Accounts of harm and conflicts of interest in transvaginal mesh: Professional evaluations during an Australian Senate Inquiry
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...
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| Main Authors: | , , |
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| Format: | Book |
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Elsevier,
2024-06-01T00:00:00Z.
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| Summary: | 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. |
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| Item Description: | 2667-3215 10.1016/j.ssmqr.2024.100441 |