Accounts of harm and conflicts of interest in transvaginal mesh: Professional evaluations during an Australian Senate Inquiry

Abstract

Transvaginal mesh (TVM) surgeries were introduced as an innovative treatment for stress urine incontinency (SUI) and/or pelvic organ prolapse (POP) in 1996. Years after rapid adoption of these surgeries into practice, it emerged that TVM-associated adverse events were uncommon but potentially severe. This initiated global action, including an Australian Commonwealth Government Senate Inquiry, in 2017. This inquiry was both a causal factor in, and surrounded by, a significant epistemic shift towards recognition of women's own accounts of their experience. The Inquiry generated copious data, mostly publicly available. There has been no systematic investigation of how professional stakeholders—clinicians, health services, regulators and manufacturers—contributed to the epistemic environment of this inquiry. Method: We analysed 42 submissions made by professional stakeholders to this inquiry, and documents from 5 public hearings. We used framework analysis methods, applying deductive and developing inductive codes from the documents, and charting patterns across the documents.Our aim was to map:1. Professionals’ contribution to the epistemic environment of this inquiry;2. How professional actors constructed TVM-associated problems and proposed potential solutions; and,3. The relevance of conflicts of interest in TVM-associated harms. Results: We categorised the reasoning of professionals into two groups:a. Contesting the significance of, or evidence for, TVM-associated harms; andb. Denying or minimising conflict of interest.Professionals’ advocacy regarding policy solutions emphasised incremental change, aiming to retain TVM procedures to treat SUI and, under certain conditions, POP. Conclusion: Contestation regarding harms led to a testimonial quietening of TVM-affected women's interests. The close and normalised relationship between treating professionals and TVM manufacturers may have created a conflicted environment for practice. It seems unlikely that self-regulation will be adequate to ensure that harms are minimised, conflicts of interests well-managed, and patients' interests are the first priority when innovative surgical treatment options become available to practice.

Keywords

• Transvaginal mesh
• Testimonial quietening
• Senate inquiry
• Patient harm
• Conflict of interest