Kath Sansom

In this opinion piece, Kath Sansom, founder of Sling the Mesh, looks at why an audit of pelvic mesh outcomes due to be published in April 2023 has again failed to capture the true extent of the harm caused by the procedure. She outlines why the approach taken by the Government and NHS Digital was flawed and why it is so important to understand both the proportion of women who have experienced harm as a result of the procedure, and the nature of their injuries and side effects. The definition of ‘success’ for incontinence mesh surgery was based on The British Society of Urogynaecology (BSUG) ‘pad test question’, which looked at whether a woman was using fewer incontinence pads after surgery. Like most women who had a mesh sling for incontinence implanted, I passed this test with flying colours. But the complications I experienced as a result of the surgery were painful, debilitating and life-changing, an experience shared by thousands of women who have had a pelvic mesh implant. For both incontinence and prolapse mesh, outcome logging merely looked at whether the prolapse had been fixed and did not query the onset of new pain or complications. Lack of follow-up, data collection and recognition of mesh as the cause of women's symptoms when they present with complications has led to a gross underestimation of the scale of pelvic mesh-related harm. So the prospect of an audit that would look to remedy this was a positive one. In 2020, the final report of the Independent Medicines and Medical Devices Safety (IMMDS) Review, ‘First Do No Harm’, called for “a retrospective audit and follow-up of women who had pelvic mesh surgery in 2010,” to be conducted by NHS Digital. The report highlighted that this should provide “far greater detail on mesh complications in the decade after surgery,” and that NHS Digital should make “every effort” to obtain sufficient data.[1] On 5 December 2022, the Minister for Women, Maria Caulfield MP, confirmed in the Commons that an audit had been completed following the acceptance of the IMMDS Review’s recommendation and would be published in 2023.[2] However, the record later had to be corrected, as it became clear in a further parliamentary question that, contrary to the stated intention of NHS Digital who conducted the audit, “...only Hospital Episode Statistic data was used in the audit and no other data was employed. Patients were not contacted as part of this audit.”[3] History repeats itself - the NHS audits the same data I was horrified to find out that instead of making “every effort” to get accurate information, NHS Digital have simply repeated the same exercise they carried out in 2018 in their retrospective audit of annual Hospital Episode Statistics (HES) data on mesh implant procedures. For the 2023 audit, they used the same approach taken in the 2018 audit and exclusively used HES data. This approach was highlighted in ‘First Do No Harm’ as being “widely criticised for its omissions, [for example] lack of any private sector data and for its implied underestimate of long-term complications.”[1] I wrote to the Health and Social Care Select Committee on behalf of Sling the Mesh in December 2022 to highlight the shortcomings of using HES data in isolation.[4] The Committee shared our concerns, highlighting that: “Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”... Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to proactively contact those who have had the procedure about their postoperative experiences and possible side effects.”[2] NHS Digital’s approach does not paint a true picture of the extent of the harm caused by pelvic mesh. There are many issues with using purely HES data for a mesh audit, namely that: HES data does not capture complications, as women have not been followed up and therefore the spectrum of suffering has not been logged. it does not take into account any data from GPs or primary care, where potentially thousands of women have sought help for their mesh complications. Most of these women will not yet have set foot in a hospital for consultation or treatment. it does not take into account data from private hospitals, which may be recorded differently or not have been logged at all. there are discrepancies in how pelvic mesh insertion and removal is logged by different trusts and healthcare professionals. HES data sometimes lacks necessary detail on the nature of treatment. For example, until recently, there was no specific HES code for rectopexy mesh insertion or removal, which means the specific issues associated with this surgery are difficult to identify through data. How should the Government conduct an audit of mesh patients? If the Government is serious about understanding the true extent of harm caused by pelvic mesh, it needs to contact all women who have had mesh surgery within a specific time period to establish whether they have had complications or injuries over the following years. Mesh has a ticking time bomb nature, in that it can be fine for many months or even years before causing problems like erosion, so this long term follow-up is crucial to gauge the extent of harm. Instead of using unreliable and incomplete data, an audit needs to take the approach of the Paterson Inquiry and recall all affected patients.[5] If the cost of such an exercise would be prohibitively high, they could take a sample of women from across the country and use their findings to estimate the extent and nature of harm caused by pelvic mesh. Why is a reliable pelvic mesh audit important? Being able to quantify the extent of the harm is important so that we can establish an accurate figure of risk; what percentage of women suffer harm due to pelvic mesh, and what is the likelihood of more of them developing complications in years to come? Until we have this knowledge, the Government and regulatory system can’t learn the necessary lessons from the mesh scandal to ensure other devices don’t cause this degree of harm. Health services will also continue failing women when they seek help for injuries and complications that are likely to have been caused by mesh. So many women have also been subject to the secondary harm of gaslighting and not having their symptoms taken seriously by healthcare professionals. Having accurate data on harm caused by mesh would help put an end to the healthcare system seeing women’s concerns as ‘hysterical hearsay’. It would also help women understand that their complications must be taken seriously and that their symptoms are not ‘all in their heads’. Why is the Government not pushing for an accurate audit? When compared to the Government response to Paterson, the retrospective mesh audit seems like a token effort. Why is the Government less willing to understand and tackle the issues associated with mesh complications? Perhaps because, rather than being the responsibility of “one bad apple”, the harm caused by pelvic mesh is the responsibility of a system that failed to research, regulate and monitor the effects of medical devices designed to be implanted inside people’s bodies. There is also the fact that knowing the true extent of the harm caused by pelvic mesh has the potential to create a huge financial burden, if the Government ever agrees to fulfil its responsibility to set up a Redress Agency for women harmed by pelvic mesh surgery. Related reading The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims (17 January 2023) Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog (19 July 2022) “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery (1 May 2022) References 1 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020 2 Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response Sixth report of session, 20 January 2023 3 Question on surgical mesh implants. Parallel Parliament, 14 December 2022 4 Letter to Health Select Committee December 2022. Sling the Mesh, December 2022 5 Government response to the independent inquiry report into the issues raised by former surgeon Ian Paterson. Department of Health and Social Care, 16 December 2021

In this opinion piece, Kath Sansom, founder of campaign group Sling the Mesh, looks at flaws in the Government’s approach to women harmed by pelvic mesh surgery receiving financial redress. She highlights the unsuccessful case of Sarah*, who attempted to bring a clinical negligence case after suffering multiple complications as a result of pelvic mesh, to demonstrate that the national Redress Agency recommended by the Cumberlege Review is still very necessary. It’s so important that mesh-injured women are able to access redress for their injuries, many of which are life-changing. Often, financial support is not a bonus but is necessary, as women have had to leave their jobs or reduce their hours to cope, move to accessible housing or sell their home to live with family. Many have also experienced marriage breakdown as a result of mesh complications. One in four women in Sling The Mesh need a stick to help them walk, so need to pay for mobility aids or scooters, and there are also the ongoing costs of travel to doctors and hospital appointments. Waiting times are up to four years for mesh removal, so many women cash in savings or pensions to pay for private removal which costs thousands. The psychological impact of mesh injuries also takes a toll and with long NHS mental health waiting lists, many turn to the private sector for counselling for post traumatic stress disorder (PTSD) and trauma. Likewise, many women have difficulty accessing NHS Physiotherapy so turn to the private sector for specialised physio to help mobilise internal pelvic scar tissue which can cause ongoing pain after mesh removal. The concept of redress is about proactively correcting a wrong that has been done to a group or individual. It differs from clinical negligence, which is about identifying and proving that the actions of an individual healthcare professional or service caused specific harm. Redress involves an authority taking responsibility for harm that has been caused under its watch, whereas clinical negligence is an adversarial process with strict legal boundaries. In 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review’s report, ‘First Do No Harm’ (Cumberlege Review), called for “a new independent Redress Agency for those harmed by medicines and medical devices” to be created, based on models operating effectively in other countries.[1] This Agency was to offer women harmed by mesh a specific, non-adversarial route to compensation. However, in its official response to the report, the Department for Health and Social Care (DHSC) rejected this recommendation, stating that “while the government is sympathetic to the experiences of those patients who gave evidence to the report, our primary focus is on improving future medicines and medical devices safety.”[2] The Government's failure to accept the IMMDS recommendations around setting up a Redress Agency means that the clinical negligence system is the only route left to women to pursue financial compensation, and it is a long, onerous process that is often unsuccessful. Sarah’s story - failures in the clinical negligence route Sarah* has spent the last two years fighting for redress through a clinical negligence case because of injuries following pelvic mesh surgery. Over the past few years, she has gone through two episodes of mesh erosion, two surgeries and an episode of sepsis. Since the mesh device was implanted, she has also experienced fibromyalgia and arthritis of the sacroiliac joints. She recently received a letter from the Head of Clinical Negligence at the law firm she was working with, informing her that they would not take her case forward. It was unlikely to be successful as she had her surgery before complications for mesh surgery were fully understood, and prior to 2013 when National Institute for Health and Care and Excellence (NICE) guidelines for urinary stress incontinence were changed. The letter stated: "The difficulty with your claim is that your TVT/mesh insertion surgery took place quite some time ago in 2007 when this was considered to be the gold standard to treat stress urinary incontinence, because the mesh surgery was quick, relatively simple and did not require a prolonged stay in hospital. It was only later on that the problems with mesh and the risks associated with mesh became fully known.” "A court would assess your claim based on the state of medical knowledge and expertise that existed at the time you had the mesh surgery in April 2007, with the problems and risks associated with mesh only becoming known at a later stage. "Consequently, a court will take the view that the consultant advising you at the time of your surgery in 2007 could only advise you based on the state of medical knowledge that existed at that time and cannot be held legally to blame for the treatment and advice that he gave you, if the risks associated with mesh only became apparent afterwards. "Therefore, unfortunately, further to the above we believe that if your claim proceeded further with the commencement of court proceedings, we would not have a reasonable prospect of success." It is my view that, given the evidence of harm caused by pelvic mesh, a woman who underwent surgery in 2007 should be equally entitled to redress as a woman who had surgery much later. I highlighted the issue with Helen Hughes, Chief Executive of Patient Safety Learning, who responded, “When responding to the IMMDS Review, the Government rejected a recommendation to introduce a separate redress scheme for mesh on the basis that patients could take healthcare providers to court for clinical negligence, or manufacturers for product liability. However, as this case sadly illustrates, the legal complexities involved in this means that for many mesh-injured patients this is simply not an option, leaving them with no alternative route to help meet the cost of any additional care and support they may need.” A national Redress Agency is the only way to offer equitable redress A Redress Agency specifically aimed at women with pelvic mesh injuries would offer a more equitable, compassionate route to secure compensation. As well as women having a higher chance of success going through a Redress Agency, women would not be forced to face the stress of legal action that often lasts for years while dealing with the pain and limitations they live with as a result of their injuries. At the moment, it does not appear that the political will or financial provision exists to make this a reality. *name changed for anonymity Related reading Tokenism in patient engagement is unethical—but it is also dangerous. A blog by Kath Sansom Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery References 1 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020 2 Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021

In this blog, Kath Sansom, founder of the Sling the Mesh campaign, unpacks the findings of a medical device performance study into polypropylene mesh published by the Emergency Care Research Institute (ECRI) in the US. The document highlights significant gaps in evidence about the risk of complications associated with polypropylene (PP) surgical mesh. PP mesh has been widely used in surgery for stress urinary incontinence (SUI) and transvaginal or transabdominal prolapse since the 1990s,[1] and hernia repair since the 1950s.[2] In spite of this long history, there is a surprising lack of research into the link between surgical mesh and autoimmune conditions. Among the many complications reported by women who have had vaginal mesh surgery, autoimmune symptoms feature high on the list. One member of the Sling the Mesh Facebook group was recently looking for answers about her own autoimmune symptoms when she came across a Medical device material performance study polypropylene safety profile put together by the ECRI. This blog will look at the key issues that it highlights concerning surgical mesh research. What did the ECRI report aim to find out? Produced by US non-profit organisation the ECRI, on behalf of the FDA Center for Devices and Radiological Health (CDRH), the report looks at existing research literature about PP mesh degradation and physiological responses to PP mesh. The authors of the report conducted a systematic review of 158 articles that were selected for inclusion, to answer five questions posed by the FDA[3]: What is the typical/expected local host response to polypropylene? Does the material elicit a persistent or exaggerated response that may lead to systemic signs or symptoms, beyond known direct toxicity problems? Are there any patient-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response? Are there any material-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response? What critical information gaps exist and what research is needed to better understand this issue? Key findings Surgical mesh results in high infection and hospitalisation rates The report states that “data pointed to infection in 40% of event reports associated with PP mesh. There were five deaths, and when patient harm was reported, 44% required intervention or hospitalisation.”[3] This is a very high incidence of infection that warrants further research. There is low quality of evidence around pain, mesh migration and hernia mesh The report found moderate to low quality of evidence about inflammation, mesh migration and pain related to general surgical mesh and transvaginal prolapse mesh. They found no evidence at all relating local responses for diaphragmatic hernia meshes and male SUI mesh. The report calls for higher quality of evidence on local responses to PP mesh. There are big research gaps around systemic responses Worryingly, questions 3 and 4 posed by the FDA—which consider factors that contribute to a immunological or systemic response—could not be answered. The ECRI concluded that “none of the studies provided useful information regarding material-related factors that may affect a sustained immunological/systemic response.”[3] This is because there were few studies that reported any data related to systemic reactions, and where they did, the quality of evidence was low. The report calls for “higher quality of evidence around systemic responses to PP mesh as there is currently very low to low quality of evidence.”[3] This applies to both PP as a material and specific PP mesh devices. Some mesh causes more complications than others The report states that “evidence suggested that lightweight PP mesh was less likely than heavier weight PP mesh to cause pain or foreign body sensation.”[3] Mesh-specific research is needed to identify which patients are most at risk of complications from individual mesh products. Although mesh is no longer being used in the UK to treat female SUI and prolapse, it is still being used in a wide range of other surgical procedures in the UK, and there are no restrictions on its use in many countries. The report highlights that, “there were no studies on diaphragmatic hernia mesh and male SUI mesh that met the inclusion criteria, either in terms of local or systemic responses,” and calls for specific studies on these procedures and devices. What’s next for surgical mesh research? The huge gaps in research evidence about PP mesh that the report highlights have serious implications. As there is little ‘evidence’ of harm, it allows the healthcare system to ignore the concerns of patients suffering with debilitating complications. This is particularly the case with systemic reactions to mesh—until we have some clear, peer-reviewed evidence around the link between autoimmune conditions, the pattern of patients having their symptoms dismissed will continue. We need health services and funders to take this knowledge gap seriously and invest in understanding the true extent of harm caused by surgical mesh. Related reading Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (April 2021) Ineffective medical device recalls are a patient safety scandal (October 2021) Mesh News Desk - Strattice hernia mesh trial preparation underway (17 October 2022) References 1 Kent C. Transvaginal mesh timeline: the gynaecological scandal that rocked the world. Medical Device Network, 9 January 2020 2 Baylón K, Rodríguez-Camarillo P, Elías-Zúñiga A et al. Past, Present and Future of Surgical Meshes: A Review. Membranes. 7 September 2017 3 Lucas S. Medical Device Material Performance Study: Polypropylene Safety Profile. Emergency Care Research Institute, 2020

Nine specialist mesh centres have been set up by NHS England to offer removal surgery and other treatment to women suffering from complications and pain as a result of vaginal mesh surgery, but women are reporting that they are not operating effectively. In this opinion piece, Kath Sansom highlights ten problems with these specialist mesh centres, evidenced by the real experiences of women who are part of the Sling the Mesh campaign Facebook group. NHS England set up a handful of specialist mesh centres in April 2021 to offer treatment and support to women harmed by vaginal mesh surgery. But they aren’t achieving what they need to, and this failure is leaving thousands of women harmed by mesh without help to deal with their life-changing complications, and without hope that their pain will ever be taken seriously. Here are ten problems with specialist mesh centres, identified through my regular contact with thousands of women suffering from mesh complications. 1. There are long waiting lists of sometimes more than a year just for the first consultation Some women are waiting years for removal and some are being labelled ‘veteran patients’ and then deprioritised. These women are waiting an unacceptably long time to be seen. One woman recently posted on the Sling the Mesh Facebook group that she was finally having her mesh removal surgery after four years of waiting. Another described how she had her surgery cancelled, when she was in a gown waiting to be taken to theatre; this was the second time this had happened. 2. Some women are feeling that they are being coerced out of mesh removal surgery during the informed consent process One woman said, “I was sent for an MRI scan and told my mesh looked fine but have read on the page you can't tell from scans. Now I don't know what to think” 3. Some mesh centres are being run by the surgeons who have persistently promoted mesh and denied that it causes problems We see that behaviour continuing in consultations. One woman described her experience: “When I met the surgeon at the mesh centre I was told lots of people have had great outcomes and it felt like they thought I was exaggerating my pain.” 4. There is a lack of transparency and fully informed consent This includes over what kind of removal is being done, and there has also been a lack of honesty over what can and cannot be achieved. 5. There is no joined up thinking in terms of how removals are performed There is also no consistency in training; or indeed any specialist training at all. One woman described her uncertainty about the surgeon’s skills and training: “I just didn’t feel confident in his care. He had only done 15 mesh removals before, and not on a regular basis.” 6. There is no consistency in how outcomes are logged and there are currently no published outcomes We are told that two centres are running long term follow up, but we don't know whether centres are asking the same questions or aiming to assess meaningful quality of life issues for women. 7. There has been poor aftercare Some women have ended up in local A&E departments with severe pain, blood clots or infections, being treated by local healthcare professionals who have not heard of mesh before. In addition, physiotherapy to mobilise scar tissue is not offered as standard, so women end up having to pay privately. 8. Some mesh centres are making women feel more anxious about becoming incontinent again, rather than focusing on the opportunity to reduce their pain through removal One woman said, “I finally got to see a surgeon at a mesh centre and they told me I would probably end up worse off and would be incontinent again - they made me scared to go ahead.” More research needs to be done to understand the options, and a framework should be established offering treatment that gives women the best chance of retaining continence after surgery. For example, Kelly's plication is a relatively minor procedure that can be performed at the same time as mesh removal, but not many surgeons consider it. Autologous slings and colposuspensions are also options. 9. Some specialist mesh centres are still referring women to meaningless pain clinics where they are treated as if the pain "is all in their head." Before a removal will be considered, a large proportion of women are having to jump through the hoop of having been to a pain clinic. One woman said, “I saw the consultant today and expected to progress for removal but now I've got to do pain clinics by zoom - how is that going to help me?” Another said, “I'm confused. I went to the mesh centre and was told that the pain is probably nothing to do with the mesh. I've been referred for counselling.” 10.The prevalence of autoimmune diseases after mesh surgery needs to be logged We need to track the high proportion of women who develop these conditions when mesh is in place, or years later. Fibromyalgia, dry eyes and irritable bowel syndrome are the most commonly reported conditions, but we also see a staggering number of women developing ‘rare’ conditions such as lupus, Hashimotos and Sjörgens syndrome. Many women are not being taken seriously when they raise concerns about their systemic systems and mesh. One said, “I asked if my dry eyes and fibromyalgia were autoimmune issues caused by the mesh and the consultant laughed and said my eyes were a long way from my pelvis and how can you prove the link!” Related reading Specialist mesh centres are failing to offer adequate support to women harmed by mesh (Patient Safety Learning and Sling the Mesh) “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery ‘Mesh removal surgery is a postcode lottery’ - patients harmed by surgical mesh need accessible, consistent treatment Tokenism in patient engagement is unethical—but it is also dangerous. A blog by Kath Sansom

In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that when health services fail to engage meaningfully with patients it causes patient safety issues. Drawing on her own experience as a patient and the founder of a large patient support group, she talks about the invaluable perspective that patients who have experienced healthcare harm can offer policymakers. She also explains why it is important to hear from a wide group of patients who have experienced a variety of issues. After years of struggle to get our voices heard, the final report of the Cumberlege Review gave women harmed by mesh a ray of hope that perhaps help, and redress, were at hand. The report recommended that the NHS establish specialist mesh centres across the country to provide mesh removal and other treatment options to women suffering from debilitating complications as a result of pelvic mesh surgery. As Founder of Sling the Mesh, I was keen that our 9,000+ members were involved in the process of designing how these specialist centres would be set up. It had taken us a long time to get here and we knew our voice had made a difference to patient safety; it was our concerns as patients that had brought incontinence mesh surgery to a halt and resulted in a ban on vaginal prolapse mesh surgery. The huge group of women who belong to Sling the Mesh and other patient support groups had valid questions and concerns about how the centres would run, and how they would ensure swift and beneficial access to the treatment they so desperately needed. It was absolutely essential that NHS decision-makers understood the range of issues women were facing—from the need for removal to dealing with the autoimmune conditions women were developing after mesh surgery. A tokenistic approach to patient engagement So in November 2020, I established contact with the commissioner in charge of setting up the centres and they agreed to meet with me and members of Sling the Mesh. This meeting was postponed several times and eventually cancelled. Instead of maintaining direct contact with me, the commissioner put me in touch with a communications colleague. No meeting—or any form of meaningful engagement—ever happened. Reading through the stakeholder engagement document, it appears that of the three women who were engaged as patient representatives, two had not had mesh surgery. The one who had was not engaged in any support groups, and this will have limited her ability to raise the wide range of issues and concerns faced by women harmed by mesh. I couldn’t believe that this was the NHS’s choice of patient voice, over the several active and well-engaged mesh patient support groups that are so easy to find. I’m left wondering why they chose not to engage with us. Lack of patient voice leads to further patient safety issues The outcome of the specialist mesh centre process has been incredibly disappointing to women harmed by mesh. A recent blog by Patient Safety Learning and Sling the Mesh outlines some of the key issues—problems that could have been foreseen and potentially avoided by engaging with a more representative selection of end users during the commissioning process. When setting up a service, failure to engage with the patients it is being designed for creates serious risks to patient safety. Lived experience of patient safety issues is not an additional 'skill' to be added into the mix of voices; it comes from painful loss and is often offered to health services and commissioners at great personal cost. The suffering of people who have experienced harm motivates them to prevent it happening to anyone else, and is grounded in a reality that no surgeon, policymaker or politician can comprehend. That’s why it’s important not to choose the easy way out when it comes to patient engagement; the voices that can really speak with authority on the issues need to be front and centre when developing services. This is especially vital in cases like vaginal mesh where it has taken governments and the NHS so many years to listen to patients’ concerns. As people harmed by a medical device we were told would help us, we know the life-changing consequences of healthcare harm, and will do everything in our power to seek the right level of support for victims and prevent it happening again. A safer approach to engaging patients We need to see a change in the way policymakers view patient engagement. There may be fears within NHS management that the observations and requests of patient representatives will stretch resources and have the potential to cause reputational damage. But if we don’t start seeing those voices as essential, we will never make meaningful progress in improving patient safety. Related reading ‘Mesh removal surgery is a postcode lottery’ - patients harmed by surgical mesh need accessible, consistent treatment Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog Specialist mesh centres are failing to offer adequate support to women harmed by mesh (Patient Safety Learning and Sling the Mesh)

In this opinion piece, Kath Sansom, founder of the Sling the Mesh campaign, highlights the many issues that women face when trying to get pelvic mesh slings surgically removed. She calls for the NHS to give patients a voice and to develop a robust and consistent plan to tackle the issues faced by patients harmed by surgical mesh. In Spring 2021, I was due to meet a senior NHS official, along with a group of pelvic mesh campaigners, to ask for consistent training of all surgeons performing mesh removal procedures. That meeting was cancelled, and I’m calling for it to be reinstated, and fast. We desperately need action to sort out the inadequate, piecemeal approach the NHS has taken to redress the harm caused by surgical mesh. I manage a Facebook support group of over 9,200 women, most of whom are still living with debilitating pain and side effects caused by pelvic mesh. Each experience tells of harm added to harm - of mesh removal surgery being hard to access and inconsistent, and of hopelessly long waiting lists. Mesh specialist centres - inconsistent and inaccessible There are seven mesh complication centres in the UK[1] - six in England, one in Scotland and none in Wales or Northern Ireland - but assessment and surgical procedures vary hugely between these centres: There is no consistent training for surgeons undertaking mesh removal, with each centre taking its own approach. This needs to be addressed urgently with centralised training and standards to ensure that the most effective, evidence-based approach is taken for each and every woman. Some surgeons seem reluctant to undertake mesh removal and many women are sent away with no treatment other than to ‘keep taking painkillers’. It shouldn’t be that the care a patient is offered depends on a surgeon’s preference. There are only seven mesh specialist centres, meaning some women have to travel hundreds of miles for every appointment. Many have to undergo surgery without a family member or friend with them because of travel costs. In addition, there is only one centre in the country, in London, that will consider removing rectopexy mesh. This mesh may have been implanted in a smaller number of patients, but the incidence and severity of harm seems to be even greater than for women with transvaginal mesh. When patients are offered mesh removal surgery, waiting times are often in excess of two years. As with many other areas of the healthcare system, the problem has been worsened by the Covid-19 pandemic. Emerging victims of the surgical mesh scandal The Cumberlege Review began to shed some light on the harm caused to women who had pelvic mesh implanted. But the story is so much bigger than pelvic mesh - new patients who have had mesh implanted in other areas of the body are increasingly approaching Sling the Mesh, reporting pain and other side effects. There has been no review in England into the use of mesh to treat hernias[2], and we are seeing an increasing number of women reporting complications after mesh has been inserted into the abdomen following TRAM flap surgery[3], a procedure where abdominal tissue is used in breast reconstruction. Many of these people report being told by their surgeons that their pain is caused by ‘anxiety’; much the same story women with transvaginal mesh complications were given six years ago before the media started covering this issue extensively. This amounts to medical gaslighting and adds to the harm caused by the initial insertion of mesh devices. The NHS needs to learn from the hard lessons of the pelvic mesh scandal and take a joined-up and patient-centred approach to dealing with these emerging issues. The NHS needs to listen and take action Baroness Cumberlege’s review should have marked a sea change in the treatment of women who have suffered harm as a result of transvaginal mesh. But the NHS response has lacked will and focus, leaving thousands of patients still living with pain and distress as a result of surgical harm. Those individuals and agencies with the power to bring consistency and compassion to mesh removal surgery need to listen to the patients who have suffered life-changing injury. And taking the time to meet with us would be a good first step. Suggested reading Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies - a blog by Kath Sansom Ineffective medical device recalls are a patient safety scandal - a blog by Kath Sansom A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Transvaginal Mesh Timeline (7 December 2017) References 1. 'England Mesh Complication Centres Announced'. British Society of Urogynaecology website, 5 February 2021 2. 'Hernia mesh complications "affect more than 100,000"'. BBC website, accessed 22 November 2021 3. 'Breast reconstruction using tissue from your tummy'. Macmillan Cancer Support website, accessed 22 November 2021

A medical device is any piece of equipment, material or apparatus used to diagnose or treat a medical condition. When a medical device is recalled because of safety concerns, it can affect a large number of patients, often on a global scale. However, manufacturers and regulators of these devices don’t often have effective ways to ensure patients know about safety concerns, understand the risks or know what to do if their medical device is recalled. This blog by Kath Samson, founder of the Sling the Mesh campaign, looks at some of the issues around medical device recalls. She suggests ways that device manufacturers and regulators can improve their communication with patients and healthcare staff when a medical device is recalled. During an online meeting with the Patient Engagement Advisory Committee of the US Food and Drug Administration, I was struck by the huge problems that continue to exist around medical device recalls. I have been campaigning on these issues since 2015 and progress has been painfully slow. Although the meeting had a US-focus, the issues addressed are global. Medical devices travel across the world to be implanted in or used by patients - we have the technology to keep track of them and if we don’t start using it, an increasing number of patients will be harmed. Here are some of the issues raised in the meeting: Lack of global monitoring and reporting systems There is no robust, joined up system globally for medical device recalls. The current patchwork of local systems means that information takes a long time to disseminate, so harm continues to happen to patients who are unaware they are living with a dangerous device. A barcode tracking system of Unique Device Identifiers (UDI) that allows medical devices to be tracked does in theory exist, but it is not being used consistently. Manufacturers and healthcare providers need to use UDI as standard, but this is not currently happening. Lack of a legal and regulatory framework As seen in the case of the surgical mesh scandal,[1] official bodies are often reluctant to carry out retrospective audits that would reveal the scale of the problem and the harm that has been caused. It is also hard to understand why most medical device recalls are voluntary, meaning manufacturers have no legal obligation to ensure patients are informed. For something that poses such a risk to patients’ safety, that legal obligation needs to exist. The voluntary nature of recalls also has the effect of making safety concerns appear less serious. In reality, continued use of the device may cause significant harm. There are also many medical devices still on the market with huge safety concerns that haven't even been recalled, suggesting that the threshold for recalling medical devices needs rethinking. ‘Equivalence’ and flaws in the approval processes In the current approval framework, medical devices seen as ‘equivalent’ can bypass clinical trials and other safety processes as they are seen as simply replacing an older model. In reality these devices often bear little resemblance to their predecessor and need to be separately trialled. The first vaginal mesh was approved for use on equivalence to a hernia mesh in 1996, even though it was to be used to treat a different issue in a different part of the anatomy. The hernia mesh was withdrawn in 1999, but the equivalent vaginal mesh was kept in circulation. All mesh slings date back to that first device and are still being implanted globally - they are only suspended in the UK. These devices are considered safe and not requiring a recall, but their approval was flawed in the first place. [2] Equivalence has resulted in huge amounts of harm and continues to present a major risk to patient safety. Its use to approve high-risk medical devices must stop, and this is something I have lobbied the MHRA about. Other problems with the way medical devices are approved include selective use of data to demonstrate the benefits of treatment with a particular device (known as p-hacking), inadequate patient follow-up and poor post-market surveillance. Lack of information for patients Patients are often given little or no knowledge about the actual medical device that has been implanted into their body - details such as brand names and serial numbers that would enable them to support their own safety. This means that even if patients do hear about a device recall, they won’t know whether the recall applies to them and whether they need to seek help. This lack of knowledge is a source of great anxiety for many patients, which can itself lead to further harm. Patients are also often unaware of the risks surrounding their medical device - both at the point of implantation or issue, and following a recall. For example, many women who were implanted with surgical mesh have received no advice about whether it is safer to have the mesh removed or leave it implanted. Lack of measures to remedy problems and support patients One of the most worrying issues is that when a device has been recalled, there is no guidance on what needs to happen next for the patients affected. If a device has been implanted, there is no official pathway for medics or patients on how to seek help and remedy harm. Patients are left feeling abandoned. A further concern is that patients are not always offered an equivalent solution after their device has been recalled. Medical devices are not issued without a good reason, and the health issue that warranted its use is therefore likely to return. Ways to improve medical device safety If they are willing to, manufacturers and regulators can improve patient safety by communicating with and supporting patients through medical device recalls. Here are some ways they can do this: When a patient reports an issue, conduct reviews quickly. After a device has been recalled, review similar or equivalent devices to ensure they do not pose similar safety risks. Use easy-to-understand language in device recalls. Involve patients meaningfully in recall processes to better understand how to communicate with different patient groups. In recalls, better inform patients about risks, symptoms and what to do next so that they can support their own safety. Use all available communication channels to communicate recalls with patients, including social media, text messages and email. Promote and make tools for reporting side effects and adverse events, such as the Yellow Card scheme in the UK, readily available. These steps will help, but there are so many more systemic issues for regulators to address. I will continue to campaign for a system that takes medical devices, and the patients that use them, seriously. When a device designed to improve patients’ health causes harm, we need rigorous systems that will both enable doctors to support harmed patients and prevent similar harms happening in future. Further reading Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies - a blog by Kath Sansom A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Analysing the Cumberlege Review: Who should join the dots for patient safety? (16 July 2020) Transvaginal mesh timeline (Dr Carl Heneghan, 7 December 2017) References 1 The Guardian, What does pelvic mesh do and why are women suing over it? – explainer (31 August 2017) 2 BMJ Open, Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process (6 December 2017)

In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that the UK regulatory systems for medicines and healthcare have not been fit for purpose for a number of years. Framed within the context of the Cumberlege Review, Kath uses evidence and personal insight to highlight flaws in the system, and to make the case for urgent reform.  Falling asleep at the wheel causing a multiple car crash is considered such a serious offence in law that the driver could face up to 14 years in prison.[1] When it comes to falling asleep at the medical regulation wheel, however, causing major harm to patients, the result appears to be a review, knuckles rapped, a few negative media reports and then business as usual. Campaigners celebrated when Baroness Cumberlege called for urgent reform of the way healthcare treatments are regulated in her First Do No Harm Report.[2] But really, this is old news. As long ago as 2005, the Government called for reform of the Medicine and Health Regulatory Agency (MHRA), after finding it complacent and incompetent. The review uncovered a worrying level of Influence from industry.[3] [4] [5] Sixteen years later, in 2021, however, it’s the same story, similar platitudes. Disasters like mesh, valproate and Primodos, must never happen again. But didn’t we hear this after the metal hip and PIP breast implant tragedies? To ignore overhauling the MHRA for a second time would be irresponsible at best. Criminal at worst and lead to health disasters ad infinitum. A relentless ground hog day of people queuing in the wings, waiting to take spotlight on the human disaster stage. The MHRA is the UK body that’s supposed to check that the drugs we take, and the implants put into our bodies, are safe. All too often, though, patient reports of harm are not listened to or are dismissed as subjective, unscientific and anecdotal.[6] Regulation is so disjointed it’s beyond a joke. Reports of harm are made to different bodies at different times, so identifying and responding to adverse trends is difficult. Especially if those receiving the reports have limited requirements to communicate with each other, let alone work cooperatively. Baroness Cumberlege asked regulators and arms lengths bodies including the MHRA, if they could explain how this had happened. “They could not assist us,” she said.[7] In its evidence to the review, campaign group Sling The Mesh said: “The MHRA has been too close to the industry… underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff…[we] have little faith in the ability of medical institutions that are responsible for patient safety to be open and transparent over patient safety failings.” So how should this gargantuan mess be fixed? In 2005, the Government listed 48 recommendations to the MRHA,[8] and in 2020 the First Do No Harm report added powerful calls to action to improve patient safety. Below are 20 crucial points, drawn from these and my own insights: 1. Make it a legal requirement for NHS and private doctors to report adverse events. At the moment it’s voluntary. Industry is mandated to report, but only clinicians at the coal face know how drugs and devices are faring. The current system is designed to fail. To prove the seismic malfunction, let’s look to the mesh tragedy. A study found that only a third of surgeons reported mesh complications.[9] In one year alone, (2008), there were more than 1,000 women readmitted to hospital suffering early mesh sling complications.[10] Yet when the MHRA published almost a decade’s worth of mesh complications their records showed just 291 by comparison. Where had all the missing women gone?[11] In its evidence to the Cumberlege review, the MHRA said: “We agree there is under-reporting of adverse events to MHRA. Our written and oral evidence illustrates the work we are doing to improve this and how this data is considered, along with many different data sources, to monitor and act fast when a safety concern emerges.” Is this Unicorn theory? Campaigners deserve an update on what specific measures the MHRA has put in place. We have no idea what they are. 2. A proper awareness campaign of the Yellow Card system Before becoming a patient advocate, I’d only heard this term on the football pitch. 3. The responsibility for representing industry interests should move into the remit of the Department of Trade and Industry This would free up the Department of Health to concentrate solely on healthcare regulation and health promotion. Entwining the two is fatal. 4. Keep a closer eye on ‘me too’ treatments Mesh and many other devices are approved on a piggy-back system called Equivalence. It means if there’s something similar on the market its approved without clinical trials. Patients are the human guinea pigs. 5. Patients must be allowed to engage with the MHRA in a meaningful way in the pre and post market approval process It is currently mostly industry commentating. 6. Patient warnings must come sooner The MHRA should be modelled on the American MAUDE database system[12] with transparent reporting by public and clinicians and a trigger warning system when trends of harm are spotted. 7. Implantable devices need a barcode track and trace system to help spot trends 8. A new improved MHRA database should link up with international recalls and product warnings It’s crazy that one country can consider a product safe for use when another does not. 9. When trends are spotted there should be immediate notices to hospitals to update their Information For Use leaflets (IFUs) 10. All MHRA licensing decisions should be made public 11. Coroner court cases should look at contributory factors and not just conclusions to see if, for example, mesh played a part This information should be linked to the MHRA database. 12. Pre and post market approval must be standard for permanently implanted devices 13. Databases should be standard for permanently implanted devices Consideration should be given to comparable databases for specific medications, especially those taken during pregnancy. A new prototype registry is being built to log outcomes from pelvic floor surgery. It is hoped this will act as a forerunner to databases for other permanently implanted devices in the future, and linked to the Yellow Card system. 14. Stop the revolving door culture There must be a cooling off period before a person can jump from industry to a senior regulatory role in the MHRA, otherwise they’re simply marking their own homework.[13] Approximately 11% of staff in the medical devices division of the MHRA were previously employed in industry.[14] [15] 15. Look at new funding models [16] The activities of the MHRA are currently funded primarily through the pharmaceutical industry on the medicines side, and 95% through the Department of Health and Social Care on devices. Additional funds for clinical trials and inspections of notified bodies come mostly from the Department of Health and Social Care. 16. Act on Duty of Candour breaches Doctors have a professional duty of candour to be honest with patients if things go wrong. Failure to comply is a criminal offence However, the Professional Standards Authority (PSA) report that the regulators are not identifying duty of candour breaches or considering them as part of fitness to practise panels. 17. When a safety issue is raised the MHRA should work to binding timescales on risk management, set according to the degree of public health urgency, as they are by the EU framework The MHRA should publish performance data and inform the Patient Safety Commissioner of non-compliance. 18. The regulation of medicines and medical devices has been governed by EU laws since the UK joined in 1973 Brexit means a new legal framework will be required for the MHRA. Cumberlege says we have “a unique opportunity to shape the UK regulatory agenda using what we heard and learnt throughout this review.” 19. The MHRA only maintains a list of lowest risk devices like bandages and non-electric wheelchairs and not medium to higher risk devices like pacemakers and mesh This is a function of current EU device regulatory structure. The MHRA may only find out a device is being used in the UK if there’s a problem. A register of devices similar to the Australian Register[17] should be created and maintained by the MHRA. This will make it possible to know which devices are (or were) on the UK market at any given time. Entry on the register should be a condition for selling in the UK, with the MHRA able to de-register devices and remove from sale if necessary. 20. Prompt, co-ordinated response by the healthcare system to safety issues This calls for a system-wide intelligence unit to aid early signal detection, drawing on various sources of information, pharmacovigilance and issues raised by the Patient Safety Commissioner. Final thoughts In short, campaigners believe the MHRA has become a system of passive regulation that, by its own admission, becomes even more lax when it comes to medical implants / devices. In 2014 the MHRA carried out an internal investigation which says “we must take devices as seriously as medicines”, but admits resources for the devices division “have been diminishing over the years due to austerity measures”. The PIP breast scandal and mesh were tragedies waiting to happen.[18] Further reading: Women are duped into believing the most common mesh operation is safe, campaigners say Medicines and Healthcare Products Regulatory Agency: Summaries of the Safety/Adverse Effects of Vaginal Tapes/Slings/Meshes for Stress Urinary Incontinence and Prolapse Ineffective medical device recalls are a patient safety scandal - a blog by Kath Sansom Follow 2 Posted by Kath Sansom References RAC, Driving offences and their punishments (2019) The Independent Medicines and Medical Devices Safety Review, First Do No Harm, (2020). House of Commons Health Committee, The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05; 2005:Vol 1:2005 Select Committee on Health Minutes of Evidence, (October 2004) Collier J. New arrangements for the Medicines and Healthcare products Regulatory Agency. BMJ. 2005;330(7497):917 The Independent Medicines and Medical Devices Safety Review, First Do No Harm 2020 The Independent Medicines and Medical Devices Safety Review, First Do No Harm 2020 House of Commons Health Committee, The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05; 2005;Vol 1:p114 Duckett J, Morley R, Monga A et al. Mesh removal after vaginal surgery: what happens in the UK? International Urogynecology Journal 2017;Vol. 28(7):989-992 RCOG, Hospital Episode Statistics as a source of information on safety and quality in gynaecology to support revalidation 2012; p22:table 3.4 MHRA, A summary of the evidence on the benefits and risks of vaginal mesh; 2014:p29 US Food and Drug Administration, MAUDE - Manufacturer and User Facility Device Experience The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 2020 UK Government, John Wilkinson OBE, Director of Devices to retire; 2019 UK Government, Dr Ian Hudson biography The Independent Medicines and Medical Devices Safety Review, First Do No Harm (2.60) Australian Government Department of Health, Database of Adverse Event Notifications (DAEN) 2018 Stephenson, T. Expert Clinical Advice – MHRA Medical Devices Report of the independent review on MHRA access to clinical advice and engagement with the clinical community in relation to medical devices; p1-5

Kath Sansom, is a journalist and campaigner who, following a pelvic mesh implant, was left in intense pain and subsequently founded the Sling the Mesh campaign. In this powerful opinion piece, Kath highlights the lack of transparency and reporting around financial conflicts of interest in UK healthcare, and why this poses a serious threat to patient safety.  Drawing on legislation that was introduced in the US and recommendations from the Cumberlege Review, Kath calls for urgent action to be taken to prevent patients from suffering harm in the future.  Corruption, greed and deceit, sound like the basis of a gripping crime novel or a binge-worthy Netflix series, but for patient campaigners it’s what we find on an alarming basis when it comes to the lucrative world of healthcare. We’re in an age of miracles where modern medicine can achieve remarkable things, but this can lead to patient safety taking a backseat when shareholders have dollar signs in their sights. We hear how tragedies such as the mesh scandal, Primodos, Valproate, metal hips and PIP breast implants must never happen again. But until we have tougher regulations, alongside strict rules forcing both doctors and industry to declare money and gifts which have exchanged hands in return for lectures, research, training and more, then tragedies will keep happening. Mandatory reporting of conflicts of interest was one of nine key recommendations by the Baroness Cumberlege First Do No Harm review. Clinicians and industry should be forced to declare. Some argue that taking a gift will not lead to bias, but studies prove otherwise.[1] [2] As patient campaigners we will always argue there is no such thing as a free lunch. As a matter of urgency, the UK needs a Sunshine style payment act, as was put in place in America in 2013. There are similar versions of this in Denmark and France. The act provides a public database to search who pays our doctors. It is so easy, a 10-year old could use it. Simply pop in a doctor’s name and hey presto! You can see money they’ve taken for sandwiches, training, research, papers and much more. We know of one medic who took more than £2 million from 2013 to 2019, leading to a huge question mark over his slick, pro-mesh website, which assures women that mesh implants are safe with minimal risks.[3] A Sunshine style act would make it a legal requirement for healthcare giants to declare all monies and gifts given to doctors, teaching hospitals and research institutions. Taking money from industry can lead to a ‘marking their own exam papers’, buddy culture, where certain healthcare treatments are pushed over others – not because they are better or safer even, but because of, for example, a great session on the golf course with free wine afterwards with the wives. In the UK our reporting system is currently voluntary, to a database called Disclosure UK, set up in 2016.[4] But it is clear this is not working. Firstly, because of EU privacy law, declaration is voluntary. Health professionals can exclude certain payments or opt out entirely. And there is no option for a nil return so if a doctor isn’t listed this could mean either no payments were received, or the doctor declined to be identified.[5] Additionally, the NHS is not great at logging employee interests, according to a BMJ study, which found that no NHS Trusts in England met all the transparency criteria. The BMJ contacted 236 Trusts, of which 217 responded: 51 did not provide a Gifts and Hospitality Register and only 31 of the registers contained enough information to assess employees’ conflicts of interest. Despite obligations to report, the current system is not functioning adequately.[6] Scottish GP, Margaret Mc Cartney, is among a medic-led campaign for a Sunshine style payment act in the UK. She said: “Doctors may receive money and benefits from a wide range of sources. “They may be paid by the pharmaceutical industry to give lectures to other doctors. They may run companies that sell health services to the NHS. They may receive hospitality, such as food and drink, or accept free travel and hotel accommodation from industry in order to attend conferences. “They may accept free training about which treatments work best, that has been funded by drug companies. They may be paid by industry to conduct research. They may be paid by PR companies working on behalf of drug companies, or providers of health services, such as companies making supplements, health products, or foods.” As patients we deserve to know who is funding our doctors, including if a husband or wife has financial interests. It's not necessarily a bad thing if doctors are paid for their time and expertise. For example, working for NICE, or giving expert views to court. However, it's important such information is provided as a legal requirement and is freely available on a public database, so patients can draw their own conclusions. Sling the Mesh (STM) recommendations Consider the introduction of an American style Physicians Sunshine Payment Act to ensure mandatory reporting of all payments from industry to clinicians. STM believes an American style Physician Payments Sunshine Act is essential in the UK to ensure mandatory reporting of all payments from industry to medical professionals. In this we are joined by the British Medical Journal and by prominent medical professionals such as Dr Ben Goldacre of the University of Oxford. Such an act would have the aim of increasing transparency around the financial relationships between healthcare professionals and drug and device companies. The existence of a financial payment from a drug or device company to a doctor or author of a medical study does not, of course, carry with it an automatic assumption of bias, or wrongdoing. However, it has been proven that industry payments to doctors can affect their treatment of patients.[7] [8] In addition, it has also been shown that studies sponsored by drugs or device companies are more likely to find results that favour the company.[9] [10] It is argued that industry sponsorship of clinical trials, and the payments industry makes to medical professionals, are an inevitable part of the development and use of drugs and devices. Whatever arguments are made for the necessity of personal payments to medical professionals by drugs and device companies, it would seem sensible that all such payments are publicly declared. This would enable the broader influence of industry on the use of particular drugs and devices to be assessed. Whilst rules and recommendations for the declaration of industry payments already exist in the UK, at present they are haphazard and fragmented Since 2016, the Association of the British Pharmaceutical Industry (ABPI) has maintained a database of payments to healthcare professionals from drug companies. This database is known as Disclosure UK.[11] However, disclosure of payments to this database is not mandatory for healthcare professionals, and the database does not cover payments made to healthcare professionals from medical device companies. For these reasons the Disclosure UK database is not sufficient for the purpose described above. In addition, in 2016, a rule was introduced that required NHS hospitals to keep a list of gifts and payments to NHS staff, but it is unclear whether this is being adhered to. A recent analysis by Dr Ben Goldacre and others of clinicians’ conflict of interest disclosures to NHS hospital employers in England showed that “recording of employees’ conflicts of interest by NHS trusts is poor”.[12] STM believe the most practical solution is the enactment of an American style Physician Payments Sunshine Act. In the United States reporting of all payments made to medical doctors by both drug and device companies is now mandatory. It is the responsibility of the companies to declare such payments to the US Government’s Centers for Medicare & Medicaid Services (CMS). A publicly accessible database of such payments is maintained by the CMS[13] Such a system should also work well within the UK. Further reading Mesh expert failed to declare £100,000 funding Medical device firms’ payments to doctors far outstripped those from pharma, study shows References [1] Spurling G, Mansfield P, Montgomery B, et al. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review PLoS Med 2010;7(10) [2] Lexchin J, Bero L A, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review BMJ 2003;326:1167 [3] Open Payments Search Tool [4] Disclosure UK, The Association of the British Pharmaceutical Industry [5] Adlington K, Godlee F. Disclosure UK: transparency should no longer be an optional extra BMJ 2016;354:i3730 [6] Feldman HR, DeVito NJ, Mendel J, et al. A cross-sectional study of all clinicians’ conflict of interest disclosures to NHS hospital employers in England 2015-2016 BMJ Open 2018;8:e019952 [7] Ornstein C, Tigas M and Grochowski Jones R. Now There’s Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds ProPublica 2016 [8] Farquhar C, Vercellini P, Marjoribanks J. Gynaecologists and industry: ain't no sunshine Human Reproduction 2017;2(8):1543–1548 [9] Lundh, A, Lexchin J, Mintzes B et al. Industry sponsorship and research outcome: systematic review with meta-analysis Intensive Care 2018;Med 44:1603–1612 [10] Lexchin J, Bero L A, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review BMJ 2003;326:1167 [11] Adlington K, Godlee F. Disclosure UK: transparency should no longer be an optional extra BMJ 2016;354:i3730 [12] Feldman HR, DeVito NJ, Mendel J, et al. A cross-sectional study of all clinicians’ conflict of interest disclosures to NHS hospital employers in England 2015-2016 BMJ Open 2018;8:e019952 [13] Open Payments Search Tool