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Ethicon Media Monitoring 7/20/2017
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Senior doctors call for a public inquiry into vaginal mesh implants after hundreds of women sue the NHS for agony caused by surgery
Jul 20, 2017 | Daily Mail
By Caludia Tanner
Senior doctors have called for a public inquiry into the use of vaginal mesh surgery in Britain, saying it could be akin to the thalidomide scandal. -
Mesh Injured Fill Parliament Gathering in UK on Pelvic Mesh
Jul 19, 2017 | Mesh Medical Device Newsdesk
Mesh campaigners call it a successful rally that brought hundreds of mesh-injured and their families face to face with government at the London Parliament building on Tuesday. -
Vaginal mesh implant sufferers take fight to Westminster's door
Jul 19, 2017 | Belfast Telegraph
By Donna Deeney
An estimated 10,000 women from across the UK are suffering physical pain as a result of vaginal mesh implants, in what has been described by the Shadow Secretary of State for Northern Ireland as a "massive health scandal". -
A pelvic mesh Senate inquiry needs to focus on women: health advocate
Jul 20, 2017 | Newcastle Herald
DANNY Vadasz’s executive summary of a submission to the Senate inquiry into pelvic mesh, that’s holding a first public hearing on August 3, is considered, reasonable and scathing of Australia’s health system. -
Doctor calls for public inquiry as women and their families weep at emotional Parliamentary meeting into the mesh implant scandal
Jul 19, 2017 | Cambs Times
By John Elworthy
It was standing room only as women and their families from across Britain crammed into a committee room joined by MPs and high profile doctors for an emotional mesh lobby in support of Sling the Mesh. -
Connah’s Quay woman’s hopes for a public inquiry after Parliamentary mesh meeting
Jul 19, 2017 | Deeside.com
A health campaigner from Connah’s Quay has high hopes for a public inquiry into the use of mesh implants after an emotional parliamentary meeting on the subject.
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Jul 20, 2017 | Daily Mail
By Caludia Tanner
· Over 800 women in permanent pain are suing the NHS or mesh manufacturers
· Doctors say there are more victims and compare it to the thalidomide scandal
· They say complication rates are 'unacceptably high' – 19% for some types
· Oxford professor calls for a public inquiry while campaigners want a ban
Senior doctors have called for a public inquiry into the use of vaginal mesh surgery in Britain, saying it could be akin to the thalidomide scandal.
It emerged earlier this year that the standard procedure to treat problems caused by childbirth has left hundreds of women in agony, with more than 800 suing the NHS and device manufacturers.
But experts say the true number of victims could be much higher than officially reported and that hospital readmission rates for one form of mesh surgery is as high as 19 per cent.
A meeting held at the Houses of Parliament was organised by Labour MP for Pontypridd Owen Smith, along with campaign group Sling the Mesh, which wants to see the procedure banned entirely.
Speaking at a meeting, Carl Heneghan, professor of evidence-based medicine at the University of Oxford said: 'With thalidomide you could see the visual representation. [With mesh] you can't see it.
'We should have a public inquiry.'
Certain implants have cut into women's vaginas, causing discomfort so severe that one sufferer was nearly driven to suicide.Other patients have been left unable to walk, work or have sex.
The meshes are implanted to treat incontinence after childbirth and pelvic organ prolapse, which occurs when the bladder pushes against the vagina's walls.
Between April 2007 and March 2015, over 92,000 women had vaginal mesh implants fitted in England.
According to NHS data, around one in 11 have experienced problems.
Complications 'unacceptably high'
However, professor Heneghan and Dr Sohier Elneil, a consultant urogynaecologist at University College Hospital, told the meeting that complication rates for some types of the surgery are 'unacceptably high'.
Their warning raises questions about whether the procedure is being performed appropriately.
Dr Elneil said that unpublished research by her team, based on the NHS's Hospital Episode Statistics, show that the surgery has a readmission rate of 8.9 per cent.
She added that the majority of these patients needed some form of subsequent procedure.
'These are not minor complications,' she said.
However, a report by the Medicines and Healthcare Products Regulatory Agency (MHRA), the government watchdog, suggested the rate of pain or 'erosion' for mesh procedures is just one to two per cent rate.
Professor Heneghan disagreed and cited a recent Lancet study, which showed that the readmission rate for one form of the surgery was 19 per cent.
An MHRA spokeswoman said: 'Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients.
'MHRA strongly encourages the reporting of issues related to all medical devices.
'When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.'
NHS TRIED TO DODGE MEDIA ATTENTION OVER VAGINA MESHES
The NHS tried to dodge media attention over the vaginal mesh implants that left hundreds of women in agony.
The procedure cut into their vaginas and left many in discomfort so severe they have been left unable to work, walk or have sex.
It has now emerged the NHS actively sought to avoid courting headlines over the matter.
Minutes from an NHS meeting back in October show an agreement to 'take the press element out of' a campaign for women experiencing complications from the devices.
The meeting's minutes, seen by the Press Association, outline the Medicines & Healthcare products Regulatory Agency's (MHRA) yellow card campaign, which targets under-reporting of mesh complications.
Officials said they should 'look into taking the press element out of the mesh yellow card campaign' and 'investigate whether there can be a general yellow card campaign, of which mesh is one element, to avoid media attention on mesh'.
http://www.dailymail.co.uk/health/article-4710002/Doctors-call-public-inquiry-vaginal-meshes.html
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Mesh Injured Fill Parliament Gathering in UK on Pelvic Mesh
Jul 19, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 19, 2017 ~ Mesh campaigners call it a successful rally that brought hundreds of mesh-injured and their families face to face with government at the London Parliament building on Tuesday.
It was an emotional public gathering as women wept in Parliament about the aftermath of a simple mesh medical device implant procedure that was supposed to provide a solution.
There was standing room only in a committee room where Members of Parliament and high profile doctors met with campaigners including Kath Sansom, a journalist at CambsTimes and founder of Sling The Mesh campaign.
An estimated 126,000 mesh implants have been used on English women since 2006, with at least 10,000 complications reported.
The group wants a UK wide ban on the use of pelvic mesh.
Women who’ve suffered the outcomes, their husbands and children cried during the two-hour meeting. Women spoke of their life after a simple implant – how it’s left them disabled, depressed, without employment, and with suicidal thoughts, all because of a simple 20-minute procedure promised to cure incontinence or prolapse.
MP Owen Smith chaired the event, who pledged to meet with Britain’s Health Secretary, Jeremy Hunt.
Retired Surgeon John Osborne was in attendance. He had tried to warn the medical community in the 1990’s but his voice was not heard then. Dr. Osborne now says he’s appalled at what he’s hearing.
“I want to apologise on behalf of my profession,” quoting Dr. Osborne by CambTimes.co.uk.
Mesh removal doctor, Dr. Suzy Elneil, is quoted as saying “I find meeting the women hard, yet equally they are the reason I keep going.” She said that in 1997 when she watched her first mesh sling incontinence surgery it was like seeing a car crash in slow motion happening in the pelvis.
The first meeting of the newly formed All Party Parliamentary Group on Mesh Implants, will be held in September. The group wants a debate before Parliament.
Kath Sansome of Sling The Mesh tells Mesh News Desk,
“It was an incredible day that nobody will forget in a hurry, emotional and powerful. It was one of the largest committee rooms in the Houses of Parliament and MP Owen Smith said it was the most packed meeting he had ever seen. Standing room only. It achieved everything and more and raised vital awareness amongst MPs so that once it comes to a debate theywill realize the seriousness of this issue. More than 20 MPs came and others tried to get in but the room was too packed. The APPG into mesh is great as it will be a task force to effect change. I’m absolutely delighted with the result.”
A government inquiry into mesh – The English Group Work Party, is due out Tuesday, July 25. A similar report issued by the Scottish government was labelled a whitewash.
Dawn Payne, calls herself a “mesh survivor,” and was at Parliament for the gathering. She tells MND to be there was a privledge.
“To be shoulder to shoulder with fellow mesh victims whilst they recounted their individual stories and the awful consequences of this device was nothing short of humbling.
“The panel of experts who gave insight into the under reporting of problems and the devastating effects of these devices truly showed the passion we all feel regarding the need to prevent others from sadly following in our footsteps.
“To hear the retired surgeon John Osborne apologise to us all because he knew it was a flawed procedure and had voiced his opinion but wasn’t listened to, was very emotive. He was visibly moved as were many in the room.
“Professor Carl Henegen (editor of British Medical Journal) demonstrated how easy it was for the pharmaceutical companies to gain permits to launch this mesh without the need to prove its safety, shocking!
“Soheir Elniel, the savour of many mesh victims who has become a pariah amongst some of the medical professionals because she dare speak against the lucrative mesh and those who peddle it without thought for the devastation they wreak. Soheir is left to salvage what she can of people’s lives. You could see the compassion of this amazing lady who wiped the tears from her face.
“I thank God for Kath Sansom and Sling The Mesh, for Owen Smith and everyone who is trying to get our voice heard.“I left Parliament yesterday a changed person, every single person in that room could feel the emotion the sadness of lives lost to this hell but also the overwhelming sense of hope that we are the ones who can make this change.”
Beside a ban on pelvic mesh, the group wants a full Parliamentary hearing on the use of pelvic mesh in the country. ###
http://www.meshmedicaldevicenewsdesk.com/mesh-injured-fill-parliament-gathering-uk-pelvic-mesh/
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Vaginal mesh implant sufferers take fight to Westminster's door
Jul 19, 2017 | Belfast Telegraph
By Donna Deeney
An estimated 10,000 women from across the UK are suffering physical pain as a result of vaginal mesh implants, in what has been described by the Shadow Secretary of State for Northern Ireland as a "massive health scandal".
Owen Smith was among a group of MPs who met with more than 100 women who shared their stories of pain and trauma they suffered after having the procedure following complications of childbirth.
They want a total ban on the procedure, or a moratorium on it similar to one introduced in Scotland in 2014.
One woman, Jackie Harvey from Banbridge, told the Belfast Telegraph that while more than 170 women from Northern Ireland have contacted her support group, the actual numbers affected could be many times higher.
"I was fitted with an implant in 2005 and given little or no information about the risks," she said.
"Two years later I started to experience pain in my legs, back and groin but it was two years after that before the connection between my symptoms and the implant.
" I read about another woman who had the exact same symptoms and she also had an implant fitted.
"There isn't a single surgeon in Northern Ireland who can remove these implants. It is such a dangerous operation because they become embedded in a woman's bladder or they can come right through the vaginal wall.
"The amount of physical damage and mental anguish caused is horrendous and it has led to the breakdown of so many marriages and relationships. We need a total ban on this procedure otherwise the number of women suffering will continue to grow."
Mr Smith said: "If the volume of women we are talking about here - perhaps 10,000 or more in the UK - are accurate, then this is a massive health scandal. Over 100 women from across the UK including Northern Ireland, some in wheelchairs, some using walking sticks, came to Parliament for this very emotional meeting where woman after woman explained the devastating effects the mesh implants have had on their lives.
"An all-party Parliamentary group on mesh has been established as a result of this meeting, which will seek a meeting with the Health Secretary Jeremy Hunt and the Labour front bench and the body responsible for the registration, testing and approval of devices."
Meanwhile, the former chair of the Northern Ireland Royal College of Obstetricians and Gynaecologists, Dr Robin Ashe, said complication rates for the devices were very low.
"The use of mesh for the management of urinal incontinence is regarded as a safe and effective procedure in the right circumstances and in the right hands," he said.
"As time has progressed, we have realised that one needs to be very careful about the circumstances under which these devices are placed.
"Our complication rates for the devices in the management of urinal incontinence... are very low in the short and medium-term. What might be coming about now is, over a long period of time, we are recognising more complications and that requires to be evaluated further."
http://www.belfasttelegraph.co.uk/news/uk/vaginal-mesh-implant-sufferers-take-fight-to-westminsters-door-35944456.html
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A pelvic mesh Senate inquiry needs to focus on women: health advocate
Jul 20, 2017 | Newcastle Herald
DANNY Vadasz’s executive summary of a submission to the Senate inquiry into pelvic mesh, that’s holding a first public hearing on August 3, is considered, reasonable and scathing of Australia’s health system.
The summary is at the front of the Victorian Health Issues Centre submission to the inquiry, after a survey of more than 2200 Australian women who have had pelvic mesh surgery to treat incontinence or pelvic organ prolapse after childbirth.
About 20 Hunter women responded.
Mr Vadasz’s executive summary presents the Senate inquiry with a damning assessment of the health system, as experienced by women who walked into surgeries trusting their doctors, and the regulatory processes that allowed pelvic mesh devices to be marketed in Australia as safe for use.
The women’s trust has been betrayed. And when women went to doctors for help they were told the problems were in their heads or worse, they were ignored and not believed. When they complained to regulators their complaints were recorded, but not acted on. The women were silenced, shamed by the consequences of the mesh surgery, and isolated.
That scenario will sound very familiar to people in the Hunter.
It’s why it is no surprise that Mr Vadasz’s executive summary includes a section in which he compares the treatment of women pelvic mesh victims with the treatment of victims of institutional child sexual abuse.
It’s why he is particularly scathing of public debate on pelvic mesh that includes minimising the serious and permanent harm done to some women, because many others have not been harmed or have benefited from mesh surgery.
It was a similar argument used against adults who had been sexually abused by priests in churches. Because the churches “did good work”, the crimes committed against children needed to be seen in that context.
Women who will give evidence to the Senate inquiry, and Mr Vadasz and the Health Issues Centre, will argue the Australian health system is rife with public statements about protecting and caring for the community, but the pelvic mesh catastrophe has exposed that as a falsehood.
It is time to silence the doctors, regulators, bureaucrats and corporations, and listen to the women.
It’s called being patient-focused.
http://www.theherald.com.au/story/4800881/trust-betrayed-now-lets-hear-from-patients/
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Jul 19, 2017 | Cambs Times
By John Elworthy
It was standing room only as women and their families from across Britain crammed into a committee room joined by MPs and high profile doctors for an emotional mesh lobby in support of Sling the Mesh.
The campaign was launched by our journalist Kath Sansom.
MP Owen Smith, who chaired the event, pledged to meet with health secretary Jeremy Hunt and table an urgent debate saying: “This is not political this is about women’s health.
“Following the lobby of Parliament an All Party Parliamentary Group on Mesh Implants is being established. It will meet for the first time in September.
“Mesh is a much bigger problem than admitted, better data collection is needed, the proper risk rate must be uncovered.
“I am pleased we were able to give women a sense of being heard and of some progress being made.”
Mr Smith will now meet with Labour front benchers and the MHRA to discuss the problems.
“I have grave concerns that the MHRA is a weak body. I don’t intend to let this go,” he said.
“Next step is a debate in the House of Parliament.”
Women, husbands and their children cried during the two hour meeting as women told how mesh had left them disabled, husbands left them or they had lost jobs and suffered depression or severe anxiety from having a simple 20 minute operation - sold as a quick and simple fix to incontinence or prolapse often caused by childbirth.
Professor Carl Heneghan, editor of the BMJ and professor of evidence based medicine, called for a public enquiry and spoke of the gaps in auditing of patient complications, not just for mesh, but across the board in the NHS.
He said: “Mesh could change the shape of the future across the board.”
Retired surgeon John Osborne, said he tried to warn the medical community about the danger of mesh from the 90s but nobody listened.
He said: “First do no harm. Hearing all these stories; it’s appalling what’s happened. I want to apologise on behalf of my profession.”
Mesh removal expert Suzy Elneil said: “I find meeting the women hard, yet equally they are the reason I keep going.
“It shocks me and upsets me knowing there’s a better way,” she said and added when she watched her first mesh sling incontinence operation in 1997 it was like seeing a slow motion car crash in the pelvis.
Owen added: ”This is the first time women have been heard in Westminster. You’ve done something really important today.”
Karen Preater, 40, told how she was left with intense pain after mesh surgery to treat incontinence.
She said: “My kids don’t remember the mum from three and a half years ago. I don’t do the things I used to do. If I didn’t have my children I wouldn’t be here today.”
Carol Williams, 58, sobbed as she told the meeting how she had been admitted to the Priory clinic after becoming suicidal due to an escalating set of complications from pelvic prolapse mesh.
Others spoke of “cheese wire” pain, removal of organs that had become ensnared in the mesh, loss of sex lives and the psychological toll of not being listened to by doctors.
John Elworthy, editor of the Cambs Times, said: “Keeping up with Kath on her campaign work has been easy, every time you hear a keyboard being typed furiously at the other end of the room you sense she’s working on the social media campaign to hammer home the message.
“Her capacity to combine work for us and run what has become a fast growing national campaign is both extraordinary and exhilarating.
“I’ve been privileged to work over many years with campaigning and spirited journalists but rarely have I encountered anyone with such determined application,”
Lawyers Wedlake Bell have launched a class action for women in England and Wales against mesh makers Johnson & Johnson.
• For details visit Sling The Mesh.
• Around 126,000 mesh implants and tapes for incontinence and prolapse have been used in England alone since 2006.
• Rachel Newton, head of policy at The Chartered Society of Physiotherapy, said: “The CSP recommends that women should be offered physiotherapy before, and as a possible alternative to, surgery. However, due to a shortage of specialist pelvic health physiotherapists, some women do not receive their first physiotherapy appointment until after they have gone through surgery. This is too late for many women. Given the outcomes of the report in Scotland in March of this year, the CSP welcomes today’s lobby and a wider review.”
http://www.cambstimes.co.uk/news/doctor-calls-for-public-inquiry-as-women-and-their-families-weep-at-emotional-parliamentary-meeting-into-the-mesh-implant-scandal-1-5112764
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Connah’s Quay woman’s hopes for a public inquiry after Parliamentary mesh meeting
Jul 19, 2017 | Deeside.com
A health campaigner from Connah’s Quay has high hopes for a public inquiry into the use of mesh implants after an emotional parliamentary meeting on the subject.Maxine Cooper was one of more than 70 women and a handful of men from the Sling the Mesh campaign who attended a Westminster lobby yesterday (Tuesday) hosted by Owen Smith, MP for Pontypridd.
They have all suffered excruciatingly painful complications following the insertion of mesh tape intended to cure incontinence and/or prolapse caused by childbirth or hernias.
The meeting was addressed by Carl Heneghan, professor of evidence-based medicine at the University of Oxford. He compared mesh use with the thalidomide scandal, saying that there was evidence that mesh procedures carry significantly more risk than official figures suggest.
He said that because mesh injuries are not visible like the effects of thalidomide were, that there should be a public inquiry.
Sohier Elneil, a consultant urogynaecologist at University College Hospital, said that complication rates for some types of procedure appeared to be unacceptably high, and raised questions about whether the surgery was being used inappropriately.
She said that unpublished research by her team, based on Hospital Episode Statistics, suggests that urinary incontinence surgery has a readmission rate of 8.9 per cent and that most of these patients needed further procedures for major complications.John Osborne, a retired obstetrician and gynaecologist also addressed the room and Kath Sansom, mesh survivor and founder of Sling the Mesh, said:
Sling the Mesh has more than 2,200 members on its Facebook support page where women battle to come to terms with the physical, mental and emotional harm caused by an operation we were assured had low risks and was an effective treatment option ideal for busy mums.
The women told assembled MPs, aides and reporters about their individual stories, including Carol Williams from Holywell, who has been quoted in a report in The Guardian.Maxine said about the event:
Carol from Holywell spoke and brought the whole room to tears as she’s been told she’s such a bad case that nothing can be done. It was so sad to see all the women there crying and even the male MPs had tears in their eyes. To hear the stories of women who’ve lost their bowels and bladders, who are walking with sticks or mobility scooters – it was amazing. They were so brave to say what they were saying – it was heart-wrenching.
Maxine has been supported in her campaign by Carl Sargeant, Assembly Member for Alyn and Deeside, who has met with Welsh Health Secretary Vaughan Gething to ask for a review into mesh procedures in Wales.
He has also been writing on Maxine’s behalf to Betsi Cadwaladr University Health Board to assist with access to the right appointments and investigations for her.
While in London Maxine took the opportunity to introduce herself to Sohier Elneil, an expert in mesh removal, who confirmed she had received Maxine’s referral letters and would see her as soon as possible.
Carl Sargeant said:
I’m proud of Maxine for travelling to London despite being in crippling pain to do her bit for the campaign.
I’m also delighted for her that she will soon have an appointment with Ms Elneil. What Maxine has done in speaking out and campaigning like this has been to raise awareness among other women and to show that we won’t go away without a fight.
Owen Smith is launching an All Party Parliamentary Group into mesh and will bring the issue to debate in the autumn. The English Group Working Party mesh report is expected on Tuesday.Maxine added:
I don’t know what my prognosis is going to be – it’s scary.
They’ve known for years the complications mesh can cause and the fact they’re still implanting it knowing the complications is disgraceful.
The retired gynaecologist said he was ashamed of the profession – when he spoke out no one would listen to him. If they won’t listen to doctors and experts what chance have we got?
I want to stop this from happening to other women. We may not have been saved but hopefully we can save other women from making a big mistake. They want to keep it quiet but we’re not going to keep quiet.
http://www.deeside.com/connahs-quay-womans-hopes-public-inquiry-parliamentary-mesh-meeting/
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