Preview Newsletter
Ethicon Media Monitoring 4/9/2019
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Garrard Swings Back to MDL Critics in Pelvic Mesh Litigation
Apr 8, 2019 | Mesh Medical Device News Desk
By Jane Akre
In a 77-page response to be filed Tuesday in the pelvic mesh multidistrict litigation (MDL), Henry Garrard, who heads the executive committee in this MDL, objects to the four law firms who say they are not being adequately recognized for their work in this litigation... -
'I was in tears and he was doing things with his phone,' says mesh-injured woman
Apr 8, 2019 | Newcastle Herald
By Joanne McCarthy
ONE of Australia's most senior health bureaucrats is under fire for repeatedly using his phone during an emotional presentation by pelvic and hernia mesh victims at a forum where the Morrison Government was slammed for its response to a series of medical device scandals. -
Agony of the women left behind by the national mesh scandal: After a change in medical guidelines thousands of women will be spared controversial surgery, but who will help the victims left behind?
Apr 8, 2019 | Daily Mail
By Lois Rogers
At 79, Pearl Oakley worries she is doomed to spend the rest of her life in pain and housebound as a result of an operation she had 20 years ago for incontinence going horribly wrong. -
Woman who sued NHS for £2.5m claiming operation left her in agony seen in clubs celebrating hen night
Apr 8, 2019 | Telegraph
A woman who tried to claim £2.5m from the NHS after claiming that having vaginal mesh fitted had left her in constant pain has been sent to prison after pictures showed her enjoying her daughter's Ibiza hen party -
Lesley Elder jailed over false £2.5m NHS claim
Apr 8, 2019 | BBC News
A woman who tried to cheat the NHS out of more than £2m by exaggerating injuries from botched surgery has been jailed after she was spotted at a hen party in Ibiza. -
Woman who sued NHS for £2.5m after botched surgery spotted PARTYING on Ibiza hen do
Apr 8, 2019 | Daily Star
By Sian Harrison
Lesley Maria Elder, 50, from Poole, Dorset, claimed she was left disabled by constant pain following a vaginal mesh operation and could no longer work or do routine tasks without help. -
Jailed: £2.5m NHS con mum caught partying at hen do
Apr 8, 2019 | Metro
A MOTHER who tried to cheat £2.5million out of the NHS by exaggerating injuries from botched surgery has been jailed after she was spotted at a hen party in Ibiza. -
NHS to face legal action if mesh restrictions are ignored
Apr 9, 2019 | Med-Tech Innovation News
By Reece Armstrong
NHS Trusts could face legal action if they do not enforce ‘high vigilance restrictions’ in the use of mesh following new guidance published by the National Institute of Clinical Excellence (NICE). -
The 'Feminine hygiene’ market is predicted to reach $42.7bn by 2022 – but it's doing more harm than we realise
Apr 8, 2019 | The Independent
By Athena Lamnisos
We thought we might see the beginning of the end of unnecessary products when Goop agreed to settle for $145,000 for making unproven scientific claims about its vaginal eggs. It seems not. -
Litigation funder Burford raises $300 million for post-settlement deals
Apr 8, 2019 | Reuters
By Alison Frankel
When I first read an announcement Monday from Burford Capital, I thought the tectonic plates of litigation finance had shifted.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Garrard Swings Back to MDL Critics in Pelvic Mesh Litigation
Apr 8, 2019 | Mesh Medical Device News Desk
By Jane Akre
In a 77-page response to be filed Tuesday in the pelvic mesh multidistrict litigation (MDL), Henry Garrard, who heads the executive committee in this MDL, objects to the four law firms who say they are not being adequately recognized for their work in this litigation and are being shorted millions of dollars of the fees collected from pelvic mesh settlements and jury verdicts, despite conducting the most high-profile trials.
Image: Garrard leaving federal court Charleston WV, July 2013
In a firm but constrained style, Garrard strenuously objects to airing of “dirty laundry” by two law firms who allege bill padding and preferential treatment.
Mazie Slater of New Jersey and Kline Specter of Philadelphia claim those firms who have cozied up to the executive committee of the pelvic mesh MDL in Charleston, WV are seeing the highest dollar reward while the firms, that have done the most heavy lifting – collecting evidence, conducting depositions and taking cases to trial successfully – are having their hours and rates cut by the MDL executive committee.
Two other objectors are New York firm Bernstein Liebhard and Anderson Law firm of Cleveland, Ohio. The objectors are seeking an independent review of the allocation by the Fees and Cost Committee (FCC) and have each submitted their objections to the court.
Each settlement and verdict is assessed 5% to go to a common benefit which allows lawyers to share in discovery without reinventing the wheel for each of the 104,000 plaintiffs who filed product liability cases against seven mesh makers in the MDL. That money is to reimburse to fees and costs advanced by the firms.
That’s how it was to work in theory.
In reality, the very few bellwether trials conducted failed to set the “value” of a pelvic mesh case for settlement purposes. All except a few of the 94 law firms involved in the MDL, never saw the inside of a courtroom with a pelvic mesh trial. Instead, they shuffled paperwork lining each plaintiff up for a settlement taking 40% for their effort.
Now, all want to share in the enormous and growing pot of money which is valued at $350 million resulting from $7.25 billion in pelvic mesh settlements and verdicts.
Dirty Laundry
Garrard, of Blasingame Garrard, Athens, GA, who chairs the Fee and Cost Committee (FCC) calls the allocation process fair and transparent and objects to the public airing of “dirty laundry.”
“The sort of caustic rhetoric from the remaining objectors directed at the committee, its members and the Court-appointed External Review Specialist, among others, is unfortunate,” says Garrard in in response to the four objecting law firms challenging the Common Benefit Fee and Cost Committee (FCC) made of members of eight law firms, and External Review Specialist of the MDL.
Airing their “dirty laundry” says Garrard, serves no purpose.
Among those accusations – Pensacola, Florida lawyer, Bryan Aylstock reportedly refused to allow his partner Renee Baggett to sign the fee committees written recommendation unless his firm received more in fees, about $10 million more.
Mazie Slater calls it a “disturbing” and “glaring example of self-dealing.” Garrard calls the recitation false.
External Review Specialist, retired Judge Daniel Stack has accused law firm, Motley Rice, of padding its time with “thousands of phantom hours” including time to re-review documents already reviewed.
Kline Specter has been highly critical of the firms that took on more defective product cases than they could ever handle and as a result, settled for “puny” amounts when compared to multimillion dollar verdicts the Philadelphia firm has achieved.
Settlement averages are in the range of $40,000 for an Ethicon case, but are as low as $500 to zero after legal expenses and any medical liens are cleared. Mazie Slater obtained the largest settlement of $5 million in the Wicker case, which never went to trial.
“The leaders in this litigation did the worst possible thing to the detriment of all plaintiff mesh victims and their attorneys: they settled their inventories way too cheaply, making it difficult for other attorneys to settle their cases reasonably,” attorney Shanin Specter said in a November 2018 filing.
“The FCC will simply state that the attacks on the FCC firms and their work are unfounded.” Garrard writes. He points to 90 of the 94 firms agreeing with the allocation process.
But it was not all smooth sailing.
Of the 94 firms, 27 chose to appear in person to appeal to the FCC. That resulted in changes to allocated monies to 17 firms. All but one of those were resolved. Eight firms objected to the FCC’s Final Written Recommendation. After a number of back and forth objections, an additional $10.9 million was reallocated.
That left just four dissatisfied.
Garrard Objects
Mazie Slater conducted the bulk of its cases against Ethicon (Johnson & Johnson) and formed the Gynecare Work Group to fund the New Jersey Ethicon litigation which focused on the Prolift pelvic mesh to treat pelvic organ prolapse. Fifteen firms paid into the group and Adam Slater says that formed the foundational work for all Ethicon litigation.
Garrard says the FCC did consider pre-MDL time for the New Jersey firm and while the Prolift work was important, most of the Ethicon MDL trials focused on SUI sling products such as TVT-Retropubic, Obturator, TVT-Secur, TVT-Abbrevo and Exact.
The MDL leadership had agreed to work cooperatively with firms outside of the West Virginia MDL, such as New Jersey and Philadelphia but no New Jersey firm was ever appointed to the Fee and Cost Committee, even though reportedly there was a request to do so.
Mazie Slater points to the eight firms on the FCC committee which got an average award of more than $27 million and which comprises 62.5% of the fund.
Garrard says the eight firms of the FCC were collectively responsible for almost 300,000 recognized common benefit hours and were responsible for resolving more than 75% of cases filed in the MDL while taking the largest financial risk.
Referring to Kline Specter and Mazie Slater, Garrard says the groundwork by the two firms was provided for their plaintiffs’ cases in New Jersey and Philadelphia and not for the common good. He points to the use of Prolift mesh expert Dr. Anne Weber who Mazie Slater reserved to be its expert in Prolift cases and not shared with the MDL until recently.
Every firm was evaluated by the same process, writes Garrard, who notes that the review process took two years.
Garrard complains the objector’s submissions of time and expenses were in direct violation of the Court’s express instructions and referring to Mazie Slater submissions as “largely indecipherable,” full of “dismal record keeping” and “improperly documented time,” so vague as to be meaningless.
Judge Goodwin has the option to review the records to credit Mazie Slater for many submissions.
Disparate Treatment
Mazie Slater writes there is no more example of disparate treatment than in the hourly fees awarded to the FCC members.
According to Law.com the FCC cut 455 of Bernstein Liebhard’s 4,407 billable hours from final allocation. It wanted $3.2 million. Its hourly fee was $352 while Blasingame Burch had a fee award of $847 an hour.
Mazie Slater was awarded an average hourly rate of $202 for 29,752 hours submitted and $309 an hour for more than 19-thousand hours.
In contract, the average weighted hourly rate going to FCC firms was $730 /hr. That includes $728/hr. going to a West Virginia firm that took no depositions and tried no cases.
Mazie Slater was eventually awarded $6.2 million.
In a 26-page objection, filed in the MDL March 26, Adam Slater points to five law firms that will average $41 million in fees, while Mazie Slater’s expenses and hours were cut by the Fees and Cost Committee (FCC) whose members are at the top of the compensation list.
Ben Anderson who conducted 60 depositions, is a member of a one-person law firm.
Garrard argues his cannot be compared to the 21 person firm of Aylstock or 47 lawyers with Motley Rice in terms of compensation.
Kline Specter has conducted more pelvic mesh cases against Ethicon than any other filed in the Philadelphia Court of Common Pleas, which has resulted in $146 million in verdicts for its clients but Garrard says the firm has been “a consumer-rather than a producer – of common benefit work product generated by others who led the Ethicon litigation.”
Its trial success was largely the result of common benefit work done by the MDL that it “now seeks to disparage,” Garrard insists.
MDL Judge Joseph Goodwin to Decide
Ultimately the final word rests with the man overseeing the largest MDL ever consolidated in one court – Judge Joseph Goodwin. The common benefit fees are based on $7.25 billion in pelvic mesh settlements so far. As Judge Goodwin encourages more firms to settle with mesh makers that final number is expected to reach $11 billion, raising the common benefit fee fund to $550 million when the pelvic mesh MDL is finally closed.
Garrard wants Judge Goodwin to give final approval to the Final Written Recommendation of the FCC.
Judge Goodwin will consider the allocation matters and deem whether additional hours and dollars should be reallocated.
He might also weigh in on the airing of dirty laundry and the irrefutable fact that those firms who claim they’re not being recognized for their work by this MDL have also delivered the highest dollar and most jury verdicts so far among thousands of mesh-injured plaintiffs.
https://www.meshmedicaldevicenewsdesk.com/garrard-swings-back-to-mdl-critics-in-pelvic-mesh-litigation/
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'I was in tears and he was doing things with his phone,' says mesh-injured woman
Apr 8, 2019 | Newcastle Herald
By Joanne McCarthy
ONE of Australia's most senior health bureaucrats is under fire for repeatedly using his phone during an emotional presentation by pelvic and hernia mesh victims at a forum where the Morrison Government was slammed for its response to a series of medical device scandals.
Department of Health deputy secretary Professor John Skerritt used the touchscreen on his phone during a 30-minute film presentation that included a woman saying she was in constant pain and "totally incontinent, living in urine-soaked pads", and another saying "We've lost our mental health, our physical health and many of us contemplate suicide every day".
Professor Skerritt's phone use angered women who wept during the presentation, only minutes after Greens Senator Rachel Siewert cried during a Skyped speech while talking about the impact of devastating submissionsby pelvic mesh victims to a Senate inquiry she chaired in 2018.
Nicolle Germano, whose pelvic mesh surgery in 2013 has left her with severe, permanent injuries requiring self-catheterisation every four hours, said she was gobsmacked to see Professor Skerritt beside her "with his head down and his phone in his lap" repeatedly through the film, or reading notes for a speech he delivered after the presentation.
"I was blown away. It was unbelievable he did not give the most important part of the day his full attention. I'm pretty hardened but hearing the stories of all those people so badly affected by mesh really hurt me, and he didn't even look up for a lot of it," Ms Germano said.
"I was in tears and he was doing things with his phone. I thought 'You didn't even hear that'. That's what it's been like for years - mesh victims trying to get people in the health system to listen."
In his speech Professor Skerritt said it was "very important for us to hear directly from individuals who have had adverse effects with medicines and devices and to hear their personal stories" to make sure products on the market "are as safe as possible".
In response to questions about the phone use a Department of Health spokesperson said Professor Skerritt had "special dispensation" to appear at the forum rather than Budget Estimates, but he was "required to provide support to those attending on his behalf".
"After international developments overnight on Thursday, urgent planning was required for a meeting of the TGA's breast implant expert reference group - being held (on Monday) - to discuss macro-textured breast implants," the spokesperson said.
"A number of other media enquiries and briefing requests also required Professor Skerritt's urgent attention. Professor Skerritt cleared his schedule as much as possible to attend the forum, where he recognised the serious impacts on the women who were affected and the need for the health system to work together to address the issue of mesh injuries.
"Professor Skerritt has reassured those who attended the forum and other affected women that the TGA is totally committed to ensuring that the regulation of medical devices protects the health and wellbeing of all Australian women."
The phone use on Friday was only hours after Professor Skerritt revealed a medical device national action plan, headed "The safety of Australian patients comes first", was developed in 2018 but not released until last Thursday, on the eve of a federal election where health is a key issue, because "politicians decide when things go out".
The plan aims to improve how devices get on the market, strengthen monitoring and "significantly improve" transparency about device approvals, after sustained criticism of device regulator, the Therapeutic Goods Administration, following a series of scandals, including pelvic mesh device approvals that have left some women with catastrophic injuries.
The action plan's release also follows a Department of Health report in the European Medical Journal in January showing only an estimated 0.5 per cent of adverse events involving implanted medical devices are reported to the TGA under a risk alert system that has operated for more than two decades.
The device action plan was announced on the first day of a forum in Melbourne organised by health consumer groups from across Australia aiming to make health system reforms a federal election issue.
Professor Skerritt told mesh-injured women that "much of the writing behind the action plan was done last year but we do not control when documents like that are released".
"I would have loved to have released that action plan ages ago but it's not my job and politicians decide when things go out," he said.
"It sounds like a cop-out but really, it's the same right across government."
Professor Skerritt said the TGA had discussed problems with the device adverse event reporting system "with all political parties", including making health care facilities and hospitals mandatory reporters of device adverse events.
"Governments have not had an appetite at any point in time, governments have not had an appetite to look at mandating the reporting by hospitals and health care facilities until the announcement this week and that's governments of both colour," Professor Skerritt said.
On Friday pelvic mesh and hernia mesh-injured people booed and jeered after a pre-taped film in which the Federal Government announced $2.3 million to fund a pelvic mesh registry for women implanted with devices in future.
A government spokesman told the forum he was "sorry for what has happened in the past" but was "delighted" to announce a $2.3 million registry "that we should always have had".
"So this is your moment, it's overdue recognition, but it's real action and it will protect women, it will protect their health and it will also protect their mental health. And it's an acknowledgement of that which has occurred in the past, on our watch, thanks to your work," the spokesman said.
"I want to thank you, I want to acknowledge the suffering of those who have suffered historic wrongs, but above all else it will give you a real note of hope that going forward this registry will help you and help us make a profound difference."
Forum participants booed, called the announcement "delusional", and strongly criticised the "This is your moment" comment.
"Our moment to be what, shat on again?" said Mesh Injured Australia Incorporated founder Justine Watson, who attempted suicide because of the severity of mesh device complications.
The government has not acted on a pelvic mesh Senate inquiry recommendation for a retrospective audit of an estimated 150,000 devices implanted in women since the late 1980s, after damning evidence that authorities have no firm data on how many women were implanted or have complications.
Injured women and health consumer groups say the audit is a "top priority" because stronger regulatory action can be delayed while accurate complication rates for different mesh devices remain unclear. Senator Siewert told the forum she was "disappointed" at the lack of action on a retrospective audit.
Two Newcastle women, who did not want to be named because of legal cases against a device manufacturer, said they were shocked and angered by Professor Skerritt's phone use during the film presentation, and despairing after the government spokesman's comments.
"The registry is for what happens in future, but what about financial assistance for everything we've already endured and have to endure in the future?" said one of the women.
"It's too late for so many of us. They're convinced there's just a few mesh-injured people because doctors have told them that, but they don't know and they don't want to know because then something would have to be done about it."
The TGA has not initiated criminal or civil penalty proceedings against any pelvic mesh manufacturers, despite manufacturers being the only mandatory reporters of device adverse events, and confirmation only a fraction of adverse events have been reported to the regulator over the past two decades. The TGA has only initiated criminal proceedings against four medical device manufacturers in the past decade.
Professor Skerritt told a forum event it was "very easy" to explain the lack of criminal proceedings against device manufacturers because "in order to prosecute a company in a criminal way you have to provide.. that there's been deliberate withholding of evidence by companies".
He said it was a failure of the legislation that more legal cases had not proceeded.
Professor Skerritt told the forum the TGA had only recently obtained powers to increase monitoring of drug manufacturers, but the increased powers did not extend to device companies.
Extending the powers to medical devices was "a decision of whoever our political masters will be", Professor Skerritt said.
https://www.theherald.com.au/story/6003623/department-of-health-defends-executive-over-phone-use-during-mesh-forum/
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Apr 8, 2019 | Daily Mail
By Lois Rogers
At 79, Pearl Oakley worries she is doomed to spend the rest of her life in pain and housebound as a result of an operation she had 20 years ago for incontinence going horribly wrong.
Christine Doppelt, who is 76, lives in constant fear of the return of the searing agony she endured for years after a similar surgical catastrophe. She found an NHS specialist who was able to help her, but he has since moved to Singapore.
Jackie Harvey has only avoided Pearl and Christine's fate after spending £7,000 on expert private surgery.
Helen, who has graced the pages of Tatler magazine but spoke to Good Health on condition of anonymity, is half way through an extensive series of even more costly private surgery to repair the same problem.
These four are just some of the more than 6,000 women left maimed or crippled by the use of plastic mesh implants — introduced as a cheap operation for those with incontinence or prolapse.
After almost a decade of campaigning by Good Health, the NHS has admitted the material can 'migrate' and disintegrate, becoming embedded in tissue.
Last July, it said that the tape should not be used for urinary incontinence.
NICE issued new guidance last week saying that mesh should still be an option for women who have not responded to non-surgical measures for stress incontinence but that they 'should be fully informed of the risks'.
The guidelines now recommend, too, that women with 'suspected or confirmed mesh-related complications' should be investigated by consultants in centres specialising in treating these issues.
But there has been no coordinated effort, as yet, to train surgeons in how to remove the mesh without causing further damage. It is complex surgery and there are concerns about the procedures some women are being offered.
'Although a number of specialist surgeons have developed expertise in the technique, opinions vary about who has the correct skills and which doctors' organisations should provide mesh removal training and who should validate it,' says Mohammed Belal, a consultant urological surgeon at University Hospitals Birmingham NHS Foundation Trust.
In the meantime, thousands of women damaged by the mesh have little idea where to turn for help.
Up to one in four women experiences injuries to pelvic organs during childbirth. While most recover, thousands go on to suffer lifelong incontinence.
In the past, this was treated with skilled and complex procedures using the woman's own tissue to construct a 'sling' to support the womb or bladder.
Plastic mesh tape was introduced 30 years ago by the NHS as a cheap alternative, but there was little testing of its long-term safety before it was put on the market.
Although there are no records of the number of women who have had it, they are believed to number more than 100,000.
Many have had no problems with the implant, but in others the tape has moved and disintegrated, its tiny razor-like fragments slicing into muscles or nerves, piercing the vagina, bladder and bowel.
As well as pain and incontinence, some women have suffered such severe damage to nerves that they struggle to walk.
Until Good Health began reporting these damaged women's problems, doctors routinely dismissed their complaints.
Pearl, a twice-divorced mother of four, who is a retired auxiliary nurse from Himley, West Midlands, says she has been in 'constant agony' for years.
'This mesh has curtailed and dominated my life,' she says. 'I had three of them implanted, one on top of the other, about 18 months apart. The first one was inserted in about 1989, when the product was in its infancy. Frankly, I think I was used as a guinea pig.
'None of them cured the problem, and all three are still in situ.
'I've been told the mesh has grown into other organs and cannot be removed.
'I try to keep my problems covered up but I always have to carry spare clothing. I don't seek out company and I have become quite isolated because I never know when I'm going to be embarrassed.
'When I said none of them had worked and I was now suffering pain as well as incontinence, the surgeon got impatient with me.'
The only option left for Pearl is a sacral nerve stimulation device — which is similar to a pacemaker and produces an electrical signal to prevent the incontinence.
'Afterwards, you can't bend or pick things up off the floor and apparently these gadgets set off alarms in shops and other places,' says Pearl. 'I honestly think that at my age I can't take it.'
Christine, who lives in Fulham, West London, and is a retired psychotherapist, has been similarly incapacitated since she had the mesh inserted in 2002.
'I have been told it's far too dangerous to try to take it out,' she says. 'I could end up with a colostomy bag, which is not an attractive prospect at all.
'I have had a huge amount of pain — every time I went to the loo, and constant urinary tract infections from it,' she says. 'It turned out the mesh was eroding into my urethra.
'It was treated by burning or melting bits off the plastic with an internal laser, which has been done four times. The first was ten years ago. I had a second procedure six months later and a third two years after that.
'Then more bits started to stick into my bladder, and I had a fourth laser treatment five years ago. Now, every time I get a twinge, I worry I'm in for more agony.
'I found a specialist urogynaecologist at St George's Hospital in Tooting, South London, who knew how to do the lasering. But he went to Singapore and I worry that if it happens again there will be no one who knows what to do.'
Helen, 54, who has three children and lives in Sussex, says she had the mesh put in ten years ago for stress incontinence.
'At first it seemed to work, but within six months it moved out of place and I began to have problems going to the loo,' she says. 'I started getting urge incontinence, where the bladder goes into a spasm and shoots urine out at high pressure. It was terribly painful because your bladder is trying to expel it faster than it can.
'I was diagnosed with irritable bladder syndrome and for years I had treatment every six months to stretch my bladder, but the symptoms just got worse.
'Sex became incredibly painful but I was told that was all down to the menopause.'
Helen finally went to see a specialist who discovered the mesh was strangling the ureter where it goes into the bladder.
'On the ultrasound, it looked like a grape — so swollen that it was about to burst,' she says.
'And some of the tape was sticking into my vagina, which was why sex was painful.
'I had swelling round my ankles, wrists and face; my ankles looked as if they were broken. This was because the urine was being pushed back into my kidneys and causing inflammation and fluid retention.
'The surgeon said he would take out all the tape, which would get rid of the pain, but that the incontinence would return because my bladder wouldn't be strong enough to contain the urine.' The surgeon explained he would then use some of her labia to replace the tape.
'I had the first operation and it was a huge success — the pain has completely gone and I look as if I have lost half a stone,' says Helen. 'At the moment my bladder can't hold more than a teacup of urine — but at least I'm not in pain and it doesn't come shooting out.'
Jackie, 50, a civil servant and mother-of-two who lives in Banbridge, Co. Down, Northern Ireland, set up an Irish branch of the women's pressure group Sling The Mesh in 2016. Within three years her network grew from 50 to 600.
Jackie had the mesh implanted after giving birth in 2005.
'It worked fantastically with no side-effects for seven years, then it began to deteriorate and I was in terrible pain,' she says.
In 2015, she went back to the surgeon — but 'she refused to believe it was the cause of my pain and said my problems were nothing to do with the mesh'.
Jackie then paid £800 for an ultrasound scan which showed the mesh was in the wrong place — but still, she says, she wasn't believed. When a rheumatologist diagnosed her with fibromyalgia — a condition characterised by
widespread pain — she was put on a waiting list to see a specialist. But it was the same specialist who'd already told her there was nothing wrong with her.
'There was no point waiting to see someone who was almost certain to turn me away again,' she says. 'I had a life to live and I wanted to live it.'
Last year, Jackie paid £7,000 to have the mesh removed privately by Natalia Price, a surgeon who also works in the NHS in Oxford and who'd been recommended by other patients.
'Although it was instant relief from the pain, I'm now getting nerve problems with my back and legs,' she says.
Helen is due to have an expert pelvic repair with the old-fashioned stitching method, using the patient's own tissue. However, the introduction of the mesh means very few gynaecologists or urologists now have the specialist skills required for this intricate surgery.
More than 6,000 women have come forward via the Sling The Mesh pressure group complaining of damage from implanted surgical mesh.
In July, the NHS agreed to suspend the use of mesh for incontinence but the British Society of Urogynaecology, which represents most of the surgeons using the mesh, then issued a statement claiming 95 per cent of mesh implant operations were problem free.
As things stand, NHS England is still meant to be deciding on the criteria for specialist mesh removal centres.
However, some senior doctors predict that the consultation — which may result in as few as five recognised centres — will lead to a turf war as specialists bicker over who has the right to the jobs and the lucrative NHS contracts.
Meanwhile, a subgroup of the Royal College of Obstetricians and Gynaecologists (RCOG) has circulated a list of 25 centres where there are urogynaecological surgeons.
But in a letter sent to the centres last July, David Richmond, president of the RCOG, warned: 'Being on the list does not endorse competency but merely compliance with correct personnel and agreement to correct processes.' Mr Belal suggests there are still going to be long waiting lists.
'The repairs using the women's own tissue do not always work, and because of the introduction of the mesh, we now don't have a sufficient body of people able to do the treatment,' he says
Kath Sansom, who runs Sling The Mesh, said: 'We want a national standalone centre where doctors have the right skills and training, and patients can feel safe.
'At the moment, there are only five specialists in the country who we think have the necessary expertise and we would recommend. We want to see a programme where these surgeons are used to train others.'
https://www.dailymail.co.uk/health/article-6900685/Victims-national-mesh-scandal-reveal-agony-housebound-pain-20-years.html
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Apr 8, 2019 | Telegraph
A woman who tried to claim £2.5m from the NHS after claiming that having vaginal mesh fitted had left her in constant pain has been sent to prison after pictures showed her enjoying her daughter's Ibiza hen party
Lesley Maria Elder, 50, from Poole, Dorset, was caught after photos on social media showed her taking part in the celebrations in night clubs on the party island.
Elder claimed she was left disabled by constant pain following a vaginal mesh operation and could no longer work or do routine tasks without help.
She sued the George Eliot Hospital NHS Trust in Nuneaton, where she underwent the surgery in 2010, for £2.5 million.
But a judge found she had "grossly, dishonestly and repeatedly" exaggerated her symptoms.
Undercover surveillance also showed Elder was able to go shopping and to walk her dog regularly, without the aid of a walking stick.
Elder was jailed for five months at the High Court in London for contempt of court over her false claims.
She was sentenced in her absence.
Judge Karen Walden-Smith said: "This was a deliberate and persistent making of false statements for the purpose of falsely recovering significant monies from a publicly-funded body."
The court was told Elder suffered a genuine injury as a result of the surgery, which it later transpired was not necessary because she had been misdiagnosed.
The NHS trust admitted liability but disputed the amount she claimed, and a judge at a county court in 2017 ruled she was entitled to just £120,000 instead.
https://www.telegraph.co.uk/news/2019/04/08/woman-tried-claim-2m-nhs-sent-prison-pictures-show-daughters/
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Lesley Elder jailed over false £2.5m NHS claim
Apr 8, 2019 | BBC News
A woman who tried to cheat the NHS out of more than £2m by exaggerating injuries from botched surgery has been jailed after she was spotted at a hen party in Ibiza.
Lesley Elder, 50, from Poole, Dorset, claimed she was left in constant pain after a vaginal mesh operation.
She sued the George Eliot Hospital NHS Trust in Nuneaton, where she underwent the surgery in 2010, for £2.5m.
Elder was jailed for five months at the High Court for contempt of court.
The court heard Elder suffered a genuine injury as a result of the surgery, which it later transpired was not necessary because she had been misdiagnosed.
Judge Karen Walden-Smith found she had "grossly, dishonestly and repeatedly" exaggerated her symptoms after photographs appeared on Facebook of her at her daughter's hen party in the Spanish resort.
'Deliberate and persistent'
She had claimed to be "isolated and dependent on others for routine tasks", but undercover surveillance showed she was able to go shopping and to walk her dog regularly, without the aid of a walking stick.
The NHS trust admitted liability but disputed the amount she claimed, and a judge at a county court in 2017 ruled she was entitled to just £120,000.
It brought committal proceedings against her at the High Court over the lies she had told during the county court case.
Passing sentence at the High Court, Judge Walden-Smith said: "This was a deliberate and persistent making of false statements for the purpose of falsely recovering significant monies from a publicly funded body."
The sentencing was delayed after Elder appeared to take a number of pills shortly before the judge came into court.
She was taken to hospital and the hearing went ahead in her absence.
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Woman who sued NHS for £2.5m after botched surgery spotted PARTYING on Ibiza hen do
Apr 8, 2019 | Daily Star
By Sian Harrison
Lesley Maria Elder, 50, from Poole, Dorset, claimed she was left disabled by constant pain following a vaginal mesh operation and could no longer work or do routine tasks without help.
She sued the George Eliot Hospital NHS Trust in Nuneaton, where she underwent the surgery in 2010, for £2.5million.
But a judge found she had “grossly, dishonestly and repeatedly” exaggerated her symptoms after photographs appeared on Facebook of her at her daughter’s hen party in the Spanish resort.
Undercover surveillance also showed she was able to go shopping and to walk her dog regularly, without the aid of a walking stick. Elder was jailed for five months at the High Court in London for contempt of court over her false claims.
She was sentenced in her absence after apparently taking an overdose of painkillers in court shortly before the hearing started.
Judge Karen Walden-Smith said: “This was a deliberate and persistent making of false statements for the purpose of falsely recovering significant monies from a publicly-funded body.”
The judge said only immediate custody was possible, given the “great seriousness” of the contempt committed by Elder.
She added: “This was an attempt to effectively defraud the NHS of a sum of more than £2million – public funds which are desperately needed for frontline services.”
The judge told the court Elder suffered a genuine injury as a result of the surgery, which it later transpired was not necessary because she had been misdiagnosed.
Judge Walden-Smith said Elder’s claims involved “extensive and widespread exaggeration and lies” – including her assertion that she could not go to her daughter’s hen party when in fact she was there and “fully participating”.
The judge said her mitigation included the fact she had suffered actual harm as a result of the unnecessary surgery and her previous good character.
She had also donated a kidney to her ex-partner to prevent her daughter from having to do so, which has had a further impact on her health.
The sentencing was delayed after Elder appeared to take a number of pills shortly before the judge came into court. She was taken to hospital and the judge went ahead with the hearing in her absence. Elder is likely to be released from prison after serving half her sentence.
The NHS trust admitted liability but disputed the amount she claimed, and a judge at a county court in 2017 ruled she was entitled to just £120,000.
Judge Iain Hughes QC rejected her claims that she had become isolated and dependent on others for routine tasks including housework and shopping following the surgery.
He found she had not suffered the significant disability she alleged after surveillance footage showed her walking unaided, visiting the zoo with her grandson and shopping.
The NHS Trust brought committal proceedings against her at the High Court over the lies she had told during the county court case.
https://www.dailystar.co.uk/news/latest-news/770811/ibiza-hen-do-george-eliot-hospital-nhs-trust-surgery-nuneaton-lesley-maria-elder
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Jailed: £2.5m NHS con mum caught partying at hen do
Apr 8, 2019 | Metro
A MOTHER who tried to cheat £2.5million out of the NHS by exaggerating injuries from botched surgery has been jailed after she was spotted at a hen party in Ibiza.
Lesley Maria Elder, 50, claimed she was left disabled by constant pain after a vaginal mesh operation and could no longer do routine tasks without help.
She sued the George Eliot Hospital NHS Trust in Nuneaton, Warwickshire, where she had the surgery in 2010.
But a judge found she had ‘grossly, dishonestly and repeatedly’ exaggerated her symptoms after photos appeared on Facebook of her at her daughter Tania’s hen do in the Spanish resort.
Undercover surveillance also showed she was able to go shopping and to walk her dog without the aid of a walking stick.
Elder, of Poole, Dorset, was jailed for five months at London’s High Court for contempt of court over her false claims. She was sentenced in her absence after apparently taking an overdose of painkillers shortly before the hearing began.
Judge Karen Walden-Smith said: ‘This was an attempt to effectively defraud the NHS of a sum of more than £2million — public funds which are desperately needed for frontline services.’ The judge told the court Elder suffered a genuine injury as a result of the surgery, which it later transpired was not necessary because she had been misdiagnosed.
The NHS trust admitted liability but disputed the amount she claimed, and a judge at a county court in 2017 ruled she was entitled to just £120,000. The trust brought proceedings against her over the lies she had told.
Helen Vernon, chief executive at NHS Resolution, said: ‘Fraudulent claims for compensation against the NHS take money away from patient care. We are pleased that the seriousness of this case has been recognised by the courts.’
https://www.metro.news/jailed-2-5m-nhs-con-mum-caught-partying-at-hen-do/1511814/
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NHS to face legal action if mesh restrictions are ignored
Apr 9, 2019 | Med-Tech Innovation News
By Reece Armstrong
NHS Trusts could face legal action if they do not enforce ‘high vigilance restrictions’ in the use of mesh following new guidance published by the National Institute of Clinical Excellence (NICE).
The new guidelines, which were met with criticism and dismay by mesh campaigners and politicians, lift a previously imposed ban on mesh products for stress urinary incontinence (SUI) and pelvic organ prolapse (POP), and now allow implants to be used as long as the patient is fully aware of the risks.
Now, prominent campaign group Sling the Mesh has sought legal advice from Thompsons Solicitors in an attempt to ensure no more patients are put at risk.
The legal advice given states that the new NICE guidelines cannot act as a ‘green light’ for surgeons to start using mesh as doing so would be unlawful.
Last year, baroness Cumberlege who chairs an independent review into side effects from mesh, recommended ‘high vigilance restriction’ on surgical mesh until a range of criteria could be met.
The restrictions (below) were imposed by the NHS, with individual Trusts now facing potential legal action if they do not adhere to the restrictions set out by baroness Cumberlege.
· Surgeons should only undertake operations for stress urinary incontinence (SUI) if they are appropriately trained, and only if they undertake operations regularly;
· Surgeons must report every procedure to a national database;
· A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;
· Reporting of complications via Medicines and Healthcare products Regulatory Agency (MHRA) is linked to the register;
· Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh;
· NICE guidelines on the use of mesh for SUI are published.
A letter sent out by Sling the Mesh and Thompsons Solicitors to the NHS states that the NICE guidelines ignore the evidence-based views that led to mesh’s original restriction back in July 2018. In particular, they argue that the updated NICE guidelines cannot come back into effect until all the all the conditions in restriction have been satisfied.
More so, Sling the Mesh and Thompsons Solicitors argue that NICE guidelines risk causing confusion for patients and surgeons, making them potentially liable to make uninformed surgical decisions.
Linda Millband, lead lawyer for clinical negligence at Thompsons Solicitors, said: “We know that more people will be harmed if mesh comes back into use. NHS England and every Trust need to understand that they can only implement the new NICE guidelines when all six of the conditions set out in July 2018 are met and if they start to use mesh again having failed to meet all those conditions, we will sue them.”
"Any Trust seeking to restart mesh use isn't just putting the cart before the horse - the cart is still in flat pack,” Millband added.
Kath Sansom, director of campaign group Sling the Mesh, said: “We expect baroness Cumberlege to reach a different conclusion to NICE. We have taken advice from Thompsons Solicitors and to make sure that no more patients are put at risk letters are going to NHS England and every hospital Trust making clear that the new guidelines are not a green light to restart the use of mesh, and that the July 2018 restrictions remain in place.
“NHS Trusts can easily avoid legal action, they simply have to confirm that, as we are absolutely confident is the case, having not met any or all of the six conditions attached to the July 2018 restriction, they will not be restarting use of mesh.”
https://www.medicalplasticsnews.com/news/nhs-trusts-could-face-legal-action-over-use-of-surgical-mesh/
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Apr 8, 2019 | The Independent
By Athena Lamnisos
We thought we might see the beginning of the end of unnecessary products when Goop agreed to settle for $145,000 for making unproven scientific claims about its vaginal eggs. It seems not.
“Feminine hygiene” is on a roll. The global market is predicted to reach $42.7bn in revenue by 2022 (more than a 6 per cent growth since 2016).
Now, I’m delighted that the vulva and the vagina are getting more attention – indeed, as CEO of gynaecological charity, The Eve Appeal, we’ve worked with a gynae army of clinicians, charities and women’s health experts who are all working to reduce the stigma and taboos that surround female reproductive health. We launched the Vagina Dialogues in 2014 and led the taboo-busting way, helping women understand their own bodies and not be too embarrassed or ashamed to seek medical advice or be seen by doctor if they think something is wrong.
Front and central to changing behaviour and the culture around gynae health are three principles: 1) using proper, anatomical words for parts of the body is vital – there is strong evidence that the use of euphemistic and silly language is a barrier to women knowing their own bodies; 2) ensuring all information is factual and based on clinical evidence; and finally – 3) this is not just a conversation for women.
To break culture around these taboos, everyone must be included. So why does a gynae cancer charity focused on prevention care so truly, madly, deeply about all this?
Our ambition is to stop these cancers before they start. The symptoms for the five gynae cancers are all different but if you don’t equip people with the language and the knowledge to know their normal, recognise changes to bleeding, discharge, skin colour and appearance, pelvic pain, changes to bowel and urinary habits – then they won’t know when something is wrong and get themselves to the doctor or seek further information.
Our research tells us that women are woefully unaware of what is going on inside their pelvis or between their legs. According to latest stats from YouGov, nearly one in five women think that they urinate and menstruate from the same hole.
We hear from women who are aware of the signs of ovarian cancer but who haven’t been to the doctor when they’ve experienced these symptoms because they’ve had a hysterectomy, so mistakenly believe they can’t be at risk (a hysterectomy most commonly removes the womb NOT the ovaries).
There is no evidence – not a shred – that we NEED special vaginal washes. We do not work with a single gynaecologist or GP who recommends them. We’ve just done some research with over 1000 health care professionals – they don’t recommend them either.
The reason is clear: they aren’t necessary, they can cause infections, and most worrying, can mask symptoms like itching and then delay a woman seeking medical advice when something may be wrong.
Just talk to a women who has suffered from lichen sclerosis and then been diagnosed with vulval cancer some years later. She will tell you the harm that can be done from concealing symptoms and not finding the underlying cause or understanding the risks.
Everyone is aware of body shaming (too fat, too thin) – it still happens, but there’s an acceptance that it’s wrong. “Internal body shaming” happens around women’s bodies – it’s the embarrassment that stops women attending screening, the shame that allows some to accept profuse and heavy bleeding without seeking help, and the stigma that makes them pause when they notice that their discharge smells and looks different, but not ask for advice.
We see the consequences of this in so many reproductive health issues – late diagnosis of endometriosis, the vaginal mesh scandal and at Eve, in delayed diagnosis of gynaecological cancers. If you want to use special hygiene products – go right ahead, spend your pounds on the full range of wipes, exfoliators, douches, highlighters (yes, highlighters) and masks (yes, masks, for your vulva) making it on to the market – just don’t believe that it’s necessary or good for your health. And be aware that you’re literally being sold shame in a bottle.
The language used – “hygiene”, “intimate”, “discrete”, perpetuates the myth that a woman's body is an embarrassing place and you need to prepare it to make an appearance – even to a doctor or nurse.
Athena Lamnisos is CEO of The Eve Appeal
https://www.independent.co.uk/voices/feminine-hygiene-gynaecological-cancer-women-goop-gwenyth-paltrow-a8859836.html
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Litigation funder Burford raises $300 million for post-settlement deals
Apr 8, 2019 | Reuters
By Alison Frankel
When I first read an announcement Monday from Burford Capital, I thought the tectonic plates of litigation finance had shifted.
The industry, as you know, is really two different businesses: funders such as Burford, Harbour, IMF Bentham and Therium, which invest in commercial litigation in exchange for a cut of any recovery; and consumer operations, like Oasis and Lawcash, that advance money to plaintiffs at relatively high interest rates. The business models are completely different. Making money on the commercial side requires exhaustive due diligence about big-money litigation and arbitration. The consumer model, in which advances are vastly smaller, takes much less vetting but way more volume.
Burford’s press release Monday announced a new $300 million fund focused on investments in cases that have already settled. The fund, it said, would “meet the needs of law firms awaiting payment of their fees and clients eager to release cash from the settlement, who find it attractive to secure financing against those expected receipts.” Advances to clients waiting for their settlements to come through? Was Burford getting into the consumer business?
Burford CEO Christopher Bogart set me straight in an interview about the new fund: The market for those advances, he said, is not consumers but businesses engaged in the sort of big cases Burford typically finances. And the law firms that obtain advances against their receivables, Bogart said, are expected to be mostly commercial litigation shops already working with the litigation financier. The new fund, he said, is not a mass torts play, although Bogart said Burford would not rule out funding for a plaintiffs firm based on its anticipated contingency fees.
“This is a service for our clients,” Bogart said. “It’s not particularly lucrative for us. We’re doing this because our clients want it.” Burford will charge “single-digit” interest rates to law firms and clients that receive funding based on post-settlement receivables, Bogart said. Such investments carry very little risk but also present less upside than funding a case in exchange for a share of the recovery. Bogart analogized Burford’s role in post-settlement funding to that of a bank offering a loan with settlement receivables as collateral, although litigation financiers typically structure funding agreements to avoid banking regulations.
Burford previously inherited a $400 million post-settlement fund when it acquired the litigation financier Gerchen Keller in 2016. That fund expired this year. The newly announced fund is its successor. (The Gerchen Keller post-settlement fund ran into controversy in early 2016, when the former business development officer of a Texas plaintiffs' firm said in a lawsuit against the firm that Gerchen Keller had paid $45 million to acquire a docket of pelvic mesh claims of allegedly suspicious origin; Gerchen Keller declined to comment on the lawsuit, which was settled confidentially.)
Burford’s new fund did not go unnoticed by longtime foes of litigation funding. John Beisner of Skadden Arps Slate Meagher & Flom, who frequently represents the U.S. Chamber’s Institute for Legal Reform, said there’s a “possibility for mischief” when a funder provides money to both law firms and law firm clients.
ILR and its allies have been ferociously lobbying the federal judiciary’s Committee on Rules of Practice and Procedure to amend civil procedure rules to require the disclosure of litigation funding agreements. It’s a good bet that litigation funding opponents will find some way to argue that Burford’s new fund is yet another justification for transparency.
https://www.reuters.com/article/us-otc-funding/litigation-funder-burford-raises-300-million-for-post-settlement-deals-idUSKCN1RK2AU
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