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Ethicon Media Monitoring 3/6/2017
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Mesh sufferers quit expert group over 'diluted' report
Mar 5, 2017 | BBC
By Lucy Adams
Two patient representatives have quit the independent review group looking at the safety of mesh implants. -
‘Betrayed’ victims quit mesh implants inquiry
Mar 6, 2017 | The Sunday Post
By Marion Scott
VICTIMS of one of Scotland’s biggest medical negligence scandals have resigned from the official inquiry into it – claiming it is a “whitewash”. -
Mesh News Desk, Welcome March
Mar 5, 2017 | Mesh Medical Device Newsdesk
By Jane Akre
If you are considering a hernia or pelvic mesh implant, you have come to the right place.
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Mesh sufferers quit expert group over 'diluted' report
Mar 5, 2017 | BBC
By Lucy Adams
Two patient representatives have quit the independent review group looking at the safety of mesh implants.
Olive McIlroy and Elaine Holmes, who both suffered severe complications following mesh implant surgery, claimed the final report had been watered down.
It follows claims that an entire chapter has been removed from the report ahead of its publication.
Scotland's Health Secretary Shona Robison has said she will meet with the women to discuss their concerns.
Correspondence seen by the BBC shows that one expert member of the review group has written to its chairwoman to raise concerns about the report.
The letter states that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.
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.
What's the issue with mesh implants?
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants 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, campaigners gave evidence to the Holyrood Petitions Committee. Several of them were in wheelchairs, unable to walk because of surgical complications.
As a result Alex Neil, the Scottish government's health secretary at the time, wrote to health boards requesting a suspension in the use of mesh implants by the NHS in Scotland pending the review group's investigation into their safety.
An interim report was delivered in October 2015 and the final conclusions are expected to be published soon.
However, Ms McIlroy and Ms Holmes - who are part of the Scottish Mesh Survivors campaign - have resigned as patients' representatives on the group, saying the report had "changed beyond recognition from the interim report".
The women said they were saddened and appalled to discover that an entire chapter had been removed from the review group's final report.
Their resignation letter to the chairwoman of the review group states: "The remit suggests 'consensus' - if patient-friendly, shared-decision tables are destroyed and replaced with clinician's directive counselling then obviously there will not be consensus.
"The ridiculous amount of tables now included in Chapter 5 only serves to confuse, not explain.
"There is no clinical interpretation to explain what the results actually mean to the lay person and if the findings are scientifically and or clinically significant."
Elaine Holmes, from East Renfrewshire, told BBC Scotland she had seen a draft of the final report and it was like "night and day" when compared to the previous one.
She said: "We looked at one chapter and it was completely biased.
"It would speak of the benefits of mesh but not the risks.
"For the non-mesh equivalent, which is called colposuspension, it would talk about the risk but not the benefits. It was just so biased it was unbelievable."
Ms Holmes said that despite contributing to the review group for almost three years her voice had been ignored.
They said the group and its final report now lacked integrity and independence.
live McIlroy, from Renfrew, also said the new report was "unrecognisable" from the one 18 months ago.
She said: "To me it is that they just diluted the content in favour of mesh procedures.
"It seems to me unacceptable that they can risk even one patient suffering severe complications.
"It's not about the numbers, it's about the severity of the complications when things do go wrong."
Ms McIlroy added: "The colposuspension non-mesh procedures have been going on since the sixties.
"There is no litigation with them, there is no campaign of patients who have been severely adversely injured through the procedure."
She said that was not the case with mesh implants.
"Alarm bells are ringing all over the world," she said.
"It's not just us and it's not just here.
"We are not trying to sensationalise or make a point, we are just trying to get at the truth and they don't want the real truth to come out."
Labour MSP Neil Findlay, who has been campaigning on the issue, said: "This is a truly astonishing turn of events.
"Elaine and Olive took part in the mesh review group in good faith and, despite their pain and disability, put their heart and soul into it to try and ensure that no more women would be horribly injured like they were."Potential risks
He added: "The mesh scandal is a global scandal but in Scotland we had the chance to lead the world in protecting women from life-changing injuries, but instead of doing so the government has shown themselves to be complicit in one of the biggest medical cover-ups in the history of Scotland's NHS."
Scottish Conservative MSP Jackson Carlaw said: "Nicola Sturgeon promised me in parliament only a few weeks ago that the sudden resignation of the previous chair of the review and her replacement with a health board official with a direct interest in mesh implants would have no impact on the independent conclusions reached.
"Now we find that the conclusions in the interim report appear to have been abandoned, even while mesh is reclassified across Europe as a "high risk procedure", in favour of what Elaine & Olive and thousands of Mesh survivors believe is a "whitewash"."
The latest resignations come after the chair of the review group stood down in December.
Public Health expert Dr Lesley Wilkie quit just months before the final report was due to go out.
In December, the BBC revealed that hundreds of mesh implant operations had been performed in Scotland despite ministers recommending their suspension.
Figures obtained by the BBC revealed that 404 women had received mesh and tape implants since the health secretary called for the suspension in June 2014.
The Scottish government said the position had been made clear.
Those boards still using mesh implants said they discussed all the potential risks with patients before surgery.
In a statement, the Health Secretary Shona Robison said: "I have been made aware of the resignations of two of the inquiry's members.
"I intend to meet with them so I can hear their concerns directly.
http://www.bbc.com/news/uk-scotland-39157683
"The independent review continues its work to produce its final report and we expect them to publish it this Spring. I am grateful to all members for their expertise and considerable efforts over the years."
http://www.bbc.com/news/uk-scotland-39157683
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‘Betrayed’ victims quit mesh implants inquiry
Mar 6, 2017 | The Sunday Post
By Marion Scott
VICTIMS of one of Scotland’s biggest medical negligence scandals have resigned from the official inquiry into it – claiming it is a “whitewash”.
Campaigners Elaine Holmes and Olive McIlroy were patient representatives on an investigation set up three years ago into the dangers of controversial mesh implant surgery.
But last night they resigned from the inquiry just a month before its final report is published – claiming key evidence of the dangers of the implants has been ignored.
Elaine and Olive were asked to participate in the inquiry after ex-Health Secretary Alex Neil agreed to a full investigation into how implants used to treat bladder problems and pelvic organ prolapse left victims with appalling injuries.
And Elaine and Olive welcomed an interim report, published 15 months ago, which said NHS Scotland should stop routinely using the implants which have crippled hundreds of thousands of women worldwide.
But they are furious about the final report, which they have seen a draft copy of, and which they say “favours” a resumption in a use of the procedure.
Elaine and Olive claim the report excludes evidence, in some cases from the Scottish Government’s own experts, which shows mesh implants for bladder problems can cause “life-changing injuries”.
It also, they say, ignores evidence from the US that up to 40% of women are injured by the “hooks” used to anchor mesh implants.
The campaigners also claim the report ignored European Union guidelines which reclassified all surgical mesh as “high risk”.
The report panel, which includes surgeons, NHS personnel and government officials, has rejected calls by some of its own medical members for the mandatory reporting of all complications associated with implants, in favour of a system used by only one-in-four specialists.
Elaine, 52, from Newton Mearns, East Renfrewshire, who spends long periods in a wheelchair due to extensive nerve damage, said: “We’ve been betrayed.
“This ‘independent’ review has chosen to ignore all the warnings and rejected or buried evidence which does not suit an agenda dictated by pro-mesh surgeons.”
Now the pair fear a suspension in mesh surgery ordered by Alex Neil in 2014 will be lifted and procedures they want banned will be reintroduced.
They are also angry the report makes no mention of three criminal investigations by the US Government against mesh manufacturers, some of which have already paid out £1.5 billion in compensation to victims.
The campaigners claim they are not the only people involved in the inquiry who are concerned by the final findings.
Olive, 60, from Renfrew, who walks with the aid of crutches, said: “At least one expert within the group has alerted everyone involved about their concerns over the report’s failings.”
The women are also concerned about the leadership of the inquiry following the resignation for “personal reasons” of the original chairperson, retired public health expert Lesley Wilkie.
She was replaced by Tracey Gillies, medical director of NHS Lothian, one of two Health Boards which ignored Mr Neil’s suspension order and implanted mesh in almost 400 more women.
MSP Neil Findlay, chair of the Scottish Parliamentary Health Committee, said: “Nicola Sturgeon stood up in Parliament on Thursday and defended almost 170 reviews being held, insisting she would never stop listening to the people.
“But mesh victims have been ignored, abused and marginalised.
“We had the chance to lead the world and protect women from this global scandal.
“But this a truly astonishing and shameful turn of events.”
Top lawyer George Clark of Quantum Claims, which represents hundreds of victims, said: “The outcome of this review is astonishing given Scotland is facing the biggest medical claim in legal history.”
Last night Health Secretary Shona Robison said: “I have been made aware of the resignations of two of the inquiry’s members. I intend to meet with them so I can hear their concerns directly.
“The independent review continues its work to produce its final report and we expect them to publish it this Spring. I am grateful to all members for their expertise and considerable efforts over the years.”
https://www.sundaypost.com/fp/betrayed-victims-quit-mesh-implants-inquiry/
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Mar 5, 2017 | Mesh Medical Device Newsdesk
By Jane Akre
Thanks for stopping by Mesh Medical Device News Desk.
If you are considering a hernia or pelvic mesh implant, you have come to the right place.
There are at least 100,000 lawsuits currently filed in the U.S. to address the injuries allegedly caused by polypropylene pelvic mesh. For now there has been a lull in mesh litigation as, behind the scenes, mesh manufacturers and the injured are at a standoff.
Manufacturers are in an holding out on offering settlements to make the litigation go away, while patients wait for their day in court.
It is an unsustainable standoff and the federal judge in charge of this massive litigation wants both sides to settle. He is doing what he can to force that to happen, unfortunately at the detriment of many women who are offered little to replace the lives they’ve lost.
To make matters worse, some law firms have decided to clear their books of mesh litigation moving onto other mass torts. Some are encouraging women to take what is offered rather than go back to seek additional funds.
Please think twice before you receive a polypropylene mesh implant.
Doctors have been advised by the FDA not to use mesh as a first line of treatment are still doing so. Women tell Mesh News Desk they are promised the mesh today is different. It’ still polypropylene and no one can yet tell you why it does not work in some women, or in some men for hernia repair. There is no way to know if you will be one of the unlucky ones, even if your doctor is an “expert.”
UCLA is looking into why so many women and men suffer autoimmune issues following their mesh implants. You can join the registry here.
Shouldice Clinic in Toronto does a non-mesh repair for hernias. There are a few mesh removal doctors around the country but the better step might be, if you are a candidate, to have your first repair for incontinence, prolapse or hernia to be a non-mesh repair.
The stories are too sad from those who trusted their doctors and decided to go ahead and follow his lead.
So while this is all being sorted out, many decades from now we will look back at this very dark chapter on patient health. Clarity and answers simply do not exist today.
See the story “Top 10 Myths Women are Told Today about Pelvic Mesh” here
If you are told you need polypropylene mesh to correct prolapse or incontinence, you will need to direct your own medical care and be a truly informed consumer. We hope these pages help you toward that goal.
Mesh News Desk does not give legal or medical advice. We may send you some doctors names as a courtesy. If you are seeking a law firm you might fill out the Lawyer Evaluation form on the first page, run by Sundown Marketing. Please do not comment with your last name.
Onward Friends!
Jane Akre, Editor, Mesh News Desk
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