What’s next for Botulinum Toxin - is the aesthetics market in need of reform?

The results of the UK’s largest academic study examining patients who experienced an adverse outcome following the aesthetic administration of Botulinum Toxin injections has been published in the ‘Skin Health and Disease’ journal this month.

Botulinum Toxin is an injectable drug which is more commonly known by the brand name “Botox”.

The study collected data from 511 patients who had received Botulinum Toxin injections  and evaluated the data relating to “long-lasting physical, psychological, emotional, and financial sequelae of complications arising from cosmetic Botulinum Toxin injections in the UK.” It is the first in a wider study looking at the cosmetic injectables industry and the impact of these procedures on public health.

The headlines from the study are as follows:

• 79% of patients who responded reported experiencing an adverse effect following the administration of Botulinum Toxin for cosmetic purposes. The most commonly reported adverse experiences were ‘anxiety’ and ‘pain’. Others reported adverse effects included ‘depression’, ‘headaches’, ‘brain fog’, ‘tinnitus’, ‘panic attacks’ and ‘bladder/UTI/urination problems’.
• 69% reported a long-term consequence following the administration of Botulinum Toxin.
• 68.4% of patients reported not having recovered physically, 63.5% reported not having recovered emotionally and 61.7% said that they had not recovered psychologically.

The results of the study also revealed that patients who experience adverse side effects and complications from Botulinum Toxin injections do not know how to report their concerns and/or where to go for help.

Next steps

It is important to note that the study is observational only; it does not examine whether the adverse side effects experienced by participants are a direct result of the Botulinum Toxin injection or a side effect of concerns relating to how it is administered.

The authors of the study do, however, note that the reported anxiety which patients in the study attributed to their Botulinum Toxin injections may represent an association between the administration of Botulinum Toxin and the patients’ complications.

The plan is for the next part of the study to look at what is causing the adverse effects and whether there is a causal link between the administration of Botulinum Toxin and the adverse effects experienced by some patients. To conduct this analysis, more information will need to be collected from patients and practitioners including, for example, the specific product and batch administered.

What does this mean for the aesthetics market?

The UK cosmetics industry is a burgeoning and highly profitable sector. It is important to note that many of those who practice in this area are not trained medical professionals, and therefore patients should conduct thorough research ahead of any procedure to ensure they understand the experience, qualifications and training of the practitioner they are seeking treatment from.

Doctors who are registered and/or have a licence to practise, who perform non-surgical aesthetic procedures such as Botulinum Toxin injections, have to be commercial, given the nature of the sector. Many comment that there is a tension between this commerciality and the traditional duties incumbent upon doctors set out in the GMC’s standards and guidelines (such as Good Medical Practice), and further that the approach to regulation of doctors does not comfortably work well in aesthetics sector.

Below are some particular areas that aesthetic doctors may wish reflect upon:

1. Assessing the patient

It goes without saying that a thorough assessment of the patient to assess whether they are suitable for treatment is needed. The assessment needs to be a consultative process. In particular, doctors must consider their patient’s psychological needs and assess whether the patient is at risk, mentally vulnerable and/or has any contraindications to treatment. There is a need to identify patients at risk of an adverse emotional response to cosmetic procedures, patients with addiction to cosmetic work and patients with risk factors for conditions such as body dysmorphia.  

The doctor’s assessment and conclusions should be clearly documented in the patient’s records.

2. Discussing risks

When consenting a patient for aesthetic treatment, doctors should think carefully about what information they should give to the patient regarding the possible outcomes and adverse effects. As the study shows, the ever-increasing number of patients undergoing non-surgical aesthetic procedures in the UK naturally increases the potential risk of adverse outcomes.

3. Information on the Yellow Card Scheme

In the UK, complications that arise following the administration of Botulinum Toxin should be reported to the Medicines and Health Regulatory Agency (MHRA) via the Yellow Card Scheme in the same way as any other prescription only medicine (“POM”).

Reporting adverse outcomes experienced by patients helps the MHRA identify issues with medicines such as Botulinum Toxin, which might not have been previously known about. Reports are used alongside other safety information and “help the MHRA to take action if any trends associated to the safety or efficacy of a healthcare product are identified”. The MHRA will review the issue and take action to minimise risk and maximise benefit to the patients.

The obligation on doctors to use the Yellow Card Scheme is explicitly set out in the GMC’s guidance, ‘Good practice in prescribing and managing medicines and devices’.

Further, the GMC’s ‘Guidance for doctors who offer cosmetic interventions’, states that doctors “must tell patients how to report complications and adverse reactions.” Despite this, the study found that 92% of participants reported not being told by their practitioner about the Yellow Card Scheme (caveat that not all patients would have been treated by doctors).

Many doctors are actively advocating for better regulation and safety measures in this sector, which is of primary importance to protect patients. Bodies such as the Joint Council for Cosmetic Practitioners (JCCP) aim to oversee voluntary regulation and the Cosmetic Standards Practice Authority (CPSA) to set evidence-based practice standards.

We will be keenly watching the developments in the aesthetics market, and how the current healthcare regulators, such as the GMC, rise to the challenges.

Further information

If you have any questions regarding this blog, please contact Georgia Rose or Shannett Thompson in our Regulatory team. 

About the authors

Georgia Rose is an Associate in the Regulatory team with a broad base of clients across the team’s various sectors of specialism. She is an expert in healthcare regulation and acts for doctors in fitness to practise proceedings brought by the General Medical Council (GMC). She represents doctors at all stages of investigations, from initial contact, in Interim Order (IO) hearings, in substantive hearings before the Medical Practitioners Tribunal Service (MPTS), review hearings, restoration hearings and in appeals. She has several years’ experience acting as a panel solicitor for all three of the UK’s major medical defence organisations.

Shannett Thompson is a Partner in the Regulatory Team and is the firm’s Training Principal. She has trained in the NHS and commenced her career exclusively defending doctors. She provides regulatory advice predominantly in the health and social care and education sectors.