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The Patient Safety Commissioner outlines the range of different stakeholders she has met within her first 100 days in office, including patients, healthcare staff, patient safety specialists and healthcare providers. She also details the number of different areas of concern that have been raised with her in this period, including: pelvic mesh complications isotretinoin side effects painful gynaecological investigations Covid vaccination concerns mental health difficulties fluoroquinolone side effects Yellow Card scheme reporting concerns about electroconvulsive therapy. The report then sets out in more detail her reflections on patient safety concerns relating to the three medical interventions covered by the Independent Medicines and Medical Devices Safety Review: pelvic mesh, Sodium valproate and Primodos. She also highlights some positive areas of patient safety work she has encountered in her first 100 days in office, including the Scan 4 Safety initiative, NHS Resolution’s work on consent resources and how the new Patient Safety Incident Response Framework (PSIRF) is seeking to ensure that patients’ voices are included in incident investigations. The report concludes by setting out her top three priorities: 1. Culture Change The Patient Safety Commissioner plans to: hold a public consultation on the Principles of Better Patient Safety for the Patient Safety Commissioner work with healthcare leaders to put patient voice at the core of their activity and reporting amplify patients’ voices in all parts of the health system to ensure they are heard identify and highlight where patient voice is neglected challenge organisations to identify a named patient voice on all Boards and to place patient stories at the top of their meeting agendas campaign to improve the use of Yellow Card reporting campaign to see the NHS number used as the default and unique identifier ·work to ensure patients are engaged in the development of all national specifications develop the Patient Safety Commissioner website as a hub of best practice in championing patient voice. 2. Pelvic mesh The Patient Safety Commissioner plans to: co-produce resources for patients and GPs about side effects from pelvic mesh surgery work with NHS England to provide patients choice of access to specialist mesh centres work with the health system to ensure that information is available to all patients on national registries. 3. Sodium valproate The Patient Safety Commissioner plans to: support the health system to include the views of all stakeholders including patients to reduce harm from sodium valproate to the lowest possible level work with health leaders to ensure that all relevant patients are on a Pregnancy Prevention Plan (PPP) and given the necessary information collaborate with partners to ensure annual reviews are carried out by specialist prescribers work with partners across health to eliminate dispensing of sodium valproate in unlabelled white boxes work with professional regulators to streamline the advice to their registrants on sodium valproate and contraception raise patient awareness through charity collaboration.

Recommendations Physicians at all stages in their careers need to be conscious of the demands placed on them professionally and personally and should balance those demands with rest to avoid excessive fatigue or overcommitment. The medical directors of outpatient units and chairs of hospital departments of obstetrics and gynaecology may consider developing call schedules and associated policies that balance the need for continuity of care and the health care providers’ need for rest. With the growing concern about the potential consequences of health care provider fatigue on patient safety, physicians should commit to evaluating the effects that fatigue has on their professional and personal lives and should demonstrate willingness to adjust workloads, work hours, and time commitments to avoid fatigue when caring for patients.

Sarah's tips for women when speaking to medical professionals Know your body and come prepared Equip yourself with evidence and knowledge Rule out the worst-case scenarios Bring back-up Treat it like a collaboration Try to understand the challenges your doctor faces

What is an Adjournment Debate? There is a 30 minute Adjournment Debate at the end of each day's sitting of the House of Commons. They provide an opportunity for an individual backbench MP to raise an issue and receive a response from the relevant Minister. Unlike many other debates, these take place without a question which the House of Commons must then make a decision on. Foetal valproate spectrum disorder: Fatalities Caroline Nokes, MP for Romsey and Southampton North, opened this debate by talking about the case of Jake Alcroft, a 21-year-old who died in April this year after an infection triggered by problems with his kidneys. The coroner listed foetal valproate syndrome as a contributing factor to his death because of the physical damage done to Jake as an exposed baby, which meant that his bowel and bladder did not work properly and he relied on urostomy and colostomy bags. Some key points highlighted in this debate included: Warnings about sodium valproate and the risks during pregnancy are still not being consistently displayed on pharmacy prescriptions. Some of the recommendations made in relation to this by the Independent Medicines and Medical Devices Safety (IMMDS) Review have still not been implemented effectively. There are concerns that the illness can continue down the generations, and that is not yet well understood but it is causing real fear for the families who have been affected so far. Towards the end of this debate, Caroline Nokes made three requests for the Minister: To acknowledge that sodium valproate has contributed to a death. Asking if she was satisfied that the pregnancy prevention programme is adequately effective and that the information is properly communicated to women of child-bearing age. Calling for redress for patients and families affected by this, as recommended by the IMMDS Review. Maria Caulfield MP, Minister for Mental Health and the Women's Health Strategy, provided the Government response at the end of this debate.

View an up-to-date spreadsheet of responses to the campaign’s ‘Dissatisfaction Survey’ so far. These are women’s lived experiences of horrendous outpatient hysteroscopy procedures have been shared with the Campaign Against Painful Hysteroscopy Survey.

Bell Ribeiro-Addy, Member of Parliament (MP) for Streatham, who secured this debate, highlighted some of the key statistics around black maternal health and mortality in the UK: Black babies have a 121% increased risk of stillbirth and a 50% increased risk of neonatal death. Asian babies have a 55% increased risk of stillbirth and a 66% increased risk of neonatal mortality. Black women have a 43% higher risk of miscarriage, and black ethnicity is now regarded as a risk factor for miscarriage. She also referred to the findings of black maternal experiences survey carried out by grassroots organisation Five X More published earlier this year. She noted that this report highlights all the negative interactions that women experienced with healthcare professionals, from feeling discriminated against in their care to receiving a poor standard of care, which put their safety at risk, and being denied pain relief because of the trope that black women are less likely to feel pain. The Government response in this debate was provided by Maria Caulfield MP, Minister for Mental Health and Women’s Health Strategy.

Dear Matt Hancock and Nadine Dorries, We ask the DHSC to make provision for all NHS Trusts to work with the RCoA and RCOG to establish safely monitored IV ‘conscious’ sedation with analgesia as a treatment option for hysteroscopy+/-biopsy. Currently, Trusts put almost all patients through Trial by Outpatient Hysteroscopy and only those patients who fail (usually due to acute pain) are allowed a GA. There is no routine option of IV sedation with analgesia or spinal anaesthesia. We ask too that NHS Trusts give all hysteroscopy patients upfront a fully informed ‘Montgomery’/ GMC CHOICE of: o no anaesthetic o LA / regional / epidural o IV sedation with analgesia o GA The choice should be made after thorough discussion with the patient about her medical history, risk factors and preferences. WHAT IS HYSTEROSCOPY? Hysteroscopy is endoscopy of the womb. Like colonoscopy, it’s used to detect cancer, pre-cancer and benign abnormalities. Hysteroscopy done in outpatients with miniature surgical tools enables the removal of polyps and small fibroids without an incision or general anaesthetic [GA]. Here the similarity with colonoscopy ends. For NHS colonoscopy, the patient is routinely offered a CHOICE of Entonox or IV sedation with analgesia. Some patients request and receive GA. The risk of perforation (and potential death) is less when performed on a patient under IV ‘conscious’ sedation than under GA. The NHS therefore wisely prefers colonoscopy under ‘conscious’ sedation to GA. NHS colonoscopy services aim to protect patients from severe pain. Apart from assuring basic human respect and dignity, the NHS recognises that people traumatised by a severely painful colonoscopy may delay or not return for vital cancer diagnosis or treatment. UPDATE FROM THE CAMPAIGN AGAINST PAINFUL HYSTEROSCOPY [CAPH] Severely painful outpatient hysteroscopy is the next medical scandal after vaginal mesh. Cheap, quick and easy-to-use NHS vaginal mesh kits helped the majority of patients, and saved precious time and resources. Cheap, quick and easy-ish NHS outpatient hysteroscopy [OPH] without anaesthesia/sedation causes severe pain/distress/trauma to approx. 25% patients and saves precious time and resources. Like the vaginal mesh campaigners, hysteroscopy patients who’d been seriously harmed by a flawed medical policy started asking questions. Hysteroscopists assured us that our excruciating and unforgettable pain was very ‘unusual’ and affected only 2% to 5% of patients. This statistic didn’t fit with patients’ observation of OPH clinics. So these ‘unusual’ women started googling, then exchanging stories via social media. Soon they formed into Facebook and Twitter groups. Involved politicians. Interrogated health authorities. Looked for medical explanations. Approached professional colleges and societies. Sought out empathetic and intelligent doctors. Studied the law of informed medical choice and consent. By 2014 a campaign was born, greatly assisted by Lyn Brown, MP (Lab, West Ham) who was prepared to stick her neck out for her constituents and for other women who’d been traumatised and dismissed as ‘incorrect’ in their perception of hysteroscopy pain. These women were clearly of the ‘wrong demographic’! Too anxious, had too narrow cervical canals, too tilted wombs, were too emotionally labile, too black, too white, too rich, too poor, too educated, too urban... By early 2020 the Campaign Against Hysteroscopy had amassed a google survey of 1,000+ hideous, predominantly NHS, stories. We sought stories of specifically painful hysteroscopy since our aim was to identify any common features in patients’ medical histories or the operating teams’ conduct of a painful procedure. We hoped that our findings would aid future patient selection and choice. We gave our results to the Presidents of RCOG and the British Society for Gynaecological Endoscopy. The survey’s free text was shocking: It was barbaric and one of the most painful experiences of my life including vaginal childbirth. I begged them to stop but they wouldn’t. It was like torture It was a terrible experience that I don’t think I will ever forget Just before lockdown, the Health Service Journal published an analysis of our survey [Matt Discombe, HSJ, 2 March 2020] “Around 520 women who attended NHS hospitals in England to undergo hysteroscopies — a procedure which uses narrow telescopes to examine the womb to diagnose the cause of heavy or abnormal bleeding — have told a survey their doctors carried on with their procedures even when they were in severe pain.” We continued our on-going survey, asking about pre/post-menopausal status; vaginal/caesarean delivery/nulliparity; endometriosis/dysmenorrhea/previous traumatic gynae; mental health; hospital information about pain risk; choice of LA/GA/IV sedation; pain-scores at different OPH stages; whether the hysteroscopist stopped if the patient was in pain/distressed; preferred mode of future hysteroscopy, etc. At the end of the survey we asked, “Is there anything else you’d like to tell us?” I was given a brown paper bag to breath into as I hyperventilate with the pain. The male consultant made fun of me. Anaesthetic should be compulsory, I have a high pain threshold but was most painful thing I have ever felt, still feeling traumatised after the event. Staff were appalling. 5 nurses and doctor laughed when they could see I was in terrible pain, shocking The pain after the procedure was finished, was excruciating, body started to go into shock. Ended up in A&E pumped full of morphine and admitted overnight for observation. Never again unless under GA. Ask them if they are in pain rather than asking them about their last holiday whilst their uterus is dilated. I am a midwife myself and spoke to the consultant explaining how anxious I felt regarding the procedure, as I had had a very painful / difficult removal of mirena coil previously and been told I had a cervical stenosis: I asked could I have sedation and was declined saying it would only be “ brief discomfort” and to just take painkillers a couple of hours before At one point that evening I was so confused and in pain, feeling sick and with a high resting heart rate that I nearly called an ambulance. I was alone. Nobody suggested I should have someone at home with me. Felt embarrassed because of yelling (due to the incredibly sharp pain) The doctor and nurse were fine but I was screaming in pain and doctor counted down from 10 to 1 to try to get me to hold on until she could finish it Gas and air made me feel light headed but made absolutely no difference to the pain I experienced. The Cumberlege Review ‘First Do No Harm’ of July 2020 categorised breaches of patient safety into themes. [https://www.immdsreview.org.uk/Report.html] Three of these themes sum up the current harms caused by an over-zealous, blanket NHS policy of reduced-cost OPH: Cumberlege Theme 1, "No-one is listening" – Hysteroscopists lack empathy; they ignore patients’ requests for GA and fail to stop when the patient is in distress. Cumberlege Theme 3, "I was never told" - Hysteroscopists fail to warn patients of the risk of severe pain and don’t tell patients upfront that they have the option of GA. Cumberlege Theme 10, "Collecting what matters" - Hysteroscopists are wilfully blind to Patient Reported Outcomes – they belittle and don’t record the patients’ own short-term, medium-term and long-term outcomes when these cause severe pain and PTSD. CAPH has frequently heard of hysteroscopists telling GPs that a crying patient “tolerated the procedure well”. WHAT IS THE DATA ON HYSTEROSCOPY PAIN? Just as with vaginal mesh, very few gynaecologists have systematically collected pain scores from all their OPH patients. When OPH pain-scores are reported in English journals usually only the median or mean scores are given. Hundreds of members of our Action/Support group were never asked for a pain-score. NHS OPH pain audits obtained by CAPH under the Freedom of Information Act shows that currently 1 in 4 NHS England hysteroscopy outpatients typically suffers severe pain of 7/10 or more. [ www.whatdotheyknow.com - see ‘Outpatient hysteroscopy/biopsy’] The British Society for Gynaecological Endoscopy’s 2019 bespoke 81-hospital survey of 5,000+ hysteroscopy patients from BSGE members’ own NHS clinics reports a mean pain-score of 5.2/10. So clearly it’s not the “mild discomfort” that most patient leaflets claim. Nor is it now feasible to say that severe pain is experienced by only 2-5% of patients. [ www.bsge.org.uk BSGE Ambulatory Care Network Meeting Feb 2020] CAPH has asked for the full range of BSGE members’ OPH pain-scores under FOIA. The British Journal of Anaesthesia this year published a review evaluating patients’ reported pain compared with hysteroscopists’ assessment of OPH pain over 8 years at Royal Berkshire Trust – a good clinic which is barely mentioned in our survey. [Harrison, Salomons 2020]. 17.6% of patients reported severe pain of 7/10 or more, while 7.8% reported no pain. The authors concluded that since patients were likely to experience pain then they should be warned of this. WHAT DOES THE NHS TELL PATIENTS ABOUT HYSTEROSCOPY PAIN? NHS hysteroscopy services appear to follow ex-Cancer Tsar Prof Sean Duffy’s opinion “Overall we think that too much emphasis is put on the issue of pain surrounding outpatient hysteroscopy.” [BMJ. 2001 Jan 6; 322(7277): 47] Patient leaflets almost invariably tell women to expect “mild discomfort”, on a par with moderate period pain. So, without any pre-op assessment the NHS pushes almost all women through Trial by Outpatient Hysteroscopy and reserves GA for those who ‘fail’. The womb endoscopy patient is NOT routinely offered the option of GA. If she asks for one, the request is usually declined – even before the covid-19 pandemic. Thus the vast majority of NHS clinics wilfully ignore the RCOG/BSGE 2018 statement instructing gynaecologists to offer all hysteroscopy patients the choice of GA up-front, and to stop an OPH if the patient is distressed. [https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg59/] Yes, there are some excellent, highly skilled and compassionate OPH clinics but, sadly, most put cost-effectiveness before compassion or ‘Montgomery’ informed patient choice, thus denying patients genuine informed consent. Most hospital leaflets tell patients to take over-the-counter meds from home. There is no pre-med in clinic. The woman gets a ‘vocal local’ – hairdresser chit-chat- pioneered in rural Kenya by Marie Stopes. The woman is sometimes held down if distressed and agitated. She may receive potentially painful injections into the cervix as ‘rescue analgesia’. Unfortunately the cervical LA doesn’t anaesthetise the top of the womb, from which the cancer-detecting biopsy is taken. [www.bsge.org.uk Ambulatory Care Network 2020 Keynote Speaker on ‘patchy and unpredictable’ cervical LA] WHAT DOES THE CAMPAIGN AGAINST PAINFUL HYSTEROSCOPY WANT? 1. Every single NHS hospital to use – at the very least – the RCOG patient leaflet (CAPH helped write) which mentions the risk of SEVERE pain outlines clinical risk-factors for severe pain offers patients upfront the option of a GA/IV sedation with analgesia 2. The DHSC and RCOG to work with the Royal College of Anaesthetists to train hysteroscopy teams and establish safe IV conscious sedation with analgesia as a CHOICE available to all womb endoscopy patients. 3. The DHSC to permanently remove any Best Practice Tariff or financial incentive which removes timely access to GA, IV sedation with analgesia or other anaesthetist supported service. 4. A pre-op assessment for all hysteroscopy patients, meaning an end to ‘See & Treat’ clinics, which often coerce women into polyp and fibroid removal without patients having time to consider whether they’d prefer GA/ IV sedation/ regional anaesthesia rather than a local which doesn’t anaesthetise the top of the womb. The current ‘One-Stop’ clinic endangers women who attend the clinic alone and then have to drive or travel home on their own, often in severe pain, bleeding and traumatised. This is unacceptable and must stop. 5. Standardised, regulated, updated high quality training and accreditation for all hysteroscopists together with up to date equipment. Hysteroscopists should be taught to recognise cohorts at high risk of severe pain, develop listening skills and treat women with respect. 6. Full transparency about the financial sponsorship of NHS hysteroscopists’ training by the medical devices industry and the resulting bias towards particular manufacturers’ preferences and cost-effectiveness rather than patient experience. 7. Severe procedural pain to be classed and recorded as a Serious Adverse Event. Yours faithfully, Elaine Falkner (Chair), Pamela Howe (Secretary), Jocelyn Lewis, Lorraine Shilcock, Denise Shafeie, Gill Johnson, Katharine Tylko (on behalf of) The Campaign Against Painful Hysteroscopy www.hysteroscopyaction.org.uk Twitter: @hysteroscopyA Facebook: Campaign Against Painful Hysteroscopy

My health has always been a ‘challenge’ as they say. I had a stoma in 1988, when I was 28 years old, for bowel disease. They were never sure if it was Crohn's disease or ulcerative colitis, but I was more than happy to kiss my rotten colon goodbye. It restored my bowel health and I carried on working and living my life with my husband and child. Two years after the ileostomy, I had further abdominal problems and a MRI suggested ovarian cancer. I had an emergency laparotomy which revealed severe endometriosis which had obliterated my whole pelvis and infiltrated my internal organs. The gynaecologist closed me up and said nothing could be done as my pelvis was ‘frozen’ and I would have to be treated medically. The condition plagued me for the next 20 years; I developed cysts in the pelvis which were drained repeatedly. My health was at times poor but I still managed to work and live my life. In 2010, my gynaecologist retired and I was referred to a new team. They were based 80 miles from where I lived, which was a nuisance but I felt it was worth the journey to have the best. They were adamant I needed a hysterectomy – they were not happy with the recent imaging and felt one of the cysts looked suspect. I spent years putting this off as I was very fearful. I had been told it could be very easy to make things much worse. In 2012 my mum had a massive brain haemorrhage and I became her carer, but by 2014 they were still saying I needed the surgery to find out what the suspect mass actually was so, reluctantly, I agreed. January 2015 The hysterectomy went ahead at a private hospital. I was in BUPA, my mother was brain damaged and I was her carer, I needed this op out of the way so I could go back to caring for her. I awoke from the surgery to be told it had been very difficult – I felt totally wiped out. Two days after the operation, there was no improvement. I was encouraged to get up from the bed; I could barely move but I managed a few steps when I felt something running down my legs forming a green puddle on the floor. My bowel had perforated and the contents were flooding out of my vagina. My consultant was away and I was transferred late at night to the local NHS hospital. That was a nightmare in itself as they at first wouldn’t accept me. I lay there in A&E with warm liquid pumping out of me with every spasm of my bowel. I was convinced it was blood and I tried not to think of my loved ones whom I thought I’d never see again. My poor husband looked on helplessly; he spent a freezing night in the car as he wanted to be near me. I spent 3 months in hospital being fed through my central vein. I was told I may never eat or drink again and my whole life just fell apart. It was explained the suspect mass was in fact a twisted mess of bowel, adhesions and goodness knows what possibly caused by the repeated aspirations I’d had for the endometriosis. I was told because of the perforation I now had a fistula which is essentially a connection between my small bowel and my skin. Despite my numerous surgical experiences, I had never heard of such a thing but Dr Google soon educated me and it did not make good reading. I became seriously depressed, wanting my life to end. I was discharged in the spring of 2015 to a totally different world. I could by now eat small amounts but the holes appearing on my abdominal wall were evidence the fistula had not healed. I was too afraid to move as any activity meant I’d have ominous discharges from various orifices. I totally lost confidence in myself, the doctors and the world in general… I became a recluse. Life with a fistula was difficult. Apart from the constant dressings required to contain the output, I was in permanent pain and suffered frequent infections. Considering I had gone into hospital reasonably well and come out like this was almost too much to bear. I tried to access mental health support but I was put on a waiting list whilst my mental state got progressively worse. I was told I would have to wait for two years for the fistula to be repaired. It was a long wait, my daughter had a baby so that kept me going and I looked forward to being free of this demon within. I missed the old capable me so much. March 2017 The repair op took place this time in the NHS hospital, albeit as a private patient again. I couldn’t wait any longer and so once again made use of my medical insurance. Again I had serious complications. The days that followed the surgery were horrific, I truly wanted to die. My gut had stopped working, a condition called ileus. Bile was building up in the stomach so I had a nasogastric tube inserted; the thirst was causing me to have hallucinations. I tried to impress upon everyone how ill I was feeling, but I didn’t feel believed; they told me I was anxious and all my problems were normal post op things. My husband called as usual to visit, getting more worried as each day was passing. I had spiked a temperature of 39.6⁰C. I cried into his chest as I tried to sit up to relieve the horrific symptoms I was experiencing. Next minute I had no breath, I was suffocating. My husband called for help and, even at that point, I was told I was having a panic attack until the nurse saw my oxygen levels – they were 71% which was dangerously low. I was having a stage 1 respiratory arrest, and I was rushed to ICU and spent days fighting for my life. A three month hospital stay followed and this further catastrophe had resulted in a fistula worse than the one I went in with. I now had to wear three stoma bags, two of which leaked constantly. I felt a mutilated mess. Again, I left hospital a broken shell, with no support apart from my family who were also finding it hard to accept what had happened to me. Life now... It’s now 3 years since the failed repair and I have never recovered. It actually made things much worse. As well as the fistulae and three stoma bags, I now have bladder problems as part of my bladder was excised during the last op and gallbladder disease thanks to the parenteral nutrition. The inflammation in my body has led to autoimmune diseases, such as scleritis, which is an agonising and destructive eye condition. The whole awful experience has left me a broken, psychological wreck. I finally accessed mental health support at the end of 2019 and have been diagnosed with post traumatic stress disorder (PTSD), anxiety and depression. Life is difficult. In my mind there are so many unresolved issues which have plunged me into a deep pit of depression I can’t get out of. The therapy I now receive is ‘systemic’ so basically addresses how my husband and I are responding to the trauma, rather than the trauma itself. The initial trauma of my surgery going so wrong has now been followed by a second trauma of lack of support, feelings of worthlessness and the consequences of having a complex condition whilst living in rural west Wales where my local hospital can’t treat me. How I wish I’d said NO to that fateful hysterectomy! But we don’t do we. The surgeons are the experts, they lead and we follow, that’s how it works. Lamb to the slaughter springs to mind. That is probably unfair, my surgical luck was bound to run out one day, but I am angry at losing one of life’s most important gifts – good health. To make matters worse I’ve discovered that the suspect mass that they told me had to come out, had actually been identified 30 years previously. It was a harmless benign fibroma. That makes things harder to bear as I realise I probably never even needed the surgery. I didn’t complain or even ask many questions as I was too ill, traumatised and exhausted. My mother ended up in a home, my marriage is understandably struggling, my husband and I no longer work. I had nothing left to challenge anyone. My psychologist says I need answers to help me move on but I’m now told it’s too late. I have to go back to that hospital because I am now so complex my local hospitals won’t treat me. It’s a 3 hour round trip to a place that absolutely terrifies me. An enterocutaneous fistula is a very rare complication of surgery. But as I told my Consultant, it’s only rare until it happens to you. Then statistics become irrelevant. They seem to overlook the fact that there is a person behind that tiny statistic, who has to somehow learn to live again with all the fallout of that disastrous surgical experience.