Oral Presentation Australasian Association of Bioethics & Health Law and New Zealand Bioethics Conference

The regulation of Surgical Innovation: A qualitative study (940)

Alice Toms 1 2 , Giles Birchley 2 , Robert Hinchcliffe 3 , Richard Huxtable 2
  1. NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom
  2. Centre for Ethics, University of Bristol, Bristol, United Kingdom
  3. Bristol Medical School, University of Bristol, Bristol, United Kingdom

This paper presents preliminary results of a doctoral study exploring the regulation of surgical innovation. Numerous ethical concerns about surgical innovation have been raised that indicate a need for better regulation (Rogers et al.,2019). These include lack of accountability, harm to patients and conflicts of interest. The topic has entered public consciousness in response to new surgical procedures going wrong. Examples of this include the vaginal mesh implant, which caused long term harm to many patients, and the metal on metal hip replacement, which was surgically ineffective and required revision in many patients, whilst causing additional harm through metal toxicity.

Preliminary research to address some of these issues has been undertaken, including ongoing attempts to conceptualise surgical innovation and its attendant ethical issues. While this research is welcome, our systematic review of research on the topic suggests patient and surgical expert narratives have yet to be adequately explored.

To begin to understand how these groups view the current regulatory system, qualitative semi-structured interviews were conducted with two diverse samples – surgical patients and experts in surgical innovation (including surgeons and policymakers with practical/research interests in surgical innovation)- to explore their views and experiences. Interviews discussed how participants conceptualised innovation, their views on current ways of regulating innovation, and whether they believed regulation could be improved.  

This paper presents the preliminary findings of a thematic analysis of these interviews and explores how these findings might inform the development of better regulation.



  1. Rogers, W., Hutchison, K. and McNair, A. (2019). Ethical Issues Across the IDEAL Stages of Surgical Innovation. Annals of Surgery, 269(2), pp.229-233.