeons and all were academic researchers. Dr David Zargaran, the lead author of the study, and his team found an overall complication rate of 16% when they analysed 30 studies involving 17,352 injections of botulinum toxin into the face. The most common complications involved localised skin reactions such as bruising (5%), headaches (3%) and facial paresis (2%) in which parts of the face such as the eyelid or eyebrow are paralysed.1 Problems with complication reporting have been highlighted previously, with a survey of 461 aesthetic practitioners conducted by insurance provider Hamilton Fraser Cosmetic Insurance revealing more than half of aesthetic practitioners did not report their complications in 2019.2

Dr Zargaran’s research team found that only 188 adverse reactions were reported to the Medicines and Healthcare products Regulatory Agency (MHRA) over the past 29 years, equating to less than 10 adverse events a year across the UK. This suggests that complications are being heavily underreported to the regulatory agency, with the study calling the current data a ‘significant underestimate’.1

We spoke to aesthetic nurse prescriber and trustee at the Joint Council for Cosmetic Practitioners (JCCP), Andrew Rankin, and consultant plastic, reconstructive and aesthetic surgeon Mr Dalvi Humzah, to find out on why this might be the case.

Prescribing to non-medics

While the study indicates non-medic injectors as being the main cause for concern, Mr Humzah believes that the focus should instead be put on those who are prescribing the medicine to them. He says, “Botulinum toxin is a prescription-only medicine, so non-medics can only get their hands on it if someone with a medical background is prescribing it for them. If you, as an a healthcare professional, are making the decision to do this, then you have to understand that all of the issues relating to that prescription come back to you, and it’s your responsibility to report the complications. In this instance, rather than a greater regulation for non-medics or on toxin itself, what we really need is a greater regulation on the relationship between prescribers and non-prescribers.” 

Rankin agrees, noting, “Non-medically trained injectors aren’t regulated and have no obligation to report complications to anyone, such as the MHRA, the product manufacturer, or a regulatory body. What is worrying is that the person who prescribed them the botulinum toxin has an obligation to follow-up on the treatment and identify a problem and report it, and they obviously didn’t. The law states that non-medics can inject prescription medicines under the supervision of a regulated professional and, until the law changes, what I would like to see wider adoption of the standards of oversight that the public and professional regulators expect, and greater enforcement where it is lacking.”

Know your anatomy

Rankin notes that many of the side effects reported in the study can probably be put down to practitioner error, rather than a problem with the substance itself assuming appropriately regulated products are being used. He adds, “Given the lack of reporting, it’s very difficult to understand exactly what the incidence of complications are, but I’m sure they vary from one practitioner to another.” Mr Humzah emphasises the importance of all practitioners knowing facial anatomy in order to minimise the risk of complications occurring. “A lot of it is knowing where you’re injecting – the standard three-point injection model doesn’t follow the anatomy carefully,” he says, adding, “you have to learn how to tailor your injections, and to do that you really have to understand the face or area of injection. Hands-on training courses can be really useful for teaching you how deep you should be injecting, and letting you practice this.”

The importance of reporting

Mr Humzah explains that it’s extremely important for all practitioners to report botulinum toxin complications, or all aesthetic complications for that matter, to the MHRA using the yellow card reporting scheme, the medical device manufacturer, their regulatory body, or to the JCCP if they are a member. “The MHRA needs to be able to track all complications/side effects, so that they can see if there are any that might be becoming more common than expected, and they can look into why this might be,” he says.

Rankin adds that this is important for ensuring public safety, noting, “It’s only by the MHRA understanding what is going on with any particular medicine or medical device that it can intervene. This may mean taking products off the market, providing more regulation for its use, or changing its instructions, but if people don’t report complications the MHRA may only have part of the picture, hampering effective action and increasing public risk.”

Rankin also emphasises that the lack of reporting makes it difficult to push for regulatory change. He comments, “Because complications in aesthetics are heavily underreported, as evidenced by this study, we currently have very little evidence to support any question about a risk to public safety. Any authority will request evidence from us to make changes to the law and to the regulation of our industry. We need substantive rather than anecdotal evidence and if practitioners don’t report complications, we have nothing meaningful to present.”

Mr Humzah believes that training providers have a responsibility to ensure practitioners are reminded of the importance of reporting complications to the MHRA, product manufacturers, or their regulatory bodies. He concludes, “I’ve noticed that a lot of the time, when complications are discussed, the only thing that’s spoken about is how to rectify it or how to prevent it. While this is of course extremely important, providers also need to press upon delegates that they should be notifying the relevant people should any complications arise. All too often this gets forgotten about, and I think this needs to be specifically mentioned every single time.”

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