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Ethicon Media Monitoring 9/28/2017
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Mesh implant surgery 'decimated my quality of life'
Sep 28, 2017 | BBC Scotland
Lorna Farrell was left in constant pain after mesh implant surgery and feels let down by a review looking at the safety of the implants in Scotland. -
Mesh expert raises concerns over patient safety
Sep 28, 2017 | The Scotsman
By Kevan Christie
The expert at the centre of a review group looking at the safety of mesh implants in Scotland has spoken about why he resigned. -
'I feel like I'm on fire down there': Woman awarded $57 MILLION from Johnson & Johnson over faulty vaginal mesh implant speaks out about her extreme pain
Sep 28, 2017 | The Daily Mail
By Danielle Zoellner
A woman who was awarded $57 million in a lawsuit against Johnson & Johnson is the first person in the United States to speak out about the severe pain she suffered from the faulty vaginal mesh implant. -
Scottish Mesh Campaigners Blast Official Report Before Parliamentary Committee
Sep 28, 2017 | Mesh Medical Device Newsdesk
An official report by Scottish medical experts on the pelvic mesh mess in that country, is being called a “whitewash” and Thursday, campaigners, who have resigned in disgust, take their outrage directly to a Parliamentary Committee. -
Mesh implants report failed on ‘reducing harm’
Sep 28, 2017 | The Times
By Lucinda Cameron
A clinician who resigned from a review group examining the safety of mesh implants has said he did not feel its report achieved the “reduction of harm” he expected. -
Doctor in mesh implants review group ‘didn’t feel comfortable’ with final report
Sep 28, 2017 | Press Association (In Evening Express)
A clinician who resigned from a review group looking at the safety of mesh implants has said he did not feel the report achieved the “reduction of harm” he expected. -
Vaginal mesh expert says surgery puts patients at risk in Scotland
Sep 27, 2017 | Herald Scotland
By Jody Harrison
AN expert who stepped down from a review group looking at the safety of mesh implants in Scotland has said that he believed patient safety was being put at risk. -
AM Calls for Clarity on Group Investigating Mesh Use
Sep 28, 2017 | Deeside
AN AM has called for clarity on a national group investigating the use of mesh procedures in Wales.
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Mesh implant surgery 'decimated my quality of life'
Sep 28, 2017 | BBC Scotland
Lorna Farrell was left in constant pain after mesh implant surgery and feels let down by a review looking at the safety of the implants in Scotland.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
The procedure is still in use but more than 400 women are suing the NHS over the implants.
http://www.bbc.com/news/av/uk-scotland-41416042/mesh-implant-surgery-decimated-my-quality-of-life
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Mesh expert raises concerns over patient safety
Sep 28, 2017 | The Scotsman
By Kevan Christie
The expert at the centre of a review group looking at the safety of mesh implants in Scotland has spoken about why he resigned.
Dr Wael Agur said he believed patient safety was being put at risk and mesh should only be used in exceptional circumstances due to the risk of "irreversible" damage.
The Scottish government said no evidence had been deleted or hidden from the review group's report.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Over the past 20 years, more than 100,000 women across the UK have had transvaginal mesh implants - including more than 20,000 in Scotland.
But some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
In 2014, former Scottish Health Secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.
Dr Agur, a consultant urogynecologist, was a member of the review group but said he was forced to step down earlier this year after an entire chapter of the final report was removed and put in the appendices.
It followed the resignation of two patient representatives on the group who claimed the report had been "watered down" and that it was ultimately "a whitewash".
At the time, Health Secretary Shona Robison said no evidence would be hidden in the group's final report.
Dr Agur said he reviewed the most up-to-date research in the UK and internationally and concluded that non-mesh surgical procedures were safer, but said that such conclusions were removed or changed.
He said: "It was so important that we got this right. Not just for women in Scotland but for women around the world. Scotland was the only country where an independent review was running to look at the benefits and risks of these procedures."I believe the report has left the door slightly open for some procedures to be performed and that should not have happened."
Dr Agur said he believed mesh use should be avoided in future in all but the rarest circumstances because of the risks of "acute" and "irreversible" damage.
http://www.scotsman.com/news/mesh-expert-raises-concerns-over-patient-safety-1-4571534
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Sep 28, 2017 | The Daily Mail
By Danielle Zoellner
· Ella Ebaugh, 51, sued Johnson & Johnson and Ethicon after her mesh implant caused severe abdominal pain and burning
· A Pennsylvania jury said the companies were negligent and the product was defective
· This is one lawsuit of many against Johnson & Johnson and its many mesh implant devices on the market
· The devices are used for women who are experiencing pelvic organ prolapse and urinary problems, which is commonly caused after giving birth
· Ethicon said in a statement it plans to appeal the jury's verdict
A woman who was awarded $57 million in a lawsuit against Johnson & Johnson is the first person in the United States to speak out about the severe pain she suffered from the faulty vaginal mesh implant.
Ella Ebaugh, 51, has had three surgeries since getting the implant because the mesh eroded into her urethra. But it still isn't completely gone.
Vaginal mesh, or pelvic mesh, is implanted by surgeons to help with pelvic organ prolapse and urinary problems in women.
But recently, Johnson & Johnson and other companies who sell these implants have seen a rise in lawsuits that the mesh is causing serious problem such as abdominal pain, vaginal pain and an inability to have sex.
Ebaugh, from Pennsylvania, was awarded the money from a jury in Philadelphia after they found the company to be negligent and its product defective, according toCBS News.
More lawsuits remain, though, as thousands of women nationwide say they too are experiencing problems with the popular device.
Ebaugh was implanted with Johnson & Johnson's Ethicon vaginal mesh.
She told CBS that the mesh eroded into her urethra and forced her to get surgery three times to repair the damage.
But some of the mesh is still embedded in her body and causing extreme pain.
Ebaugh got the implant after having five children and suffering from urinary incontinence, which means involuntary urine leakage.
Urinary incontinence is a common reason why hundreds of thousands of women worldwide have received the implants.
But Ebaugh has had nothing but pain and discomfort since she opted for the surgical solution.
'I feel like I'm on fire you know down there,' she said.
Since the surgery she has also experienced horrible pain when she sits and stands.
Ethicon, the creator of mesh product Ebaugh received, is planning to appeal the verdict.
'Ethicon is confident in the positive impact our pelvic mesh products have had. The use of mesh to treat stress urinary incontinence is supported by medical experts, medical societies, physicians and regulatory organizations around the world,' the company said in a statement.
This isn't the first lawsuit Johnson & Johnson has experienced for the controversial mesh implants.
They were told to pay $20 million to a woman in New Jersey last month because of her own pain from a TVT-Secur vaginal mesh insert.
This insert also eroded in her body forcing her to undergo multiple surgeries to remove it.
Johnson & Johnson now faces more than a thousand lawsuits nationwide as more women come forward saying that they also have experienced severe problems with their own surgeries.
And this problem isn't just in the United States.
Women in the UK have spoken against the implants saying they also are experiencing discomfort and pain from their own surgeries.
Five years ago, Johnson & Johnson stopped selling four of its mesh inserts after people said they were faulty.
But medical experts still claim that the mesh inserts are safe and effective for women help treat pelvic and urinary problems.
HOW MANY WOMEN SUFFER?According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.
Yet, a study by Case Western Reserve University found that up to 42 percent of patients experience side effects.
Of which, 77 percent report severe pain and 30 percent claim to have a lost or reduced sex life.
Urinary infections have been reported in around 22 percent of cases, while bladder perforation occurs in up to 31 percent of incidences.
Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life.
According to Kath Samson, head of the Sling The Mesh campaign, surgeons often refuse to accept vaginal mesh implants are causing recipient's pain, and are not obligated to report such complications anyway.
She said: 'Less than 40 percent of surgeons report vaginal mesh implant side effects.
'In last 10 years, 126,000 mesh and tape implants have been fitted in England alone.
'In that period around 7,800 women have gone into hospital with a mesh complication, but the number reported to the MHRA is just over 1,000.
'Many more women would have experienced pain but never gone to hospital.'
http://www.dailymail.co.uk/health/article-4926888/Johnson-Johnson-57-million-woman-mesh-implant.html
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Scottish Mesh Campaigners Blast Official Report Before Parliamentary Committee
Sep 28, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 27, 2017 ~ An official report by Scottish medical experts on the pelvic mesh mess in that country, is being called a “whitewash” and Thursday, campaigners, who have resigned in disgust, take their outrage directly to a Parliamentary Committee.
Scotland is once again taking the lead in making public the pelvic mesh mess in that country.
Thursday, mesh-injured campaigners and experts will testify to the Petitions Committee – which allows the public to petition Parliament to make changes that citizens believe is needed.
At issue is a controversial final report of the Independent Review of Transvaginal Mesh Implants, issued March 27, 2017, which campaigners call a “whitewash.”
The report indicates mesh benefits outweigh risks in stress urinary incontinence (SUI) procedures, TVT (tension-free vaginal tape) is effective, and the suspension on mesh procedures in Scotland should be lifted.
In June 2013, Scotland became the first country to suspend the use of synthetic mesh to treat incontinence (SUI) and pelvic organ prolapse (POP).
The Petitions Committee will examine what relationship the officials who produced the report have to mesh manufacturers, and why that issue was not made more transparent.
Reporter Marion Scott explains to Mesh News Desk the significance of the committee.
“It is hugely influential and has the power to hold inquiries, commission reports, require government ministers and public servants to give evidence and answer questions.
It has the power to recommend changes in many areas and is made up of politicians from all different parties so it is free to do things other committees are not.”
The proceedings will be televised.
UROGYNECOLOGIST EXPERT RESIGNS
Urogynecologist, Dr. Wael Agur was an expert brought in to contribute to the official report on the mesh issue in Scotland until he decided to resign in protest last March. He was joined by two patient representatives of Scottish Mesh Survivors, an active group of mesh-injured women.
In his peitition to the Committee, he is critical of the report saying it “allowed the highest risk mesh procedures despite lack of proven benefit over standard non-mesh alternatives.”
There is no reliable evidence on safety and efficacy of these products he adds, and the report does not “adequately warn surgeons and patients against the serious risks associated with transobturator mesh tape.”
He believes pelvic mesh should only be used in exceptional circumstances, due to the risk of “irreversible” damage, reports the Herald Scotland.
Dr. Agur says the final report must reinstate the original deleted Chapter Six in which compares the risks associated with mesh and non-mesh procedures. His conclusions that non-mesh repairs are safer was removed or changed, he says.
The report also does not recommend mandatory recording of all mesh procedures in a national registry in order to keep an eye on complication figures in the future.
Campaigners and Dr. Agul want a continued suspension of mesh procedures in Scotland and a rejection of the official report, which allowed some mesh procedures to be reinstated. The inquiry will ask mesh manufacturers to prove the mesh implants and procedures are safe, and if that proof is not forthcoming, it is unlikely mesh procedures will be reintroduced in Scotland.
Scott says, “One thing is for sure. The Mesh controversy is not over. It’s only just beginning here. There is also huge support for Mr. Neil’s international mesh summit.
Scotland is very unhappy with the UK’s medical watchdog (MHRA) which is almost wholly funded by industry.”
The MHRA concludes benefits outweigh the risks of all of these devices if used as intended. Their use continues in England.
Scott adds that a number of politicians want Scotland to have its own watchdog and to be more proactive in protecting patients. That would include requiring doctors to step up reporting adverse incidents, true informed choice, and a device registry mandates reporting adverse events so they can be accurately tracked.
In Scotland more than 400 women are sue the Scottish health boards and mesh makers due to their complications. ##
LEARN MORE:
The Herald, Vaginal Mesh expert says surgery puts patients at risk in Scotland, September 27, 2017
http://www.heraldscotland.com/news/15560407.Mesh_expert_says_surgery_puts_patients_at_risk/
MND, Scottish Mesh Inquiry Blows-Up, May 23, 2017
https://www.meshmedicaldevicenewsdesk.com/scottish-mesh-inquiry-blow/The Independent Review of Transvaginal Mesh Implants, published March 27, 2017 is here.
MND, Scotland Calls for International Summit on Mesh Crisis, Sept 26, 2017
https://www.meshmedicaldevicenewsdesk.com/scotland-calls-international-summit-mesh-crisis/
MND, Pelvic Mesh Procedures Halted in Scotland, June 2016
https://www.meshmedicaldevicenewsdesk.com/pelvic-mesh-implant-procedures-halted-scotland/MND, Scotland Becomes First Country Suspend Use of Pelvic Mesh, June 2014
https://www.meshmedicaldevicenewsdesk.com/breaking-news-scotland-bans-transvaginal-mesh/
Thursday will be petitions committee, submission of Dr.Wael Agur
http://www.parliament.scot/S5_PublicPetitionsCommittee/Submissions%202017/PE1517JJJ.pdfhttps://www.meshmedicaldevicenewsdesk.com/scottish-mesh-campaigners-blast-official-report-parliamentary-committee/
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Mesh implants report failed on ‘reducing harm’
Sep 28, 2017 | The Times
By Lucinda Cameron
A clinician who resigned from a review group examining the safety of mesh implants has said he did not feel its report achieved the “reduction of harm” he expected.
Dr Wael Agur said the report left the door “slightly open” for some mesh implant procedures to be performed, which he does not believe should have happened.
The review, published in March, concluded that mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, that patients should be offered a range of treatments — mesh and non-mesh — and that they must be given the information to make “informed choices”.
Thousands of women in Scotland have been treated using the implants — a simple, less invasive alternative to traditional surgical approaches — but some have suffered painful and debilitating complications.
Dr Agur, a consultant urogynaecologist, said key data that he believed was crucial to inform the recommendations was put into an appendix of the report.
He told the BBC: “I stood down as I didn’t feel comfortable that the report has achieved the reduction of harm that I expected it to achieve.”
Two patients also resigned from the review panel, saying the report had been “diluted”. Dr Agur will give evidence at Holyrood tomorrow.
https://www.thetimes.co.uk/article/mesh-implants-report-failed-on-reducing-harm-23xs6nxvf
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Doctor in mesh implants review group ‘didn’t feel comfortable’ with final report
Sep 28, 2017 | Press Association (In Evening Express)
A clinician who resigned from a review group looking at the safety of mesh implants has said he did not feel the report achieved the “reduction of harm” he expected.
Dr Wael Agur said the report left the door “slightly open” for some mesh implant procedures to be performed, which he does not believe should have happened.
The review, published in March, concluded mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, that patients should be offered a range of treatments – mesh and non-mesh – and they must be given the information to make ”informed choices”.
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
Dr Agur, a consultant urogynaecologist, said key data he believed was crucial to inform the recommendations was removed from the body of the report into an appendix and an annexe.
He told the BBC: “I stood down as I didn’t feel comfortable that the report has achieved the reduction of harm that I expected it to achieve.
“It was so important that we got this right. Not just for the women in Scotland but for the women around the world. It’s important also to remember that Scotland is leading on this matter.
“Scotland is the only country where an independent review was running and looking in full detail at the benefits and risks of these procedures and promising women in Scotland, the UK and around the world that we are going to come up with independent recommendations that reduce harm to women.”
Mesh survivors Olive McIlroy and Elaine Holmes also resigned from the review panel, claiming the final report had been ”diluted”.
Dr Agur told the broadcaster: “I do believe that in some points Scotland is still in the lead but I expected more reduction of harm. From my own experience and my own interpretation of evidence I do believe that the report could have done more to reduce harm without losing value.
“I believe that the report has left the door slightly open for some procedures to be performed and I do not believe that that should have happened.”
He concluded the procedure should either not be performed at all or restricted to clearly defined situations where a group of surgeons, and not just a single surgeon, should decide.
Dr Agur will give evidence to the Petitions Committee at the Scottish Parliament on Thursday.
Synthetic transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
In June 2014, then health secretary Alex Neil asked health boards to suspend the use of the implants after a campaign by women who have suffered serious side effects.
Scotland’s Chief Medical Officer, Dr Catherine Calderwood, told the BBC she had “fully accepted” the recommendations made by the independent review and had been clear that the suspension of the use of mesh implants should remain in place until she was satisfied they had been implemented.
She added: “The cabinet secretary met with the chair of the independent review, who informed us that some evidence has been presented in a different format to that of the interim report, but that no evidence has been deleted or hidden.
“The interim report is available to read on the independent review’s website and the final report builds on that.
“The clinician who resigned from the review group drafted an alternative version of one chapter which was not agreed by the rest of the group, but in the interests of transparency was published on the Scottish government website.”
She said a review is being carried out into the process of the independent review.
She added: “We are ensuring that all women who wish treatment for urinary incontinence and pelvic organ prolapse receive the appropriate treatment for their symptoms by offering the full range of options available and that they are fully informed of the risks and benefits for them.”
https://www.eveningexpress.co.uk/news/scotland/doctor-in-mesh-implants-review-group-didnt-feel-comfortable-with-final-report/
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Vaginal mesh expert says surgery puts patients at risk in Scotland
Sep 27, 2017 | Herald Scotland
By Jody Harrison
AN expert who stepped down from a review group looking at the safety of mesh implants in Scotland has said that he believed patient safety was being put at risk.
Dr Wael Agur said mesh should only be used in exceptional circumstances due to the risk of "irreversible" damage.
The consultant urogynecologist quit the group earlier this year after an entire chapter of the final report was removed and put in the appendices.
His resignation followed those of two patient representatives who claimed the report had been "watered down" and that it was ultimately "a whitewash".
Transvaginal mesh implants are used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
But some patients have suffered painful and debilitating complications, and more than 400 women are taking legal action against Scottish health boards and manufacturers as a result of their surgery.
The Scottish government said no evidence had been deleted or hidden from the review group's report. However, use of the surgery has been suspended until guidelines contained in the review can be implemented.
Dr Wael Agur told BBC Scotland he had reviewed the most up-to-date research in the UK and internationally and concluded that non-mesh surgical procedures were safer, but said that such conclusions were removed or changed.
Dr Wael Agur
He said: "It was so important that we got this right. Not just for women in Scotland but for women around the world. Scotland was the only country where an independent review was running to look at the benefits and risks of these procedures.
"I believe the report has left the door slightly open for some procedures to be performed and that should not have happened."
Dr Agur said he believed mesh use should be avoided in future in all but the rarest circumstances because of the risks of "acute" and "irreversible" damage.
He added: "Whitewash is a political term and I am not a politician. I'm a clinician and a researcher and a surgeon and I can tell you that I looked into the evidence that compares all these procedures and I concluded that they should either not be performed at all or restricted to clearly defined situations where not a single surgeon but a group of surgeons nationally should decide."
Based on the evidence gathered, he said he expected the review group to conclude that mesh use should not continue and that the suspension should remain in place.
He said that ultimately the report gives surgeons in Scotland and globally the impression that its use should continue.
On Thursday, Dr Agur will give evidence to the Petitions Committee at the Scottish Parliament.
In his written submission, he states: "The report did not adequately warn surgeons and patients against the serious risks with the transobturator mesh tape (the type most commonly used in Scotland).
"The report ignored the best evidence on mesh-related adverse events that described the prevalence of a negative outcome to be as frequent as 15% (1 in 7).
"On interpreting the evidence tables comparing safety of surgical procedures, I came to the following conclusions: Non-mesh procedures are safer than mesh procedures for incontinence. Transobturator tape is too risky to be offered, except in very rare circumstances. Prolapse mesh has no benefit and is too risky to be offered."
His submission to MSPs adds: "As the chapter was deleted, its evidence did not inform the recommendations of the final report."
Scotland's Chief Medical Officer, Dr Catherine Calderwood, said she had "fully accepted" the recommendations made by the independent review and had been clear that the suspension of the use of mesh implants should remain in place until she was satisfied they had been implemented.
She added: "The cabinet secretary met with the chair of the independent review, who informed us that some evidence has been presented in a different format to that of the interim report, but that no evidence has been deleted or hidden.
"The interim report is available to read on the independent review's website and the final report builds on that.
"The clinician who resigned from the review group drafted an alternative version of one chapter which was not agreed by the rest of the group, but in the interests of transparency was published on the Scottish government website.
"A review is being carried out into the process of the independent Review, which will make recommendations about the conduct of future similar reviews and will report back next year."
http://www.heraldscotland.com/news/15560407.Mesh_expert_says_surgery_puts_patients_at_risk/
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AM Calls for Clarity on Group Investigating Mesh Use
Sep 28, 2017 | Deeside
AN AM has called for clarity on a national group investigating the use of mesh procedures in Wales.
Alyn and Deeside AM Carl Sargeant has been writing to Health Secretary Vaughan Gething since July on behalf of Maxine Cooper of Connah’s Quay.
She is one of many women suffering excruciating complications after insertion of Tension-Free Vaginal Tape (TVT) or Tension-Free Vaginal Tape Obturator (TVTO) procedures to cure incontinence or prolapse. Men who have the tape inserted to correct hernias are also affected.
Mr Sargeant asked for an urgent review of mesh procedures in Wales. He also asked the Cabinet Secretary to look into increasing awareness of symptoms among GPs so that complications can be properly diagnosed and evidenced.
Mr Gething’s response earlier this month said a task and finish group would consider the latest recommendations made in Scotland and England in the light of practice already adopted within NHS Wales.
The letter did not however answer a number of specific concerns so Mr Sargeant wrote a further letter highlighting these.
A response received yesterday, September 26, still did not address the concerns, with Mr Gething merely saying that the group would consider the points raised.
Today Carl Sargeant said: “In all honesty I’m disappointed by the lack of detail in the Cabinet Secretary’s response.
“I have written back asking who the members of the group are, when they are meeting, and when they will be reporting to the Cabinet Secretary.
“I’d also like to know how the group will collect their evidence and whether, in line with the Wellbeing of Future Generations Act, the group will be informed directly by persons affected by mesh and tape procedures.
“I truly hope for a more comprehensive response. Maxine is currently recovering from an excruciating procedure to remove the mesh and has been told recouperation will take at least six months.
After that she will need further operations, and sadly her story is the same as hundreds of women suffering across Wales.”
http://www.deeside.com/calls-clarity-group-investigating-mesh-use/
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