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Surgical mesh is a medical device implanted to support organs in various procedures. Thousands of women in the UK had mesh surgically implanted to treat pelvic organ prolapse and stress urinary incontinence, until its use was suspended due to safety concerns in 2018.[1] Surgical mesh has been linked to a wide range of serious health issues including chronic pain, incontinence, painful sex, recurrent infections, loss of mobility and autoimmune diseases. Prior to the suspension, women injured by mesh had been raising concerns about the safety of the procedure for years and campaigning for change through patient groups including Sling the Mesh. In 2020, the Independent Medicines and Medical Devices Safety (IMDDS) Review’s report, ‘First Do No Harm’, highlighted the lack of research evidence about safety aspects of pelvic mesh, the failure of the health system to listen to women injured by mesh and a lack of awareness among healthcare professionals about mesh complications.[2] One of the key recommendations of the report was that the Government should establish specialist mesh centres to offer comprehensive treatment, care and advice, including removal surgery, to women harmed by pelvic mesh implants. In response, the NHS has now established ten specialist mesh centres across the UK—nine in England and one in Scotland.[3] However, these specialist centres are beset with problems, preventing women harmed by mesh from receiving desperately needed treatment. Specialist mesh centres - what are the patient safety issues? 1. Long waiting lists The mesh specialist centres have unacceptably long waiting lists, with many women being told they won’t have an initial consultation for at least a year. Kath Sansom, founder of Sling the Mesh, said, “So many women on our Sling the Mesh Facebook page are reporting really long waiting lists to be seen for a first consultation—they feel hopeless about ever getting appropriate support and treatment for their complications.” 2. Lack of awareness among healthcare professionals Many healthcare professionals are simply not aware that mesh specialist centres exist. This is leading to women being told that nothing can be done for them, and that they are “too complicated” to deal with.[4] Addressing MPs in a Westminster Hall debate in February 2022, Alec Shelbrooke MP, co-chair of the Surgical Mesh All-Party Parliamentary Group, stated that “GPs are unaware of mesh complication centres and the referral process.”[5] 3. Surgical training inconsistencies In a previous blog, Patient Safety Learning and Sling the Mesh outlined concerns around inconsistencies in training for surgeons performing mesh removal which is undermining women’s confidence in the specialist centres.[6] One woman also told us, “[a surgeon] did offer to remove the mesh, but I just didn’t feel confident in his care as he had only done 15 mesh removals before, and not on a regular basis.”[7] 4. Centres being run by surgeons who implanted mesh Many women are reluctant to be treated by surgeons who spent years inserting the devices that have caused them so much suffering. Many members of the Sling the Mesh Facebook group have reported that surgeons who originally implanted their mesh did not take their concerns seriously. However, when women requested a second opinion, the mesh was often found to be causing obvious, visible damage, including slicing through nerves, the bladder and the vaginal wall, causing infections and pulling organs out of position. This breakdown in trust between surgeons and their patients undermines women’s confidence in the centres set up to treat their complications. 5. Lack of understanding about autoimmune complications A large number of women with surgical mesh implants report developing symptoms of autoimmune conditions such as lupus and Sjögren's syndrome following the surgery. In addition, around 50% of members on the Sling the Mesh Facebook group report suffering from fibromyalgia symptoms—although fibromyalgia isn’t currently officially recognised as a autoimmune condition, emerging studies are beginning to recognise a connection.[8] There have been small studies into the link between mesh and autoimmunity,[9] but much more research is needed to understand the issue and ensure women with these symptoms can receive appropriate treatment. Many women report that when they tell healthcare professionals about their symptoms, the link between mesh and autoimmune conditions is not acknowledged and little support is offered. This lack of understanding is present in specialties that deal with autoimmune conditions, such as rheumatology and immunology, as well as mesh specialist centres. Autoimmune conditions can have a major impact on health and quality of life, and this is another area where women feel that the specialist mesh centres are failing to deal with the devastating effects of surgical mesh. 6. Lack of appropriate after-care There is no guarantee for women who receive mesh removal surgery that it will improve their symptoms, and many feel that mesh centres are not offering enough post-operative support. Kath Sansom told The BMJ, “There is either very little or no aftercare, leaving some women having to go to their local [emergency department] with dangerous issues like pelvic blood clots or sepsis.”[5] How will specialist mesh centres overcome these issues? The Government and NHS leadership must recognise these issues and find ways to address both the shortage of provision and the lack of trust many women have in specialist centres. This will certainly involve bigger investments in training for surgeons, awareness raising amongst healthcare professionals and measures to address the damaged relationship between women and the healthcare system. There also needs to be consistent, joined up logging of women’s outcomes following removals. This would establish a trusted database that highlights which surgeons and centres are performing well, and who needs additional training. Another way to offer more timely care is to look beyond the NHS and give women more choice in where they have removal surgery and who assesses their case. The Scottish Government announced in July 2022 that NHS patients in Scotland would be eligible for funding to travel to a clinic in Missouri, USA for transvaginal mesh removal surgery.[10] The Scottish Government also has an existing deal with a Spire Healthcare facility in Bristol that allows Scottish women to access mesh removal surgery. The message from Scottish Health and Social Care Secretary Humza Yousaf MSP to women seeking removal surgery was that “we won’t put up any unnecessary barriers in your way.”[10] However, this option is not yet available in other parts of the UK, and some women have expressed concerns about travelling on a long haul flight after major, complex surgery. There are also worries about how aftercare would work if there were complications from a surgery performed outside of the UK. Establishing specialist mesh centres was only the first step in addressing the issues women face in getting the support they need. It is vital that the Government and NHS increase their efforts to ensure all women have fast and equitable access to mesh removal surgery. References 1 Devlin H. Government halts vaginal mesh surgery in NHS hospitals. The Guardian, 9 July 2018 2 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review. Independent Medicines and Medical Devices Safety Review, 8 July 2020 3 Vaginal Mesh Complications. The British Association of Urological Surgeons website, last accessed 3 August 2022 4 Community post: Doctors shocking comments to women harmed by mesh. Patient Safety Learning , 22 June 2022 5 Wise, J. Specialist surgical mesh centres are not working, MPs are told. BMJ, 4 February 2022 6 Mesh Complications Training Pathway: Patient experiences must be recognised. Patient Safety Learning & Sling the Mesh, 17 February 2022 7 “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery. Patient Safety Learning, 1 May 2022 8 New study shows Fibromyalgia likely the result of autoimmune problems. Kings College London website, last accessed 1 September 2022 9 Cohen Tervaert, J. Autoinflammatory/autoimmunity syndrome induced by adjuvants in patients after a polypropylene mesh implantation. Best Practice & Research Clinical Rheumatology. 2018:32:4;511-520. 10 Dewar, C. Mesh patients to be able to travel to US for removal surgery. STV News, 12 July 2022 Related reading 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 ‘Mesh removal surgery is a postcode lottery’ - patients harmed by surgical mesh need accessible, consistent treatment

For people with diabetes (PWD), hospitals can feel like unsafe places. As a result, many are afraid of having to access emergency care or stay in hospital as an inpatient. This is partly because PWD are experts at self-management, with intricate knowledge of their own bodies. I have personal experience of this, having had type 1 diabetes myself for nearly two decades. As PWD, although we can't always predict how our diabetes will behave, our decisions on how to react to every situation become instinctive. When control is taken from our hands it feels terrifying; how could anyone else make a safe decision on our behalf? It feels like handing your baby over to a stranger! Harm in hospital - a reality for people with diabetes Sadly, all too often these fears are based in reality. When appropriately trained, healthcare professionals can make safe medication decisions for PWD, but research reveals a shockingly high prevalence of harm due to diabetes-related medication and treatment errors.[2] A recent blog on the hub looked at safety concerns raised by the Healthcare Safety Investigation Branch (HSIB) about insulin administration errors in hospitals. In HSIB’s reference case, the husband of the patient in question (who was in hospital for reasons other than diabetes) had raised concerns about the potential for a dosing error on two separate occasions, but he had not been listened to by staff. As a result, the patient was given five times her prescribed dose of insulin, in what could have been a fatal incident. These concerns go back years, with various organisations including Diabetes UK highlighting the need for action to make hospitals safer for people with diabetes.[1] The Getting It Right First Time (GIRFT) report on Diabetes published in November 2020 outlined some serious patient safety issues, including the fact that many hospitals have no effective system to identify patients with diabetes and have not trained ward staff in the safe use of insulin.[2] It also highlighted inconsistent timings and content of hospital food as an issue for PWD. According to GIRFT, the risk of developing diabetic ketoacidosis (DKA)—a life-threatening complication of type 1 diabetes—is between 40-60 times higher in hospital than the background incidence rate of the type 1 population. Most people with diabetes who have stayed in hospital will have their own tale to tell about issues with the care they received. My own experience bears out this concern that many healthcare professionals simply don’t know enough about the condition to look after people with diabetes safely and respectfully. Six years ago I had a planned caesarean section and my diabetes team warned me, “Whatever happens, don’t let them take your insulin pump. They’ll try, but you keep hold of it!” As diabetes specialists, they knew that as long as I was able to, I was the best person to administer my insulin and monitor my blood sugar levels. Type 1 diabetes is a balancing act, and being put unnecessarily on a sliding scale (a glucose and insulin drip often given to PWD when they are in hospital) can damage the equilibrium we work so hard to achieve, and can cause many issues. Of course, sometimes your medical situation may mean that the best course of action is being put on a sliding scale or someone else taking over your diabetes control. But there is a tendency for doctors to see it as the safe option, when it can be unnecessary and less safe than letting an inpatient look after their own insulin needs. Unfortunately, my diabetes team was right—as soon as the anaesthetist saw my pump he was insistent he should take it from me, and I had to be incredibly assertive to be allowed to keep it on. In the end, I did keep it connected and managed excellent control throughout my three days in hospital. Despite the excellent care I received from many other healthcare professionals, the incident left me feeling on edge and like I couldn’t fully trust the staff. What people with diabetes fear most about staying in hospital It’s wrong that the very setting supposedly designed to bring us back to health is a place that seems unsafe to many people with diabetes. Wanting to better understand the issues, I recently asked the diabetes online community on Twitter why going to hospital was scary—and their responses were horrifying. I received Tweets from people in different countries, demonstrating that the problem is not confined to the NHS—people from around the world all told similar stories and raised similar concerns to people in the UK. Here are some of the issues they raised: Lack of healthcare professional knowledge about diabetes A number of people reported nurses not understanding the difference between type 1 and type 2 diabetes, with sometimes dangerous consequences. There were numerous reports of people with type 1 diabetes being denied insulin. One person said they had been denied insulin because they were over 50 and it was assumed they “must have type 2.” Another person described how an A&E consultant did not realise they needed insulin all the time, and refused to administer any more once they were out of DKA. This resulted in them going back into DKA and needing further treatment which could have been avoided with the right knowledge. Many PWD talked about the fact that healthcare professionals in inpatient settings did not know anything about how insulin pumps and continuous glucose monitors (CGM) worked. Some had never even seen them before. With these devices becoming more and more common in the UK, it seems important that all healthcare professionals are trained to understand what they are, and the basics of how they work. No one would expect an intricate knowledge of how they work, but being able to recognise them, knowing where to look for more information and seeking to facilitate their use in inpatient settings would be a good start. Treating hypoglycaemia (low blood sugar) in hospital was also described by many as being very difficult. One person said, “I told them on a few occasions I felt ‘low’. Finally Lucozade got wheeled out but it was almost an inconvenience.” Having diabetes technology and equipment taken away Many PWD reported a fear of devices amongst medical professionals, describing how their monitors and pumps were taken and “locked away.” In one particularly worrying account, someone described being sedated when they protested against having their pump taken away. Many people described intense fear and the feeling of having all power taken away from them as a patient when their devices were removed. Healthcare professionals not listening to or trusting people with diabetes Most people were understanding that healthcare professionals can’t be expected to know everything about diabetes. However, the most commonly expressed frustration was about not being listened to when sharing information about their diabetes. This is the issue that was raised in the HSIB investigation. There was a perception that some healthcare professionals are “arrogant” and assume their knowledge is superior to that of their patient. Some people reported receiving sarcastic and disparaging remarks from healthcare professionals, which heightened their sense of being unsafe. One person said, “It’s dead hard to have to fight your corner while feeling so unwell.” Another person who had type 1 for many years reported being ‘diagnosed with type 1’ while in hospital, despite repeatedly telling staff she already had the condition. Lack of systems to support safety There were numerous reports of insulin drips running out and people being left without any insulin for hours. The reason often given for this was that no doctor was available to sign off the prescription. People also reported a lack of checks in places, for example, in nurse administration of insulin via a sliding scale. One person said, “The nurse left the glucose drip on but turned off the insulin. It terrifies me to think how bad this could have been.” One person reported a fellow patient having to fetch a nurse from the nurses station because no one was responding to their call button when they needed hypo treatment. This kind of scenario is doubtless linked to NHS staffing shortages that are currently causing many safety issues for staff and patients. Alongside these horror stories, I did come across examples of good practice which left PWD feeling confident that the care they were receiving was safe. One Twitter user described being able to keep her pump and continuous glucose monitor on during brain surgery, and was told by the medical team looking after her, “You are the expert on your condition, you advise us.” Another said, “In recent years [I have] been really impressed with how all staff just leave me to my own devices.” Another said that, “most HCP listened to me as T1 myself and welcomed my input.” However, most of these positive experiences were qualified with a ‘but’ followed by a story of a negative or dangerous experience of emergency or inpatient care. You can read more of the comments I received from PWD in this community thread on the hub. Improving safety: policy, training and staff attitudes This lack of consistency across services is a major problem—we can never plan where or when we will need hospital treatment, so it is important that issues are addressed across all trusts and settings. The GIRFT report highlights this issue, recognising that “there is still a large degree of variation in the quality and availability of targeted inpatient services, and in the frequency of hospital-acquired harm resulting from poor diabetes care.”[2] The National Diabetes Inpatient Audit (NaDIA) has been carried out across 81% hospitals over the past few years and is a useful tool in providing data to help specialities and trusts identify and overcome diabetes-related safety issues. For example, its 2021 report highlighted an increased prevalence of DKA among patients in surgical specialties and recommended “the establishment of processes to ensure that insulin is not stopped in people with type 1 diabetes.”[3] The information provided by NaDIA and the GIRFT recommendations are good steps forward, but whether services will have the resources and capacity to take action, is another question. People with diabetes tend to be great educators on the condition they live with, and some reported using their hospital stay as an opportunity to educate healthcare professionals looking after them about diabetes. But it shouldn’t be down to them. Diabetes is a complex condition that requires attention to detail and accurate knowledge to manage safely. Not everyone can be an expert, but helping staff identify when to ask for help from someone who is—and having the humility to do it—should be a priority. The GIRFT report observed that having an increased presence of diabetes specialists in inpatient settings can hugely reduce the number of diabetes medication errors. It recommends the presence of a seven-day multidisciplinary diabetes inpatient team in every hospital to ensure appropriate planning and support for patients with diabetes, whatever they are in hospital for.[2] Perhaps most importantly, hospital staff need to be trained to ask people with diabetes about their management and have a degree of trust in their judgement. Only then will PWD feel confident about going to hospital, whether in an emergency or for elective treatment—shared decision making shouldn’t stop at the hospital door. References 1 Making hospitals safe for people with diabetes. Diabetes UK, 2017 2 Rayman G, Kar, P. Diabetes GIRFT Programme National Specialty Report. NHS England & NHS Improvement. November 2020 3 National Diabetes Inpatient Audit (NaDIA) Harms 2020, England. Healthcare Quality Improvement Partnership. 2021

A new investigation report has been published by HSIB with the aim of helping to improve patient safety in relation to administering high-strength insulin from a pen device to patients with diabetes in a hospital setting.[1] The investigation focuses on the case of Kathleen who has type 2 diabetes and was using a high-strength insulin administered from an insulin pen device to manage her condition. The insulin in her pen device was Humulin R U-500 insulin, which is five times the strength of most insulins. On being admitted to hospital (for a reason unrelated to her diabetes) a nurse administered her insulin as measured by an insulin syringe, rather than the pen device. However, the syringe was intended for use with standard strength insulin and as a result Kathleen was given five times the dose of insulin that she had been prescribed. She received two overdoses of insulin in this way and on both occasions becoming hypoglycaemic (a condition where a person’s blood glucose level becomes too low, which can be dangerous if not treated quickly) and requiring medical treatment. Findings of the investigation Key findings from this investigation included: Variation among trusts in their use of high-strength insulin and the number of patients on these medications. Staff not always being familiar with the different range of high-strength insulins and associated pen devices, with significant variation in training and competency with respect of administering insulin. National safeguards were found to be inadequate to support the safe use of high-strength insulin by healthcare professionals. Inconsistent numbers of diabetes specialist nurses employed across trusts to supporting upskilling staff in relation to diabetes management. A “wholly preventable” incident? The patient safety incident described in this investigation is classed by NHS England and NHS Improvement as a Never Event. These are defined as: “Serious Incidents that are wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers”.[2] A National Patient Safety Alert in 2016 highlighted the risks associated with this specific type of incident and actions required by NHS organisations.[3] This included ensuring staff are made aware of the risks of extracting insulin from pen devices and that they have appropriate training to use these devices. However, in a report published last year, citing the specific case from this investigation, HSIB stated that in their view the barriers to prevent this type of incident “were neither strong nor systemic”.[4] They suggested that this event did not fit the definition of being “wholly preventable” and should be removed from the Never Event list, with new work needed to develop systemic safety barriers to prevent this reoccurring. In response, NHS England and NHS Improvement noted they reviewed the list of Never Events on an ongoing basis and would welcome any suggestions for implementing stronger safety barriers but made no specific commitments for action regarding this insulin safety incident. The findings of this investigation indicate that the barriers that are supposed to be in place tp ensure that this type of incident is “wholly preventable” may not be present amongst all healthcare providers. Patient Safety Learning is concerned that this reference case is unlikely to be a one-off and that there remains a significant risk of avoidable harm from this incident occurring again elsewhere in the NHS. Patient and family engagement Patient engagement is key to improving patient safety. In our report, A Blueprint for Action, we identify this as one of the six foundations of safer care.[5] We believe that 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. This investigation serves to underline the important role that a patient’s family members can play in highlighting patient safety issues. It was Kathleen’s husband who highlighted concerns with the Nurse Practitioner about her two hypoglycaemic events and querying the dosage she received. This intervention subsequently resulted in the awareness that she had been receiving the incorrect doses because the insulin had been administered by using a syringe rather than a pen device. This case raises concerns about how a patient’s family member’s expertise is used by healthcare professionals. The report states that Kathleen’s husband had initially told staff on the surgical ward about her medication, including that her insulin was five times stronger than standard insulin. However, we know from the investigation that despite providing this information, this wrong dosage was still given. The report notes that: “Kathleen’s family had concerns that the nurse administering Kathleen’s insulin in hospital might not be the staff member they had spoken with." Because of this, her Husband felt that "…it puts the responsibility on me' to ensure that Kathleen was given the correct dose.” Patients must be listened to, and their information, insights and concern must be taken seriously and responded to. In this case, Kathleen was prevented from coming to further harm by the timely action of her husband but unfortunately the opportunity to prevent the two overdoses not prevented. Importance of training The report highlights specific concerns about insulin safety training for staff, noting that at the Trust involved the national ‘Safe Use of Insulin’ e-learning programme had not been among the mandatory training requirements for staff (though it has now subsequently been included in this category). HSIB states that they were told by representatives from the NHS England and NHS Improvement National Diabetes Programme that training, appropriate to the person’s level of responsibility, should be provided to all healthcare staff involved with insulin. However, they also note that: “The investigation engaged with national leaders to consider how training and support for healthcare professionals could be enhanced to increase the knowledge around insulin use relative to each clinical role. The investigation was told that this would require support from a range of national stakeholders and would need to be co-ordinated by a central NHS body to ensure it was effective.” As a result of this, HSIB made the following Safety Observation: “It may be beneficial for insulin training to be competency based and specific to the healthcare practitioner’s role, in line with the ‘Diabetes: getting it right first time’ national specialty report.” However, there is no specific organisation who is identified as being responsible for the ownership and coordination of this task. Observations not recommendations HSIB Recommendations are directed at specific organisations who are asked to respond in 90 days of publication of the report. Their Safety Observations may or may not be directed at a specific organisation and require no formal response. This report makes no recommendations, but four observations. Patient Safety Learning is concerned that as these patient safety improvement points are only observations, with no specific organisation/s responsible for their delivery and assessment of effectiveness, these are unlikely to reduce the risk of a similar incident occurring in another trust. As noted in our recent report Mind the implementation gap, for HSIB Safety Observations there “appears to be no system to disseminate or act on these, beyond them being published towards the end of numerous patient safety reports”.[6] We believe that the impact of HSIB investigations on learning and improvement would be significantly strengthened with formal recommendations, which are then implemented in a timely and rigorous manner along with transparent performance monitoring and reporting. Considering the findings of this report, we think there may also be value in a specific assessment by NHS England and NHS Improvement of the rollout and implementation of training for healthcare professionals who dispense, prescribe and/or administer insulin (as recommended in the report Diabetes: getting it right first time.[7] References HSIB, Administering high-strength insulin from a pen device in hospital, 7 July 2022. NHS England and NHS Improvement, Never Events policy and framework, January 2018. NHS Improvement, Patient Safety Alert: Risk of severe harm and death due to withdrawing insulin from pen devices, 16 November 2016. HSIB, Never Events: analysis of HSIB’s national investigations, January 2021. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. Patient Safety Learning, Mind the implementation gap: The persistence of avoidable harm in the NHS, 7 April 2022. Getting It Right First Time, Diabetes: GIRFT Programme National Specialty Report, November 2020. Related reading Improving safety for diabetic inpatients: 4 key steps (14 June 2021) Top picks: 5 key resources about diabetes (13 June 2021)