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Ethicon Media Monitoring 4/3/2017
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Insight: Down but not out after mesh implant ‘whitewash’
Apr 1, 2017 | The Scotsman
By Dani Garavelli
We call ourselves Cagney and Lacey,” says Olive McIlroy of her friendship with Elaine Holmes. And there is something of the no-nonsense US cop duo about the women who have led the campaign against polypropylene transvaginal mesh implants in Scotland. The blend of vulnerability and bravado, maybe; and the refusal to be crushed by adversity. -
Mesh implant report set to face legal challenge
Apr 2, 2017 | Sunday Post
By Marion Scott
HEALTH Secretary Shona Robison is facing a judicial review in the Court of Session over a “whitewash” report on the safety of mesh implants. -
Nicola Sturgeon under fire after 'sneaking out bad news' in final hours before Easter break
Mar 31, 2017 | Daily Record
By Andy Philip
.... Nicola Sturgeon said she is “deeply sorry” for the suffering of survivors of mesh implant surgery. -
Craig Paton Does FMQs: Education, education, separation?
Mar 31, 2017 | CommonSpace
By Craig Paton
... The questions quickly moved on, and Kezia Dugdale rose to speak about the survivors of mesh, a medical procedure designed to treat those with organ prolapse or stress urinary incontinence, but which has had many complications, including constant pain and in some cases, organ perforation.
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Insight: Down but not out after mesh implant ‘whitewash’
Apr 1, 2017 | The Scotsman
By Dani Garavelli
We call ourselves Cagney and Lacey,” says Olive McIlroy of her friendship with Elaine Holmes. And there is something of the no-nonsense US cop duo about the women who have led the campaign against polypropylene transvaginal mesh implants in Scotland. The blend of vulnerability and bravado, maybe; and the refusal to be crushed by adversity.
Along with hundreds of other women in Scotland – and tens of thousands across the world – Holmes and McIlroy suffered devastating complications after the mesh implants were used to treat Stress Urinary Incontinence (SUI), a problem common amongst middle-aged women.
“When mesh goes wrong it goes seriously wrong,” says McIlroy. “There are women losing their bladders, losing their kidneys. They don’t have a life. The life they had is totally gone. They cannot walk, they cannot sit without pain.”
Today, the women have come to a Beefeater restaurant in East Renfrewshire – Holmes in her wheelchair and McIlroy on her crutches – to talk about the Scottish Government’s defence of a “whitewash” review into what has been described as the biggest medical scandal since thalidomide.
The women are not overly keen to share their own experiences. Holmes, the more severely affected of the two, finds it overwhelming to reflect on her life before and after. But given the report – published last week and written in the dispassionate language of the bureaucrat – provides little insight into the human impact of mesh gone wrong, it is important to capture the extent of their ordeal.
Let’s start with Holmes. After she underwent her procedure in 2011, she woke up in so much pain she couldn’t move. Though the surgeon initially played down her symptoms, it transpired the device had sliced through her urethra. Holmes was bedridden for 14 weeks, and endured several more operations, and many more hospital admissions before she regained any mobility. Six years on, she can’t drive or get in and out of a bath and can barely walk. When she tries, her left leg often gives way and she falls. Holmes suffers from fibromyalgia which causes chronic pain and affects her concentration. Her husband Jeff has retired and become her carer. Thinking of the plot of land on Colonsay they once dreamed of owning makes her cry.
McIlroy, who loved hillwalking and going to the gym, suffered groin pain for a couple of years after she had her operation in 2008, then woke up one morning unable to move. She was forced to give up her job as a home carer and, like Holmes, is in constant pain. She has given up on the heavy duty analgesics with made her feel like a zombie, and resorted to mindfulness and a TENS machine.
Neither McIlroy nor Holmes were warned of the risks. “We were told: ‘This is a 20-minute operation. You’ll feel like a new woman,’” says Holmes. Nor were they told the mesh implants were for life. “I thought it was like the contraceptive coil. I’d give it a go, and if it didn’t suit me I’d have it taken out,” says Holmes. “When I found out it was permanent, I gret for days.” Holmes has now had almost all of her mesh removed, but because it fragments inside the body, the process is tricky: like taking chewing gum out of hair.
Both McIlroy and Holmes were told their problems were “unique”; it was only once they met that they realised they were nothing of the sort. Finding each other was the best thing that could have happened to them. Though they have very different personalities – Holmes is ultra-organised, while McIlroy “thinks outside the box” – they make a formidable team.
For the past three years, the pair have fought side by side to raise awareness of the dangers of mesh implants, giving evidence at the Holyrood Petitions Committee, successfully lobbying the Scottish Government for a moratorium on their use and joining the independent review group.
They attracted cross-party support from the SNP’s Alex Neil, Labour’s Neil Findlay and the Tory Party’s Jackson Carlaw and helped produce leaflets setting out the risks of all transvaginal mesh procedures, so, in future, women could make an informed decision on treatment.
Yet now, Holmes and McIlroy are facing renewed devastation. The review, in which they invested their energies, has fallen so far short of their expectations they no longer wish to be associated with it. Defended by Health Secretary Shona Robison last week, its final report does make a series of recommendations. It says mesh should not be offered routinely for prolapses and calls for the reporting of “adverse incidents” – cases where women suffer complications – to be mandatory, in accordance with General Medical Council guidelines.
But the campaigners insist damning evidence of the dangers of mesh has been left out, or hidden away in annexes and appendices, that no mention has been made of the cases currently being settled in the US, and that at least one of the recommendations has been watered down.
The Scottish Government insists it cannot ban transvaginal mesh as the Medicines & Healthcare products Regulatory Agency (MHRA) is the body responsible for such judgments – though some challenge this contention.
Instead, the report paves the way for the moratorium – which was, in any case, breached by several health boards – to be lifted once “safeguards” have been put in place.
Its “shortcomings” came as no surprise to McIlroy and Holmes. Though, in the beginning, they worked constructively with the other members of the group and signed up to the interim report (albeit with some reservations), they eventually lost faith in the process.
For ten months, they say, they were invited to no meetings, although they later found out “sub-group meetings” had been taking place, and the tone began to change. After the departure of the chair Dr Lesley Wilkie, and one of the clinicians, they too decided to resign. “When we told the women [in the Scottish Mesh Survivors Group], the mood hit the floor,” says McIlroy. “But they understood why we couldn’t put our name to a report that was a betrayal of everything we had worked for.”
Transvaginal mesh has been commonly used in the treatment of both pelvic organ prolapses (POP) and SUI since the early 2000s. Studies suggest traditional procedures involving native tissue repair is just as effective, but using synthetic mesh is quicker and cheaper, and the surgeons require less expertise.
In Scotland, between 2000 and 2014, around 1,500 women a year underwent the treatment, which has been presented as the “gold standard” for SUI. But mesh shrinkage and mesh erosion are not uncommon. Long-lasting side effects include abdominal and pelvic pain, urinary problems, painful sexual intercourse, vaginal scarring and nerve damage.
One of the difficulties for researchers is that symptoms may not emerge for a decade, making studies based on a five year follow-up of limited use. But some reports suggest the risk of suffering serious complications could be as high as 15 per cent.
For the treatment of SUI, two different approaches have been used: transobturator and retropubic. Of the two, transobturator (the procedure McIlroy and Holmes had) is more controversial because it is more difficult to remove the mesh once implanted. However, complications exist for both procedures and removing the mesh does not necessarily mean the pain will stop.
Globally, the continued use of transvaginal mesh is shaping up to be a scandal greater than those involving metal-on-metal hip replacements and PIP breast implants. In the US, hundreds of thousands of women are currently taking cases against manufacturers, with more than £1.5 billion already paid out in compensation. Two of the manufacturers are Endo and Johnson & Johnson-owned firm Ethicon, both of which make devices used in Scottish hospitals.
Rather than comply with requirements to provide long-term safety studies, a number of mesh manufacturers have withdrawn implants from the market, citing “business reasons”. There are also currently three criminal investigations into manufacturers in the US and thousands of women in Australia and New Zealand involved in class actions.
In January, the US Food and Drug Administration upgraded the classification of trocars – the hooks used to push mesh implants through the pelvic cavity – from II (moderate to high risk) to III (high risk) in the wake of research suggesting they cause injuries in almost 40 per cent of patients. The EU is upgrading the classification on all permanent transvaginal mesh from II to III. Yet, nowhere has its use been outlawed.
In Scotland, then health secretary Alex Neil suspended mesh procedures for the duration of the independent review. But several health boards, including NHS Glasgow and Clyde and NHS Lothian, defied the moratorium on the grounds the Scottish Government had said the procedures could still go ahead if the symptoms were severe and the women had given informed consent. About 400 such procedures (some of them involving transobturator tape) are believed to have been carried out in that time, with a proportion of those women also suffering complications.
In Scotland, around 420 women are involved in civil litigation, with more coming forward every week. Thompsons solicitors are representing just under 200 of the women, three of whom had synthetic mesh implants after the suspension had been instituted. The action is being brought against both the manufacturers and the health boards and will be heard in the Court of Session.
“It is one of the largest scandals in the NHS in Scotland – and we are only seeing the tip of the iceberg so far,” says Patrick McGuire, a partner at Thompsons.
He believes the Scottish Government is being disingenuous when it says it cannot ban the mesh because the power to do so lies with the MHRA.
“I think there is some political obfuscation going on. Yes, it is up to the organisation to decide if mesh implants are legal and ought to be available to use across the NHS, but health is a devolved matter and firmly under the direction of the Scottish Health Secretary,” he says. “Irrespective of what the MHRA says, if the view is taken that there are products it is not in the best interests of Scottish people to use, it is firmly within Shona Robison’s power to tell consultants to stop using them.”
McIlroy and Holmes are involved in civil litigation through Drummond Miller, but say their priority has always been to protect future patients.
One of their greatest concerns is that the issue of informed consent is still not being taken seriously enough by health boards. Despite working hard to draw up the booklet outlining the risks, some members of the Scottish Mesh Survivors Group found out-of-date leaflets on display in several hospitals years after they should have been replaced.
And McGuire says he has evidence some consultants are still encouraging patients to undergo risky procedures. “We have spoken to two women who, as recently as this year, met with consultants and were very clearly directed – without any explanation or alternative choice – towards mesh,” says McGuire. “Fortunately, they had heard about mesh and knew enough to question this advice. After further discussion they decided not to undergo any surgery. But this shows that – despite reassurances that mesh is now only being used in very limited circumstances and with very clear informed consent – the experience of these clients is quite different.”
McIlroy and Holmes are also upset that, while the interim report expresses specific concerns over the transobturator approach, the final report merely suggests that the retropubic approach should be recommended.
As for the conclusion on mandatory reporting of adverse incidents, the women accept it as a mini-victory but ask how such a move will be enforced? Unless there are sanctions, they say, it will be largely meaningless.
The publication of the report last week was greeted with disappointment not only by Findlay and Carlaw, but by Neil, who said the loss of faith in the process was unsatisfactory and needed investigating. “I do not think that we can leave it there, for the sake of the credibility of the report and its recommendations and for the sake of future reviews of this kind,” he said.
Issues that could be addressed include the imbalance of power between victims and experts in such groups, why the clinician resigned and why his evidence was not included in the report.
In the meantime, the Chief Medical Officer Catherine Calderwood has written to health boards with strict instructions on when mesh implants can be used and an oversight group has been set up to ensure the recommendations are implemented.
Back in the Beefeater, McIlroy and Holmes are struggling with a sense of failure. But deep down they know what they’ve achieved. The Scottish Mesh Survivors group has brought solidarity and friendship to women who were struggling to cope with the terrible limitations mesh-related symptoms have placed on their once active lives.
And they have raised awareness so that – the lack of a ban notwithstanding – women are now more likely to take stock before undergoing the same procedures.
“Some of the girls emailed last night. They wrote: ‘We’re down but not out – we look forward to seeing Cagney and Lacey back in the precinct’.” says Holmes.
http://www.scotsman.com/news/health/insight-down-but-not-out-after-mesh-implant-whitewash-1-4409770
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Mesh implant report set to face legal challenge
Apr 2, 2017 | Sunday Post
By Marion Scott
HEALTH Secretary Shona Robison is facing a judicial review in the Court of Session over a “whitewash” report on the safety of mesh implants.
Lawyers for victims of the surgery are set to mount the legal challenge to establish if the dossier was “perverse or biased”.
They want Law Lords to question Ms Robison’s actions and her endorsement of a safety review condemned as a “cover up” of the dangers of the treatment for bladder ailments and pelvic organ prolapse.
The legal move comes amid claims that evidence and safety warnings were excluded from the report.
Patrick McGuire, of Thompsons Solicitors, said: “Trust has been broken and in light of very serious allegations, we will be looking to see whether certain tests can be met.”
Campaigners had hoped all mesh procedures, which have ruined the lives of hundreds of thousands of women, would no longer be used in Scotland.
European health chiefs are in the process of reclassifying all surgical mesh as “high risk” and, in the United States, mesh manufacturers have paid out £1.5 billion in compensation.
But while the Scottish report concluded mesh must not be offered “routinely” to women with pelvic organ prolapse, it “favours” a return to the use of mesh tape to treat bladder conditions.
A spokesperson for the Scottish Government said: “We have accepted the recommendations within the final independent report.
“As a result, a new oversight group will be established to ensure the conclusions are implemented.”
https://www.sundaypost.com/fp/mesh-implant-report-set-to-face-legal-challenge/
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Nicola Sturgeon under fire after 'sneaking out bad news' in final hours before Easter break
Mar 31, 2017 | Daily Record
By Andy Philip
Nicola Sturgeon was under fire at Holyrood yesterday after rushing out a string of announcements in a few hours on the last day of term.
Statements on fracking, health and enterprise fought for space at the end of a fortnight dominated by Brexit and independence.
Damning reports were also published on support for rape victims and Scotland’s overcrowded train network.
MSPs have spent around eight hours in the chamber discussing independence in the past two weeks.
And the Government haven’t set aside any time to debate the key priority of education since October.
While political focus was on the Brexit shambles at Westminster, ministers stood up at Holyrood.
At First Minister’s Questions, Sturgeon was forced to apologise to survivors of horrific mesh implant surgery, sometimes offered to women with pelvic organ prolapse.
Mental Health Minister Maureen Watt then unveiled a new 10-year mental health strategy, months after it was due to be published.
It was immediately undermined by council leaders who refused to sign it off because of significant late changes.
And Economy Secretary Keith Brown slipped out a U-turn on proposals to scrap skills agency Highlands and Islands Enterprise. The SNP gave an update on fracking but refused to give any more information on whether they will move towards a full ban.
The four announcements and questions from MSPs took up two hours and 15 minutes before Holyrood knocked off early at 4.45pm.
Sturgeon had defended her Government’s work during FMQs. But opponents said Scotland’s priorities are being put to one side.
Labour published a list of 10 Government “failings” in the past week.
They include missed cancer patient times for the fourth year running, 6000 fewer beds in hospitals since 2007 and a ditched promise on junior doctors’ hours. Labour leader Kezia Dugdale tackled Sturgeon on complaints mesh survivors have been let down.
Dugdale said: “One thing that the First Minister has not done is deliver justice for the Scottish mesh survivors.
“Their lives have been destroyed by a medical procedure that was supposed to help them to get better.”
Tory leader Ruth Davidson accused Sturgeon of ignoring her stated aim to put education at the heart of government. She highlighted a drop of 4000 teachers since the SNP took power.
Davidson said: “The First Minister talks about priorities.
“I know that she has had a tough week and that it is getting worse but is she going to stand there after forcing a two-day debate on independence, forcing through a referendum against the wishes of the people of Scotland and still say that education is her priority?”
Sturgeon hit back with a list of SNP action in the last year.
She has committed £10million to support food and drink, signed an economic partnership with Bavaria, chaired a meeting on the future of social security and announced 300 jobs in Glasgow, among other things.
Sturgeon added: “I will take no lectures about the day job.
“It is just a pity that so much of our day job is spent cleaning up the mess made by a Tory Government.”
The SNP were accused of dragging out a decision on fracking after revealing “nothing” in a statement on the mining practice.
Energy Minister Paul Wheelhouse updated Holyrood on a consultation but had little to say on what the Government will do.
Parliament voted to support an outright ban last June. The SNP abstained while they stick to a temporary ban on fracking.
Labour MSP Claudia Beamish, who is trying to legislate for a ban, said: “The minister just spent 10 minutes of Parliament’s time saying nothing.”
Enterprise
Economy Secretary Keith Brown U-turned on plans to scrap a skills agency.
He told MSPs the board of Highlands and Islands Enterprise will remain after pressure from campaigners.
And he announced a new “strategic board” to oversee links across Scotland.
Opposition parties and Highland MSPs were angry about the plan to replace the local board with a single national agency.
Labour Highlands and Islands MSP Rhoda Grant said: “The independence of the board should never have been put at risk.”
Health
The SNP’s delayed mental health strategy was undermined on the day it was published after council leaders refused to sign it off.
A leaked email revealed anger at last-minute changes shortly before Mental Health Minister Maureen Watt set out her 10-year plan in Holyrood.
The 40-point plan includes 800 extra staff in A&E, GP practices, police custody suites and prisons, supported by £35million.
But Cosla said: “It is no longer a joint mental health strategy.”
Mesh
Nicola Sturgeon said she is “deeply sorry” for the suffering of survivors of mesh implant surgery.
The First Minister spoke out before the SNP Government said they would ask health boards to adopt recommendations of an independent probe branded a “whitewash” by campaigners.
The inquiry began after major problems with mesh implants were exposed by our sister paper the Sunday Mail. They were sometimes used to treat conditions such as incontinence and pelvic organ prolapse.
http://www.dailyrecord.co.uk/news/scottish-news/nicola-sturgeon-under-fire-after-10131406
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Craig Paton Does FMQs: Education, education, separation?
Mar 31, 2017 | CommonSpace
By Craig Paton
IT'S that time of the week again, and we have arrived at yet another First Minister’s Questions, and the thought on everyone’s mind is how much, if any, of Nicola Sturgeon’s legs we'll see this week.
Well, none. They were blocked by the podium, so you can go home, Daily Mail.
Unfortunately due to the volume of chatter that took place, there will have to be some omissions, but if you have a spare 50 minutes and fancy seeing some politicians have a go at each other, then have a watch.
Ruth Davidson on separation, separation, separation
Ruth Davidson arose first to ask the first minister if she believed there were enough teachers in Scottish schools. Sturgeon promptly launched into an answer that discussed the challenges to recruiting new teachers, saying that they have worked hard to fund local authorities, to "maintain the numbers of teachers in our schools".
Davidson rose in response, saying: "The simple and correct answer there was 'no there aren’t'." Her withering retort was met with guffaws of appreciation from the Tory benches, some of whom hadn’t laughed that hard since the au pair said she wanted a pay rise.
As Davidson gave statistics that showed that the number of teachers had fallen by 4,000 in the SNP term, it was clear to see that the education secretary, John Swinney, was not happy, murmuring in the ears of the first minister as Davidson spoke. One can only imagine the kind of expletives he was using.
In response, Sturgeon hit back: "Who is focusing on these matters and who, at every opportunity, tries to shoehorn in references to the constitution?"
When Sturgeon pointed to rising levels of exam passes and the amount of school leavers in positive destinations, the Tory benches again erupted in contemptuous laughter - it even awoke Alexander Stewart from his slumber, a man who is the human equivalent of white toast covered sparingly in low fat margarine.
Davidson was not satisfied with this answer. She quoted Sir Tom Hunter, who – after complimenting the measures being taken – asked if independence should be the government’s priority. She ended by saying: "Separation or education, which is it, first minister?"
In response, Sturgeon hit back: "Who is focusing on these matters and who, at every opportunity, tries to shoehorn in references to the constitution?
"The Conservatives debate, and we deliver," said the first minister. By now, the whole chamber was very close to descending into a West Side Story style gang fight.
Dugdale asks about survivors of Mesh
The questions quickly moved on, and Kezia Dugdale rose to speak about the survivors of mesh, a medical procedure designed to treat those with organ prolapse or stress urinary incontinence, but which has had many complications, including constant pain and in some cases, organ perforation.
Sturgeon began by offering her apologies to the women that Dugdale discussed, and to the many other who have been impacted by mesh. She also said that Health Secretary Shona Robison will make a statement later in the day to the chamber about the review, which had returned eight conclusions for local health boards to take forward.
Dugdale was not satisfied, calling the report a "cover up", and adding that it was a "national scandal". She pointed to the resounding approval given by the review group to the first draft, and then taken away when the final report was written.
Sturgeon stated that the eight recommendations now must be carried out in a way that restores the faith of the women involved, asking members to be patient and listen to the statement made by Robison.
Patrick Harvie and the Great Repeal Bill
Green leader Patrick Harvie rose to ask about the UK Government’s repeal bill, which he described as "absurd". He asked if the first minister agreed that the bill should not be allowed to "change legislation that is not specifically reserved under the Scotland Act".
To the shock of all in the chamber, Sturgeon agreed, saying that the biggest risk to recruitment for public services is Brexit, while Christine Grahame attempted to get some sort of stain out of her top - drop some Cillit Bang on that Christine, saliva isn’t strong enough.
She continued, saying that under the Scotland Act, any devolved powers that come back from Brussels, such as fishing, should be devolved to Holyrood. She added her suspicions that the bill may end in a "power grab on this parliament".
"I don’t expect the Tories to back us up," the first minister jibed, "but at that point I’ll be looking very carefully at the Labour benches. Not even Labour, under those circumstances, could stay subservient to the Tories."
Anas Sarwar’s battle of the letters
Labour MSP for the Glasgow region, Anas Sarwar, asked the first minister about the government’s progress on cutting the amount of hours worked by junior doctors.
Sturgeon stated that since the campaign by Brian Connelly, whose daughter died driving home from her shift as a junior doctor, there had been "real improvements in the hours that junior doctors work". She also pointed out that the practice of junior doctors working seven nights in a row is now at an end.
Sarwar retorted, in what looked to be a bit of a setup on his part, by reading from a letter sent by Mr Connelly to the health secretary, which stated: "You have broken your commitment to implement an actual working week of 48 hours." Brian Connelly there, ripping apart an argument in 14 words via paper.
Sturgeon again paid tribute to the work of Brian Connelly, saying that due to his efforts there had been an end to the scheduling of junior doctors working seven nights straight.
In what will henceforth be known in political circles as the Battle of the Letters, Sturgeon produced her own correspondence, this time from Robison to Connelly in 2015, in which she stated: "I believe that we can commit to [a 48-hour working week], as the longer term aim but as I said, I wish to be in a position to meet this commitment with a firm and achievable timescale." Letter vs. Letter. Who wins? You decide.
Sturgeon again paid tribute to the work of Connelly, saying that due to his efforts there had been an end to the scheduling of junior doctors working seven nights straight.
Sarwar took issue with the first minister's assertion that this was over - he says that it has not - and attempted to raise a point of order, which was rejected by Presiding Officer Ken Macintosh.
FMQs ended on a bit of a sour note this week, but please come back next week for the best of what our democracy has to offer.
Picture courtesy of The Scottish Parliament
https://www.commonspace.scot/articles/10685/craig-paton-does-fmqs-education-education-separation
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