Preview Newsletter
Ethicon Media Monitoring 8/16/2017
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Lawyers to Mesh Plaintiffs – Settle or Be Dropped!
Aug 15, 2017 | Mesh Medical Device Newsdesk
Mesh News Desk is hearing from countless women who are being threatened with no option but to settle their transvaginal mesh case, even when the numbers do not come close to being a reasonable settlement for what she has endured. -
Concern over vaginal mesh implant risk to mothers
Aug 16, 2017 | The Times
By Kat Lay
About one woman in 15 fitted with a device to help with complications after childbirth later has it removed, according to new figures. -
'Scandal' of vaginal mesh removal rates revealed by NHS records
Aug 15, 2017 | The Guradian
By Hannah Devlin
Traumatic complications mean one in 15 women fitted with the most common type of mesh support will require surgery to extract it, figures suggest -
Vaginal mesh implants: 'I really thought I was dying'
Aug 15, 2017 | The Guradian
By Hannah Devlin
Six years ago, Carolyn Churchill, 57, from near Pontypridd in Wales, was in a long-term relationship, worked as a chef, and spent hours each week walking with her dogs and looking after her granddaughter’s pony. She was busy and content, but was bothered by stress incontinence, which affects roughly 10% of women. -
Doctors accused of accepting benefits to push controversial vaginal mesh implants - with one manufacturer paying out more than $4m - despite procedure destroying lives of thousands of women
Aug 15, 2017 | The Daily Mail
By Alexandra Thompson
Doctors have been accused of accepting benefits to encourage women to have controversial vaginal mesh implants fitted. -
Vaginal Mesh ‘Scandal’ As Thousands Forced To Have Implants Removed Due To Complications
Aug 15, 2017 | HuffPost UK
By Rachel Moss
Thousands of women have been forced to have surgery to remove vaginal mesh implants due to complications, NHS records suggest. -
Calls for national register of surgical devices
Aug 15, 2017 | ABC Online
By Sophie Scott
The Federal Government is coming under increased pressure to create a national register of medical devices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Lawyers to Mesh Plaintiffs – Settle or Be Dropped!
Aug 15, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 15, 2017 ~ Mesh News Desk is hearing from countless women who are being threatened with no option but to settle their transvaginal mesh case, even when the numbers do not come close to being a reasonable settlement for what she has endured.
Some of that is due to the nature of this litigation, negotiate with the defendant mesh makers to move cases through the court rather than making whole the individual, as a trial is more likely to do, understanding that mesh injuries are often permanent.
MND finds that lawyers threatening to drop their clients may be in violation of their ethical obligations.
SETTLE OR BE DROPPED!
According to a January 10, 2017 order (Ethicon Jan 10 2017), by Judge Joseph Goodwin, who is overseeing the mesh litigation in his federal court in Charleston, WV, more than 100 lawsuits filed against Ethicon have been put on the inactive list.
The reason – the plaintiff (and her representatives) and Ethicon “have agreed to a settlement model with regard to Ethicon.”
This did not necessarily mean that the plaintiff agreed to the settlement. Her law firm might have agreed in principal to settle. Then it is up to her law firm to convince the client to accept the terms the defendant is offering.
The mesh manufacturers generally demand 95% of the group agree to an amount being offered. If there is agreement, Judge Goodwin said the Plaintiffs and Ethicon “may submit an agreed order of dismissal with prejudice on or before July 1, 2017.” An August ruling extended that deadline to October 1, 2017. Ethicon Doc #4401 here.
That means the case is over and cannot be resubmitted.
But what if the mesh-injured plaintiff doesn’t agree to the settlement dollars? After insurance and Medicare is paid, medical bills and any loans, the 5% common benefit fund and a bit withheld for later – some of those checks are pretty lean. MNDhas even seen settlement checks under $2,000.What if the mesh-injured says no to the settlement?
The Court will hold a hearing to determine the appropriate action. One of the avenues would be to reinstate the claim to the active docket of the multidistrict litigation (MDL) for good cause.
“Good cause includes, but is not limited to, a plaintiff’s refusal or inability to consummate settlement. Such motion must be accompanied by an affidavit from plaintiff explaining such refusal or inability.”
Judge Goodwin said the counsel for plaintiffs and defendants were supposed to provide quarterly reports to clients as progress was being made in the case.
THREATSOne plaintiff on the list of 126 plaintiffs, we’ll call her “Suzy” tells MND she received no updates. She did, however, receive calls telling her her only option was to settle for the amount offered or the law firm would drop her case.
She does not want to settle for the amount she is being offered. Suzy is catastrophically injured and will need a lifetime of care due to damage from her Ethicon pelvic mesh implant. A number of clients have also complained about their law firm gave them a June 30th date to accept or reject the settlement offers.
Some plaintiffs tell MND they refused the settlement offer. What then? MND reached out to Suzy’s law firm that has set a date for settlement looking for comment but there was no response. There are a number of plaintiffs’ firms engaged in the same practice.
DROP THE CLIENT, SAYS MESH MAKER
It is not widely known, but at least one mesh manufacturer is heavily influencing how plaintiffs’ firms treat their clients.
In one confidential settlement agreement, obtained by MND, the push to drop the client is stipulated by the defendant mesh manufacturer.
It says the plaintiffs’ lawyer agrees “to take all necessary steps to disengage and withdraw from the representation of any Claimant who declines a settlement offer under this Master Settlement Agreement or who fails to provide an executed Release.”
This is in direct conflict with the model rules of professional conduct. The right to settle or not remains firmly with the client!
Forcing a lawyer representing the mesh injured runs afoul of the Model Rules of Professional Conduct 1.2 (a), which requires lawyers to abide by their client’s decision.
Elizabeth Burch, a law professor at the University of Georgia tells MND, ”As I’ve written in the past, it’s my opinion that withdrawal provisions are unethical. The limited mesh settlements that I’ve examined all contain mandatory recommendation and withdrawal provisions, which require the attorney to recommend the deal to all of her clients and to then withdraw from those who refuse.”
Professor Burch continues, “Lawyers may withdraw for no reason at all if it won’t have a materially adverse effect on the client’s interests. But in circumstances like these, it becomes very hard to find replacement counsel. Finally, according to rule 5.6(b), lawyers can’t participate in making an agreement that restricts the lawyer’s right to practice as part of settling a client’s case.”
DEFENSE SAYS DISENGAGE
As if suggesting the plaintiffs’ lawyer force a settlement even when it may not be in the clients’ best interest, one mesh maker goes even further to dictate how lawyers represent their clients.
On page 42 of one Master Settlement, it admits it cannot tell those lawyers how to practice law, but as part of the agreement it requires law firms to agree, “that they have no present intent to solicit or represent new clients for the purpose of bringing Claims against (the mesh maker) in connection with (the mesh maker’s) Mesh Products or (the mesh makers) Mesh Product Injuries.”
The documents dictate plaintiff’s firms will agree that they will not actively solicit prospective mesh clients through the media including television, radio or websites, either directly or indirectly.
CONSENT VERSUS CLOSURE
Professor Howard Erichson, at Fordham, has written a good bit on the ethics of agreements like this.
Published in the Cornell Law Review, Consent versus Closure (here), Erichson asks “if a lawyer wishes to withdraw from a client who declines a recommended settlement, may the lawyer terminate the relationship?”
Erichson notes Rule 1.16(b) says yes, the lawyer can, “if the withdrawal will have no material adverse effect on the interests of the client.”
For example, in the Vioxx litigation, an injured client searching for a replacement lawyer wouldn’t find one because all of the firms agreed to get out of Vioxx litigation. Obviously then, it would present a hardship to the client/plaintiff.
But a law firm can withdraw if the client insists on taking an action that the law firm disagrees with, if the action will burden the lawyer financially, and if there is any other good cause for withdrawal, such as a fundamental disagreement.
However, it bears repeating that the client is in charge and it ultimately is his or her decision whether to accept or reject a settlement.
The general rule is that the lawyer may not withdraw because the client refuses to settle.
The client may fire his/her lawyer, but according to Erichman, “Cases overwhelmingly reject the idea that a lawyer may fire a client for declining a settlement against the lawyer’s advice.” P.287
“The lawyer may not burden the client’s ability to make settlement decision by structuring the representation agreement so as to allow the lawyer to withdraw, or to ratchet up the cost of representation, if the client refused an offer of settlement.”
STATUTE OF LIMITATIONS
There is an additional complication if the law firms drops a case.
In some litigation, Mesh News Desk has learned that a complaint was never filed in her case, not even a short form as a placeholder.
Unless there is a tolling agreement, the statute of limitations continues, according to a lawyer handling mesh claims.
Under that circumstance, the injured plaintiff will never be able to find another law firm because her statute of limitations may have expired. ###
https://www.meshmedicaldevicenewsdesk.com/lawyers-mesh-plaintiffs-settle-dropped/
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Concern over vaginal mesh implant risk to mothers
Aug 16, 2017 | The Times
By Kat Lay
About one woman in 15 fitted with a device to help with complications after childbirth later has it removed, according to new figures.
Experts described the removal rate of vaginal mesh implants, which are used to treat urinary incontinence and prolapse after childbirth, as “a scandal”.
Senior doctors last month called for a public inquiry into the use of vaginal mesh surgery in Britain.
While the procedure works well for many women, others complain of “cheese wire” pain, a loss of sex life and many even require the removal of organs because of further complications.
Removal is a major operation as the mesh implants are designed to be permanent and become embedded in surrounding tissue.
Figures obtained by The Guardian show that between 2006 and 2016 there were just over 75,000 trans-vaginal tape implants fitted and 4,900 procedures to remove them — a removal rate of about 6.5 per cent. A government report in 2014 estimated the rate was only 0.9 per cent.
Sohier Elneil, a consultant urogynaecologist at University College Hospital, said the removal rate was a “scandal” and that the patients involved would be those with more serious complications.
The Medicines and Healthcare products Regulatory Agency said: “We are not aware of evidence which would lead to the conclusion these devices are inherently unsafe if used as intended.”
https://www.thetimes.co.uk/article/concern-over-vaginal-mesh-implant-risk-to-mothers-xml2snd5l
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'Scandal' of vaginal mesh removal rates revealed by NHS records
Aug 15, 2017 | The Guradian
By Hannah Devlin
Traumatic complications mean one in 15 women fitted with the most common type of mesh support will require surgery to extract it, figures suggest
Thousands of women have undergone surgery to have vaginal mesh implants removed during the past decade, according to NHS records that reveal the scale of traumatic complications linked to the devices.
The figures, obtained by the Guardian, suggest that around one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted due to complications.What's your experience of vaginal mesh implants?
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Sohier Elneil, a consultant urogynaecological surgeon at University College Hospital, London, who has carried out hundreds of removal procedures, described the removal rate as a “scandal”, adding that these patients were likely to represent those with more serious complications.
Another surgeon, Mark Slack, a consultant gynaecologist at Addenbrooke’s Hospital Cambridge, who has previously defended the benefits of mesh surgery, said he was “absolutely shocked” by the failure rate, although he questioned whether the figures for complete removals could be an overestimate.
The implants have been widely used as a simple, less invasive alternative to traditional surgical approaches for treating urinary incontinence and prolapse, conditions that can commonly occur after childbirth. For the majority of women the operation is successful.
However, concerns are mounting over the severe complications suffered by large numbers of patients, including chronic pain, mesh cutting through tissue into the vagina and being left unable to walk or have sex. Johnson & Johnson, whose subsidiary Ethicon produces one of the most widely used mesh products, is fighting a major class action in Australia and could face legal proceedings in the UK.
In the past decade about 1 in 15 of all women who have had this mesh introduced have had it partially or fully removed
In Scotland, the use of mesh devices was suspended in 2014 pending a review, and the US Food and Drug Administration has issued safety warnings about the risks of mesh surgery. The NHS maintains that the available evidence supports the continued use of the devices to treat incontinence, but its own records raise questions about whether some patients are being exposed to unacceptable risks.
NHS Digital records show that between 2006 to 2016 just over 75,000 trans-vaginal tape (TVT) implants – the most common kind – were fitted. During the same period, more than 4,900 procedures were carried out to remove TVT implants – around 6.5% of the number put in.
More than 1,000 removals were also carried out for a second type of mesh, called transobturator tape (TVT-O), which had been inserted into 44,000 women over the ten year period. Johnson & Johnson are understood to produce the majority of vaginal mesh products used in the UK.
The figures imply much higher complication rates than those typically reported in both short-term clinical trials and a 2014 government report assessing the risks and benefits of vaginal mesh, which estimated the removal rate for TVT at 0.9% and the rate of complications, such as pain, at below 1.5%.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, said: “What this is showing is significant, very high rates of removals, which are only likely to get worse. It suggests that one in 15 women will need a removal at some point.”
TVT implants have been widely used across Europe and in the US since the early 2000s, when they started to be favoured over traditional open-surgery procedures, which took longer to perform, involved a lengthier recovery for patients and were associated with their own range of complications. A TVT procedure typically takes 3o minutes and is performed using keyhole surgery. Patients often go home the same day and trials have found impressive success rates for resolving incontinence.
Elneil said that many patients believe the procedure will be a “simple and easy fix” for a distressing problem. “A lot of patients weren’t worried, they thought: ‘I’ll be back in work next week,’” she said. “The removal is a completely different story.”
After being placed in the body, the plastic mesh becomes embedded in the surrounding tissue and is designed to be permanent. Full removal can require hours of surgery and can risk damage to nerves and nearby organs, including the bladder and bowel. According to NHS figures, 1,769 complete removal procedures have been carried out since 2006.
Slack explained: “You go in vaginally and take out the mesh there, then you go in through the tummy and chisel out the mesh with some difficulty. It’s very much not within the skill mix of the vast majority of surgeons.”
The surgeon said that the figure for partial removals (3,137 since 2006) is consistent with his clinical experience that “we are taking out snippets of mesh here, there and everywhere on a weekly basis”. However, he questioned whether the figures for complete removals, which are far higher than he expected, could be an overestimate due to misreporting by doctors.
Yet a recent survey of UK gynaecologists appears to support the NHS figures.
In a statement, Johnson & Johnson said: “We empathise with those patients who have had complications associated with pelvic mesh procedures, but we believe it is important to recognise that their experiences do not speak for the vast majority of women whose lives have been improved through treatment with pelvic mesh devices.”
The Medicines and Healthcare products Regulatory Agency (MHRA) said no device was without risk. It added: “In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of evidence which would lead to the conclusion these devices are inherently unsafe if used as intended.”
If you are a woman who has experienced problems with a mesh implant, these can be reported to the MHRA. The British Society of Urogynaecology has compiled a list of units with experience in treating mesh complications.
https://www.theguardian.com/society/2017/aug/15/scandal-of-vaginal-mesh-removal-rates-revealed-by-nhs-records
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Vaginal mesh implants: 'I really thought I was dying'
Aug 15, 2017 | The Guradian
By Hannah Devlin
Six years ago, Carolyn Churchill, 57, from near Pontypridd in Wales, was in a long-term relationship, worked as a chef, and spent hours each week walking with her dogs and looking after her granddaughter’s pony. She was busy and content, but was bothered by stress incontinence, which affects roughly 10% of women.
“Never knowing when you’re going out if you’re going to wee yourself. It really got to the stage where it was embarrassing,” she recalls.
She was referred to a specialist who advised a TVT mesh implant, which Churchill believed would be a quick fix. As the epidural wore off after surgery, though, she immediately felt something was amiss. “I was in absolute agony, but they wouldn’t listen to me and made me feel like some sort of baby, and that it was normal,” she says. “If I could have walked to the A&E that night, I would’ve begged them to take it out.”
Churchill experienced “ripping, burning” pains in her side and legs, numbness in the soles of her feet and suddenly found it impossible to bend over. Three months after the initial surgery, she had to leave her job. “It’s very difficult to explain, particularly if your boss is a man,” she says.
For months she could not contemplate sex with her partner of 14 years.
“When we actually managed it, my partner said ‘What the hell is that?’” she recalls. Churchill discovered the mesh had eroded the wall of her vagina and poked through. “I was horrified,” she says.
She had surgery under general anaesthetic to cut away the protruding mesh, but her other symptoms did not improve. Doctors appeared reluctant to accept that the implant could be to blame, though.
“I was sent for hip X-rays, I was sent for physiotherapy, which made the pain worse. They offered me mental health counselling,” she says. “They even sent me to the GUM [sexual health] clinic for counselling on having sex. I said, ‘It’s not that I don’t want to ...’.”
Cancer was investigated as a possible explanation for persistent bleeding, she says. “I was terrified because I lost my sister to cancer, and my mother. I kept thinking, ‘I have got it but they can’t find it’. I really thought I was dying.”
She describes the prevailing attitude as “there’s nothing wrong with the mesh – it’s you”.
When she asked if she could have the mesh taken out, she was told this was not guaranteed to stop the pain – and that removal carried its own risk of complications. “It was hell trying to make that decision,” she says.
Churchill finally had her mesh fully removed in May 2016, a major surgical procedure with a lengthy recovery period.
Today, she feels better physically, but remains traumatised and says her life has been permanently altered by her experience. She talks of lost time with her grandchildren and how caring for her 93-year-old father has been a struggle. Her relationship broke down and she is unsure if she will work again.
Who does she blame for her experience? “I think the government should take responsibility,” says Churchill. “When there was all the problems with breast implants they stood up and said it would never happen again. And all that time, it was already happening to thousands of us. I want someone to stand up and say sorry for what they’ve done to us.”
If you are a woman who has experienced problems with a mesh implant, these can be reported to the MHRA. The British Society of Urogynaecology has compiled a list of units with experience in treating mesh complications.
https://www.theguardian.com/society/2017/aug/15/vaginal-mesh-implants-i-really-thought-i-was-dying
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Aug 15, 2017 | The Daily Mail
By Alexandra Thompson
· Manufacturer-sponsored studies are more likely to show mesh implant benefits
· Doctors given educational trip to Rio for recruiting patients into mesh study
· Coloplast Corporation paid more than $4million in 2016 alone to doctors
· Members of UK Government panel assessing mesh had links to pharma giants
· More than 800 women are suing the NHS as they have been left unable to walk
Doctors have been accused of accepting benefits to encourage women to have controversial vaginal mesh implants fitted.The lives of thousands of women who have had the procedure on the NHS have been destroyed prompting calls for a public inquiry and ban.
Now it has emerged one manufacturer of the mesh paid doctors more than $4million in 2016 alone to fund their travels, consultancy fees, and even food and drink.
It has also been claimed that many of the studies that reveal a benefit from having an implant were sponsored by mesh manufacturers - leading to fears of a risk of bias and conflicts of interest.
In a case reported in 2014, Dr Aethele Khunda from South Tees Hospitals was given an educational trip to Rio de Janeiro for recruiting the most patients as a principle investigator into a vaginal mesh implant study.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, told MailOnline: 'Every doctor who has been paid says it doesn't affect their judgement but its blindly obvious to others that you see the benefits if you are being paid.'
Lead Urogynaecologist at the University of Glasgow Dr Wael Agur added: 'Evidence has shown the studies sponsored by industry are more likely to show favourable results towards mesh procedures.'
Vaginal mesh implants are offered to women suffering from stress urinary incontinence or pelvic organ prolapse, yet more than 800 are suing the NHS and the implants' manufacturers after suffering crippling pain that has left many unable to have sex or even walk.
The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention.
On the back of these conflict of interest allegations, Kath Sansom, who had the procedure in 2015 and leads 'Sling The Mesh', a campaign group seeking to have the implant banned in the UK, said: 'Doctors want the prestige of running the trial, manufacturers want profits and no one cares about women.'
Mesh manufacturer Coloplast Corporation paid more than $4million in 2016 alone to US doctors and teaching hospitals, according to the Centers for Medicare and Medicaid Services' Open Payment database.
Of this, more than $700,000 was spent on travel and lodging, $608,000 on consultancy fees, and $338,000 on food and drink.
Coloplast declined to comment.
In 2016 alone, obstetrician-gynecologist Dr Vincent Lucente from the Institute of Pelvic Medicine & Reconstructive Surgery in North Wales, Pennsylvania, received more than $318,000 from six pharmaceutical companies. Of which, 85.7 per cent came from Coloplast.
Speaking to Minimally Invasive Surgery for Women, Dr Lucenete said vaginal mesh implant surgeries are 'really starting to show some promising results', adding 'the permanent materials are outperforming the traditional surgery without an implant by a significant margin.'
When asked about the complications of surgery, Dr Lucenete said they are 'the traditional ones that you have any time that you go and have a surgical intervention.'
Dr Lucente did not respond to a request for comment.
On the back of these conflicts of interest allegations, Ms Sansom told MailOnline: 'Mesh implant manufacturers take on surgeons to train others how to use the devices.
'These surgeons are often given education grants and travel scholarships. They're put up in hotels.
'Doctors build up a relationship with manufacturers and are then asked to carry out a study.
'Doctors want the prestige of running the trial, manufacturers want profits and no one cares about women.'
'Studies that show benefit were sponsored by mesh manufacturers '
Dr Agur told MailOnline: 'Evidence has shown the studies sponsored by industry are more likely to show favourable results towards mesh procedures.'
He referred to the PROSPECT study, which is the largest vaginal mesh implant trial conducted on prolapse to date.
The study found no significant difference in pelvic organ prolapse symptoms between women who had artificial mesh implants fitted and those who had their vaginas surgically tightened or received a mesh made from animal tissue.
PROSPECT was funded by the Department of Health and received no sponsorship from mesh manufacturers.
Dr Agur added: 'Many of the studies that show benefit were sponsored by mesh manufacturers, where there is a risk of bias and conflicts of interest.'
Professor Heneghan added: 'Every doctor who has been paid says it doesn't affect their judgement but its blindly obvious to others that you see the benefits if you are being paid. Conflicts of interest distort medicine.
'Journals have a policy to declare conflicts of interest but no one polices that.'
A Cochrane report published in July 2015 said the TVT mesh is successful in eight out of 10 cases. Yet the report's authors admit 13 of the studies analysed are at high-risk for bias.
The report stated the procedure has a lower risk of immediate complications compared to other treatments. The team of eight researchers wrote in the journal: 'Our results support the use of mesh procedures for incontinence.'
ravel fellowships to Australia
Ms Samsom previously accused consultant gynaecologist and urogynaecologist Dr Mark Slack of having conflicts of interest when they appeared together on BBC Radio 4's flagship show Women's Hour.
Dr Slack's website states he received a travelling fellowship to Australia from Ethicon, which is owned by Johnson & Johnson.
Ethicon removed its mesh product Prosima from the market in 2012 after the FDA ordered it conduct a trial into the product's safety. Dr Slack was involved in collecting data supporting Prosima's approval.
Dr Slack told MailOnline: 'The Ethicon travelling fellowship is an annual award made by the Royal College of Obstetricians and Gynaecologists to enable members of the college to undertake study in different institutions in other parts of the world.
'I participated in ethically approved peer-reviewed studies which were carried out under the principles of Good Clinical Practice in clinical trials.
'During this time I provided consultancy services to the company for which I received travel support and standard consultancy fees.
'Despite being a co-inventor of the vaginal support device I decided to waive any royalties as I believed that would have been a conflict of interest.
'Over a period of a few years I provided expert witness against certain defective mesh products in the Supreme court in the USA. I include this as evidence of my impartiality.'
An Ethicon spokesperson added: 'Prosima was adequately supported by clinical studies prior to marketing.
'In June 2012, Ethicon announced a business decision to discontinue the global commercialization of some of our pelvic-mesh products around the world, including Prosima, for reasons unrelated to the safety or efficacy of these products.
'It is customary for us to engage with leading physicians, researchers and medical societies. Ethicon's engagement with the medical community concerning our pelvic mesh products has been appropriate and responsible.'
Trips to Rio
In December 2014, reports emerged that Dr Khunda from South Tees Hospitals was given a trip to Rio de Janeiro for recruiting the most patients into a vaginal mesh implant study.
Labour shadow health secretary Neil Findlay said: 'Given the hundreds of thousands of women who have reported horrific injuries caused by mesh implants, I am astonished this can happen in the NHS,' the Daily Record reported.
A South Tees Hospitals spokesperson told MailOnline: 'In 2014, the Trust was involved in a study by Aberdeen University comparing the efficacy of vaginal slings for certain women's health conditions.
'This trial was conducted throughout the UK, funded by the Human Tissue Authority and was part of the National Institute for Health Research portfolio.
'The full statement of December 2014, provided by Professor Andrew Owens, director of research and development, stated that as the centre with the highest recruitment in this period, consultant Aethele Khunda the local principal investigator, was offered and accepted an educational grant organised by the Scottish Pelvic Floor Network to attend the International Continence Society meeting which took place in Rio and where he and a colleague presented a paper.
'This has not and will not in any way compromise the integrity of the doctor or nurse who is duty bound to always act in the patient's best interest and provide unbiased information to them.'
Ethicon also came under fire when news emerged in October 2014 of two doctors on a UK Government panel assessing mesh implants having links to the pharmaceutical giant.
Dr Ash Monga, a consultant gynaecologist at University Hospital Southampton, described himself as a 'consultant for Gynecare', which is an Ethicon implant, in a 2009 research paper.
He told MailOnline: 'This consultancy refers to research project with Gynecare which involved the development of a patch for overactive bladder; it had nothing to do with meshes, prolapse or stress incontinence. It never came to market.'
Dr Karen Guerrero, a surgeon at Glasgow's Victoria Infirmary, received 'educational sponsorships' – including travel costs – from the company.
She told MailOnline: 'I was invited to the University of Oxford in September 2015 to teach UK surgeons on the subject of non-mesh alternative surgery, this being one of my areas of expertise.
'The course organisers covered my expenses only and I did not receive a fee for this.
'I can confirm that since I have been part of the Scottish Government panel assessing mesh implants, I have not received any monies from mesh companies.'
http://www.dailymail.co.uk/health/article-4774940/Doctors-benefits-pushing-vaginal-mesh-implants.html
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Vaginal Mesh ‘Scandal’ As Thousands Forced To Have Implants Removed Due To Complications
Aug 15, 2017 | HuffPost UK
By Rachel Moss
Thousands of women have been forced to have surgery to remove vaginal mesh implants due to complications, NHS records suggest.
Figures obtained by the Guardian suggest that around one in 15 women fitted with the most common type of mesh implant later require surgery to have it removed.
Vaginal mesh implants, sometimes referred to as sling implants, are given to women who experience pelvic organ prolapse and incontinence, often after childbirth.
The treatment is common in the UK, with more than 92,000 women receiving a vaginal mesh implant between April 2007 and March 2015 in England alone.
The latest figures contribute to growing controversy around the use of vaginal mesh, after the BBC revealed that more than 800 women are suing the NHS or device manufacturers after experiencing complications.
The Guardian reports that between 2006 and 2016, just over 75,000 women received the most common type of vaginal mesh implant, called a trans-vaginal tape (TVT).
In the same 10-year period, almost 5,000 procedures were carried out to remove TVT implants.
What’s more, between 2006 and 2016 the NHS carried out more than 1,000 removals of the second most common type of vaginal mesh implant, called transobturator tape (TVT-O).
Sohier Elneil, a consultant urogynaecological surgeon at University College Hospital in London, told the paper the removal rate was a “scandal”, while Mark Slack, a consultant gynaecologist at Addenbrooke’s Hospital, Cambridge, said he was “absolutely shocked” by the figures.
Dr Ismail, a consultant gynaecologist and obstetrician from Queensway Gynaecology Clinic, previously explained how vaginal mesh works.
“It is purely a synthetic net material used in the placement of a weak connective tissue or ligaments, suspending the vagina and uterus,” he told HuffPost UK.
He added that complications are usually caused by the mesh eroding and breaking down into smaller pieces, which potentially move.
“The vagina area being stitched up is a weak point of the vaginal wall,” he said. “The mesh can find its own way through this weak point and protrude outside the vagina.”
Many women who’ve experienced this have spoken out about experiencing intense pain, sometimes leaving them unable to walk, work or have sex.
Cat Lee, a 43-year-old former Huddersfield University lecturer now uses a mobility scooter after experiencing complications with her implant.
“I’m now registered disabled, unemployed and can’t even go out for drinks with my girlfriends,” she said.
“Ten years on, I’m convinced that the so-called ‘simple’ vaginal mesh surgery has ruined my life.”
However, Dr Ismail supports the overall use of the treatment and said the majority of women should not be worried “at all” or consider having implants removed.
“If they are asymptomatic, just leave them [the mesh implants] alone,” he told HuffPost UK. “If they are happy and are continent and are able to control urination, they’ve had a successful operation and that is fantastic news - 90% of people are like that.
“Anyone reading the news might think 90% of the women have the complication and 10% get better, but it’s the other way around.”
In response to the NHS figures, a spokesperson from the Medicines And Healthcare Products Regulatory Agency (MHRA) told HuffPost UK: “Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.
“We are committed to helping address the serious concerns raised by some patients. We have undertaken work to assess the findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.”
The spokesperson added that MHRA continues to see “that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances”.
“This is supported by the greater proportion of the clinical community and patients,” they said.
“In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.
“We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card scheme, or via https://www.gov.uk/report-problem-medicine-medical-device.”
http://www.huffingtonpost.co.uk/entry/vaginal-mesh-scandal-as-thousands-forced-to-have-implants-removed-due-to-complications_uk_599307e5e4b09096429a12c7
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Calls for national register of surgical devices
Aug 15, 2017 | ABC Online
By Sophie Scott
The Federal Government is coming under increased pressure to create a national register of medical devices.
Both doctors' groups and health authorities are backing a register as concern mounts over problems with the use of surgical mesh to treat pelvic floor problems after childbirth.
Meanwhile the Therapeutic Goods Administration has told a senate inquiry it hasn't officially recalled the problem brands, meaning the potentially damaging surgical devices could still be sitting on hospital shelves.
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Professor Steve Robson, president, Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Professor John Skerritt, deputy secretary, Therapeutic Goods Administration.http://www.abc.net.au/worldtoday/content/2016/s4718642.htm?section=world
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