Showing posts with label Retained Foreign Objects. Show all posts
Showing posts with label Retained Foreign Objects. Show all posts

Wednesday, 15 October 2014

You won't believe these medical errors

Studies have suggested that medical errors may be the third-leading cause of death in the United States, right behind heart disease and cancer.

For the past eight years in an effort to curb the number of preventable mistakes that happen in Indiana, hospitals, ambulatory surgery centers, abortion clinics and birthing centers have been required to report 28 serious adverse events to the Indiana State Department of Health.

In 2013, 111 medical errors occurred at 293 facilities, according to a report recently released by state health officials. That's more medical errors than have occurred in any year since the state started requiring facilities to report these events.

As in seven of the eight years that the report has been produced, serious bed sores lead this year's list of preventable medical errors, with 45 such incidents...

Bedsores


Once again, so-called pressure ulcers, acquired after a person is admitted, topped the list. An average of 32 stage three or four sores have occurred each year.

In 2013, 45 incidents of serious bedsores were reported, more than in any other year since the report was first published.

The elderly and others who are confined to bed because of illness are particularly prone to bedsores. So facilities are supposed to keep a watchful eye on their patients to ensure that small problems don't get out of hand and potentially lead to lethal infections.

Foreign objects


In some cases, surgeons are supposed to take things out of one's body. In others, they're supposed to put things in (think stents for clogged arteries). But on 27 occasions, surgeons in Indiana left a "foreign object" in a patient after surgery.

The Indiana State Department of Health does not require facilities to go into detail on their reports, so it's impossible to know exactly what those foreign objects were.

NoThing Left Behind, a national project to reduce the number of "retained surgical items" notes that common objects left behind include soft goods/sponges, needles, instruments and "miscellaneous small items."

Although one incident occurred in the previous year and was just reported now, the total is more than a 50 percent increase from the number of such events reported for 2012.
 

Wrong site surgeries

You've heard stories about doctors removing the wrong leg, operating on the opposite arm. Some patients have even taken to marking the right body part before they go under the knife.

Still, mistakes happen. On 13 occasions in the past year, an Indiana hospital performed surgery on the wrong body part, and in five cases, the fault was that of an ambulatory surgery center, for a total of 18 such incidents.

It should be noted that even if a surgeon stops before actually doing the full surgery, it counts under this category. So that could mean anything from a doctor numbing the wrong leg and then realizing his or her mistake before proceeding to actually operating on that leg.

In two other cases, the wrong surgical procedure was done.


Serious falls

It seems so mundane, but fall prevention is a critical piece of what hospitals must do to keep patients as healthy as possible. On 12 occasions, all in hospitals, a patient's fall resulted in either death or a serious disability.

Each year, an estimated 700,000 to 1 million patients fall in hospitals. Of these, as many as half result in an injury.

To encourage hospitals to work harder to prevent falls, the federal government in 2008 started refusing to pay for extra care necessitated by a fall while a patient was hospitalized.


This article is courtesy of indystar.com.

Thursday, 10 October 2013

Doubling of NHS 'never events' never happened

Three papers report that 'never events' - the most serious of patient safety incidents - have doubled on the NHS in the past year. But they haven't - they've fallen.

Sometimes, and often with tragic consequences, NHS patient care goes badly wrong. These 'never events' are what the Department of Health (DH) terms "serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers."

According to at least four papers last week, 299 such incidents occurred in the 2012/13 financial year. This sparked a consistent array of headlines:
(Express) - NHS blunders double

(Telegraph) - 
Potentially fatal 'never' errors double in year on NHS

(Mail) - 
Extreme 'never event' NHS blunders ... double in a year

Except this isn't the case. NHS 'never events' have not doubled. In fact, they've fallen. Full Fact got in touch with NHS England who, after some delay, clarified that the figures used by the papers were actually taking figures from two different - and non-comparable - datasets:

"The correct comparison is between data taken from the NHS serious incident management system (STEIS), which shows that the number of never events reported in the NHS was 326 in 2011/12 and around 299 in 2012/13 (note this latter figure is subject to alteration following further verification)."

So the available data (that isn't yet fully verified) actually suggests the number of never events is falling, not doubling.

What went wrong?

It all comes down to measurement. The concept of a 'never event' has been around since 2009 but started out with just eight different 'categories'. Since 2012, the list has been expanded to cover 25 types of incident, everything from surgery in the wrong place and 'foreign objects' left in the body after an operation to badly scalding patients and allowing transferred prisoners to escape.

But, surprisingly, these aren't all recorded in one place. Formerly a never event was reported to a Strategic Health Authority (SHA) when these still existed, but some were also reported to a database called the National Reporting and Learning System (NRLS), which centrally collates patient safety incident reports. As the DH points out:

"This is a separate reporting system and the majority of these reports correspond to incidents also reported to the SHAs, so the totals cannot be added together."

In fact, the figures can differ a lot. Last year (in 2011/12) SHAs recorded 326 never events, but the NRLS only recorded 163. That 163 figure was used in the comparison with this year's 299 figure - hence the claims that incidents have 'doubled'.

Now that NHS England has confirmed the 299 figure is from the 2012/13 SHAs data, it's the 326 figure we should be using in comparison with this year.

This is all still very confusing of course. The good news is that the NHS itself is aware of this, and is developing a single system of incident reporting. From next month, NHS England will be publishing records of never events on a quarterly basis.

Waiting on corrections

While it might not be the press' fault that the earlier numbers were confused, the record still needs to be corrected. NHS England confirmed that a letter of clarification has been sent to the papers involved. We'll be keeping watch to make sure the matter is set straight.

This article is courtesy from Full Fat.

Monday, 12 August 2013

Examples of past surgical errors

For most of us, the thought of going in for surgery is a scary one. The only thing that we have to hold onto is the notion that our doctor or surgeon is looking out for our best interests and he or she is a professional in his or her field. However, there are times when mistakes that could have and should have been avoided were in fact made, and this can result in complications during surgery, further injury or even death. Some of the examples of past surgical errors that have actually occurred are quite a scary thought. 

Some of them include:
  • Not enough anaesthetic provided through the procedure (anaesthetic awareness)
  • Damage to organs that should not have been affected during that particular surgical procedure (surgical error)
  • Failed sterilisation operations that result in pregnancy
  • A lack of replacement blood available
  • A ruptured bowel
  • Surgical equipment forgotten inside the body of the patient (never events)
  • Nerve damage
Am I eligible to make a claim?

This list of claims that have been made in the past is quite shocking, but they are not the only consequences that can occur as a result of surgical errors. If you feel that you suffered from inadequate surgery or suffered some form of injury as a result of a surgical error, then you could certainly be eligible to make a claim and it is worth at least making an appointment with a personal injury solicitor. 


Most of the more reputable firms offer free consultation with no obligation of further action. Simply phone them and explain your case of surgical errors and they would be happy to look into it. As well as giving you advice about your particular case, they should be able to offer advice on the best ways of financing it so that money doesn’t become an issue later on.

Friday, 10 May 2013

The safest cities in the UK to have surgery

Never events as coined by the BBC are medical accidents so serious yet avoidable that they should never occur if the correct procedures in place. Hence ‘never events’ are likely caused by malpractice and negligence.

The NHS Trusts below each had one ‘never event’ over the last 4 years; hence these cities appear to be the safest in the UK to be operated on in.


Avon & Wiltshire Mental Health Partnership NHS Trust
Barnsley Hospitals NHS Foundation Trust
Berkshire West PCT
Birmingham Women's NHS Foundation Trust
Bolton
Brighton & Hove City PCT
Calderdale and Huddersfield NHS Foundation Trust
Retained foreign object post-operation
Calderdale Independent/Non NHS Providers
Cornwall Independent Treatment Centre
Coventry and Warwickshire Partnership NHS Trust
Cumbria Partnership NHS Foundation Trust
Dorset County Hospital NHS Foundation Trust
East Lancashire Hospitals NHS Trust
East London NHS Foundation Trust
Emerson's Green Treatment Centre
Gateshead Health NHS Foundation Trust
Harbour Hospital
Hertfordshire PCT
Hillingdon PCT
Ipswich Hospital NHS Trust
Lister Surgicentre (Clinicentre Ltd)
Mid Cheshire Hospitals NHS Foundation Trust
Mid Yorkshire Hospitals NHS Trust
Middlesbrough PCT
NHS South East Essex
NHS West Essex
Norfolk PCT
North East Essex PCT
North Essex Partnership NHS Foundation Trust
North West London sector
Northamptonshire Healthcare NHS Foundation Trust
Nottinghamshire County PCT - Provider   
Nottinghamshire Healthcare NHS Trust   
Nuffield Health - Exeter Hospital   
Nuffield Hospital Leeds   
Outer London North East sector   
Oxford Health NHS Foundation Trust   
Partnerships in Care
Pennine Care
Plymouth Independent Treatment Centre
Poole Hospital NHS Foundation Trust
Princess Alexandra Hospital NHS Trust
Shepton Mallet Treatment Centre
Somerset Primary Care Trust
South London and Maudsley NHS Foundation Trust
South Tyneside Healthcare NHS Trust
South West Yorkshire partnership NHS Foundation Trust
Southampton City PCT (Moorgreen)
Southern Health NHS Foundation Trust
St Helen's & Knowsley Hospitals NHS Trust   
tockport NHS Foundation Trust    1
Stoke on Trent Community Health Services (NHS Stoke on Trent provider arm)   
Tameside Hospital NHS Foundation Trust
The Manor Hospital, Oxford
The Rotherham NHS Foundation Trust
The Rotherham NHS Foundation Trust
The Royal Marsden Hospital NHS Foundation Trust
The Winfield Hospital   
Trafford Healthcare NHS Trust*   
University Hospitals Morcambe Bay NHS Foundation Trust
University Hospital of South Manchester NHS Foundation Trust
Warrington & Halton Hospitals NHS Foundation Trust
West Kent PCT
Wiltshire Primary Care Trust
Wirral University Teaching Hospital NHS Foundation Trust

The worst NHS hospitals in Britain to have surgery at

A recent BBC report has revealed that across NHS hospitals there have been more than 750 ‘never events’. These are medical accidents which have serious implications but which are also quite preventable and therefore should never happen.

These ‘never events’ include:


•    Retained foreign object post operation – where surgical sponges, swabs or utensils are left behind in a patient.
•    Wrong site surgery – when the wrong body part is operated on.
•    Misplaced naso-or oro-gastric tubes – where a tube going from the nose or mouth to the stomach is inserted in such a way that it is misplaced.
•    Wrong implant/ prosthesis – the wrong implant of prosthesis being used.
•    Air embolism – when an air bubble gets into the circulatory system causing obstructions.
 

The worst offending hospitals listed by the BBC are below:
 

Barts Health NHS Trust - 11 errors, four cases of retained foreign object post-operation, three wrong site surgery errors, two misplaced naso-or oro-gastric tubes, one wrong implant/prosthesis and one air embolism.
 

Guy's and St Thomas' NHS Foundation Trust had 15 errors, eight of these were wrong site surgery and there were an additional four cases of retained foreign objects and two cases where the wrong implant/prosthesis were used, additionally there was also a misplaced naso-or oro-gastric tube error.
 

Imperial College Healthcare NHS Trust had 11 errors, including eight retained foreign object post-operation, two were wrong site surgery and one cases of a misplaced naso-or oro-gastric tube.

Mid Essex Hospital Services NHS Trust
had 11 incidents, being being retained foreign object post-operation, two were misplaced naso-or oro-gastric tubes, and they had one case of maladministration of Insulin, and also one wrong site surgery.
 

Nottingham university hospitals NHS Trust had 13 errors, eight retained surgical objects post-operation, four wrong site surgeries and one wrong route administration of chemotherapy. 

Plymouth Hospitals NHS Trust had 14 errors, six being retained foreign bodies, four cases of the wrong body part being operated on, two patients had misplaced naso-or oro-gastric tubes, maladministration of insulin to one patient and maladministration of potassium fluids to another.
 

West Hertfordshire Hospitals had 11 errors in total, five were wrong site surgery, five were retained foreign objects and they had one case of a misplaced naso/oro-gastric tube.

The United Lincolnshire Hospitals NHS Trust
had 12 errors, four of which were objects left in after surgery, three were wrong site surgery, two were wrong implants, two were transfusions of incompatible blood types and the maladministration of potassium fluids to one patient.

322 retained foreign objects left inside NHS patients after operations

A recent BBC report has revealed that over the last 4 years there have been hundreds of NHS patients nationwide who have retained foreign objects after operation.

In total 322 cases of Retained Foreign Body surgical errors were uncovered. Retained Foreign Bodies (RFBs) are objects which are left behind by the surgical team after closure. Common RFBs include: surgical implements, surgical mesh or cotton padding that can all be accidentally left inside the patient after surgical closure.
 

Objects left inside the body after operation are dangerous because of the inflammatory response from the body which can result in an abscess which causing obstructions of the bowl, perforations or fistulisation. All of these symptoms cause considerable pain and discomfort for the patient. On top of this 69% of RFBs require re-operation or the management of the complication, such as pain medication.

There are also cases where these surgical objects, such as surgical sponge, have migrated to another part of the body and caused considerable harm. There was a case in the USA where a piece of surgical sponge migrated to a patient’s lung and caused a pulmonary embolism.
 

Sponges and cotton left in a patient can also cause misdiagnosis since they can bear resemblance to small primary tumors with certain imaging techniques such as x-ray.

With all of these consequences in mind it is no wonder that the BBC grouped Retained Foreign Bodies in their list of ‘never' events. These are mistakes that should never, ever happen, not accidents or slips but cases of malpractice.

Hospitals reveal 750 'should never happen' blunders

Get Adobe Flash player
More than 750 patients have suffered after preventable mistakes in England's hospitals over the past four years, a BBC investigation has found.

This video is courtesy of BBC News.

Wednesday, 8 May 2013

Left-behind items in surgery a common problem

With healthcare costs the way they are, when you are having surgery, you would expect the surgeon to perform the operation in a nearly perfect manner. Although nobody is perfect, you certainly expect that the surgeon would not make an obvious error. However, the reality is that this is often the case. A recent article in USA Today points out that surgeons leave behind surgical items in their patients more than 12 times per day.

In addition, an investigation conducted by USA Today found that although items such as clamps, forceps and other surgical items are sometimes left behind, the most common left-behind object was the humble cotton surgical sponge. This object is used to soak up blood and other fluids during surgical procedures.


Shockingly, there is not a federal mandate to report these types of surgical errors. According to what little government data exists on the subject, objects are left behind in about 3,000 surgeries per year. However, since the data is incomplete, this number is likely too low. The USA Today investigation of studies, statistics and medical malpractice lawsuits found that the actual number is closer to 4,500 to 6,000 per year.


Effective solutions are rarely used


According to the investigation, hospitals are hesitant to implement solutions, despite the seriousness and prevalence of these errors. In most hospitals, surgical staffs count the number of sponges. However, it is easy to lose count or miscount, so this method has limited effectiveness.
A better solution is to equip sponges and other surgical tools with electronic tracking devices, which allow a computer to quickly and accurately do the counting. However, despite the low cost of $8 to $12 per procedure, fewer than 15 percent of hospitals have implemented this system, according to the investigation.


Left-behind objects can cost the patient and the hospital dearly. According to Medicare data, to correct the damage done by left-behind objects, patients can expect to pay an average of $60,000. Additionally, hospitals can expect to shell out an average of between $100,000 and $200,000 in medical malpractice lawsuits.


Consult a medical malpractice attorney


In addition to the financial costs, there is the suffering that victims of left-behind objects can experience. This mistake can cause pain for months or years following the operation. Often the error is not discovered until infections or other complications develop. This delay can result in the loss of a body part or even death.


If you or a loved one have been the victim of medical malpractice, you may be entitled to recover medical expenses, lost wages and damages for pain and suffering. Contact an experienced medical malpractice attorney who can evaluate your case and work to recover the maximum amount of compensation due to you under the law.

This article is courtesy of The Digital Journal and was provided by DeVore Acton & Stafford, PA Visit us at www.devact.com

Monday, 6 May 2013

NHS patients want summit with health secretary as they reveal agony after prolapse operations

Health Secretary Alex Neil was yesterday urged to meet more than 100 Scots women whose lives have been ruined by plastic mesh used to treat prolapse problems.

The growing scale of the scandal has become clear after scores more NHS patients contacted the Sunday Mail when we revealed last week the horrendous pain being endured by many surgery victims.

We told of the escalating concerns surrounding polypropylene mesh implants used to correct bladder and pelvic floor problems after ops left patients in agony.

Some were left unable to walk, others had their sex lives ruined and many have endured a series of gruelling operations as surgeons struggle to remove the mesh.

In America, one victim has been awarded £10million compensation after the vaginal mesh sliced through her organ walls.

In Scotland, it is believed around 6000 women have had the procedures.

Experts believe hundreds may now be suffering from complications, including organ damage, caused by the mesh.

Yesterday, Shadow Health Minister Jackie Baillie said: “I’m shocked at the numbers, especially as this may still only be the tip of the iceberg. I’ll be asking Health Secretary Alex Neil to meet some of these women so he can hear their
experiences.

“We need clear and decisive action from the Scottish Government.

“From evidence we’re hearing, many of these women have not even been given one-to-one consultations.

“They haven’t been offered alternatives to the mesh and tape procedures.

“And they haven’t been made aware of possible side-effects or the difficulties of removing mesh.

“This highlights the long-overdue need for a national register for every single implant.”

Last month, Linda Gross was awarded almost £10million after a US jury ruled she was not told about possible complications. Medical giants Johnson & Johnson deny their product is responsible and are appealing the verdict.

It has been reported that Johnson & Johnson, their subsidiary Ethicon and other firms face claims from 4000 women who say they have been left in agony after their mesh cut into organ walls.

In Scotland, lawyer Cameron Fyfe, of Drummond Miller, said: “We’ve been inundated with calls from women
desperate for help and each story is more horrifying than the last.

“I fully expect this to end up being one of the biggest group actions the Scottish civil courts have ever seen.”

Lawyer Victoria Ulph, of Martin & Co, said: “I’ve heard from a number of women who weren’t given one-to-one consultations with their surgeons so how could they be making informed choices?”

The Scottish Government said: “There are a small number of surgeons in NHS Scotland who provide this service. They monitor patients and, where required, provide aftercare.

“Mr Neil meets with his opposition opposite numbers regularly and can discuss this matter further at the next meeting.”

Antonia McCulloch, 47, from Largs, Ayrshire, had mesh implants to correct bladder and bowel
prolapse last May at the Royal Alexandra Hospital in Paisley.

She said: “Immediately prior to
the surgery, four of us were taken into a room so there was no proper chance to discuss such an intimate procedure in front of the others.

“We weren’t told the mesh couldn’t be easily removed or how awful any complications could be – or there’s no way I would have gone ahead.

“Any concerns raised were swept aside and we were assured it wasn’t a complex procedure.

“Before I knew it, I was waking up in recovery, screaming in pain.

“Nursing staff were dismissive, telling me I couldn’t be feeling so much pain. But I was in agony.

“I was rushed back into hospital three days after being discharged and again a few days later.

“On June 19 last year, 20 days after my first surgery, the mesh was already starting to push its way through my body. I’ve had six operations but they still haven’t managed to get all the mesh out.”

Mum-of-two Antonia has spent months off her job as a shop assistant and cleaner.

Antonia McCulloch, 47, from Largs, Ayrshire, had mesh implants to correct bladder and bowel prolapse last May at the Royal Alexandra Hospital in Paisley.

She said: “Immediately prior to the surgery, four of us were taken into a room so there was no proper chance to discuss such an intimate procedure in front of the others.

“We weren’t told the mesh couldn’t be easily removed or how awful any complications could be – or there’s no way I would have gone ahead.

“Any concerns raised were swept aside and we were assured it wasn’t a complex procedure.

“Before I knew it, I was waking up in recovery, screaming in pain. “Nursing staff were dismissive, telling me I couldn’t be feeling so much pain. But I was in agony.

“I was rushed back into hospital three days after being discharged and again a few days later.

“On June 19 last year, 20 days after my first surgery, the mesh was already starting to push its way through my body. I’ve had six operations but they still haven’t managed to get all the mesh out.”

Mum-of-two Antonia has spent months off her job as a shop assistant and cleaner.

She said: “I don’t feel 47, I feel like I’m 74. Some days the pain is so bad, I’m physically sick.

“When I complained to the hospital, I was told I was unlucky.

“But after reading the Sunday Mail, there seems to be an awful lot of unlucky women out there.

“I just want my life back. I used to ride horses, cycle and loved to walk. Now I can’t even lift my baby granddaughter. I don’t know when this nightmare will end.”

NHS Greater Glasgow and Clyde said: “Any risks associated with surgery should be fully discussed with patients. We’d be happy to discuss any concerns patients may have after their procedure.”

Anne Marie Conley, 51, from Kilmaurs, Ayrshire, has been admitted to hospital six times since her op four years ago.

She had mesh surgery at Crosshouse Hospital in Kilmarnock in 2009 for bladder and bowel prolapse.

She said: “After the procedure, I had to be rushed back in and given six pints of blood during a 12-hour blood transfusion.

“Eighteen days after the first surgery, I had an operation to remove all the mesh.

“But I’ve had procedure after procedure and I still feel the mesh. It’s like there’s something dead inside me.

“I’ve spent 18 months on steroids to control the pain but nothing works. Doctors put a camera into my bladder and I could see all the debris, the purple and black patches inside me.

“There’s no way I would have consented to this if it had been properly explained to me.

“Until I read the Sunday Mail, I thought I was suffering on my own as doctors kept saying that what happened to me was rare.”

Mandy Yule, of NHS Ayrshire and Arran, said: “We’re sorry Ms Conley feels we did not meet the high standards we strive for. We would urge anyone with concerns about our services to talk to us directly.”

Josephine McLaughlan, from Barrhead, Renfrewshire, is surviving on morphine to kill the pain after seven operations.

The 60-year-old had a mesh procedure for bowel prolapse in 2011 at the RAH, Paisley.

She said: “I was asked to sign a consent form. Nobody explained about complications or if there were alternatives.

“When I awoke after that first surgery, I was haemorrhaging and could already feel the tape coming through my body.

“Within six weeks, I’d had so many infections, the surgeon agreed to start removing the mesh. I’ve had another six ops so far. I’m on massive doses of morphine to try to dull the pain and I now walk with a stick.

“I’ve just turned 60 and feel my life is over.

“I can’t go anywhere unless I’m within sight of a toilet.”

Josephine, who used to work as a catering manager at Reid Kerr College in Paisley, said: “I’ve been made to feel as if I’m a nuisance and I’m the only one with these complications.

“When I read the Sunday Mail last week, I couldn’t believe so many others are going through the same thing.”

 This article is courtesy of the Daily Record.

Thursday, 2 May 2013

Mesh scandal: Lawyer on why £7m compensation case will not be the last

The lawyer who won a landmark £7million compensation for a mesh implant victim yesterday said women were not being properly warned of the risks.

Attorney Adam Slater won the huge payout after the life of his client Linda Gross was ruined by the plastic mesh, used to treat prolapse and bladder problems.

In court, he told how a number of internal emails revealed concerns about the safety of the product, which can end up cutting into organs but is difficult – and sometimes impossible – to remove.

He explained how all the risks had not been made clear to doctors –or their patients.

Speaking to the Sunday Mail, Slater said: “There were 28 complications which were not mentioned. They also claimed in brochures that the mesh was soft. In fact, it has been shown that, once inside the body, mesh can go hard and it can cut through tissue and organs.

“Reports also show there is a lifelong danger of erosion, of the mesh becoming exposed.

“Women need to know that information so they are aware of what can happen even a decade or more after surgery. When mesh goes bad, it can have devastating effects, leaving women with very little quality of life.”
 Linda, a nurse from South Dakota, has been awarded around £2million in compensation from Ethicon – a subsidiary of medical giant Johnson & Johnson – for her suffering and another £5million in punitive damages after a jury decided the
company had misled her and her surgeon about the risks of the operation.

She has already backed a Sunday Mail campaign highlighting the plight of scores
of Scots women left with a legacy of terrible pain and uncertainty after NHS operations involving vaginal mesh and tape.

Women have been forced to give up work because of the pain, their sex lives have been ruined, some have been disabled and others have faced up to seven more operations as surgeons try and fail to remove the mesh.

Many of the women have told us they were not properly warned of the possible consequences if the operation went wrong and that, afterwards, doctors insisted they had just been very unlucky and were isolated cases.

Scottish Health Secretary Alex Neil is to meet Scottish victims next month at Holyrood to discuss their calls for an inquiry, better information and
support and a national register of all implants.

Documents uncovered by Slater and his legal team revealed that leading surgeons called for mesh marketing to be halted four years ago while failure rates and the impact of failed surgery on patients was properly researched.

Documents also showed that concerns from one of the scientists who helped to develop the mesh implant at the centre of the US case were not included in instructions to doctors using the product.

Patients around the world are now launching legal actions against a number of mesh manufacturers, with cases in Scotland, the US, Canada, New Zealand and Australia.

We can reveal the International Urogynecological Association said in a 2009 report: “When complications arise, multiple surgeries to address them may be required, substantial morbidity [failures] may ensue and the patient’s quality of life may be affected.

“The widespread marketing of these technologies should be avoided until level 1 evidence becomes available demonstrating their superiority over traditional repairs, with acceptable rates of morbidity.”

Slater said: “Women need to know there are many other alternatives and there are doctors prepared to listen to them and help them.”

He won his court battle against Ethicon – who deny any wrongdoing and are appealing the ruling – after he produced evidence which showed that the firm did not include warnings about the complications that could arise with a product called Gynecare Prolift.

In January 2005, two months before the launch of Prolift, one of the main scientists behind the implant, Axel Arnaud, wrote to Ethicon marketing director Ophelie Berthier asking for a warning about the possible impact on patients’ sex lives be included in the instructions to doctors. But the warning was not immediately issued.

The following year, Linda, 47, was fitted with Prolift, which Ethicon withdrew last year along with three other mesh products for what they describe as commercial reasons.

Slater said: “If Linda had got a much more extensive discussion of the risks, she wouldn’t have gone ahead.”

The lawyer revealed that many positive medical papers written about mesh were penned by doctors being paid by Ethicon.

He added: “We found they had been paid as consultants to Ethicon. How could they give a fair view if they were on the payroll?

“The manufacturer also failed to warn doctors just how very difficult it can be to remove this stuff once it’s inside the body.”

Los Angeles doctor Shlomo Raz said that he had hundreds of patients coming to see him every month, desperate for mesh removal, some even arriving from the UK.

During questioning in Linda’s trial, Ethicon’s former medical affairs director Charlotte Owens was asked if she knew women had ended up with lifelong pain and disability. She said: “We knew there would be some patients with complications with the product, yes.”

Slater said: “This was not spelled out in the instructions for use, which are supposed to warn doctors about all the adverse effects the mesh could have. Doctors and their patients needed to know about all of this.

“Governments need to make sure that manufacturers and doctors are required to publish all the material so the public can see and judge for themselves.”

During trial, Ethicon’s own internal documents from 2005 revealed that Vincent Lucente, a doctor who they had invited to write about their product, said: “Returning for surgery to deal with a bad Prolift will be a disaster”.

Another 2005 internal email from Ethicon’s medical director David Robinson, referring to highlighted bladder problems, stated: “If this starts getting reported, it is going to scare the daylights out of docs.”

Adam said: “We can’t stop the suffering of those who’ve already undergone procedures that have gone bad. By raising awareness, we can prevent others in the future.”

Ethicon are appealing the ruling. Vice-president of communications Sheri Woodruff said: “We are confident Ethicon have acted appropriately and responsibly in the research, development and marketing of our pelvic mesh products.

“We continue to work with the Medical and Healthcare Products Regulatory Agency and other regulatory authorities to monitor and ensure the safety of our products.

“Ethicon are diligent about informing both surgeons and patients about the potential adverse events associated with transvaginal mesh products.”


This article is courtesy of the Daily Record.

Monday, 1 April 2013

Tracers, counts help defense in retained foreign object cases

Retained foreign object following repeat cesarean

A Virginia woman underwent a repeat cesarean delivery in 2006. The operation was complicated by a left uterine artery laceration, which was repaired. All sponge and needle counts were correct before the abdomen was closed. More than 3 years later the woman developed severe abdominal pain. An emergency exploratory laparotomy revealed massive pelvic-abdominal adhesions. Surgeons also found a 6 cm x 6 cm mass encased by omentum and adhered to a loop of small bowel, part of the cecum, appendix, and right fallopian tube.

During removal the mass opened and a laparotomy pad was found inside. The patient developed sepsis, hypotension, tachycardia, peritonitis, and acute respiratory distress syndrome. A year later she underwent a laparoscopic incisional hernia repair with mesh. After this surgery she was readmitted to the hospital with difficulty breathing and was diagnosed with postoperative pneumonia. Two years later she underwent a second hernia repair, which she claimed she had delayed due to her fear of surgery and complications, and she continued to have abdominal pain and limitation of her activities.

The woman sued the original obstetrician, claiming the laparotomy pad was left behind during the cesarean and that the physician failed to ensure that the sponge count was accurate. She also argued that if the laparotomy pad was left during an earlier operation the defendant obstetrician was negligent in failing to perform a proper intraoperative examination of the abdomen during the cesarean.

The physician claimed that the sponge count was reported as correct by the operating room staff and he properly relied on that information, and that there was no requirement for him to find a laparotomy pad left behind during a prior operation. A defense verdict was returned.

Claim of retained laparotomy pad

A California woman underwent an exploratory laparotomy in 2003. This was performed by her gynecologist, who had been involved with her 5 previous surgeries, including 2 cesareans and a hysterectomy. She had suffered from pain from severe adhesions, and her physician recommended the laparotomy to reduce the adhesions and to prevent future adhesions with placement of Gore-Tex mesh. Seven years later, the patient began having epigastric pain. Because of insurance changes she went to a different physician. This doctor ordered a CT scan that identified a foreign body encapsulated in scar tissue in her lower abdomen. The patient went to a surgeon, who decided to remove the foreign body.

The patient sued her original gynecologist and the hospital, claiming they were negligent in leaving a laparotomy pad in her abdomen in 2003.

The defense argued that the object removed in 2010 was not a retained laparotomy pad. He contended that the object was actually the mesh placed in 2003 and that it became encapsulated in scar tissue due to the patient’s propensity to develop adhesions and that the mesh then migrated within her abdomen. A defense verdict was returned.

Legal perspective

A retained foreign object (RFO) after a surgical procedure is negligence per se, of course, as has been addressed many times in previous Legally Speaking columns and other pieces in this magazine. Often the negligence is admitted and the dispute in a subsequent malpractice case is over the amount of damages claimed for the reoperation or complications from the RFO, and any long-term injury that is shown to be related to it.

These cases are interesting in that they were both defense verdicts and the issues were proving when the RFO was left in the abdomen and what the object was. In the first case, because the patient had a previous cesarean, she could not show that the physician and hospital sued actually left the laparotomy pad during the procedure they performed, and she did not convince the jury that if they did not leave it, there was a duty to find one left during a previous surgery. Because the sponge and needle count were correct, the jury found for the defense.

In the second case, the defense showed that laparotomy pads have radiopaque tracers. A CT scan done 5 days after the laparotomy in 2003 detected no tracer, and a 2010 CT scan also did not show any radiopaque tracer. The RFO was more likely the mesh that was inserted and purposefully left in the abdomen in 2003.

Delivery to diabetic patient complicated by shoulder dystocia

A 23-year-old Maryland woman was 38 and 6/7 weeks’ gestation when she went to a hospital with contractions in 2008. She previously had a term vaginal delivery. She developed type 2 diabetes before her pregnancy. Her admitting glucose was 143, she was noted to have a 25-lb weight gain, a fundal height of 40 cm, and estimated fetal weight of 8 lb, 13 oz. A pelvic exam indicated the cervix was 3- to 4-cm dilated and 100% effaced and the baby was at -1 station. Oxytocin was started to augment labor and the obstetrician noted a reassuring fetal heart rate (FHR).

Because of the patient’s diabetes and suspected macrosomia, a pediatrician attended the delivery. A shoulder dystocia was encountered and the infant was delivered using several maneuvers after about 40 seconds. The patient sustained a second-degree perineal laceration. The infant had Apgar scores of 5 and 9, and weighed 10 lb, 2 oz. The infant was diagnosed with a brachial plexus injury and underwent surgery that found a combination of an avulsion injury and rupture of C5 and C6. Despite nerve grafts she has a significant functional disability in the affected arm. Settlement discussions between the parties resulted in a $1.475 million settlement for the child.

Bowel perforation following removal of pelvic mass

A 58-year-old Virginia woman was admitted to a hospital in 2009 for an exploratory laparotomy for removal of a pelvic mass and a left salpingo-oophorectomy. The operating gynecologist encountered extensive adhesions during the procedure, including an adhesion of the large pelvic mass to the pelvic sidewall. He also had difficulty visualizing all the mass, had to use blind blunt dissection at certain points during the surgery, and found it difficult to remove the mass through the incision.

On the second postoperative day the patient complained of shortness of breath (SOB), intermittent chest pain, and a temperature of 103°. The next day she continued to have SOB and was unable to walk. CT scans ruled out a deep vein thrombosis or pulmonary embolism, but did show the patient’s lung volumes were significantly decreased from preoperative levels. She continued to have SOB and temperature spikes for the next 3 days and was discharged on day 7 post-op despite SOB. Two days after discharge she experienced severe abdominal pain and continued SOB and was brought back to the hospital via ambulance. A CT scan then revealed free air in the pelvis, ascites, and extensive inflammatory changes likely due to bowel perforation.

The patient was intubated and emergently air-lifted to a regional trauma center for treatment. An exploratory laparotomy found a liter of fecal fluid and a perforation at the recto-sigmoid junction, which was repaired. A colostomy was performed. The patient was in the intensive care unit for 5 days and developed renal failure, required blood transfusions, and was hospitalized for 19 days. She had extensive home care after discharge. The colostomy was reversed about 5 months later and the patient had complications that required 6 days of hospitalization. A lawsuit was filed against the gynecologist and a settlement was reached for $600,000.

Brachial plexus injury

A Nebraska woman was pregnant in 2008 and had an ultrasound near term that estimated fetal weight to be almost 10 lb. A week later she was admitted for induction of labor. A shoulder dystocia occurred during delivery and the infant weighed 9 lb, 12 oz at birth. The infant was diagnosed with a strained C5 disc; ruptured C6, C8, and T1 discs; and an avulsion of C7. A nerve-grafting surgery was performed when the infant was 2 months old, but one arm remains shorter than the other with limited range of motion.

The patient sued the obstetrician and hospital involved with the delivery, claiming that the shoulder dystocia was mismanaged and resulted in the injury.

The defense argued that the shoulder dystocia was managed appropriately with the proper maneuvers and denied any fault in causing the injuries. A defense verdict was returned.

Claim of improper use of misoprostol for induction

An Ohio woman was admitted to the hospital at 34 weeks’ gestation in 2007. She was suffering from nausea, abdominal pain, and uterine contractions. She had a history of gestational diabetes, hypertension, and proteinuria, and was diagnosed with preeclampsia. On admission, the obstetrician decided to induce labor if the patient did not go into labor on her own.

The following day misoprostol was administered vaginally. The patient’s labor continued into the next morning, when a sudden loss of FHR tracing occurred. An electrode placed almost 20 minutes later showed fetal distress. The obstetrician attempted a vacuum extraction but was not successful and an emergency cesarean delivery was performed. A ruptured uterus was discovered and a hysterectomy was performed due to significant bleeding. The infant was diagnosed with hypoxic ischemic encephalopathy and seizures and died 3 weeks after birth.

In the lawsuit that followed this delivery the patient claimed that misoprostol was not approved for cervical ripening or induction of labor, and has known complications including uterine rupture and maternal or fetal death. The patient also claimed that the manufacturer expressly warns it is contraindicated for use during pregnancy. She argued that she was not informed of the potential adverse effects or provided another option for induction or cesarean. She further claimed that the nurses failed to properly monitor the fetus and recognize signs of fetal hypoxia or uterine rupture and failed to summon a physician in a timely manner in response to the FHR tracing.

The defense claimed that the patient did receive and sign an informed consent for induction. They argued that the FHR tracing was properly monitored and the emergency cesarean delivery was performed in a timely manner. A defense verdict was returned.

This article is courtesy of Modern Medicine.

Wednesday, 13 March 2013

USA: IU Health taking extra steps to avoid deadly surgical error

IU Health is one of a small percentage of hospital systems across the country that have invested in technology that would help prevent surgical sponges from being lost in patients’ bodies.

Surgical sponges left inside patients can create a potentially dangerous and deadly result. Still, the mistakes have been made in plenty of Indiana hospitals, some who have not made more recent investments in preventative technologies.

“They do the right thing most of the time,” said Lynn Bridgewater, Director of Operations and Perioperative Services at IU Health Methodist Hospital.

Bridgewater said her employees make mistakes, but they are leaving little room for errors involving surgical sponges in recent years.

IU Health spent more than $250,000 at three hospitals on radio frequency tracking devices that detect sensors implanted in surgical sponges. An additional $8 investment is also required during every surgery.

“Six years ago, we had 13 incidents of retained sponges, and one was too many,” said Bridgewater, who claims they also count instruments and other tools, a long-time practice.

A sponge left inside a body can cause a serious infection that may not be discovered right away.

“It’s a clear breach, a very clear act of negligence,” said Caroline Gilchrist, a medical malpractice attorney with Baker and Gilchrist in Avon.

She has had two sponge cases in recent years. She could not specifically talk to either case, claiming the cases were settled outside of court and confidentiality agreements were signed.

These incidents got real attention in Indiana when an executive order was signed requiring all hospitals and surgery centers to report if any foreign object is left inside a body.

There has been a slight decline in the amount of cases overall statewide, and some experts attribute the improvement to fewer sponge-related incidents.

“Everybody makes mistakes. The question is are you going to stand up and take responsibility for that,” said Gilcrhist.

“Hospitals are well aware that they need to report these things, but it does have a definition that must be met before its reportable, and there are some exclusions,” said Betsy Lee with the Indiana Hospital Association.

She claims not every hospital needs to make the expensive technology investment. There are other options.

An Indiana hospital can be responsible for up to $250,000 in damages if a mistake is made., though.

“It’s not a lot. In fact, that small investment is what helps me sleep at night,” said Bridgewater of the hospitals investment in the special sponges.

She added that they have had no incidents of sponges being left inside patients in five and a half years. That is when the hospital went through with the changes.


This article is courtesy of Fox 59.