Transvaginal mesh surgery in Australia: The epistemic environment for evaluation of low rate, severe adverse events following innovative surgical procedures

Background: Stress urine incontinence and pelvic organ prolapse are two common medical conditions associated with pelvic floor dysfunction. These conditions cause significant health issues for women. Although they may not typically be considered ‘severe’ conditions, they can have a significant negative impact on a woman’s quality of life. Various surgical and non-surgical options have been introduced into practice to treat these conditions. Transvaginal mesh surgery was introduced as an innovative surgical treatment option for stress urine incontinence and/or pelvic organ prolapse in women, in 1996. This is believed to have benefited a majority of women undergoing the procedure. However, years after rapid adoption of transvaginal mesh surgery into practice, it emerged that adverse events associated with this surgery, while uncommon, were potentially severe. Advances and innovation in surgery have contributed to significant progress in the healthcare industry’s capacity to provide quality care and improve outcomes. However, such advances have also sometimes generated significant ethical challenges. Transvaginal mesh surgery is such a case: an innovative surgical treatment that raised ethical challenges in surgical practice. Thus, transvaginal mesh provides an instructive example to support recognition and re-evaluation of the ethical issues faced in the surgical field.

Methods: To understand use of transvaginal mesh in Australia, and the epistemic environment for evaluation of low rate, severe adverse events following this innovative surgical procedure, I conducted empirical research to produce a thesis by compilation. I used two theoretical resources for my research: approaches from quality improvement and patient safety, and approaches from feminist bioethics. I drew evidence from the clinical peer reviewed literature, Australian print and online media, and public domain submissions and statements made to an Australian Senate Inquiry in 2017. These sources existed in the public domain, but had not been used in a systematic way to understand women’s experiences or the events that led to these experiences. I undertook qualitative analyses of data from these sources to produce my findings.

Findings: The clinical literature presented transvaginal mesh surgery as a successful treatment option, with a low rate of associated adverse events overall. It was less likely to provide adequate and accurate evidence of the number of associated harms, and contained almost no evidence of the implications of these adverse events on women’s lives. The literature was highly dependent on experts’ knowledge and expertise to recognise and highlight positive and negative outcomes associated with transvaginal mesh.

Women’s experience and perspectives were not only excluded from the clinical literature. In clinical practice settings, the negative outcomes women reported were also dismissed, de-emphasised, or considered outweighed by reported positive outcomes. This suggests a break in the feedback loop to knowledge. This break led to affected women experiencing epistemic injustice, further contributing to their suffering and compounding the harms caused. When affected women reported experiences that were epistemologically incongruent with the views of medical professionals, and regulatory and advisory groups, their testimony was dismissed both from treatment contexts and from the knowledge base. I therefore found that the epistemic injustice experienced not only exacerbated the harms caused by these newly innovative surgical procedures, but also created a gap in the epistemic environment for these procedures.

After almost two decades, emerging evidence of harms raised multiple questions regarding ethical challenges in the use of such innovative procedures, and the strategies in place to ensure patient safety and quality of care. Widespread healthcare system failures in the case of transvaginal mesh prompted the creation of major politico-legal movements of women and their supporters worldwide. In Australia, this created a hook to shift news media reporting about transvaginal mesh. The news media then played a significant role in redressing women's experienced epistemic injustice, including by amplifying previously ignored evidence of harm. This created an opportunity for previously unreported suffering to be revealed to powerful actors, in settings beyond the immediate control and epistemic authority of healthcare stakeholders, validating women's testimony and creating new hermeneutic resources for understanding transvaginal mesh. These developments provided women with greater epistemic justice, giving their testimony privileged epistemic status, such that it was considered by other actors.

In the Australian healthcare system, clinical perspectives have historically been privileged over patient perspectives in evaluating transvaginal mesh outcomes. This allowed micro-level actors to dismiss women’s lived experience, such that women’s accounts of harm had insufficient or no weight at meso and macro levels. The dismissal of reported negative outcomes was rationalised by professional actors in two ways. Firstly, by contesting the significance of, or evidence for, associated harms. This contestation led to a testimonial quieting of affected women’s interests. Secondly, by denying or minimising conflict of interest. The close and normalised relationship between treating professionals and device manufacturers may have created a conflicted environment for practice and for prioritising patients’ interests. Ultimately, that led to professionals’ advocacy regarding policy solutions emphasising incremental change, aiming to retain these procedures in practice.

Quality and patient safety theories are used to regulate healthcare systems to reduce harms, maximise quality of care, and optimise health outcomes. These theories and strategies acknowledge a need for innovation and advancement in practice, but tend not to be prescriptive regarding use of innovations. I connected quality improvement and patient safety theories to surgical ethics, especially in the context of innovative surgical procedures. I argue that the case of transvaginal mesh surgery illustrates that these two normative approaches should not be separate, but instead should be integrated, with implications for both disciplines.

Conclusion: Although quality and patient safety standards often include some rudimentary ethical considerations, such as requiring informed consent for procedures, this enters quality and safety through professional standards rather than a deep consideration of clinical ethics. More deeply incorporating ethical considerations, including regarding patient harms, epistemic injustice, and conflict of interest, would strengthen quality and patient safety by providing greater conceptual depth and better thinking tools to help address practice dilemmas. Simultaneously, clinical ethics could be strengthened through a stronger connection to quality and patient safety frameworks, which include detailed and practical thinking about patient harms, regardless of their prevalence, preventability or severity, the things that matter to patients, including their experiences of harm, and what should count as adequate benefit. I conclude that recognising and acknowledging patients’ epistemic status across all three levels of the health care system, including in processes that govern innovative surgical procedures in practice, is an essential strategy to recognise harms when they occur, and ensure they receive an adequate response.