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Ethicon Media Monitoring 10/30/2017
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Thousands of women take legal action over mesh implants
Oct 30, 2017 | Al Jazeera
By Alasdair Soussi
- Sleep is often a blessed relief for Nancy Honeyball. In a life filled with pain and discomfort, the 48-year-old's only escape is the opioid painkiller, Tramadol, which can sometimes render her bedridden for 18 hours a day. For the Scotswoman, there are few comforts in a day-to-day existence that, as a married mother-of-two, was once full, happy and pain-free. -
Agony after pelvic mesh implanted at 22 years old
Oct 30, 2017 | WA Today
By Joanne McCarthy
Teigan was 22 in 2008 when she was implanted with a "gold standard" pelvic mesh sling device for incontinence, less than two months after the birth of her second child. -
Australia's medical device regulator acts after women's outrage
Oct 30, 2017 | The Daily Advertiser
By Joanne McCarthy
AUSTRALIA’S peak drug and medical device regulator will require stronger evidence from pelvic mesh manufacturers after legal action by women and a Senate inquiry that has exposed the lack of evidence before mesh devices were approved for use more than a decade ago. -
Women’s lives at risk by Government’s refusal to suspend controversial mesh operations, campaign warns
Oct 30, 2017 | Wisbech Standard
By John Elworthy
Campaigners say the Government are putting women’s lives at risk by refusing to suspend controversial vaginal mesh operations.
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Thousands of women take legal action over mesh implants
Oct 30, 2017 | Al Jazeera
By Alasdair Soussi
Glasgow, Scotland - Sleep is often a blessed relief for Nancy Honeyball. In a life filled with pain and discomfort, the 48-year-old's only escape is the opioid painkiller, Tramadol, which can sometimes render her bedridden for 18 hours a day. For the Scotswoman, there are few comforts in a day-to-day existence that, as a married mother-of-two, was once full, happy and pain-free.
"I'm always in pain," said Honeyball, who lives with her husband, William, in the seaside town of Dunoon, Argyllshire, on Scotland's west coast.
"The tiredness just takes over - which is [largely] to do with the medication I'm on. And I can't do things in the house that I used to do."
Honeyball blames her excruciating bouts of ill-health on her vaginal mesh implant, which was fitted back in 2010 to remedy her urinary incontinence.
Over the past seven years, however, her life has been plagued by repeated urinary tract infections (UTIs). They are so severe that they have caused her crippling lower-back pain. In one of several emergency hospital visits, in October, she was hooked up to a morphine drip.The mesh implants stretch, they fray, they become quite hardened and they pull on nerves.
WAEL AGUR, CONSULTANT UROGYNECOLOGIST WITH NHS SCOTLAND
Transvaginal mesh implants, the use and associated risks of which were debated in the UK parliament on October 18, have been used worldwide to repair weakened or damaged tissue that has caused pelvic organ prolapse and urinary incontinence - common conditions in women who have given birth. They are usually made from synthetic polypropylene.
In the UK alone, more than 100,000 women have had mesh implants over the past two decades - including more than 20,000 in Scotland where, in 2014, the then Scottish health secretary of the devolved Scottish government wrote to health boards requesting the suspension of mesh devices after a successful petition by campaigners.
For many, the procedure has proven successful, but for others, such as Honeyball, lives have been put under strain.
"The mesh implants stretch, they fray, they become quite hardened and they pull on nerves," Wael Agur, a consultant urogynecologist with NHS Scotland and lecturer, told Al Jazeera.
"They become a tough structure in a sensitive area that needs to move … Although these complications are rare, it's a lifetime risk - anyone can develop any complication in their lifetime if they've had a mesh implant."Survivors' groups
The mesh controversy has spawned survivor's groups across the world.
Maria Smit, who is Dutch, cofounded a campaigning group, MeshedUp.
She said that her life was destroyed after being fitted with a mesh implant to solve a prolapse of the rectum and bladder nearly 10 years ago.
Married with three children, she told Al Jazeera that the post-operative complications surrounding her mesh surgery have caused her to become an "invalid".
"And while doctors attempted to remove parts of the mesh, it has become hard and is situated close to vital parts of my body." We have people in our group that are contemplating suicide. They have literally gone from really healthy people to being completely incapacitated
CHARLOTTE KORTE, COFOUNDER OF MESH DOWN UNDER
Because of this, no other doctor has dared make further surgical interventions.
"I'm in pain every day - all day long," said the 57-year-old, who lives in Helmond, southern Netherlands. "The pain leads from my bottom, the vagina, my groins and my hips into my legs. The nerve pain and the muscle pain dominate, but the pain in my bottom - where the doctor inserted the arms of my mesh - is also severe."
Women across the world have reported similar crippling side effects, including a loss of normal sexual function. Indeed, some male partners of women fitted with mesh have even reported being injured by the device during intercourse.
As such, legal cases brought about by women claiming to have been maimed by vaginal mesh implants have piled up over recent years.
In the UK, one in 15 of those fitted with the most common type of mesh have required surgery and more than 800 women are taking legal action against the NHS and companies which manufacture the devices.
In the US, some 100,000 legal cases have been filed, and in Australia, more than 700 women have launched legal claims citing bodily injury from implanted mesh.
Charlotte Korte, a 46-year-old New Zealander who cofounded Mesh Down Under had an implant for a prolapsed bowel in 2010 and suffered complications.
Since the group began in 2012, membership has leaped from 90 in 2014 to almost 500 people today.
"We have people in our group that are contemplating suicide," said Korte, who has two children. "They have literally gone from really healthy people to being completely incapacitated."Manufacturing company defends use
Pharmaceutical giant Johnson & Johnson, the biggest mesh implant manufacturer, said it "empathised with all women suffering from pelvic organ prolapse and stress urinary incontinence, conditions that can be serious and debilitating".
The company, which has been the subject of several legal cases, told Al Jazeera: "There are limited treatment choices for pelvic organ prolapse and stress urinary incontinence, including surgical treatment with implantable mesh, which is backed by years of clinical research and can be the preferred option for some women seeking to improve their quality of life.
"Ethicon [a Johnson & Johnson subsidiary] is confident in the positive impact our pelvic mesh products have had on the vast majority of women who have chosen this treatment option. The use of pelvic mesh devices is supported by medical experts, medical societies, physicians and regulatory organisations around the world."
While campaigners hailed the October 18 UK parliamentary debate as a breakthrough, the government rejected a call from activists such as Kath Sansom, founder of the British-based Sling the Mesh group, for a public inquiry and suspension of surgical mesh, so that the rest of the UK could fall into line with Scotland.
As for Nancy Honeyball, she is pinning her hopes for a recovery on a mesh-removal specialist in London. But in the meantime, the pressures of life and her continuing inability to properly function on a day-to-day basis remain.
"My dad is 88 and has just been recently diagnosed with Parkinson's [disease]," she explained. "He [lives] over an hour from me, but I can't just jump in the car and go and visit him like I used to … My dad relies on his faith, and when I've stayed over there I've heard him praying. And he's praying for me."
http://www.aljazeera.com/news/2017/10/thousands-women-legal-action-mesh-implants-171024083705299.html
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Agony after pelvic mesh implanted at 22 years old
Oct 30, 2017 | WA Today
By Joanne McCarthy
Teigan was 22 in 2008 when she was implanted with a "gold standard" pelvic mesh sling device for incontinence, less than two months after the birth of her second child.
Nine years later there are times when she has to lay flat on her back in a shallow warm bath to urinate because of the pain of "strangury" – an inability to void caused by the interaction of the mesh and her bladder. Urinary tract infections are frequent. The boundaries of her life are marked by the availability of toilets no more than an hour from her Hunter region home.
"This is what I have to do now. I'm scared of what I'm going to have to do in 10 years. I'm scared, especially because I haven't reached menopause and people are saying the complications can get worse with menopause. That's a long way away for me," said Teigan, 31, who agreed to speak about the devastating consequences of mesh surgery on her life, but asked that her surname be withheld because of their intimate nature.
On Thursday Australia's peak drug and medical device regulator, the Therapeutic Goods Administration, quietly announced on its website that from December, 2018 all new pelvic mesh devices will be classified high risk requiring evidence of safety and efficacy, while currently available mesh devices will have until December, 2020 to meet new evidence standards.
The changes were announced as a Senate committee prepares a final report into how mesh devices were approved for use in Australia despite serious questions about the evidence used to support them, and as women in countries including Australia, the United Kingdom, America and New Zealand have initiated more than 100,000 legal suits, in a global push where claims are estimated to top more than $20 billion.
Teigan is one of more than 800 Australian women registered in a Federal Court legal class action against Johnson & Johnson that started in July and will continue into 2018. Another 500 women are registered in a class action case against a second mesh manufacturer, American Medical Systems.
The Gold Coast specialist who implanted her Johnson & Johnson TVT device, Dr Malcolm Frazer, is scheduled to give evidence at the class action in early November as an expert witness engaged by legal firm Clayton Utz, which is representing Johnson & Johnson.
In a statement in June the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said the use of slings to treat incontinence was "a safe and effective treatment and regarded as the 'gold standard"' for incontinence surgery. A Senate inquiry in September was told complication rates after sling surgery ranged from 2–5.6 per cent.
Teigan's GP referred her to Dr Frazer in 2008 after she complained of "annoying" incontinence when she coughed or tried to move quickly following her second baby's birth.
Her hospital notes show she was in pain and unable to urinate after surgery to implant the device, was "very uncomfortable" a day after surgery because she was unable to void, was "in tears" while trying to catheterise herself, and went home after four days with a catheter in place and a urine bag strapped to her leg.
"I was pretty miserable as I only had a new baby. I felt like an old woman. It wasn't what I was expecting at all," she said.
"In hindsight I probably just needed time to recover from the pregnancy."
Teigan moved from the Gold Coast to the Hunter and did not see Dr Frazer again after a six-week post-surgical check up.
She described the following years as a gradual increase in regular urinary tract infections and pain, incontinence, increasing difficulty urinating and going to general practitioners who did not connect the complications with the TVT sling tape.
In September Royal Australian College of General Practitioners representative Dr Magdalena Simonis told the Senate inquiry there was "no excuse" for the experiences many Australian women had had when they sought help from doctors because of mesh surgery complications.
Those complications were "a new issue" for general practitioners "in terms of making the association" with mesh, Dr Simonis said.
"It has not been in our heads up until relatively recently, unfortunately."
In April this year Teigan had a third baby by caesarean because of the TVT tape.
"The pregnancy was difficult because it was really painful to walk and I'd get shooting pains up my groin at times," she said.
By June an ultrasound showed why she experienced serious pain if her bladder filled, but also why she often cannot sit to urinate if more than an hour passes between toilet breaks. The ultrasound showed the TVT sling was "the likely cause" of "kinking" of the bladder over the mesh sling – like a kinked garden hose - resulting in "strangury", which both increases the urge to urinate and restricts the ability to do so.
"I get the stinging urge to go but nothing comes out. That's when I have to lie in the bath," Teigan said.
"I feel quite limited. I don't go anywhere because I need to find a toilet before it reaches that point."
Dr Frazer said he could not comment on an individual patient.
http://www.watoday.com.au/wa-news/agony-after-pelvic-mesh-implanted-at-22-years-old-20171030-gzax6m.html
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Australia's medical device regulator acts after women's outrage
Oct 30, 2017 | The Daily Advertiser
By Joanne McCarthy
AUSTRALIA’S peak drug and medical device regulator will require stronger evidence from pelvic mesh manufacturers after legal action by women and a Senate inquiry that has exposed the lack of evidence before mesh devices were approved for use more than a decade ago.
All pelvic mesh devices on the Australian market will be classified high risk, denoting a high level of potential harm, and women will receive patient cards with details of their pelvic mesh devices, the Therapeutic Goods Administration announced in a statement on its website on October 26.
From December, 2018 all new pelvic mesh devices will have to meet “higher evidentiary requirements”, and the small number of devices for incontinence and prolapse that remain on the Australian market will be upgraded to high risk and required to meet the new standards by December, 2020.
The changes, approved by Health Minister Greg Hunt, follow a 2011 Parliamentary inquiry which questioned whether the TGA’s emphasis on post-approval monitoring could lead to devices being “trialled unofficially” on patients.
Women implanted with pelvic mesh devices for incontinence and prolapse after childbirth have told a Senate inquiry they felt like “guinea pigs” after revelations about the lack of evidence supporting the use of many pelvic mesh devices before they were first used in Australia from the late 1980s.
Australian Pelvic Mesh Support Group founder Caz Chisholm, who successfully pushed for the Senate inquiry that is due to report in late November, said mesh devices had always been classified at least medium to high risk, but the issue was about what women were told.
“No woman that I know in the support group of more than 1000 women was told by her surgeon that her device was high risk, or medium to high risk,” Ms Chisholm said.
“Once these devices are re-classified, are specialists going to tell women the device they are about to be implanted with is high risk? I don’t think so.”
Ms Chisholm slammed the TGA for “quietly announcing” the changes on its website after her group’s sustained criticism.
http://www.dailyadvertiser.com.au/story/5021573/mesh-devices-high-risk-in-new-regime/?cs=7
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Oct 30, 2017 | Wisbech Standard
By John Elworthy
Campaigners say the Government are putting women’s lives at risk by refusing to suspend controversial vaginal mesh operations.
Sling The Mesh has also issued a stern warning to health ministers saying the problem is not about lack of surgical competence but about a product not fit for purpose.
And campaigners fear surgeons are still not giving patients a full picture of risks during the consent process after seeing women join the group for advice concerned because surgeons say they are not using “that media hype mesh” but instead they are inserting a tape.
In a debate in Westminster, the Government said it would not suspend vaginal mesh or launch a public inquiry as requested by the Labour party.
Health minister Jackie Doyle Price said NICE guidelines would be published 18 months earlier than scheduled - but that turned out to be incorrect and she later had to write a four page letter to MPs to explain the misunderstanding.
Health Minister Jackie Doyle Price said: “From my perspective, the issue is not with the product but with clinical practice. That is what is going wrong.
“That is where we need to be much clearer, ensuring that women are treated properly by their clinicians, given proper advice and risk assessments, and given the opportunity to report any complications and the ability to complain and challenge.
“The Government also need to ensure that all clinicians have the most up-to-date and appropriate advice.
“The focus of this debate is the women who are suffering. The most important thing we can do, my priority is, to ensure that they get the support, care and treatment they need to alleviate a debilitating condition.”
Kath Sansom of Sling The Mesh said: “More than 135 women a week have a mesh tape implant in England alone to treat incontinence or prolapse. The refusal to call breathing space on these operations is putting these women at risk.
“It is not about surgical competence. This is the only blind operation we know of. It uses giant hooks to pierce women’s pelvic areas to insert the mesh. Surgeons can’t see where it is going. That is a huge problem.
“Also the mesh can shrink, twist or degrade. No amount of training or good surgery can account for this.”
Kath said: “Incontinence or prolapse is distressing but it is not life threatening. There are other surgery alternatives that don’t use mesh.”
Emma Hardy MP for Kingston upon Hull West and Hessle, said: “The issue of surgical mesh implants was first brought to my attention when I was visited by a constituent.
“She was advised in her 30s to have the mesh fitted, after suffering incontinence following the birth of twins and a hysterectomy.
“Its impact on her quality of life is devastating. She cannot walk very far now, she is unable to work, she is in constant pain and suffering, she is unable to partake in sports and she is having problems sleeping.”
Following the debate there was a lobby of MPs, medics and women led by MP Owen Smith who first lent his support to Sling The Mesh in January 2016.
MP Sharon Hodgson said: “The Government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.
“Labour is calling for a full inquiry to uncover the extent of the harm done by mesh implants so we can be sure that this never happens again.”
David Golten, partner and head of commercial litigation at Wedlake Bell, said: “The numbers for both the group action and “Sling the Mesh” are growing every day.
“We continue to hear the most horrific stories from the victims of mesh implants and we are examining the allegations that Johnson & Johnson and the other manufacturers, far from helping women, failed to test these devices properly leading to the life-shattering medical complications women are experiencing.
“We wish to highlight, as the Parliamentary debate did, that the safety of the mesh implants themselves has not been scrutinised properly. “There is still much more action needed from the Government and the NHS to address this issue.”
REGIONAL MPS SUPPORTING SLING THE MESH FROM ALL PARTIES
Mark Tami, MP for Alyn and Deeside, (Lab) said: “A constituent has just had a lengthy and painful surgery, but for years she was told that hers was an isolated case and there was no problem. This is a national scandal and needs to be treated in that way.”
Catherine McKinnell, MP for Newcastle upon Tyne North, (Lab) said her constituent has suffered pain, depression and sepsis. She is about to lose her job and her life has changed dramatically.
“Others shouldn’t have to suffer the same fate. It really is unacceptable that we are in 2017 and this is allowed to happen.”
Sir Oliver Heald, MP for North East Hertfordshire, (Con) said: “My constituent said to me: that it is shocking that something so agonising has not had the public recognition it deserves.”
Karin Smyth, MP for Bristol South, (Lab) said: “I understand from my constituent that NHS England will set up regional teams to look at this. Does my hon. friend agree that cannot be done on a local, ad hoc basis? There needs to be national co-ordination on this.”
Sue Hayman, MP for Workington, (Lab) said: “My constituent Alison had a mesh put in too tight. She was in appalling pain and had to travel all the way from Cumbria to Manchester to get treatment.
“Now she has had it partially removed, she is in a worse state than ever and has to go back to Manchester again. Does my hon. friend agree that something has to be done to help people with removal?”
Simon Hoare, MP for North Dorset, (Con) said: There is also a lack of awareness among the general practice community. The procedures are taking place and are deemed to be a success, but these other problems then present themselves and GPs are just not aware of the causal link and how to diagnose it.”
Brendan O’Hara, MP for Argyll and Bute (SNP) said: “My constituent Nancy contacted me recently. She had a mesh implant fitted seven years ago, and her life and that of her family have been turned upside down.
“She is in constant, crippling pain. She needs tramadol, and when the tramadol has not worked, she has been in hospital for four days on morphine.”
Jo Stevens, MP for Cardiff Central, (Lab) said: “Many mesh implants have been fitted at private hospitals rather than NHS hospitals, and we know from the recent case of convicted breast surgeon Ian Paterson that in those circumstances private hospitals deny liability for private surgeons carrying out operations on their premises.”
Jeremy Lefroy, MP for Stafford, (Con), expressed his concern that the Health and Social Care (Safety and Quality) Act 2015 was not being followed.
The law says: “The Secretary of State must by regulations impose requirements that the Secretary of State considers necessary to secure that services provided in the carrying on of regulated activities cause no avoidable harm to the persons for whom the services are provided.”
Victoria Atkins, MP for Louth and Horncastle, Con, said: “The point about long-term complications is just as important as that about the short-term complications. My constituent developed fibromyalgia as a result of the complications arising from her mesh surgery for stress urinary incontinence. Does the hon. Lady agree that long-term conditions such as that must be taken into account?”
Paul Masterton MP for East Renfrewshire, (Con) said: “As MP for a Scottish constituency, I will focus on the situation in Scotland, where the devastating effects of mesh surgery were first brought to our attention by the campaign group Scottish Mesh Survivors, which is made up of women and their families whose lives have been ruined by the procedure.
“The group is led by my constituent, Elaine Holmes, who brought the issue to the Scottish Parliament’s Public Petitions Committee in May 2014. Through the group’s efforts, a request to suspend the surgery was announced by the then Scottish Cabinet Secretary for Health and an independent review group was established.
“Scotland had an opportunity to lead the way, but, to my deepest regret, it has lost the initiative. The independent review group’s final report, which was published in March this year, has rightly been termed a whitewash.”
Owen Smith MP for Pontypridd, (Lab), said: “The story is quite simple. Since 2000, these products have been diligently marketed by the devices industry as a quick fix—an easy solution to stress-related incontinence or other problems for young women who want to maintain active lifestyles post-childbirth by doing exercise and other ordinary things that we take for granted.
“The regulators and the clinical guidelines said that the risk was between 1% and 3%. However, behind those statistics, the reality has emerged that for a significant number of women—not the majority, but a significant minority—the devices have resulted in chronic, life-changing adverse effects.”
Derek Thomas, MP for St Ives, (Con) said: “Women have written to me or sat opposite me in my surgery have introduced me to their experience: a world of untold suffering, misery, distress and anxiety, which could and should have been avoided.”
Jim Shannon, MP for Strangford, (DUP) said: “I have received a large number of emails from Northern Irish people outlining their horrific experiences and some of the ladies affected are in the Gallery today. It would seem that in an attempt to access a cheaper form of surgery, we are putting some people at risk of horrific complications.”
Mims Davies MP for Eastleigh, (Con), said: “Constituents have shared simply horrific accounts of the long-term difficulties that they have experienced as a result of having had a mesh implant.”
Carolyn Harris, MP for Swansea East, (Lab) said: “When one in 15 women fitted with the most common type of mesh will require surgery to extract it, it is clear that the issue needs to be addressed nationally. The figures are staggering and the situation is like Russian roulette.”
Dr Sarah Wollaston, MP for Totnes (Con) said: “I pay tribute to the many women who have been courageous in coming forward and discussing intensely painful and personal experiences, not only with myself but with other Members. I would like to quote one, who said:
“I am in so much pain at times that I just give up on the day. The pain never goes, it just varies in intensity.”
Chris Ruane MP for Vale of Clwyd (Lab) said: “If the companies failed to introduce proper clinical trials at the outset, they should now be queueing up to ask these women to come forward so that they can look at the specific cases where the devices have failed.
“There has been cavalier practice, and we cannot allow that to continue.”
Jo Platt MP for Leigh (Lab/Co-op) said: “I have a constituent who is suffering. She told me of her experiences of the failed procedure, which left her barely able to walk, and bedridden for three months. She spoke of the pressure that put on her family, with her children left to care for her and her husband unable to work overtime due to childcare commitments”
Alec Shelbrooke, MP for Elmet and Rothwell (Con), said: “This is the tip of the iceberg and that there are many hundreds, if not thousands, of women out there who could be struggling. Of course, they may not know yet that they will have a problem, because we do not have the data.
“My constituent who came to see me is incredibly brave. She could not make herself at all comfortable during my surgery, but leant forward with her hands on the table. She could not sit, could not stand straight and could not bend over. As the consultation went on, she was sweating more and more with pain.
“My constituent was a physiotherapist and had led a very active life. She can now barely get through a day.”
Tonia Antoniazzi, MP for Gower (Lab) said: “Women are always reluctant to speak out about the personal and intimate medical issues that they experience. Sadly, they are highlighted only when things go wrong.”
Jeff Smith, MP for Manchester, (Lab), said: “Its seriousness was brought home to me when a constituent came to see me. He had had an inguinal hernia repair that developed complications because of the mesh used in the procedure. It left him in agony; he described it as like having a metal plate wedged in his lower abdomen.
“Eventually, he had to have corrective surgery, but it did not resolve the chronic pain that he suffers. That points to one of the unique aspects of this problem, which is the difficulty of removing the mesh and correcting the initial surgery.”
Patrick Grady, MP for Glasgow North, (SNP) said; “One of the most important things that has come through clearly in the debate is the collection and analysis of data, so that a full picture of the situation can be brought up. We have heard so many times of individual cases where people are told, “This is just you; this is an isolated case,” when it very clearly is not. The evidence has to be gathered, and full investigations have to take place and continue.”
Sharon Hodgson, MP for Washington and Sunderland West, (Lab) said: “I especially want to thank Kath Sansom, who leads the Sling the Mesh campaign, for all her hard work in uniting the women affected by vaginal mesh implants and for raising awareness of the tragic impact that mesh implants have had on so many lives.
“The experiences we have heard about today are incredibly distressing. We are here to stand up for those women, and we seek answers and Government action on their behalf.”
http://www.wisbechstandard.co.uk/news/women-s-lives-at-risk-by-government-s-refusal-to-suspend-controversial-mesh-operations-campaign-warns-1-5256109
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