Transvaginal mesh in Australia: An analysis of news media reporting from 1996 to 2021

Abstract Introduction Transvaginal mesh (mesh) surgeries have been used to treat stress urinary incontinence (incontinence) and/or pelvic organ prolapse (prolapse). In Australia, as in many other countries, the harms caused by mesh eventually prompted individual and collective attempts to achieve redress. The rise of mesh surgery as a procedure, the experience of mesh‐affected women and the formal inquiries and legal actions that followed all occurred in social, cultural and discursive contexts. One strategy to understand these contexts is to track how the mesh and key actors in the mesh stories have been portrayed in mass media sources. We conducted a media analysis of the most highly read Australian newspapers and online news media platforms, focusing on how mesh and the interaction of stakeholders in mesh stories were presented to the Australian public. Method We searched systematically in the top 10 most‐read print and online media outlets in Australia. We included all articles that mentioned mesh, from the date of first use of mesh in Australia to the date of our final search (1996–2021). Result After early scant media reporting focusing on the benefits of mesh procedures, major Australian medicolegal processes created a hook to shift reporting about 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 mesh. Over time, media reports show healthcare stakeholders responding sympathetically to these new understandings in public discourse, contrasting with their statements in earlier media coverage. Conclusion We argue that mass media reporting, in synergy with medicolegal actions and the Australian Senate Inquiry, appears to have provided women with greater epistemic justice, giving their testimony privileged epistemic status such that it was considered by powerful actors. Although medical reporting is not recognised in the hierarchy of evidence embedded in the medical knowledge system, in this case, media reporting appears to have contributed to shaping medical knowledge in significant ways. Patient or Public Contribution We used publicly available data, print and online media outlets, for our analysis. Therefore, this manuscript does not contain the direct contribution of patients, service users, caregivers, people with lived experience or members of the public.


| INTRODUCTION
Transvaginal mesh (mesh) surgery was developed through collaborations between surgeons and device manufacturers, in 1996, for the treatment of stress urinary incontinence (incontinence) and/or pelvic organ prolapse (prolapse) in women. 1,2 It was aggressively promoted to practitioners and rapidly adopted in practice. 3 Clinical trials indicated mesh was effective and provided limited information regarding adverse events. [1][2][3][4] In contrast, the qualitative peerreviewed literature reveals the suffering of mesh-affected women, including their experience of epistemic injustice. 4 Epistemic injustice occurs when a person's contribution to the production of knowledge is unjustly excluded or dismissed. 5

Miranda
Fricker's influential account of epistemic injustice distinguishes two forms: testimonial and hermeneutic. 5 Testimonial injustice occurs when a person's testimony is wrongly deflated by the prejudice or judgement of another, to the degree that blocks the flow of produced knowledge. 5 Hermeneutic injustice occurs when knowledge formation is impeded due to a structurally prejudiced social gap. 5 In other words, hermeneutic injustice occurs when a person's lived experience and produced knowledge are unfairly dismissed due to a lack of relevant interpretive resources in their community, such that others cannot make sense of their account of this experience. Mesh-affected women's experience of testimonial and hermeneutic epistemic injustice caused compounding medical and psychological trauma and skewed the clinical evidence base. 4 As the public controversy surrounding the safety and efficacy of mesh increased, women globally began to share stories of post-surgical harm and complications. 4,6 It is now clear that, while benefiting some women, mesh caused iatrogenic harm to many others. 4 One approach to understanding the sociocultural and political context for these events is to examine mass media coverage. Newspapers and other news media can disseminate health information in ways that can affect individual health choices and public health policies. [7][8][9][10][11][12] News media (media) often introduce research findings or new technologies to their readership, as well as deliver critical public health messages. 13 Systematic analysis of health and medical reporting can reveal the cultural and political environment in which people experience and make sense of healthcare, [8][9][10][11][13][14][15][16] and the way in which institutions and authorities respond to and sustain public trust in healthcare practices and systems. [17][18][19][20] Public and political events such as government inquiries or legal actions also use the media to communicate to the population and to potential participants.
In Australia, mesh-associated harms eventually prompted individual and collective attempts to achieve redress. The first Australian class action was filed in 2012, and the matter was referred to the Senate Community Affairs References Committee for inquiry and report on 15 February 2017. 21 There have been similar legal actions and institutional responses in other jurisdictions (Table 1). Over 100,000 legal actions have commenced globally against mesh manufacturers (manufacturers) and healthcare providers. 4,6 To our knowledge, there has been only one study of media reporting of mesh, which focused on inaccuracies in media reporting of the US Food and Drug Administration's ban on the use of mesh for prolapse repair. 22 In this paper, we report on an analysis of Australian media reporting about mesh, for the entire period in which mesh has been in use in this jurisdiction  Initial searches identified 206 articles (see Figure 1). After excluding exact duplicates, we included all articles that mentioned  25,28,30,31 Reporting was strongly gendered with a minority of stories mentioning incontinence in men and children.
Stories told women that these conditions were not normal, 26,28,30,32 and would become increasingly debilitating if left untreated. 28 treatment. 26 In early stories especially, medical professionals framed mesh positively, emphasising transformation of the field, complete cure and quality-of-life improvements. 26,34,35,[37][38][39] Later stories were more likely to emphasise the risk of complications in all surgical procedures, the need for care, respect and consideration in treatment decision making or that mesh may be more suitable for some women than others (e.g., older women). [34][35][36][37][38] As reporting began to focus on the Senate Inquiry and class action, two starkly contrasting constructions of mesh emerged. More than two-thirds of media stories pitted women and their advocates F I G U R E 2 Distribution of articles over the study period.
(who typically used descriptors such as 'scandal', 'failed' or 'disastrous'), against manufacturers and medical professionals (who typically used descriptors such as 'up to 99% successful', 'effective and safe' or 'revolutionary'). Table 2 maps the proportion of stories reporting on harm. In many stories, these harms were presented as extreme but rare events: mesh was a 'successful simple medical procedure' but produced 'multiple, extreme, traumatic, incapacitating and life altering injuries' for some, changing their lives permanently. [40][41][42] Later reports also revealed disagreement over mesh removal procedures, which again were constructed differently by different stakeholders. 43  3.3 | How were women and their experiences represented?
Many media reports related to women's personal stories, which mirrored accounts in the qualitative literature. 4 Some illustrative quotes are provided in Supplement 3. Information is given before mesh procedures were reportedly limited (including not being informed that mesh would be used), women's symptoms after surgery were dismissed or trivialised, compounding women's trauma and women were unaware of how to report adverse events to regulators. 27 The Senate Inquiry and the class action were framed as an important source of validation for women, reflecting and vindicating their previously dismissed symptoms and revealing a new community of similarly affected women. 54,55 Gender appeared frequently in these reports. Occasional reports were uncritically gendered: for example, incontinence and prolapse were framed as a product of incompetent female embodiment, implying that 'white women can't squat' and so effectively bring these conditions upon themselves. 25 3.4 | How was the mesh problem constructed by different stakeholders, and what potential solutions were presented?
As previously noted, media reporting often constructed the issue of mesh as a battle: women and their advocates versus manufacturers, medical professionals and regulatory and healthcare system authorities. Figure 3 shows the appearance of these actors in reporting of mesh over time.
The battle between these actors was presented as one example in a series of similar incidents when women were left with no support to face devastating outcomes of cascading failures in healthcare systems. 35,47 Figure 4 depicts the competing constructions of the problem of mesh offered by different stakeholders, which we will discuss in turn below.

| Women and their advocates
Women and their advocates framed mesh as a problem in two respects: a failure of oversight, and a failure of relationality and  (72) Inability to have sex 35 (40) Infection or bleeding 34 (39) Psychological or emotional harms 34 (39) Internal lacerations or erosion 31 (35) Inability to work and financial difficulty 18 (20) Worsen incontinence 16 (18) Inability to walk, stand upright or sit 15 (17) Repeated surgeries 11 (12) Mesh breaking up 7 (8) Suicidal thoughts 6 (7) caused harm. 36 Claims of failure of relationality and recognition were even more prominent and drew attention to women's experience of mesh interventions and their aftermath. Accounts of women having their initial symptoms and symptoms post-mesh removal dismissed by doctors were prominent. 27,43,46,49,50,53,[57][58][59] Regulators and health systems were also framed as slow and inadequate in providing practical support, both before and after mesh-associated harms were recognised, 36,61 and inquiries, hearings and appeals were framed as delaying tactics by which more powerful stakeholders attempted to get 'the answers they want' despite women's suffering. 36,57,59,61 The pursuit of justice via these routes was also framed as dangerous and potentially fruitless: as the legal system is 'expensive, intrusive and F I G U R E 3 Appearance of different actors in reporting of mesh over time.
F I G U R E 4 Competing constructions of the problem of mesh in media reports.
time-consuming', participating exposed women's vulnerability, without a large class action or a powerful supporter, women risked being framed as vexatious. 46,49,50,[57][58][59] Mesh-affected women often described a personal transition to an activist or advocate identity in which they fought for recognition for all mesh-affected women, to not 'let the hurt just be buried and forgotten'. 30,41,[46][47][48]51,53,58 Women also framed their mesh experiences as undermining their ability to trust Australian medical professionals and the Australian healthcare system, preventing them from further treatment-seeking. 43

| Medical professionals
Medical professionals' construction of mesh as a problem had four areas of focus: device failure, clinical practice failure, regulatory and systems failure and sociocultural impacts.
Some clinicians located the problem with the devices themselves, arguing either that they had a faulty design 36 or that they failed when 'the device integrates within the human body'. 61 With respect to clinical practices, some clinicians distinguished expert from 'inexperienced surgeons', arguing that mesh surgery was complex, and beyond the skills of 'lesser-trained' surgeons, who they sought to blame for all adverse events, and who had the devices/procedures actively marketed to them. 28,33,34,36,39 These 'bad apples' did not just lack clinical skill. On these accounts, they obfuscated information about their capabilities and surgical outcomes, including when seeking consent from women. 30,36,42,58 Alternatively, some argued that failure to recognise mesh injury was simply because 'doctors are human and they don't all react perfectly'. 34,39 Clinical spokespeople also constructed mesh as a problem of regulatory failure, of several kinds. Licensing failures occurred when safety assessment and approval processes relied on insufficient evidence. 28,36,46,53,56 Failure to systematically collect data on device use hampered both recognition of complications and investigation of poorly performing surgeons. 40,46,53,56 And lack of regulation and oversight of practice meant that the 'bad apples' subject to a tribunal and legal actions had years of continuous practice with insufficient regulation and oversight. 36,42,58 Finally, medical professionals constructed a different kind of harm: that the legal and media environment was undermining women's trust in mesh as a treatment, and harming women by restricting their access to mesh. This included concern that helpful mesh surgeries for incontinence were being confused with harmful mesh surgeries for prolapse, and that preventing any access to mesh would be a 'hysterical' and 'regrettable' 'over-reaction' as it 'has truly been a godsend for so many women' with incontinence. 28,34,38,39,43 Medical professionals suggested that the majority of women who had benefited from mesh were ignored by the media, the federal court and the Senate Inquiry. 36 Consequently, data on mesh use and clinical practice was not systematically collected, therefore there was no reliable information on the number of women who had mesh surgeries, the number and types of devices used, or associated issues and complications. 40,53 The claim was that emerging problems were thus masked for years, exposing many women to mesh-associated complications and adding to delays in responding to the caused harm. 46,64 Once issues with mesh devices began to gain media attention (2017-2019), regulatory and healthcare system authorities were increasingly represented as providing inadequate and inappropriate responses to failures, in a setting that relies on institutional and individual self-regulation and self-monitoring. 36  representing serious mesh-related harms as 'rare' and 'transitory' reactions. 49 Witnesses for manufacturers also reportedly suggested that the debilitating pain experienced by some women could be due to existing 'competing causes' rather than mesh products, with women's continued experience of pain after mesh removal surgery cited as evidence. 63 Manufacturers claimed that mesh is highly successful and has helped many women: if mesh had some 'failures [this] is simply one of its features'. 62 Once the results of the class action and Senate Inquiry became public, manufacturers released carefully scripted statements expressing their empathy for all women who experience medical complications, while also claiming that they have 'acted ethically and responsibly'. 45,50,60 These statements described incontinence and prolapse as 'debilitating conditions' and emphasised the importance of making informed and shared decisions in assessing the 'benefits and risks of surgical procedures'. 60 The focus of these press releases was not on mesh procedures and mesh-associated complications but rather on the more general issue of medical conditions and complications. Manufacturers thus constructed mesh devices as not particularly problematic, such that a solution was not within the scope of manufacturer's responsibilities.

| Responses and proposed solutions
From 2017, as the media raised the public profile of mesh-related harms, news stories began to describe the systems in place in Australia to ensure patient safety and quality of care, analyse and depict responses to mesh-associated harms, and finally describe the perspectives of different stakeholders on recommendations and proposed solutions. In these reports, medical professionals and regulatory and healthcare system authorities were depicted as responding to mesh-caused issues while expressing their sympathy for affected women. We will outline these responses first, and then turn to proposed solutions.

Responses
Media reports depicted early responses from regulatory and healthcare system authorities as inappropriate, especially the inadequacies of the assessment and approval processes for mesh devices. 27 After 2016, stories reported that regulators and the healthcare system were responding quickly to emerging global evidence on the risks and safety of mesh devices, through continuous improvement in the regulatory system to ensure quality and patient safety standards in Australia. 36,40,41,[43][44][45][46][47]49,60 In 2018, after the Senate Inquiry report was released, an announcement was made in the media that public funds were to be allocated to establish specialist clinics to assess affected women and provide them with multidisciplinary services and support. 65 Medical professionals were portrayed as being very defensive about their role in the mesh disaster, with interviewed representatives emphasising the 'rigorous and extensive training program[s]' undertaken by surgeons to ensure their capability to deliver the best procedures and highest quality care to patients in Australia. 36,39,43 This included claims that many skilled and qualified Australian medical professionals could perform mesh implantation and removal surgery if required. 39,43 Solutions Except for manufacturers, to some extent, all stakeholders were represented in media reports as supporting proposed solutions, including better transparency and monitoring regarding the use of high-risk medical devices, such as mesh, and the establishment of specialist multidisciplinary mesh clinics. 36,41,42,47 However, as shown by Figure 5, in addition to these proposed solutions, affected women and their representatives used the media to advocate for further measures to redress a broader set of concerns and sociotechnical problems.
Medical professionals and regulatory and healthcare system authorities tended to advocate for solutions focused on the regulation of mesh devices and the improvement of clinical practice. 28,35,36,43 Solutions proposed by women and their advocates were presented in much greater detail in this media coverage, urging governments and legal authorities to hold manufactures, regulators and practitioners accountable by establishing clear responsibilities within device approval and monitoring systems. 55,59 In this reporting, mesh-affected women strongly advocated for a total ban on the use of mesh until a complete audit of past mesh procedures was conducted. 36,43,48,51 Their proposed solutions also included establishing a strong regulatory framework that demanded timely reporting to the public of applications for use of mesh devices and the number of women who will be receiving them. 54 Building on these calls for better transparency, women used media to ask for greater assurance that the normative challenges identified by the Senate Inquiry will be directly addressed-especially the need for complete transparency on possible conflict of interests for medical practitioners involved in the process of design, production, registration, licensing, approval and use of mesh devices. 36 We argue that the media played an important role in highlighting diverse accounts of mesh-including a broader range of problems and solutions-by engaging with women's accounts of experienced epistemic injustice. We also argue that this appears to have had practical implications for the evaluation of this innovative surgical intervention. We will discuss these two issues in turn.

| Epistemic injustice
As noted in our introduction, we have argued elsewhere that mesh- reporting. In other words, the testimony of powerful actors was presented in early media coverage, but women's testimony was apparently not considered newsworthy.
Our previous work also highlighted that women experienced hermeneutical injustice: their families, social groups and medical professionals did not have the conceptual resources required to make sense of their experienced symptoms. 4 This was also reflected in this media analysis. Once reporters started to take more interest in meshassociated harms and complications, women were able to elaborate in media stories, articulating their testimony and explaining their symptoms. In other words, greater media coverage provided the interpretive resources for a different understanding of the outcomes of mesh procedures. We would argue that it seems that the media provided women with some measure of hermeneutical justice, but only after the two formal processes in Australia. Once these newsworthy conflicts were launched, women were able to use the media to amplify their voices, creating new hermeneutical resources for others to understand their experiences. It is worth noting that there was a dialectic relationship between the legal and Senate actions and the media: the media presented the formal proceedings to the public, and the formal proceedings used the media as a channel through which to recruit testimony from women and their advocates.
Thus, this analysis suggests that the two formal proceedings in  As we mentioned earlier, after the initiation of two major Australian medicolegal processes against powerful stakeholders, media reporting of mesh procedures shifted. Initially acting as a promotion and marketing strategy for mesh procedures, media reporting became a means of communicating women's experiences of negative outcomes to powerful stakeholders and decision-makers.

| Evaluation of innovative surgical treatments
It seems feasible that media reporting of critiques of mesh-caused harms may have created a new opportunity for evidence of harms to become part of the evaluative frame for these innovative procedures.
After Havi Carel, this can be thought of as a process of providing patient's testimony with an epistemic privilege, that is, the privilege of being incorporated into decision making, intervention design or policy-making. 72 In this instance, the reported public statements of medical professionals and decision makers changed: initially, mesh was 'highly successful' and adverse events minimal; later, severe permanent adverse events were acknowledged publicly. The analysis of the final two time periods identified in our analysis (2017)(2018)(2019)(2020)(2021) demonstrated this change, including in relation to the next new innovative treatments for incontinence and prolapse. When quoted in stories about these new innovations, rather than simply expressing enthusiasm, these groups emphasised the need for long-term evidence of efficacy.

| Limitations
We were unable to access rankings of media outlets by circulation for each of the years in our study. For consistency, we adopted a contemporary list of the highest circulation outlets and applied this retrospectively across all years. This may mean that we have missed a small number of reports. However, this is likely to have had a negligible effect on our analysis, as there is a high degree of syndication in the Australian media, and our sample includes longstanding media brands that have dominated the market for decades.
Our study design focused on understanding how different stakeholders and issues were represented in media discourse; a different study design could have provided more information about how media values shaped the discourse and how different media actors and mastheads participated in it.

| CONCLUSION
Medical professionals and decision-makers reportedly dismissed women's accounts of mesh-associated harms in the early days of the procedure. After early, scant media reports focusing on the benefits of mesh procedures, major Australian medicolegal processes created a hook to shift reporting about mesh. The media then played a significant role in redressing epistemic injustice and amplified 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 mesh.
Over time, media reports show healthcare stakeholders responding sympathetically to these new understandings, contrasting with their statements in earlier media coverage. Therefore, we argue that in this context, media reporting in combination with medicolegal action appears to have communicated new information about outcomes, shaped medical knowledge, and provided greater recognition of women's experience.
This episode demonstrates the value and importance of being attentive to patient-centred accounts of outcomes in the evaluation of innovative surgeries. It took political and legal inquiry and media reporting of experienced harms to provide women with epistemic justice and give their testimony privileged epistemic status, such that it was considered by powerful actors. Although medical reporting is not recognised in the hierarchy of evidence embedded in the medical knowledge system, in this case, media reporting appears to have contributed to shaping medical knowledge in significant ways.