Introduction: In the United Kingdom (UK), complications that arise following the administration of Botulinum Toxin are reported to the Medicines and Health Regulatory Agency (MHRA) via the Yellow Card Reporting Scheme. Over the past decade, there has been a significant increase in the number of non-surgical aesthetic procedures. Concerns have been raised that the MHRA is not fully capturing complications in terms of volume and impact on patients.
Aim: This novel study explores the lived experiences of individuals who have experienced an adverse event following administration of Botulinum Toxin for aesthetic purposes. Using a combination of qualitative and quantitative methodologies, this analysis evaluates data relating to long-lasting physical, psychological, emotional, and financial sequelae of complications arising from cosmetic Botulinum Toxin injections in the UK.
Methods: A mixed method, qualitative and quantitative approach was adopted to gain comprehensive insights into patients' experiences. A focus group which comprised patient representatives, psychologists, and researchers reached a consensus on a 17-question survey which was disseminated via social media channels. Deductive thematic analysis was used to analyse coded themes. Furthermore, for secondary analysis, sentiment analysis was used computationally as an innovative approach to identify and categorise free text responses associated with sentiments using natural language processing (NLP).
Results: In the study, 655 responses were received, with 287 (44%) of respondents completing all questions. The mean age of respondents was 42.6 years old. 94.1% of respondents identified as female. In the sample, 79% of respondents reported an adverse event following their procedure, with the most common event being reported as 'anxiety'. Findings revealed that 69% of respondents reported long-lasting adverse effects. From the responses, 68.4% reported not having recovered physically, 63.5% of respondents stated that they had not recovered emotionally from complications, and 61.7% said that they have not recovered psychologically. In addition, 84% of respondents stated that they do not know who regulates the aesthetics industry. Furthermore, 92% of participants reported that their clinic or practitioner did not inform them about the Yellow Card Reporting Scheme. The sentiment analysis using the AFINN Lexicon yielded adjusted scores ranging from -3 to +2, with a mean value of -1.58.
Conclusion: This is the largest survey in the UK completed by patients who experienced an adverse outcome following the aesthetic administration of Botulinum Toxin. Our study highlights the extent of the challenges faced by patients who experience an adverse event from physical, emotional, psychological, and financial perspectives. The lack of awareness of MHRA reporting structures and the lack of regulation within the UK's cosmetic injectables sector represent a significant public health challenge.
© 2023 The Authors. Skin Health and Disease published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.