Wake-up call

The largest UK study into botulinum toxin adverse reactions highlights the challenges faced by patients and exposes a concerning lack of awareness about reporting structures. Contributing reporter Becki Murray looks at why it should serve as a wake-up call to the industry

A new academic study – the largest ever in the UK – has explored the experiences of individuals who suffered an adverse event following the administration of botulinum toxin for aesthetic purposes. It was overseen by a board of leading associations within aesthetics, including the Joint Council for Cosmetic Practitioners (JCCP) and the British Association of Aesthetic Practitioners (BAAPS).

Investigating the long-lasting physical, psychological, emotional, and financial effects of cosmetic toxin complications, the study revealed the challenges that patients in the UK can face from both adverse effects and when trying to access support.

Perhaps even more worryingly, it also unveiled a significant lack of awareness about Medicines and Health Regulatory Agency’s (MHRA) reporting structures. This coupled with the need for regulation within the UK’s cosmetic injectables sector has been deemed a significant public health challenge.

THE SURVEY STRUCTURE

The new research was overseen by a board of members from JCCP), BAAPS, the Cosmetic Practice Standards Authority (CPSA), and University College London (UCL).

A focus group was then formed to design and analyse a 17-question quantitative and qualitative survey. Deductive thematic analysis was used to analyse coded themes, followed by sentiment analysis to identify and categorise free-text responses. Covering the cosmetic administration of toxins between 2021-2023, individuals aged between 18 and 75 were invited to self-identity in response to a social media advert. Participants completed the survey between January 1 2023 and March 31 2023.

In total, 655 responses were received, with 287 (44%) of respondents completing all questions. Those who did not answer any, (22%), were excluded from the analysis, leaving a sample size of 511. The mean age of respondents was 42.6 years old, with 94.1% of respondents identifying as female and 84.1% identifying as white.

THE RESULTS: THE NUMBER OF ADVERSE EFFECTS

One of the study’s most striking features was the number of patients reporting an adverse outcome, especially as only 188 adverse reports are listed by the MHRA between 1991 and 2020. This immediately suggests a significant under-reporting of officially recognised adverse events within the UK.

More specifically, 79% of the survey respondents reported an adverse event, and 69% of respondents reported long-lasting adverse effects. The linguistic analysis also found that the mean sentiment of the free-form commentary was negative.

In particular, 68.4% of respondents reported not having recovered physically, 63.5% stated they had not recovered emotionally, and 61.7% said that they have not recovered psychologically. There were financial costs too, ranging from the thousands to one individual who reported costs over £1,000,000. Six individuals stated that they had been left physically disabled. Interestingly, the most common event reported was ‘anxiety’, alongside pain – the second most common - headache/migraine, panic attacks, and depression/low mood.

This suggests the aesthetics industry needs to do much more to ensure the mental well-being of patients after toxin injections. Moreover, while causality cannot be inferred from the report, the authors suggested that the responses could imply that poor regulation is contributing to increased anxiety surrounding complications.

Indeed, only 80.9% of those administering the toxin were reported as healthcare professionals, reaffirming that there is likely to be a significant number of injectors doing so without medical training. A particular cause for concern was that six respondents did not know the background of their injectors at all.

THE RESULTS: LACK OF KNOWLEDGE

Contributing to this anxiety, a concerning number of respondents did not know who regulates the aesthetics industry (84%), and confusion abounds. Of those who suggested they did know, the most frequent response (35%) was the Food and Drug Administration (FDA) despite being a UK study, and secondly ‘no one’ (26%).

As practitioners will know, in the UK, complications that arise following the administration of botulinum toxin should be reported to MHRA via the Yellow Card Reporting Scheme.

However, while the MHRA has responded to increasing toxin injection demand by increasing the accessibility of the Yellow Card scheme, 92% of participants reported that their practitioner did not inform them about it. This suggests a broad-spread lack of patient education regarding avenues for redress.

The research also suggests that patients may perceive a lack of ‘usefulness’ in reporting – highlighting a further lack of confidence in industry legislation. When asked why they did not seek help, themes emerged such as lack of trust, lack of awareness, or concerns that their healthcare professional did not believe them.

Indeed, when individuals did seek support, reportedly 78.4% of practitioners refused. A further 16.3% of respondents were guided by their practitioner to visit an accident and emergency department, while over half of respondents (54.7%) sought help from alternative channels via the NHS. Facebook groups offering peer-to-peer support are booming too. The “Botox Dysport (Side Effects) Support” Group has over 27 000 members, implying both the need for support, but also more implied trust in those facing similar experiences over industry professionals.

All the findings only emphasise the need for better legislation in the UK, as acknowledged by the JCCP’s 10-point plan, published in 2021. The move to introduce licencing is a step in the right direction, but it is hoped that the findings of this study will help inform the extent of the challenge. In particular, the authors have called for further research and policy initiatives to raise awareness of patients’ experiences and rights.

The research presented was sponsored by QUAD A – a not-for-profit organisation in the US that works to improve healthcare facilities and care quality provisions.

To read the full report, visit doi.org/10.1002/ski2.265