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The Independent Medicines and Medical Devices Safety (IMMDS) Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as “disjointed, siloed, unresponsive and defensive."[1] Over two years on from the publication of the IMMDS Review’s report, First Do No Harm, the Health and Social Care Select Committee has today published a new report reviewing the implementation of its recommendations to date.[2] The Review made nine overarching safety recommendations, of which the Government accepted four in full, two in part, one in principle and rejected two.[3] Following an evidence session held on 13 December 2022, the Health and Social Care Select Committee’s report focuses specifically on two of the three medical interventions considered by the IMMDS Review, sodium valproate and pelvic mesh implants, and makes recommendations for Government action on these issues. Implementing recommendations The Committee’s report highlights the need to ensure that the below recommendations of the IMMDS Review, which the Government accepted, are fully implemented: That the Medicines and Healthcare products Regulatory Agency (MHRA) substantially revises its approach, particularly in relation to adverse event reporting and medical device regulation and ensures that it engages more with patients and their outcomes. A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. That it sets up a register of clinicians’ interests and ensures this includes financial and non-pecuniary interests for all doctors. That it establishes a register of industry payments to clinicians. Ensuring that the MHRA is responsive to patients and their outcomes is a long-term piece of work. The MHRA has come forward with numerous activities aimed at improving its approach in this respect, including the introduction of a new Patient Involvement Strategy.[4] While the jury is still out on what the impact of this will be, Patient Safety Learning believes that to meet the Review’s recommendation will require more than just increased patient involvement; it will mean meeting patients’ expectations that healthcare products are safe and that patients are free from avoidable harm. Turning to the creation of a central patient-identifiable database and a register of industry payments, there has been a lack of significant progress on these recommendations to date. However, pilot work on the register of clinicians’ interest has taken place and it has been stated by the Minister Maria Caulfield MP that implementation of this will begin in 2023. On each of these recommendations, we support the Committee’s calls for increased urgency by the Government in regards to their implementation. We also believe that there should be openly published timetables setting out plans for this. You can read more about the importance of registering of clinicians interests, industry payments to clinicians and the need for greater transparency and reporting around financial conflicts of interest in healthcare in a blog on the hub by Sling the Mesh founder Kath Sansom.[5] Redress A central focus of the report is the need for greater support for the women and children affected by the medical interventions covered by the IMMDS Review. Related to this, one of the key recommendations of the Review was to establish a new independent Redress Agency for those harmed by medicines and medical devices. It was envisioned that: “The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”[1] However, the Government rejected this recommendation, along with a recommendation to establish separate redress schemes for patients adversely affected by hormone pregnancy tests, sodium valproate and pelvic mesh. Instead they pointed towards patients having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability. Patient Safety Learning believes, like many individual patients and patient groups, that this response was wholly unsatisfactory. A new blog published on the hub this week highlights how for many harmed patients affected by the interventions considered in the report the clinical negligence route simply is not viable.[6] In the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need. The Committee’s report notes that the Minister Maria Caulfield MP has indicated that she is willing to look at the idea of a Redress Agency, as well as separate redress schemes. We would welcome this and support the Committee’s call for a formal statement on this with “more details on what such a review would include and seek to achieve, and timeline for completion”.[2] Audit of mesh patients Another recommendation of the IMMDS Review was for a retrospective audit of women who had pelvic mesh surgery, to help gain a fuller understanding of the nature and extent of mesh associated complications, with this data informing decisions over future pelvic mesh surgery. The Committee’s report notes that while this audit is underway, there are significant concerns that it is failing to adequately capture mesh related complications due to the data it draws on. The report therefore recommends that the Government “consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.”[2] Patient Safety Learning supports this recommendation, which echoes the IMMDS Review’s intentions that as part of this audit: “Every effort should be made to obtain sufficient data, and the audit results (assuming it is feasible) should be used to inform decisions over the future of pelvic mesh surgery.”[1] Patient Safety Commissioner The Committee’s report also stresses its support for the work of the new Patient Safety Commissioner for England, Dr Henrietta Hughes, urging the Secretary of State to ensure her duties and responsibilities are not impeded by a lack of resource for and within her office. It suggests that any additional work she may be tasked with relating to reviewing redress arrangements should be accompanied by additional resources. Patient Safety Learning supports this recommendation. The Patient Safety Commissioner can play an important role in helping to tackle unsafe care and empowering patients; however, her office must have the necessary resources and support to achieve this as indicated by the Select Committee. Engaging with patients At Patient Safety Learning, we believe that patient engagement is key to improving patient safety and identify this as one of the six foundations of safer care in our report, A Blueprint for Action.[7] Patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account. We concur therefore with the Committee’s calls for the Department of Health and Social Care to improve its approach to this, following concerns raised by patients and patient groups: “We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting up care schemes such as this one. We therefore urge the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.”[2] Hormone pregnancy tests One area of disappointment though that we would note with the Select Committee’s report is that it does not consider any of these issues in relation to patients and family members affected by hormone pregnancy tests, one of the three interventions covered by the IMMDS Review. They state that they were unable to do so due to ‘ongoing litigation’. Patient Safety Learning does not believe this is acceptable. Many of the issues covered by this review, such as reforms to the MHRA, a register of clinicians’ interests and industry payments and potentially revisiting proposals for an independent Redress Agency, equally concern those affected by hormone pregnancy tests. While this may be complicated in some areas by ongoing legal proceedings, the exclusion of this group of patients is in our view impossible to justify. You can read more about this issue, and the work being done by patients and groups to fight for justice and improve patient safety, in an interview on the hub with the Chair of the Association for Children Damaged by Hormone Pregnancy Tests, Marie Lyon.[8] References The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Health and Social Care Select Committee, Follow-up on the IMMDS report and the Government’s response: Sixth Report of Session 2022-23, 20 January 2023. Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021. MHRA, Patient Involvement Strategy 2021-25, 1 October 2021. Kath Sansom, No such thing as a free lunch – why recording conflicts of interests must be mandatory, 9 April 2021. Kath Sansom, The difficult of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023. Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019. Patient Safety Learning, Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.

This report follows on from an evidence session held by the Select Committee on the 13 December 2022 to assess the Government’s progress against recommendations made in the Independent Medicines and Medical Devices Safety (IMMDS) report, First Do No Harm. This featured contributions from the Government Minister Maria Caulfield MP, patients and patient groups, and representatives from NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA). Summary of the reports recommendations The Government should: Urgently ensure that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented. Consider an alternative strategy for how to pro-actively contact pelvic mesh patients who have had the procedure about their post-operative experiences and possible side effects. Make the arrangements necessary to ensure the register of clinicians’ interests can be set up swiftly, subject to the pilot phase concluding, to prevent further delay. Move at pace to bring in the necessary secondary legislation to set this up a register of industry payments to clinicians. Ensure that the Patient Safety Commissioner for England’s ability to carry out her important role, as her duties and responsibilities is more clearly defined, is not impeded by a lack of resource for and within her office. The Department of Health and Social Care should: Respond to concerns raised about interactions and consultations with stakeholders around care schemes stemming from the review, reflecting on this experience and considering how to improve engagement with them in the future. The Secretary of State for Health and Social Care should: Make a statement detailing the Patient Safety Commissioner’s review of redress schemes for the medical interventions dealt with by the IMMDS review, and what additional resources will be made available to her to undertake it. The Minister for Mental Health and Women’s Strategy should: Make a statement on the review of redress and a possible Redress Agency, with more details on what such a review would include and seek to achieve, and timeline for completion.

At a national level the 2022 maternity survey shows that people's experiences of care have deteriorated in the last 5 years. Positive results Hospital discharge Since 2017, there has been a positive upward trend for women and other people who had recently given birth reporting that there was no delay with their discharge from hospital, from 55% to 62% in 2022. Mental health support Support for mental health during pregnancy is improving, although there remains room for further improvement. Nearly three-quarters of women and other pregnant people (71%) said their midwife definitely asked about their mental health during antenatal check-ups; an improvement compared with 69% in 2021 and 67% in 2019. Furthermore, 85% said they were given enough support for their mental health during their pregnancy; an improvement compared with 83% in 2021. In terms of postnatal care, the vast majority said a midwife or health visitor asked them about their mental health (96% compared with 95% in 2021 and 2019). Key areas for improvement Availability of staff The proportion of women and other pregnant people being given the help they needed when they contacted a midwifery team during antenatal care, dropped from 74% in 2017 to 69% in 2022. Women and other pregnant people were less likely to say they were ‘always’ able to get a member of staff to help them when they needed attention during labour and birth; 63% compared with 65% in 2021 and 72% in 2019. Results are lower still for care in hospital after the birth; 57% said they were ‘always’ able to get help, a decrease compared with 59% in 2021 and 62% in 2019. In terms of postnatal care, 70% were ‘always’ given the help they needed when contacting a midwifery or health visiting team, down from 73% in 2021 and 79% in 2019. Less than half (45%) said they could ‘always’ get support or advice about feeding their baby during evenings, nights or weekends, a downward trend since 2017 (56%). Confidence and trust Just over two-thirds (69%) of women and other pregnant people reported ‘definitely’ having confidence and trust in the staff delivering their antenatal care. Results were higher for staff involved in labour and birth (78%) but there has been a downward trend since 2017 (82%). In terms of postnatal care, while most said they ‘definitely’ had confidence and trust in the midwifery team (71%), the trend is again a downward one, from 73% in 2017. There has also been a downward trend for ‘always’ being treated with kindness and understanding whilst in hospital after the birth, from 74% to 71%. Communications and interactions with staff The proportion of women and other pregnant people saying they were given appropriate advice and support when they contacted a midwife or hospital at the start of their labour, decreased from 87% in 2017 to 82% in 2022. There has also been a downward trend since 2017 for women and other pregnant people saying that if they raised a concern during labour and birth, they felt it was taken seriously, from 81% to 77% in 2022. 59% of women and other pregnant people were always given the information and explanations they needed during their care in hospital, down from 66% in 2017. How experience varies for different groups of people Women and other pregnant people report some differences in their experiences of maternity care according to certain demographic characteristics. Some of the more consistent differences include women are more likely to report positive experiences of maternity care if they have continuity of carer or have an unassisted vaginal delivery. Women are more likely to report poorer experiences across the maternity care pathway if they have had an emergency caesarean birth, do not have continuity of carer (no named midwife) or have not had a previous pregnancy.

10:03:23 Witness(es): Emma Murphy, Founder, Independent Foetal Anti-Convulsant Trust (In-FACT); Janet Williams, Founder, Independent Foetal Anti-Convulsant Trust (In-FACT); Kath Sansom, Campaigner, Sling the Mesh Campaign. 10:36:55 Witness(es): Professor Sir Cyril Chantler, Deputy Chair, Independent Medicines and Medical Devices Safety Review; Simon Whale, Review Member and Communications Lead, Independent Medicines and Medical Devices Safety Review; Baroness Julia Cumberlege, Chair, Independent Medicines and Medical Devices Safety Review. 11:03:10 Witness(es): Maria Caulfield MP, Parliamentary Under-Secretary of State (Minister for Mental Health and Women's Strategy), Department of Health and Social Care; Dr Aidan Fowler, National Director of Patient Safety in England, Department of Health and Social Care; William Vineall, Director of NHS Quality, Safety and Investigations, Department of Health and Social Care; Celia Ingham-Clark, Medical Director for Professional Leadership and Medical Workforce, Department of Health and Social Care; Dame June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA).

The IMMDS Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: Hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as ‘disjointed, siloed, unresponsive and defensive’. In this report, the Government provides a progress update on the implementation of the Review’s recommendations, which is summarised below: Recommendation 1 - The government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by primodos, sodium valproate and pelvic mesh. Progress update - Complete. On 9 July 2020, the day after publication of the review, the Government issued an unreserved apology on behalf of the healthcare system to the women affected, as well as their children and their families, for the time the system took to listen and respond. Recommendation 2 - The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. Progress update - Complete. The Government appointed Dr Henrietta Hughes as the Patient Safety Commissioner for England on 12 July 2022. Recommendation 3 - A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. Progress update - The Government did not accept recommendation 3. Recommendation 4 - Separate schemes should be set up for each intervention – HPTs (hormone pregnancy tests), valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim. Progress update - The Government did not accept recommendation 4. In this report they point to NHS Resolution having now launched two claims gateways on their website to provide further support to patients who may wish to bring a clinical negligence claim in relation to pelvic mesh and sodium valproate. Recommendation 5 - Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy. Progress update - Complete for specialist mesh centres. There are now nine specialist centres in operation in England. They state that this ensures that women in every region have access to these services and note that each mesh centre is led by a multidisciplinary team to ensure patients get access to the specialist care and treatment that they need, including pain management and psychological support. Ongoing for medicines in pregnancy. They state that their view was that a network of new specialist centres is not the most effective way forward to help those adversely affected by medicines taken during pregnancy. The report notes that NHS England has instead taken forward work to improve care pathways for children and families adversely affected by medicines in pregnancy. Ongoing for sodium valproate. The report states that the MHRA is introducing stronger regulatory measures to continue to reduce the number of pregnancies exposed to sodium valproate, including new patients under 55 years of age needing two specialists to document that no other medicine is effective or tolerated. It notes that work continues to improve compliance with regulatory measures, with the MHRA and NHS Digital establishing the Medicines and Pregnancy Registry to track NHS prescriptions of valproate in girls and women of childbearing age in England. In 2022 to 2023, an audit will be carried out by pharmacies to measure adherence to MHRA regulations. Recommendation 6 - The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. Progress update - Ongoing. They state that the MHRA has embarked upon an ambitious organisation-wide transformation to ensure it becomes a progressive and responsive patient-focused regulator of medical products. It notes that the Agency has been establishing a new organisational structure that improves how it listens and responds to patients and the public, developing a more responsive system for reporting adverse incidents, and strengthening the evidence to support timely and robust decisions that protect patient safety. Recommendation 7 - A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient-reported outcomes measures. Progress update - Ongoing. In 2021 to 2022, a scoping exercise was undertaken to determine how best to deliver this recommendation. This provided a significant amount of learning. They state that they concluded that, for England, expanding the coverage and breadth of existing registries will best deliver harmonised data collections that contain patient, device and outcome-level data. They have an target to increase registry coverage from 15% to 80% over the next 3 years. In parallel, the report notes that the Government are working with devolved governments to develop a UK-wide approach that will enable secure data sharing, system interoperability and UK-wide coverage, where appropriate to do so. Recommendation 8 - Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests, and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. Progress update - Ongoing. The report states that they are currently piloting systems for doctors to declare their interests in NHS and independent settings across the UK. Full implementation will begin in 2023, subject to a successful review of the pilot systems. Once this system is in place for doctors, they note that they will then consider systems for other healthcare professionals. The report also notes that the Government has legislated through the Health and Care Act 2022 to enable the Secretary of State for Health and Social Care to make regulations requiring companies to publish or report information about their payments to the healthcare sector. The Government is reviewing the information gathered from stakeholders to develop plans on how best to deliver on the objectives of this recommendation. Recommendation 9 - The government should immediately set up a taskforce to implement this review’s recommendations. Its first task should be to set out a timeline for their implementation. Progress update - Not accepted. The Government did not accept recommendation 9. In this report they point to having instead established a Patient Reference Group to inform work to develop the 2021 government response. The Patient Reference Group published an independent report on their work in July 2021. Related reading Independent Medicines and Medical Devices Safety Review: A joint letter from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2022. Kath Sansom, 10 problems with NHS England’s specialist mesh centres, 3 October 2022. Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022. Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 26 July 2021.

Findings For healthcare staff, carrying out a robust assessment of risk factors for VTE is challenging, particularly in the complex and busy environment of antenatal clinics, the labour ward and on postnatal wards. Multiple competing demands, exacerbated by distractions and interruptions, mean healthcare professionals are constantly having to balance risk and safety for the pregnant women/pregnant people they care for and are trading off the thoroughness of assessments to improve efficiency. Midwives are asked to complete a number of risk assessments and screening tools to assess pregnant women’s/pregnant people’s risk at their first antenatal appointment (known as the booking appointment). However, the time needed to carry out these risks assessments may not be reflected in the time allocated for appointments. Risk assessments and screening tools are not all designed and presented in a consistent and logical way that would aid staff in completing the task. Assessment of VTE risk factors should take place routinely due to body changes in pregnancy and increased risk of VTE. Although assessing VTE risk is important, it is a relatively rare condition and there are a number of other competing risks that may take priority. Staff do not always involve pregnant women and pregnant people in, or discuss with them, the assessment of their risk factors for VTE. This means pregnant women and pregnant people may not be aware of the signs and symptoms of a possible VTE. The importance of knowing the signs and symptoms of VTE may not be fully understood or prioritised by pregnant women and pregnant people who may have other competing concerns and questions about their antenatal and postnatal care. National guidance recommends that assessment of VTE risk factors should be repeated when a pregnant woman/pregnant person presents with an ‘intercurrent problem’ (a new health issue which may or may not be related to the pregnancy). However, not all healthcare professionals understand the meaning of ‘intercurrent problem’ and therefore opportunities to reassess risk factors are missed. There is a mix of paper-based and electronic record keeping in antenatal and postnatal care. Electronic records systems may lack interoperability and suffer from poor connectivity which limits the ability of staff to access all the data, information, and knowledge they need at the time of assessment. Recommendations by MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK) for the development of a tool to make the current assessment of VTE risk factors simpler and more reproducible, have not been acted on. Safety observations It may be beneficial for organisations to consider guidance, such as the ‘principles for effectiveness and usability’ provided by the Chartered Institute of Ergonomics and Human Factors, when developing risk assessment tools. The aim being to ensure assessments are simple to use and therefore staff being more likely to do them thoroughly and avoid tick-box fatigue. It may be beneficial for organisations that make recommendations to improve the safety and care of pregnant women and pregnant people during their pregnancy and up to 6 weeks after birth, to have a process for reporting on responses to their recommendations. This would support transparency, making it easy to see what has been achieved and what remains outstanding. The aim being to enable tracking of the implementation of actions designed to improve safety and outcomes to ensure they happen. It may be beneficial if future research or funding is directed towards identifying the evidence base for the prescribing of low-molecular-weight heparin for venous thromboembolism risk in pregnancy and the first 6 weeks after birth. This will support the production of evidence-based clinical guidelines for the care and treatment of pregnant women and pregnant people at risk of VTE to ensure it is safe and effective.

The report's key findings show that: 229 women died during or up to six weeks after the end of their pregnancies in 2018 – 2020 from pregnancy-specific causes or conditions made worse by pregnancy, an increase of 24% compared to 2017-2019.Taking into account their surviving babies and previous children, 366 motherless children remain. Of the 229 women who died during or up six weeks after the end of their pregnancies, nine women died from COVID-19. Of those nine women, five were Asian women and three were Black women. Changes to maternity services and pressures because of the pandemic also contributed to some other maternal deaths. Black women were 3.7 times more likely to die compared to White women and Asian women were 1.8 times more likely to die compared to White women. A further 289 women died between six weeks and one year after the end of pregnancy. Including the deaths of 18 women who died during pregnancy or up to six weeks after pregnancy which were classified as coincidental, in total, there were 536 maternal deaths among 2,101,829 maternities. One in nine of the women who died had experienced severe and multiple disadvantage. The main elements of a multiple disadvantage were: a mental health diagnosis; substance misuse; and domestic abuse. The report notes that the figures reported are likely to be a minimum estimate due to inconsistencies in reporting these types of disadvantage. Women were three times more likely to die by suicide during or up to six weeks after the end of pregnancy in 2020 compared to the 2017 – 2019 report. Maternal suicide was also a leading cause of death in women between six weeks and a year of their pregnancies ending, accounting for 18% of the women who died between 2018 and 2020. At least half of the women who died by suicide and the majority from substance misuse had multiple adversity with a history of childhood and/or adult trauma frequently reported. Cardiovascular disorders and psychiatric disorders are now equally responsible for maternal deaths in the UK, accounting for 30% of the women who died up to six weeks after the end of pregnancy; in previous reports, cardiovascular disorders have been reported as the leading direct cause of maternal death. 86% of the women died in the postnatal period. The report demonstrates that even when the women who died as a result from COVID-19 are excluded, the number of women who died has still increased by 19% compared to 2017 – 2019, suggesting that an even greater focus on the report's recommendations for improvements to maternal healthcare are needed.