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Essure: Women in England take legal action against sterilising-device maker

Lawyers have begun legal action on behalf of 200 UK women against the makers of a sterilisation device, after claims of illness and pain.

The device, a small coil called Essure, was implanted to prevent pregnancies.

Manufacturer Bayer has already set aside more than $1.6bn (£1.2bn) to settle claims from almost 40,000 women in the US. It has withdrawn the device from the market for commercial reasons but says it stands by its safety and efficacy.

The metal coil was inserted into the fallopian tube to cause scarring, blocking the tube and preventing pregnancy. 

Introduced in 2002, it was promoted as an easy, non-surgical procedure - a new era in sterilisation. But many women who had the device fitted have now either had hysterectomies or are waiting for procedures to remove the device.

Tracey Pitcher, who lives in Hampshire, felt she had completed her family and did not want any more children.

Her doctor strongly encouraged her to have an Essure device fitted, she says. But after it had been, she began to feel very unwell.

"I just started to have heavy periods, migraines, which I had only ever had when I was pregnant so they were hormonal," she says. "My back was so painful I'd wake up crying in the middle of the night with pains in my hips and my back."

Tracey says she battled to persuade doctors to take her symptoms seriously. But the only information she received was from a Facebook group.

"... there's nobody there, there's no support apart from people that we've found ourselves, no-one will listen, because it's just 'women's things'."

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Source: BBC News, 15 November 2020

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Essex Strep A: District nurses 'most likely cause' of outbreak

The "most likely cause" of a bacterial outbreak that has seen 15 people die was district nursing teams, a document obtained by the BBC has revealed. 

At least 33 people in Essex have been infected by the strain of invasive Group A Streptococcus (iGAS) bacterium. Of 32 cases initially found in the area 29 had previously been visited by Provide nurses, files obtained showed. Mid Essex Clinical Commissioning Group (CCG) said an investigation into the cause was continuing.

Provide said it had "robust infection prevention policies" and that the cause of the infection may never be known.

The BBC submitted a request under the Freedom of Information Act to Public Health England (PHE) and the CCG, which oversaw health spending in the area, for documents relating to the outbreak.

A PHE briefing note received through the request said: "The most likely hypothesis as to cause of the outbreak is contact with, and spread via, district nursing services in the area."

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Source: BBC News, 19 October 2019

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Essex mental health trust told safety 'needs to improve'

A mental health trust prosecuted for failings after 11 patients died must make further safety improvements, the Care Quality Commission (CQC) said.

Inspectors found safety issues on male wards and psychiatric intensive care units run by Essex Partnership University NHS Foundation Trust (EPUT).

The Trust said it had taken "immediate action" to remedy the concerns.

In November, EPUT pleaded guilty to safety failings related to patient deaths between 2004 and 2015.

The CQC's report followed inspections in October and November last year at the Finchingfield Ward - a 17-bed unit in the Linden Centre in Chelmsford which provides treatment for men experiencing acute mental health difficulties.

The CQC said the visit was prompted "due to concerning information raised to the commission regarding safety incidents leading to concerns around risk of harm".

The inspection, which looked at safety only, found the following concerns:

  • Some staff did not follow the required actions to maintain patient safety.
  • Closed-circuit television showed staff who were meant to be observing were not present, and this contributed to an incident of patient absconding.
  • Staff did not keep accurate records of patient care and managers did not check the quality and accuracy. of notes.
  • Shifts were not always covered by staff with appropriate experience and competency

Stuart Dunn, head of hospital inspection at the CQC, said EPUT had "responded quickly to concerns raised" including improving security measures.

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Source: BBC News, 14 January 2021

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Essex mental health staff fell asleep on duty, inspection found

Staff fell asleep while on duty at a mental health trust, inspectors found.

The Care Quality Commission (CQC) said it was "very disappointed" to find patient safety being affected by the same issues it had seen previously.

It said on acute wards for adults of working age and psychiatric intensive care units, five patients described staff falling asleep at night.

Despite CCTV being available, managers told the CQC they could not always immediately prove staff had been sleeping as accessing the pictures could take up to a fortnight.

The CQC report added trust data from June to December 2022 recorded 20 incidents of staff falling asleep while on duty but no action was taken because the video evidence had not been viewed.

Rob Assall, the CQC's director of operations in London and the East of England, said: "When we inspected the trust, we were very disappointed to find people's safety being affected by many of the same issues we told the trust about at previous inspections.

"This is because leaders weren't always creating a culture of learning across all levels of the organisation, meaning they didn't ensure people's care was continuously improving or that they were learning from events to ensure they didn't happen again."

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Source: BBC News, 12 July 2023

 

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Essex mental health inquiry relaunched with new legal powers

A public inquiry into the deaths of at least 2,000 mental health inpatients has been relaunched with new powers.

The Essex Mental Health Independent Inquiry was established in 2021 to investigate the deaths of people on mental health wards in the county.

The number of initial responses to the inquiry from current and former staff was described as "disappointing".

The inquiry has converted to a statutory inquiry meaning witnesses can be forced to give evidence.

It is understood the new chairwoman is considering extending the inquiry's timeframe to include deaths from the start of 2000 until the end of 2023.

Baroness Kate Lampard, leading the inquiry, said: "I am determined to conduct this inquiry in a fair, thorough and balanced manner.

"I am also concerned to ensure that I do not take any longer than necessary - the recommendations from this inquiry are urgent and cannot be delayed."

She added: "To be clear from the outset, I will not be compelling families to give evidence.

"Evidence from staff, management and organisations will be gathered in a proportionate, fair and appropriate manner."

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Source: BBC News, 1 November 2023

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Essex mental health deaths inquiry given legal powers

An inquiry investigating deaths of mental health patients in Essex has been given extra powers, in a victory for campaigners.

Health Secretary Steve Barclay told Parliament that the probe would be placed on a statutory footing. It means the inquiry can force witnesses to give evidence, including former staff who have previously worked for services within the county.

Mr Barclay said he was committed to getting answers for the families.

He told the Commons: "I hope today's announcement will come as some comfort to the brave families who have done so much to raise awareness."

The Secretary of State added that under the new powers anyone refusing to give evidence could be fined.

Melanie Leahy, whose son Matthew died while an inpatient at the Linden Centre in Chelmsford in 2012, is among those who have long campaigned for the inquiry to be upgraded.

"Today's announcement marks the start of the next chapter in our mission to find out how our loved ones could be so badly failed by those who were meant to care for them," said Ms Leahy.

"I welcome today's long overdue government announcement and I look forward to working with the inquiry team as they look to shape their terms of reference."

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Source: BBC News, 28 June 2023

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Essex GP struck off over 'sexually motivated' examination

A GP accused of trying to pull down a patient's gym shorts and of touching her genitalia has been struck off the medical register.

The Medical Practitioners Tribunal Service found Dr Kamran Ali's behaviour towards four women at a surgery in Essex amounted to misconduct.

The tribunal heard he had not practised since the allegations in 2016.

The 44-year-old, of Glendale Gardens, Leigh-on-Sea, was cleared of criminal charges following a trial in 2018.

Panel chairman William Hoskins said at the tribunal on Thursday that erasing him from the register was necessary to "protect public confidence in the medical profession".

A female patient - referred to as Patient C - reported his behaviour to police in the November.

She had complained of spots on her face, white coating on her tongue and wanted a repeat prescription for anxiety medication.

The panel heard Dr Ali began to pull down her gym shorts and examined her genitalia without wearing gloves and without obtaining consent.

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Source: BBC News, 23 May 2023

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Essex coroner warns of more deaths due to lack of mental health care

A coroner overseeing a teenager's inquest has warned there will be more deaths unless mental health services improve for autistic people at risk of self-harm.

Morgan-Rose Hart, 18, who had ADHD, autism and a history of mental illness had been a patient at a unit in Harlow, Essex, for three weeks.

An inquest jury concluded she died by misadventure contributed to by neglect.

Ms Hart, from Chelmsford, died in hospital six days after she was found unresponsive in the bathroom of her mental health accommodation in the Derwent Centre in Harlow, Essex in July 2022.

The inquest into her death heard staff observations were falsified and critical observations were missed.

In her Prevention of Future Deaths report, Ms Hayes said: "There is a significant shortfall of appropriate placements for people with autism who have mental health and self-harm risks in Essex both inpatient and in the community."

She added: "During the course of the inquest the evidence revealed matters giving rise to concern.

"In my opinion, there is a risk that future deaths will occur unless action is taken."

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Source: BBC News, 8 January 2024

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Errors in overflowing EDs causing heart attacks, NHS England warns

Patients have suffered cardiac and respiratory arrests because of errors using oxygen cylinders, NHS England has warned, citing more people being cared for in “areas without access to medical gas pipeline systems” such as corridors and ambulances queuing outside A&E.

A patient safety alert issued by NHS England today identifies 120 incidents in the past year related to oxygen cylinder use, including cylinders either being empty at point of use, not switched on, inappropriately transported, or inappropriately secured. 

Some of the incidents involved “compromised oxygen delivery to the patient, leading to serious deterioration and cardiac or respiratory arrest” the alert said, and at least 43 caused harm.

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Source: HSJ, 10 January 2023

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Errors at West Suffolk hospital contributed to woman's death

Inquest finds Susan Warby, 57, received insulin she did not need after blood test mistakes. Hospital errors contributed to her death five weeks after bowel surgery, an inquest into her death has concluded.

Susan Warby, 57, who died at West Suffolk hospital in Bury St Edmunds, was incorrectly given glucose instead of saline through an arterial line that remained in place for 36 hours and resulted in inaccurate blood test readings. She was subsequently given insulin she did not need, causing bouts of extremely low blood sugar (hypoglycemia) and the development of “a brain injury of uncertain severity”, recorded Suffolk’s senior coroner, Nigel Parsley.

Speaking after the inquest was adjourned in January, Susan's husband, Jon Warby, said he was “knocked sideways completely” when he received an anonymous letter two months after her death highlighting blunders in her treatment.

Doctors at the hospital were reportedly asked for fingerprints as part of the hospital’s investigation into the letter, a move described by a Unison trade union official as a “witch-hunt” designed to identify the whistleblower.

Following January’s adjournment, Parsley instructed an independent expert to review the care that Warby received. Warby’s medical cause of death was recorded as multi-organ failure, with contributory causes including septicaemia, pneumonia and perforated diverticular disease, affecting the bowel.

Recording a narrative conclusion, Parsley wrote: “Susan Warby died as the result of the progression of a naturally occurring illness, contributed to by unnecessary insulin treatment caused by erroneous blood test results. This, in combination with her other comorbidities, reduced her physiological reserves to fight her naturally occurring illness.”

Jon Warby said in a statement: “The past two years have been incredibly difficult since losing Sue, and it is still a real struggle to come to terms with her no longer being here. The inquest has been a highly distressing time for our family, having to relive how Sue died, but we are grateful that it is over and we now have some answers as to what happened."

“After learning of the errors in Sue’s care, I wanted to know how these occurred and what action was being taken to prevent any similar incidents in the future. The trust has now made a number of changes which I am pleased about.”

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Source: The Guardian, 7 September 2020

 

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Error leaves 55,000 diabetes patients needing new tests

Errors by machines used to diagnose diabetes mean at least 55,000 people in England will need further blood tests, a BBC investigation has discovered.

Some patients have been wrongly diagnosed with type 2 diabetes and even prescribed medication they don't need - and there could be more people affected, say NHS England.

NHSE has confirmed 16 hospital trusts use the machines, made by Trinity Biotech, which have produced inaccurate test results.

In a statement, Trinity Biotech says it is working closely with the UK health regulator and has contacted all hospitals which use the machines.

The BBC first reported in September 2024 that 11,000 patients faced re-testing after a machine at Luton and Dunstable Hospital issued incorrect diabetes results.

NHS England now say type 2 diabetes diagnoses rose by 10,000 in 2024, 4% more than expected.

The procedure, known as the haemoglobin A1C test, measures average blood sugar levels which are used to diagnose type 2 diabetes and monitor the condition.

According to the medicines and healthcare regulator (MHRA), issues with the tests on these machines was first reported in April 2024.

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Source: BBC News, 5 September 2025

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Error causes 800 patients to be wrongly removed from waiting list

A trust is carrying out a review after hundreds of patients were wrongly removed from the waiting list and potentially missed out on treatment.

York and Scarborough Teaching Hospitals Foundation Trust told HSJ that roughly 800 patients of its referral to treatment waiting list, were affected.

A serious incident was declared after it emerged some patients “had their referral to treat clocks stopped erroneously, resulting in patients not receiving treatment”, according to a report to the trust board.

The trust said reviews were under way but had not yet identified any cases of “moderate or significant clinical harm”, although it admitted some patients had been significantly delayed.

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Source: HSJ, 2 June 2023

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ER doctors in the US misdiagnose patients with unusual symptoms

As many as 250,000 people die every year because they are misdiagnosed in the emergency room, with doctors failing to identify serious medical conditions like stroke, sepsis and pneumonia, according to a new analysis from the US federal government.

The study by the Agency for Healthcare Research and Quality estimates roughly 7.4 million people are inaccurately diagnosed of the 130 million annual visits to hospital emergency departments in the United States. Some 370,000 patients may suffer serious harm as a result.

Researchers from Johns Hopkins University analysed data from two decades’ worth of studies to quantify the rate of diagnostic errors in the emergency room and identify serious conditions where doctors are most likely to make a mistake.

While these errors remain relatively rare, they are most likely to occur when someone presents with symptoms that are not typical.

“This is the elephant in the room no one is paying attention to,” said Dr. David E. Newman-Toker, a neurologist at Johns Hopkins University and director of its Armstrong Institute Center for Diagnostic Excellence, and one of the study’s authors.

The findings underscore the need to look harder at where errors are being made and the medical training, technology and support that could help doctors avoid them, Dr. Newman-Toker said. “It’s not about laying the blame on the feet of emergency room physicians,” he said.

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Source: New York Times, 15 December 2022

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EPRs pose ‘persistent’ threat to patient safety

Electronic patient record systems pose “persistent” risks to patients and have directly contributed to several incidents of harm, a national safety watchdog has found.

The Health Services Safety Investigations Body (HSSIB) has today published the findings of its thematic review into patient safety issues associated with EPRs, which examined 112 of its investigations dating from 2018 to May this year.

The review found EPRs have contributed to incidents where patient care was missed, delayed or incorrect, and that the risks were “persistent despite national recommendations and guidance”.

Read full article (paywalled).

Source: Health Service Journal, 27 November 2025.

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EPR causing errors and delays two years after go-live

A trust is experiencing severe problems with its electronic patient record system two years after it was installed, HSJ research has revealed.

A “preliminary review” into the Oracle Cerner electronic patient record – called Surrey Safe Care – at Ashford and St Peter’s Hospitals (ASPH) Foundation Trust in Surrey found the emergency department was still spending “significant time” using the system, an electronic bed board was not updated in real-time, and there were booking and workflow errors in clinics.

The review, which was released to HSJ after a Freedom of Information Act request and carried out in recent months, found problems stemming from limited system training, configuration issues and insufficient technology available on wards and in clinics. The EPR went live in May 2022.

The trust also had “insufficient analysts” to provide comprehensive management information. Also, performance, utilisation and management information were described as still being “under construction.”

In a statement, ASPH said, “Annual reviews will be carried out to monitor the continual progress of this project. A new working group of clinical, operational, and digital staff will agree how we use existing resources to improve staff training, add extra functionality to the EPR, invest in appropriate technology and additional analysts.”

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Source: HSJ, 15 May 2024

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Epilepsy mortality in Scotland 'not reducing' as study finds hundreds of avoidable deaths

Campaigners have called for a change in how epilepsy services are delivered after "alarming" new research revealed that nearly 80% cent of deaths in young adults could have been avoided.

It comes as researchers behind the first ever national review into deaths linked to the condition warned that "little has improved in epilepsy care" despite previous findings of premature mortality.

They describe the situation as a "major public health problem in Scotland", adding that deaths "are not reducing, people are dying young, and many deaths are potentially avoidable”.

In particular, the Edinburgh University team found that adults aged 16 to 24 were five times more likely to die compared to the general population, a problem they said may be linked to the "vulnerable period of transition from paediatric to adult care".

Overall, for adults with epilepsy aged 16 to 54, the mortality rate was more than double that for the age group as a whole, with as many as 76% of these deaths potentially preventable and the majority occurring among patients from the most deprived areas.

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Source: The Herald, 11 November 2021

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Epilepsy drug that harms babies may damage their children too

An epilepsy drug that caused disabilities in thousands of babies after being prescribed to pregnant women could be more dangerous than previously thought.

Sodium valproate could be triggering genetic changes that mean disabilities are being passed on to second and even third generations, according to the UK’s medicines regulator.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has also raised concerns that the drug can affect male sperm and fertility, and may be linked to miscarriages and stillbirths.

Ministers are already under pressure after it emerged in April that valproate was still being prescribed to women without the legally required warnings. Six babies a month are being born after having been exposed to the drug, the MHRA has said. It can cause deformities, autism and learning disabilities.

Cat Smith, the Labour chairwoman of the all-party parliamentary group on sodium valproate, said: “This transgenerational risk is very concerning. There have been rumours that this was a possibility, but I had never heard it was accepted until last week by the MHRA."

“The harm from sodium valproate was caused by successive failures of regulators and governments, and this news means it could be an order of magnitude worse than we first thought. It underlines the need for the Treasury to step up to their responsibilities around financial redress to those families.”

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Source: Sunday Times, 19 June 2022

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Epilepsy AI tool detects brain lesions doctors miss

An artificial-intelligence (AI) tool can detect two-thirds of epilepsy brain lesions doctors often miss, say the UK researchers who have developed it, paving the way for more targeted surgery to stop seizures.

One out of every five people with epilepsy - a total of 30,000 in the UK - has uncontrolled seizures caused by brain abnormalities too subtle for the human eye to see on scans.

Child epilepsy experts say the AI tool has "huge potential" and opens up avenues for treatment.

For this study, published in JAMA Neurology, external, the researchers, from King's College London and University College London, fed their tool magnetic-resonance-imaging (MRI) scans from more than 1,185 adults and children at 23 hospitals around the world, 703 of whom had brain abnormalities.

The tool, MELD Graph, was able to process the images more quickly than a doctor could - and in more detail - which could mean more timely treatment and fewer costly tests and procedures, lead researcher Dr Konrad Wagstyl said.

The AI would require human oversight, however, and many of the abnormalities were still missed.

"AI can find about two-thirds that doctors miss - but a third are still really difficult to find."

At one hospital in Italy, the tool identified a subtle lesion missed by radiologists, in a 12-year-old boy who had tried nine different medications but still had seizures every day.

Study co-author and childhood epilepsy consultant Prof Helen Cross said it had the potential "to rapidly identify abnormalities that can be removed and potentially cure the epilepsy".

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Source: BBC News, 24 February 2025

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Epidural kit shortage could last until March, regulator says

A shortage of epidural kits in the UK is expected to last until at least March, the government's medicines regulator has warned.

The Medicines and Healthcare products Regulatory Agency (MHRA) told healthcare providers in a patient safety alert earlier this month that the shortage followed manufacturing issues concerning epidural bags.

Hospitals are being sent substitutes bags for the pain relief drug given to women in labour, while the Royal College of Anaesthetists is working with the NHS to advise hospitals on how to manage the situation.

Medical staff have expressed concern about these plans, the BBC understands, though the NHS said women "should come forward for care as usual".

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Source: BBC, 21 December 2025

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Epidural in labour can reduce risk of serious complications by 35%, study finds

Having an epidural during labour can reduce the risk of serious childbirth complications by 35%, according to research that suggests expanding access to the treatment may improve maternal health.

An epidural is an injection in the back to stop someone feeling pain in part of their body. Making them more widely available and providing more information to those who would benefit from one was even more important than previously thought, researchers said.

The study by the University of Glasgow and the University of Bristol involved 567,216 women who were in labour in Scottish NHS hospitals from 2007 and 2019, and went on to give birth vaginally or by an unplanned caesarean section. Of the total, 125,024 of the women had an epidural.

Researchers analysed the rate of serious complications, including heart attacks, eclampsia, and hysterectomies during childbirth. Having an epidural cut the risk of these events by 35%, the study found. 

The lead author, Prof Rachel Kearns, of the University of Glasgow, said: “This finding underscores the need to ensure access to epidurals, particularly for those who are most vulnerable – women facing higher medical risks or delivering prematurely. “By broadening access and improving awareness, we can significantly reduce the risk of serious health outcomes and ensure safer childbirth experiences.”

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Source: The Guardian, 22 May 2024

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Entire Covid shielding programme quietly axed for good on day of Cabinet reshuffle

The entire Covid shielding programme has been “closed” for good in an announcement slipped out at night during a Cabinet reshuffle.

Clinically extremely vulnerable people will “not be advised to shield again” in future despite fears of a huge winter wave, said the statement uploaded to the government website last week.

Furious charities today raised fears disabled and immunosuppressed people will be “cast adrift” - while others will feel “yet again forgotten by the government”.

Some 3.8million vulnerable people were advised to shield during England’s third lockdown, going outside only for exercise or health appointments. That guidance was paused on 1 April and on July 19 people were told they could follow the same rules as the rest of the population.

But the ‘Shielded Patient List’ was retained for future use and ex-shielders were given special tips, such as only meeting vaccinated people.

Last night, however, the government announced there will no longer be “centralised guidance” for clinically extremely vulnerable people.

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Source: Mirror, 16 September 2021

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Enhancing patient safety and outcomes in high-risk surgery

A team of world-leading medical experts have collaborated to improve patient safety and outcomes following high-risk surgery.

The endeavour, which includes industry specialists such as anaesthetists, surgeons, and patient representatives, is called the Improving Patient Outcomes (ImPrOve) Think Tank. The ImPrOve team has recently published its European report that highlights and looks to address a severe patient safety and health issue in which death and serious complication rates in the 30-days following high-risk surgery are alarmingly high.

The insightful report outlines an array of practices and innovations in the health sector that can improve patient safety and outcomes. These include calling for better physician training on the latest guidelines, funding for modern digital monitoring, utilisation of data from current technologies in health policies, and the right for patients to be involved in the discussion of the management of their procedure.

Perils of high-risk surgery

Around 2.4 million patients undergo high-risk surgery annually in Europe alone, with UK evidence indicating that 80% of postoperative deaths occur in a 10% sub-population of high-risk patients. If this startling trend continues throughout Europe, it is estimated that a staggering 192,000 people will die within the 30-day period following their surgery, demonstrating the immense dangers posed to patient safety and outcomes. There is an array of challenges during high-risk surgery; however, the ImPrOve Think Tank believes that potentially the most alarming complication is haemodynamic instability, which manifests as drops in blood pressure (known as IOH).

Mitigating risks and increasing patient safety

Professor Olivier Huet, the ImPrOve Chair and Professor of Anaesthesia and Intensive Care Medicine, said: “Our mission is to work collaboratively with patient representatives, clinicians and policymakers to improve perioperative patient safety and experience with the help of advanced haemodynamic monitoring technologies.

Full article here
Source: Health Europa

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English NHS breaches 52 weeks

The NHS in England is required by legislation to ensure that at least 92 per cent of patients on the waiting list have been waiting no longer than 18 weeks from referral to treatment. At the end of February, following a year of covid restrictions, that waiting time measure exceeded 52 weeks.

How much longer than 52 weeks? We don’t know, because the data stops at “52 plus”. But there is good news, because this is about to change.

Guidance was issued during March requiring two major improvements to the published RTT data.

Firstly, instead of stopping at 52 weeks plus, the weekly waiting time cohorts will continue up to 104 weeks plus.

Secondly, we are going to get a lot more information about mental health and other RTT waiting times, because the catch-all “Other” specialty is going to be broken down into medical, surgical, mental health, paediatric and the rest.

Read full story (paywalled)

Source: HSJ, 16 April 2021

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