Injuries resulting from Vaginal Mesh Implants

Written by Clinical Negligence on May 2, 2017

There has recently been a renewed surge in media reporting about the potential side effects of vaginal mesh implants and the serious health implications they can have for women. This has arisen following the BBC’s Victoria Derbyshire programme’s recent exclusive feature on this subject.

Vaginal mesh implants are a form of treatment for pelvic organ prolapse. They are usually implanted following childbirth to prevent pelvic organ prolapse and stress urinary incontinence.

Pelvic organ prolapse occurs when the tissues that hold the pelvic organs in place become weak or stretched. When pelvic organ prolapse occurs, the organs bulge (prolapse) into the vagina and sometimes past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can prolapse include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Vaginal mesh implants are made from porous absorbable or non-absorbable synthetic material, or absorbable biologic material.

Frequent complications reported regarding vaginal mesh implants include:

  • Mesh erosion through the vagina (also called exposure, extrusion or protrusion)
  • Pain
  • Infection
  • Bleeding
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation
  • Urinary problems

Other complications could include recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.

Many of these complications require additional intervention, revision surgery and hospitalization.

These complications have historically resulted in a number of clinical negligence claims against the NHS and product liability claims against various US manufacturers of these implants.

As a result of a large number of complaints about the vaginal mesh implants, the Medicines and Healthcare products Regulatory Agency (MHRA) conducted a review in 2014. The review determined that the benefits outweigh the risks; however concerns have been raised about the number of adverse incidents that have been reported. In the US, the Food and Drug Administration (FDA) has carried out similar reviews and has strengthened clinical requirements to address the safety risks caused by these implants.

There has recently been a renewed interest in bringing claims as more and more women come forward with serious injuries that have arisen as a result of vaginal mesh implants. Media sources report that more than 800 women in the UK are taking legal action against the NHS and manufacturers.

Freeths have successfully brought several claims for injuries caused by vaginal mesh implants and have experience of bringing claims against both the NHS and US manufacturers.

If you have been affected by a vaginal mesh implant please contact us for a free, confidential discussion about your options on 01865 781093 or clinicalnegligence@freeths.co.uk.

http://www.freethsoxford.co.uk/clinicalnegligence

{Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics, obtained by the Victoria Derbyshire programme.That figure includes a number of different types of implant, including TVT (trans-vaginal tape), TOT (transobturator tape), and SS tape, which is a suprapubic sling. About one in 11 women has experienced problems, the data suggests.}

Trust under investigation after a multitude of failings in the maternity department

Written by Clinical Negligence on April 24, 2017

We often comment upon the importance of NHS Trusts learning from mistakes so that they do not happen again. Where a baby has died during childbirth or soon after birth, proper investigations into the deaths are not only an important means of providing parents with answers, but can help to identify areas where improvements are required.

The Shrewsbury and Telford Hospital NHS Trust has come under investigation after the extremely sad deaths of at least seven babies in their care between September 2014 and May 2016, which were later found to have been avoidable. The BBC has also identified cases at the same Trust where parents have not been informed of investigations into the death of their child and where there are concerns over the quality and outcome of the investigation.

Disappointingly the seven avoidable deaths which have been identified occurred after a previous death of a baby boy in 2013 at the same Trust which was also deemed avoidable by the coroner at the inquest. A separate analysis of all NHS Trusts in England in 2016 rated Shrewsbury and Telford as one of the worst in the country when it came to learning from mistakes and incidents.

In light of the failings on the part of the Shrewsbury and Telford Hospital NHS Trust, Health Secretary Jeremy Hunt has now ordered NHS England and NHS Improvement to fully review the deaths and other incidents at the Trust and to contact the families involved.

The families of Sophiya Hotchkiss and Jack Burn, babies who also died at Shrewsbury and Telford, have spoken about their frustrations with regards to the Trust’s lack of investigation into their children’s deaths despite their raising numerous enquiries. Both families state that they asked the Trust to investigate the circumstances surrounding their deaths but that neither family received a response. It is understood that on both occasions, investigations were carried out by the Trust but that the families were entirely omitted from the inquiries and the subsequent findings.

In addition, the family of a baby girl, Pippa Griffiths, who died in April 2016 at 1 day old, have told how they had to force the Trust to investigate her death after she contracted the Group B Strep infection. Her parents informed healthcare staff at the Trust that their baby was vomiting brown mucus but no action was taken and no advice given. Sadly, within hours the baby had died. The Trust initially claimed that there was no action they could have taken to have prevented her death but, after her parents forced a full and proper investigation, in April 2017 a coroner ruled that her death was in fact avoidable and that the Trust failed to provide the family with relevant information that could have saved her life.

The Trust’s reluctance to carry out investigations and to involve families in the process raises serious concerns about its compliance with the Duty of Candour. This legal duty requires that all patients and their families are informed when an incident has occurred which has resulted in harm. Where something has gone wrong, healthcare professionals are not only under a duty to tell their patient or their family of this incident, they should also offer an apology and give a full explanation of the incident which took place. Further, where possible, remedies to rectify matters should also be discussed.

Bereaved parents should not be placed in a position where they are having to fight for answers, but sadly this is what these parents have been forced to do. Every parent has a right to know what happened to their baby and the experienced team at Freeths can assist parents with obtaining answers to their questions. If you, or anyone you know, has concerns about the quality of care received during childbirth, or during your child’s early days, please contact Carolyn Lowe on 01865781019 or carolyn.lowe@freeths.co.uk.

http://www.bbc.co.uk/news/health-39591929

Carolyn Lowe small

Infection and death following use of heater/cooler systems during heart surgery: Mycobacterium chimaera

Written by Clinical Negligence on February 7, 2017

Concerns have been raised across the medical profession regarding the development of an invasive, yet slowly developing, infection in patients following cardiothoracic surgery.

The cause of the development of the infection, called Mycobacterium chimaera (M. Chimaera), has been traced back to a Sorin 3T heater-cooler machine which is commonly used during cardiothoracic procedures such as coronary bypass or valve replacement operations.

The Sorin 3T heater-cooler machine is manufactured by the Sorin Group which is now part of the LivaNova Group. In America, the machine is known as the Stockert 3T system.

Heater-cooler systems are commonly used during cardiac surgeries, as well as other medical and surgical procedures, to warm or cool a patient with the aim to optimize patient care and improve patient outcomes. Devices such as the Sorin 3T heater-cooler unit utilise water tanks which provide temperature-controlled water to warming or cooling blankets covering the patient during surgery.

According to the Food and Drug Administration (FDA), the federal agency of the United States Department of Health and Human Services and Public Health England, there is the potential for the Sorin 3T heater-cooler system to carry Mycobacterium chimaera (M. Chimaera) bacteria in its water tanks and transmit infection to the patient during the procedure through the air and via the device’s exhaust vent.

A recent study demonstrates a link between the Mycobacterium chimaera (M. Chimaera) which has infected European patients undergoing open-chest cardiac surgery and the Sorin 3T heater-cooler system. This has been supported by the Sorin Group’s own testing during which it found contamination in the water supply and production line at its heater-cooler manufacturing facility in Germany.

Between 2010 and 2015 the FDA was informed of 32 cases of the infection – 8 cases in the US and 24 cases in Europe – linked to this particular device. Examination of past medical records is leading to this number steadily increasing. Recently, inquests have been held or arranged into the death of patients who have suffered from this complication. Coroners have recorded that deaths have been caused by the Mycobacterium chimaera (M.Chimaera) infection following heart surgery.

The difficulty which faces doctors in diagnosing and treating patients who have developed a Mycobacterium chimaera (M. Chimera) infection is that the bacterium is very slow growing and it may take several months or years for patients to develop any symptoms. The infection proves fatal to approximately half of affected patients but until recently, Mycobacterium chimaera (M. Chimaera) has not been routinely tested for.

Symptoms of Mycobacterium chimaera (M. Chimaera) are:

  • Fever lasting more than one week
  • Loss of energy
  • Night sweats
  • Joint or muscle pain
  • Redness, heat or pus around a surgical incision
  • In infants, a failure to grow or gain weight
  • Difficulty breathing
  • Persistent cough or cough with blood
  • Nausea
  • Vomiting

Since September 2014, all newly manufactured Sorin 3T Systems have been subjected to a cleaning and disinfection procedure as part of the manufacturing process and the contamination is believed to have been eliminated from the Sorin 3T heater-cooler production line.

In 2015 Public Health England published advice to providers of cardiothoracic surgery warning that a high percentage of UK devices may be contaminated. Sorin has issued a Field Safety Notice advising that all machines be tested.

Public Health England also suspects that the infection risk may be applicable to other similar machines.

Hospitals which have provided treatment to patients using a Sorin 3T System have been directed to inform the operating surgeons and doctors of the possibility that patients may have been subjected to an Mycobacterium chimaera infection and to determine a method for patient follow-up and monitoring. Patients who become unwell after valve replacement surgery should be tested for Mycobacterium chimaera infection. There is, however, considerable concern at the delay in information about the risk of  Mycobacterium chimaera (M. Chimaera) being publicised to doctors and patients.

Mail on Sunday Online has reported that the NHS is now tracing the 47,000 people who have had cardiac surgery since 2013. Read More: Click Here

Freeths LLP is currently advising relatives of patients who have been infected by Mycobacterium chimaera from the Sorin 3T heater-cooler system.

Should anyone have any queries regarding a potential claim relating to a Mycobacterium chimaera infection following heart surgery, please contact our clinical negligence team for further information.

Paul Balen

Paul Balen
Consultant
0845 050 3289
paul.balen@freeths.co.uk

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Serious issues at Manchester hospitals

Written by Clinical Negligence on January 25, 2017

Patients at hospitals run by Pennine Acute Hospital NHS Trust faced years of negligent treatment, misdiagnoses, poor clinical judgement, apathetic and unqualified staff, short-staffing, and chronic under resourcing.

This was the verdict of a report commissioned in early 2016 by the Trust itself and prepared by its Director of Maternity Care. Unfortunately for patients at North Manchester General and Royal Oldham Hospitals the report was then buried and only came to light (after repeated denials from the Trust that it even existed) following an investigation by the Manchester Evening News. Once exposed the report made national headlines.

The failings highlighted in the report make for disturbing and in many cases tragic reading. Among the more appalling examples of negligence identified at the Trust between 2010 and June 2016 (when the report was completed) include:

  • A premature baby being left to die alone in a room used to dispose of medical waste
  • Another baby who died because of an elementary failure to check its mother’s blood type
  • Routine failures to take basic observations and keep basic records
  • Lab results left unchecked
  • Patient records incorrectly, incompletely, or only tardily filled out
  • Lack of effective performance monitoring of the Trust’s historically high numbers of agency/locum staff
  • Newborn babies’ heart rates not being monitored properly, leading to serious and lifelong health problems (including brain damage) which would otherwise have been preventable
  • A woman misdiagnosed as mentally ill when she was actually suffering from a cerebral haemorrhage, and who was subsequently allowed to die of hypoxia over the course of several days
  • A woman who was left with a permanent colostomy because her treatable faecal peritonitis was missed by surgeons on three separate occasions over the course of 24 hours

The report identified several root causes of the problems, including an overarching “embedded culture of not responding to the needs of vulnerable women.” Habitual short-staffing was another issue with an especially negative impact on maternity care:

The effect of poor staffing numbers in clinics has meant women have fragmented care, suffered long waits and not had appropriate management.

The report goes on to describe long-standing “poor decision-making” by maternity staff resulting in “significant harm to women and real issues relating to the management of women in labour” which in turn led to “high levels of harm for babies in particular.” Over reliance on locums (one third of total staff) likewise translated into low levels of doctors and nurses with appropriate skills and experience.

The report found that between 2010 and 2015 the Trust paid out over £50million in compensation claims, more than any other NHS Trust in England. Half of this amount was maternity-related. In 2012 the Clinical Negligence Schemes Trust (a division of the NHSLA) was so alarmed by the level  of compensation payouts it warned the Trust to clean up its act. In 2014 meanwhile the Trust was subject to an external investigation because of the unusually high level of maternity deaths. The report makes it clear that very little changed. By June 2016 there had been no fewer than 12 “serious” maternity incidents since April 2016 alone, including the death of a mother, the death of two babies, and three still-births.

Following exposure of the report all families involved in serious incidents have been invited to meet with the Trust’s head of midwifery. Maternity services are now being overseen by another Trust (Central Manchester NHS Foundation Trust) and a new management team has been put in place on secondment from Salford Royal Hospital Trust. No more high-risk pregnancies are being sent to Manchester General. Trust bosses say that they are now working full-time on improving services and recruiting more and better-qualified staff. It is to be expected that many more compensation claims will follow however.

Freeths LLP provides a comprehensive clinical negligence service with free initial advice. If anyone has any queries flowing from these events please contact Phil McGough at our Nottingham office for further information.

Phillip McGough

Clinical Negligence Executive

+44(0)845 050 3290

phillip.mcgough@freeths.co.uk

Crisis in maternity care

Written by Clinical Negligence on January 17, 2017

A recent study undertaken jointly by the National Childbirth Trust and the National Federation of Women’s Institutes (NFWI) has found that 50% of new mothers have experienced “red flag” events during labour. Examples of red flag events include: waiting more than 30 minutes to be given pain relief, waiting more than 1 hour to receive stitches following an episiotomy and women in labour being left without a midwife.

The findings of the report highlight that there is a chronic shortage of midwives and this is undermining the delivery of high quality care for women and their families. In the report mothers described their care as “robotic” and that they felt it was “humiliating and degrading” and that they were treated as “a product on a conveyor belt”.

Louise Silverton, Director for midwifery at the Royal College of Midwives states “The fact that half of women have experienced a red flag event is hugely worrying. It is a sign of services under too much pressure, with too few resources and not enough staff. This ongoing shortage of midwives and underfunding of services is not delivering the service that women and their families need, and it is storing up health problems for the future that could be prevented.”

The report is published only a day after Kent Coroner, Roger Hatch, ruled that “failures, inadequate diagnosis and treatment” by the maternity unit at Maidstone and Tunbridge Wells NHS Trust led to the death of  Frances Cappuccini after she gave birth to her son (http://www.bbc.co.uk/news/uk-england-kent-38634044 ).

A spokesman for the Department of Health has recently been quoted as saying: “We want the NHS to be one of the safest places in the world to have a baby. There are over 1,500 more midwives on our maternity units since 2010, and more than 6,300 currently in training, with our changes to student funding creating thousands more training places by the end of this parliament.”

Going through labour can be a very traumatic experience for any women and negative experiences of childbirth can increase the risks for maternal postpartum depression and negatively affect a mother’s attitude toward future pregnancies and choice of delivery method. We can only hope that with further training and investment of funds, the services provided by our maternity units will improve.

If you, or anyone you know, has concerns about the quality of care received during childbirth, please contact a member of our clinical negligence team for a free, confidential discussion on the details below.

Laura Bland H&S smallCarolyn Lowe small

Humanitarian Crisis in NHS East Midlands Hospitals

Written by Clinical Negligence on January 10, 2017

The Red Cross has declared that the NHS is suffering a humanitarian crisis following it assisting various UK hospitals to free up beds and place patients back into the community. Chief executive Mike Adamson said:

The British Red Cross is on the front line, responding to the humanitarian crisis in our hospital and ambulance services across the country…we’ve seen people sent home without clothes; some suffer falls and are not found for days, while others are not washed because there is no carer there to help them.

The British Red Cross provided support to staff at the East Midlands Ambulance Service across Nottingham, Leicester, Lincoln, Kettering and Northampton on 1 January. There have been more than 18,000 trolley waits of four or more hours in the last week.

Dr Mark Holland, president of the Royal College of Acute Medicine has stated that “we have been predicting that we would face a winter from hell. I think that time has arrived.”

Dr Taj Hassan, president of the Royal College of Emergency Medicine stated that “the emergency care system is on its knees, despite the huge efforts of staff who are struggling to cope with the intense demands being put upon them.” He also added that “the scale of the crisis affecting emergency care systems has reached new heights, as we predicted…we entered this winter in the worst state of affairs possible.”

Professor Keith Willett, medical director for acute care at NHS England also admitted that demand is at its highest level ever with staff being placed under “a level of pressure we haven’t seen before”. It has been reported that 50 of 152 English trusts were at the highest or second highest levels of pressure over the Christmas period. During the period, seven trusts had to declare the highest level of emergency 15 times, meaning they were unable to give patients comprehensive care.

These comments also come after three people died at Worcestershire Royal Hospital A&E after waiting for treatment in a hospital corridor. One person died from cardiac arrest after waiting 35 hours, a second had an aneurysm and died despite treatment and it is also alleged that a patient was found hanged on a ward. Other patients had been waiting up to 54 hours for treatment. The hospital confirmed the delays and pressures on clinical treatment stating:

We can confirm that both of our A&E departments experienced an extremely busy Christmas and New Year period, and these pressures are continuing.

Peter Pinfield, chairman of Healthwatch Worcestershire – the patient care watchdog for the county – has called for an investigation saying the public needed to know the reasons behind the delays.

Here at Freeths, we specialise in clinical negligence claims, and have successfully settled claims ranging from emergency department failures, post-partum and inter-partum failures to misdiagnoses of illnesses, along with many others. If you or anyone you know has been affected by an incident of suspected medical negligence, please contact us on the details below.

Jane Williams H&S small

Jane Williams

Partner

+44(0)845 272 5724

jane.williams@freeths.co.uk

K REYNOLDS

Karen Reynolds

Partner

+44(0)845 272 5677

karen.reynolds@freeths.co.uk

Siobhan Genever H&S small

Siobhan Genever

Director

+44(0)845 272 5677

siobhan.genever@freeths.co.uk

 

NHSLA LAUNCHES MEDIATION SCHEME AFTER SUCCESSFUL PILOT

Written by Clinical Negligence on December 8, 2016

The NHSLA has announced that following a successful pilot scheme it has launched its new mediation service.  The scheme is intended to provide injured claimants with a possible resolution of their claim without the need to litigate the claim through the courts.

Contracts have been awarded to a panel of mediators.  Claimant solicitors have long thought that mediation is an ideal way of resolving disputes in Clinical Negligence claims.  Mediation has the potential to save costs and avoid protracted heavily disputed and expensive litigation.  For a long time, our lawyers at Freeths LLP have routinely offered mediation or arbitration as a way of resolving a dispute but in the past have faced firm resistance from Defendants.  We therefore fully endorse and welcome this NHS approved scheme.

Helen Vernon of the NHSLA says about the scheme:

“Mediation is an excellent forum for dispute resolution and provides injured patients and their families with an opportunity for face to face explanations and apologies when things go wrong and reducing the need for unnecessary litigation.”

Our lawyers are often told by clients that one of the most important things they hope to gain by bringing an action is an explanation and answers to their questions about what went wrong with their treatment.  Clients often also seek an apology where appropriate, which is often not achieved via formal litigation.  If mediation can provide these things as well as compensation then it is something to be very enthusiastic about.

However it remains essential that a Claimant in a Clinical Negligence action has access to skilled, specialist lawyers to analyse evidence and secure fair compensation.  It is important to realise that mediation should be used at an appropriate time in a case and this is usually after expert medical evidence has been gathered to assess the injury and the appropriate level damages that should be sought.

At Freeths LLP we have specialist and extremely experienced lawyers who can assist an injured Claimant in compiling evidence to value a claim and to assist with the mediation process.  Our consultant Paul Balen is also a mediator with Trust Mediation, one of the firms appointed to the NHSLA’s panel of mediators.

If you are concerned about medical treatment that you or a family member or friend has received or would like to discuss your options about seeking redress via mediation then please get in touch with us via the details below.

Carolle White
Chartered Legal Executive
+44(0)115 985 3367
carolle.white@freeths.co.uk…

UK ambulances fail to get to life-or-death calls on time

Written by Clinical Negligence on November 30, 2016

It has emerged that UK ambulances are struggling to reach the seriously ill and injured fast enough due to rising demand which has left NHS emergency trusts at breaking point.

Only one of the UK’s 13 ambulance trusts is meeting its target of reaching people with life-threatening conditions within 8 minutes. Delays waiting for A&E staff to be free to perform a patient handover amounted to 503,499 hours in 2015-2016 in England, Wales and Northern Ireland – a rise of 52% in two years.

It has also been revealed that it is not uncommon for trusts to run out of ambulances to send at peak times. NHS ambulance trusts took 9.4m calls in 2015.

In the East Midlands, patients waited 1 minute and 42 seconds longer for an ambulance to arrive than in 2013-2014. The College of Paramedics chair Andrew Newton said the situation was of ‘great concern’.

 If you, or anyone you know has been affected by a delay in an ambulance reaching you or a delay in being transferred to a hospital for emergency care, please contact us via the details below.

 

Naomi Solomon
Solicitor
+44(0)845 274 6830
naomi.solomon@freeths.co.uk

Claire Cooper
Solicitor
+44(0)845 274 6830
claire.cooper@freeths.co.uk

 

 

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Obstetric and Midwifery failures in Manchester

Written by Clinical Negligence on November 24, 2016

Today there is widespread reporting of the extremely sad case of a premature baby whom was left to die alone in a sluice room rather than in their mother’s arms. This serious incident (and many others) has been revealed following an internal investigation at the Pennine Acute Hospital NHS Trust. This trust manages the North Manchester General Hospital, Royal Oldham Hospital, Fairfield General Hospital, Rochdale Infirmary, Floyd Unit and various community services.


The report sadly outlines a number of avoidable deaths and long-term injuries caused by failures including staff shortages, clinical errors and poor attitude of staff. It has been reported that the Pennine Acute Hospital NHS Trust received the most legal claims and paid the most in damages out of all NHS Trusts between 2010 and 2015. Sadly nearly half of those claims related to harm caused to mothers and babies.


At Freeths LLP our specialist Clinical Negligence team have years of experience and expertise in dealing with injuries to mothers and babies caused during pregnancy, labour, and following birth. We pride ourselves on our specialist, empathetic and personable legal services for those families facing such difficult circumstances.


Our friendly specialist team work from a number of nationwide offices including our central Manchester office, which is easily accessible and close to Piccadilly Gardens. We also offer home visits.


If you feel that you, or a loved one, may have suffered harm due to poor medical care during pregnancy, labour or following birth we may be able to help you. Please contact Claire Cooper on 0845 274 6830 or Naomi Solomon on 0845 030 5742.

Naomi Solomon
Solicitor
+44(0)845 274 6830
naomi.solomon@freeths.co.uk

 

Claire Cooper
Solicitor
+44(0)845 274 6830
claire.cooper@freeths.co.uk

Safety fears in 2/3 of English A&E departments

Written by Clinical Negligence on October 31, 2016

The Care Quality Commission review has revealed that emergency care in England was one of the poorest performing parts of the NHS, caused majorly by underfunding of council care services.

Safety was cited as a major weakness of emergency care departments with 22 out of 184 units being rated as inadequate and another 95 requiring improvements in their workings. The Care Quality Commission explained that the cuts to council provided care, such as access to home help for daily living tasks, such as dressing and washing, was pushing the elderly and infirm into hospital.

The chief executive of the Care Quality Commission, David Behan, said that the state of the council care system was the worst that he could remember during his 38 year career. He said that things had reached a tipping point and called upon ministers to invest more into the council care system. Numbers of elderly people having care needs has sharply risen, and around 1 million get no help at all.

You can read more about the issues here.

If you, or anyone you know has had issues with emergency care in hospital, please contact Naomi Solomon.

Naomi Solomon

Solicitor

+44(0)845 030 5742

naomi.solomon@freeths.co.uk