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I love and support the NHS. But when things go wrong for patients and service users, the system is often too slow to change or respond effectively. I have been through complaints, the Ombudsman and Inquest processes around the poor end of life care of my late mother. Those processes took years and were almost as stressful as those last few days of my mother’s life. I would not do it again. At the time, I reported the incident in detail to the CQC (inspectors), to the CCG (commissioners), to Healthwatch (local and national), but I noted no evidence of change. In fact, the CQC continued for years to report similar failings at the same hospital. Too many other patients and service users say the same thing. I met many of these patients/users when I was part of the user/patient led group PHSOthefacts. Then, my elderly friend and neighbour asked me to be their advocate around their wishes for end of life care and unfortunately things were not perfect at all. I was able, through connections I had made from the previous experiences I mention above, to get a meeting with senior managers involved with her care. However, sadly I do not think much came of that either. I believe others could go through the same suffering my friend experienced. There are immense pressures on the NHS. Hospitals have budgets to operate within, reputations to manage and targets to meet, as well as keeping patients and staff safe. While the system is under huge pressure, and many of the known ‘complaint’ processes are not designed to improve patient safety, the good news is there is a growing awareness of the need to listen and learn from patients and service users, drawing on the best safety science and using independent experts. Safety improvement rather than simply complaining (often seen as an administrative process) is what so many patients and families most want to see so others do not suffer the same way as their loved one. Fortunately, via a convoluted route, I did discover the Patient Safety team of NHS England who was able to take one of my concerns about care very seriously. I also learned about the development of the Healthcare Safety Investigation Branch (HSIB). So the good news is that as well as traditional routes like Complaints, the Ombudsman (PHSO) and reporting to formal bodies (perceived as inadequate by too many patients/users who have been through this process), there are four developments to note of NHS dealing with events when patients suffer harm or potential harm: 1. New guidance is being developed by NHS England to help hospitals and health services address safety concerns and involve patients in this. 2. HSIB, who carry out up to 30 independent investigations a year, is developing an exemplar model of involving the patient and family perspective in these investigations. It offers an exciting, new, more change-focused, learning-focused and system-focused way of understanding and addressing many of the harmful incidents patients' experience, aligned with service users and families who wish to embark on a journey resulting in learning. Watch this HSIB video 'Why it's important that we learn from incidents'. 3. There is increasing recognition of the role of patients in all health decision-making, which is well covered in the Patients Associations' 'Shared decision making: a reality for everyone'. In fact, I recently wrote a blog for the hub on a particular patient harm issue: 'Please don't undermine my pain relief! A call for learning and respect for patients with long tern needs', which I then shared via ENGLAND.shareddecisionmaking@nhs.net and I was put in contact with a relevant Clinical Improvement Team in NHSE/I who were interested to learn more. 4. Finally, patients, service users and families can log issues on the NHS England NRLS reporting tool – although no one will get back to you personally, the information you share could be used to improve safety for future patients. However currently it is vastly under used (50 patient/family reports a year) compared to the general NHS complaints system (over 100,000 a year). In contrast, the system also logs and analyses nearly 2 million NHS staff-reported harm or potential harm incidents a year, examined by a team of NHS-employed independent patient safety experts. It may contribute to vital learning in the future and it is currently reviewed and upgraded, but to my mind the process is going too slow with regard to patient and family reporting. I think the patient, service user and family voice should be heard loud and strong. There should be a reporting option for where patients and users can go if they do not want to go through complaints, Ombudsmen, Inquest, legal or other processes (e.g. to CQC or CCG), or indeed want to do something alongside these processes and want to ensure independent health safety experts are made aware of concerning incidents. Please let me know if you are interested about developments in this latter area as there will be working groups wanting to hear the patient, service user and family experience, and I will be involved and want to ensure other harmed patient voices and their advocates are heard. The patient, service user, family and carer voice must be heard and acted on to improve patient safety at these difficult times.

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