Botox – Is there ever too much?

With the cumulative effects of Botox still yet to be fully understood for cosmetic use, it is in the interest of those practitioners that administer Botox as an aesthetic treatment to take appropriate steps before and during treatment in order to mitigate any potential claims dealing with Botox administration.

What is Botox and how does it work?

Botox popularity has been growing since the 1970s for the drug of choice in facilitating non-surgical anti-wrinkle treatment. Non-surgical treatments such as Botox and fillers account for nine out of ten procedures and the industry is worth £2.75billion in the UK.

Botox is a protein which weakens and inactivates muscles.  It is a drug, made from botulinum toxin, which blocks neuromuscular transmission.  This means that the area where the product is injected is temporarily ‘put to sleep’ – the muscle is relaxed and this results in smoothing of the skin.  The treated muscles regain their function after three to four months. There are a number of Botox preparations available such as Dysport and Azzalure, which carry varying authorisations for use on areas, typically in a recipient’s face and décolletage.

The risks and issue of toxicity in cosmetic use  

The common risks of Botox are well known across the aesthetic industry, including bruising, tiredness, temporary drooping of the eyebrow upper eyelid, skin rash, allergic reaction and muscle atrophy. 

What is less common and to be explored, is whether it is possible recipients can experience toxicity from Botox. This may cause rare, yet far more serious complications such as heart palpitations, dizziness, chest pain, tachycardia, breathlessness and hypotension.

When considering the use of Botox, there is a fundamental distinction between its long-standing use for therapeutic administrations to treat underlying clinical disorders such as muscle spacity in patients having had a stroke or Parkinson’s disease. When Botox is used for cosmetic administration it involves significantly lower dosages.  It is on this principle that the toxin itself would have been completely metabolised and inactivated between each treatment.

There is no published data to indicate the occurrence of systemic toxicity or cardiac autonomic toxicity arising from cosmetic administration of botulinum toxin.

However, it is possible that the alleged serious side effects of Botox may in part be cumulative in those that receive multiple administrations due to repeated low level toxicity. The fact someone previously received Botulinum in similar or higher dosages without adverse effects does not diminish the possibility of a toxic effect arising from repeated administrations.

In the absence of an alternative plausible explanation, there may be challenges in defending any claim of medical malpractice of this nature. Especially, if the recipient has had no prior symptoms or dysfunctions prior to starting Botox treatment and if there is a close temporal relationship between administration and the occurrence of symptoms.

Minimising exposure to claims

• Keep clear contemporaneous records of the consenting process and engage with the recipient in a thorough dialogue about the common and serious risks of the treatment.
• Counsel on the risk of toxicity and possible cumulative effects.
• Each time a Botox injection is undertaken re-consent the recipient and check that their medical history has not changed.
• Ensure the type of Botulinum toxin administered (i.e. Azzalure/ Dysport etc.) is authorised for injection in the area it is to be used on.
• Be vigilant to the number of sites injected on any one occasion to ensure the administration is appropriate and within authorisation.
• Avoid vein puncturing to prevent significant intravenous injection.
• In the event of any clinical negligence claim arising from Botox administration is pursued, ensure appropriate specialist expert input is obtained in any claim from experts in fields as aesthetics, toxicology and immunology and allergy.

If you would like to discuss this topic in more detail, please contact Monica Gosling, Solicitor, or Joanne Easterbrook, Partner.