Preview Newsletter
Ethicon Media Monitoring 12/11/2017
-
Vaginal mesh ban 'a retrograde step', surgeons say
Dec 11, 2017 | BBC
Banning vaginal mesh implants would remove an important treatment for some women suffering from a prolapse, says the Royal College of Obstetricians and Gynaecologists. -
Panorama investigation reveals medical company failed to fully inform doctors of vaginal mesh risks
Dec 11, 2017 | The Independent
By Harriet Marsden
Investigation also discovered leading mesh product was only tested in 31 women – and on sheep -
Victim reveals how mesh destroyed her life as pressure builds on health minister
Dec 10, 2017 | The Sunday Post
By Marion Scott
A MESH survivor has told how she considered taking her own life after being left in crippling agony by a catastrophic procedure. -
Panorama set to lift the lid on the vaginal mesh implant scandal
Dec 11, 2017 | Wisbeh Standard
By Kath Sansom
The documentary will lift the lid on what is called the biggest global health crisis since Thalidomide. -
Hundreds of women suffered because 'truth about dangerous mesh implants was withheld'
Dec 10, 2017 | The Herald Scotland
By Andrew Whitaker
HUNDREDS of women unnecessarily suffered devastating health complications from mesh implants because key facts about the dangers of the procedure were withheld, it has been claimed. Former health secretary Alex Neil said that misleading briefings from officials meant action over the implants was not taken earlier. -
SNP MSP Alex Neil felt he “was not being told the whole truth” by civil servants when he was health secretary
Dec 8, 2017 | Holyrood
By Tom Freeman
Civil service advice on mesh implants was not “the whole truth” felt former health secretary Alex Neil -
Medsafe brings in surgical mesh restrictions
Dec 11, 2017 | New Zealand Herald
A long list of surgical mesh products can no longer be supplied in New Zealand for transvaginal surgeries after hundreds of patients were injured, some left in agony, following their operations. -
Medsafe bars surgical mesh in some operations
Dec 11, 2017 | Radio New Zealand
ACC has paid out more than $13 million in injury claims to hundreds of patients who had problems with the mesh in the last decade. -
Medsafe introduces surgical mesh restrictions
Dec 11, 2017 | New Zealand Doctor
Medsafe is taking action in New Zealand to remove from supply and effectively limit the use of certain surgical mesh products used for urogynaecological indications. -
Medsafe effectively bans surgical mesh for pelvic operations
Dec 11, 2017 | Newstalk ZB
Surgical mesh has effectively been banned for use in pelvic organ prolapse in New Zealand. -
Medsafe removes surgical meshes from supply in New Zealand
Dec 11, 2017 | Stuff
By Cate Broughton
Surgical mesh used for some gynaecological procedures will be removed from New Zealand's supply by January 4, Medsafe has announced.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Vaginal mesh ban 'a retrograde step', surgeons say
Dec 11, 2017 | BBC
Banning vaginal mesh implants would remove an important treatment for some women suffering from a prolapse, says the Royal College of Obstetricians and Gynaecologists.
Some women benefit from the implants and should have a choice, it said.
The health watchdog NICE is expected to recommend that the implants be banned.
Around 800 women are taking legal action against the NHS and mesh manufacturers, saying they have suffered from painful complications.
When a prolapse occurs, doctors sometimes insert a mesh into the wall of the vagina to act as scaffolding to support organs - such as the uterus, bowel and bladder - which have fallen out of place.
Hundreds of women have reported problems with this plastic mesh, which is made of polypropylene.
However another smaller device made from the same material, called a tape, which is used to stem the flow of urine from a leaking bladder, has a much lower risk of complications.
Prof Linda Cardozo, a surgeon at King's College Hospital in London, said there was a misconception that all types of mesh were a problem.
She explained that she was not in favour of banning the use of mesh for prolapses.
"I don't think a total ban on anything is a good idea. It stifles the opportunity to offer the minority something that might benefit them," she said.
Draft guidelines from NICE say the implants should only be used for research - and not routine operations.
But Prof Cardozo said that a ban would stop any further research as well.
"If mesh is banned, there will be no more clinical trials," said the professor.
"Banning it is a retrograde step - we will go back to how we were a century ago when we couldn't offer women a range of options."Creating anxiety
Prof Cardozo pointed out that artificial hips and knees were not perfect when they were first introduced, but thanks to further research and progress they ended up improving lives.
"We need to be very careful that [mesh] is used in the right women by the right doctors... who have explained the risk-benefit ratio and all other types of treatment," she added.
Some doctors did not have the skills or training to put in vaginal meshes, and the devices have been overused, the professor has argued.
She also said the debate over vaginal mesh was making some women who had had surgery unnecessarily anxious.
"They are panicking because they believe something terrible may be happening inside their body as a result of tape or mesh, but most women are problem-free," said Prof Cardozo.
Kathryn Taylor was just 35 when she suffered her first prolapse.
She was later diagnosed with a condition that had weakened the muscles around her uterus and bowel.
Last year she had a second vaginal mesh implant to help keep those organs in place.
"Mesh isn't right for everyone, but it's totally changed my life for the better," Kathryn said.
"Without it I wouldn't be able to work and lead a normal life.
"I'd have to have a colostomy bag attached to my leg," she explained.
However campaigners, like Stephanie Williams, are protesting against all types of vaginal mesh and tape.
They are calling for more research into the types of mesh products used and their longer-term effects. They say women have not been given the full facts about the possible side effects.
In her own case, Stephanie says she didn't realise she was having a vaginal mesh implant and it has left her in constant pain.
"The word mesh was never mentioned," she said.
"I would not have even known what mesh meant at the time and if it was mentioned beforehand we would have looked into it before," she added.
She is now waiting to have her mesh removed.Addressing concerns
John Wilkinson, the director of devices at the Medicines and Healthcare products Regulatory Agency (MHRA) said: "Patient safety is our highest priority and we recognise some women do develop serious complications which can be very significant for the affected women."
"We also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions," he added.
Mr Wilkinson encouraged patients and doctors to report any complications linked with the mesh implants through the Yellow Card scheme.
The NHS has always insisted that the vast majority of procedures using mesh are a success and many women have benefitted from surgery.
The health watchdog - the National Institute for Health and Care Excellence (NICE) - is due to make its final recommendations next week.
Companies in the US have already paid out hundreds of millions of dollars in compensation to patients.
http://www.bbc.com/news/health-42280544
-
Panorama investigation reveals medical company failed to fully inform doctors of vaginal mesh risks
Dec 11, 2017 | The Independent
By Harriet Marsden
Investigation also discovered leading mesh product was only tested in 31 women – and on sheep
A global medical company failed to fully inform doctors of the risks of vaginal mesh implants, a BBC Panorama investigation is set to reveal.
The programme, which will air on Monday night, documents the conflicts of interest, improper trialling and weak regulatory system behind the vaginal mesh scandal, as reported in The Independent this year.
The Panorama investigation reveals that Ethicon, which markets mesh in the UK under brand name Gynecare TVT, did not update doctors with the extent of risks for its leading mesh device.
It also discovered that the product was only tested in 31 women – and on sheep – before being used in patients.
This comes just over a week after the death of Chrissy Brajcic, the first woman reported to have died from mesh complications, and the publication of a study on vaginal mesh in BMJ open revealing the failures of the regulatory system and “weak evidence” used to support device approval.
The transvaginal mesh procedure, which involves implanting a polypropylene netted device into the vaginal wall, is performed on at least 10,000 women in the UK every year to treat prolapse and incontinence.
However, mounting evidence of higher risks, severe side effectsand insufficient trialling, as well as allegations of corruption and whitewashing, have culminated in what’s been branded “the biggest health scandal since thalidomide”.
Hundreds of thousands of women in the UK, US and Australia are currently involved in lawsuits against mesh producers; at least 800 in the UK are suing the NHS. Ethicon is a wholly-owned subsidiary of multibillion-dollar Johnson and Johnson, one of the main producers of mesh implants and currently the subject of multiple class-action lawsuits.
The company produces “Instructions for Use” (IFU) leaflets to accompany mesh products, designed to explain to doctors how to insert the implants. They also explain the “adverse reactions”, or risks, associated with surgery, to help doctors explain these to patients.
In 2009, Panorama will reveal, an associate medical director at Ethicon warned, that the statements about side effects in the IFU leaflets were not sufficient, as side effects were described as “transitory”.
However, thousands of women have suffered permanent or chronic complications, sometimes manifesting years after the implant.
In an email in January 2009, the associate medical director suggested that the wording be changed for three Ethicon Gynecare TVT mesh implants, explaining: “From what I see each day, these patient experiences are not ‘transitory’ at all.”
But Ethicon admits it did not update the IFUs at the time. The company’s latest IFUs, updated in 2015, do make clear some effects may be permanent, but use incomplete and insufficient risk assessment data to do so.
Dr Wael Agur, a consultant urogynaecologist, told Panorama: “It’s so important for me as a surgeon to understand the full risks of a medical device I’m about to implant ... and my first resource would be the IFU.
“I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the instructions for use so I fully understand these and communicate them.”
The investigation also revealed that Ethicon’s TVT-Secur implant – sold worldwide, and designed to be the company’s safest mesh product – was launched in 2006 after only being tested on 31 women for five weeks, and some sheep. The product was withdrawn from the market in 2012.
Ella Ebaugh, from Pennsylvania, was fitted with a TVT-Secur device in May 2007 to help cure mild incontinence. It was one of two mesh implants she had fitted; she later had surgery to try to remove them.
She suffered chronic pain that left her needing a walking stick and mobility scooter. She sued Ethicon, and in September 2017 was awarded $57m (£42.6m) by the court – which Ethicon is currently appealing.
In her first UK interview, she told Panorama: “If I was told that I would need a wheelchair to get around, if I was told that I was going to live with permanent disabilities for the rest of my life, I wouldn’t have had a surgery for a simple stress urinary incontinence problem.”
She added: “The pain that I have I will have to live with for the rest of my life. There’s nothing they can do to help me.”
Figures compiled for Panorama by NHS Digital and NHS Wales show that the NHS has implanted more than 130,000 mesh devices in the last decade.
In that same period (2006-7 to 2016-17), there have been 6,000 procedures to remove or partially remove the implants.
However, the real number could be much higher: these figures only relate to the NHS in England and Wales, and do not include women who have paid to have the device removed privately, or who received “partial snips” to stop the mesh cutting through the vagina.
Doreen Day, aged 70, for example, had a TVT implanted in 2007 to treat pelvic organ prolapse. The surgery left her in acute pain, needing morphine and painkillers to function: “I was in sheer agony, as if I had a cheese grater inside me.”
In 2015 she travelled to Los Angeles to have her mesh partially removed at a cost of £22,000, which she paid for out of her personal savings. She is still suffering from pelvic nerve damage.
Mesh implants for prolapse have led to higher complication rates than mesh implants for incontinence.
A spokesperson for Ethicon said: “While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day-to-day lives.
“All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.”
Dr Linda Cardozo, from the Royal College of Obstetricians and Gynaecologists, echoed this, telling Panorama: “You cannot operate without complications occurring in a small minority of cases. You are never aware of complications that may occur years later, and that doesn’t just occur with these tapes and meshes.”
She has previously described a ban as a “retrograde step”, arguing: “If mesh is banned, there will be no more clinical trials. We will go back to how we were a century ago when we couldn’t offer women a range of options.”
But Kath Sansom, founder of prominent anti-TVM campaign group Sling the Mesh, claims that Dr Cardozo speaks with “a heavy bias”.
She commented to The Independent: “It is a shame that Linda Cardozo has spoken out on this issue to Panorama without declaring her ties to industry.”
Dr Cardozo has previously admitted her ties to Ethicon, and also accepts research monies from Pfizer.
In a 2012 study assessing colposuspensions for women with stress incontinence, which she co-authored, the “Conflicts of interests” section lists Dr Cardazo as a consultant for AdvaMed, Astellas, Ethicon and Pfizer, as well as a speaker honorarium and trial participant for Pfizer.
According to Ms Sansom: “Dr Cardozo should have made it very clear that she is a consultant to four industry giants, and a consultant to a UK company that promotes pharmaceutical products and medical devices to the NHS. That means she speaks with a heavy bias.”
The MHRA, the UK medical devices regulator, told Panorama it recognises that some women develop serious complications, but maintains that many women gain benefit from these surgical procedures.
It said: “We continue to work closely with NHS England, Nice and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications.
“Currently, from a regulatory perspective, these devices are acceptably safe when used as intended and as part of an appropriate treatment pathway.”
In October, a cross-party group took a debate to Parliament calling for a suspension pending full inquiry into the scandal, which the Government refused.
Later this month, England’s National Institute for Health and Care Excellence (Nice) are expected to recommend banning the mesh devices.
https://www.independent.co.uk/news/uk/vaginal-mesh-scandal-tvt-transvaginal-sling-implant-risks-thalidomide-device-bbc-panorama-a8102726.html
-
Victim reveals how mesh destroyed her life as pressure builds on health minister
Dec 10, 2017 | The Sunday Post
By Marion Scott
A MESH survivor has told how she considered taking her own life after being left in crippling agony by a catastrophic procedure.
Claire Daisley faces losing her bowel and bladder as surgeons struggle to ease the daily pain inflicted by mesh.
Yesterday, she told how she personally wrote to chief medical officer Catherine Calderwood begging for help – but got no response.
She spoke out just days after the Scottish Government and health watchdogs were condemned for failing patients as MSPs at Holyrood debated the mesh scandal.
Despite ordering health boards to stop mesh procedures three years ago, many hospitals continue to carry out the operations despite the life-changing injuries suffered by many women around the world.
Clare suffered catastrophic nerve damage when vaginal mesh, once routinely used to treat organ prolapse and incontinence problems, was implanted.
She said: “I’m in constant, chronic pain.
“I’m reliant on a wheelchair and I’m trapped inside my own home most of the time because there are steps to my door.
“Because I’ve been so badly injured, I have been accepted as suitable for treatment by NHS Greater Glasgow.”
Claire, who says she cannot face “living like this much longer”, is kept going only by the knowledge of the effect that losing her would have on her family.
She added: “I have contemplated taking my own life because every day is a nightmare.”
Doctors have told her she must wait a year or more for an operation that might ease her agony because it would cost £50,000 and the NHS doesn’t have the cash.
The sacral nerve stimulation procedure, which involves inserting a pacemaker-like device, could transform her life, Last month, in desperation, Claire, 48, a mother of three from Greenock, Inverclyde, begged Dr Calderwood to help her, but she has heard nothing.
Claire said: “If I can’t get the operation, my only other option is to have my organs removed and replaced with two stoma bags so I can at least have some control.
“I have been injured by a procedure that should never have been allowed in hospitals.
“I have to live in pain and surely the NHS has a responsibility to improve what little quality of life I have. They must restore my dignity.”
Like many mesh victims, Claire was told that the “gold standard” mesh implant would cure her bladder leaks after childbirth.
She was operated on at Inverclyde Hospital in 2011, and has been in agony ever since.
The type of device implanted into Claire has been condemned as defective on two occasions in courts in the US.
Leading expert, Dr Wael Agur, has told politicians the NHS saved £200 per surgical procedure by using mesh implants instead of the traditional own-tissue repairs that have no side effects.
Dr Agur, who no longer uses mesh because the risks outweigh any benefit, said: “In 25 years of practice, I have never seen a woman who underwent non-mesh surgery suffering for the rest of her life.
“Tragically, many of the mesh procedures were unnecessary.”
Claire added that she was “disgusted” to discover the NHS saved £200 per operation by using mesh.
She said: “I was given no choice, only mesh. The NHS saved a few pounds and destroyed my life in the process.
“They don’t even give mesh victims incontinence supplies which are fit for purpose.
“They force us to take cheaper alternatives which don’t do the job to save pennies.
“My life has been devastated.”
National Services Scotland, whose role is to “support the efficient and effective operation of NHS Scotland”, said last night that the sacral nerve service (SNS) based in Glasgow is only for patients with bladder problems, and added that six centres across Scotland carry out the procedure for bowel problems.
A spokesman added: “A review of the national service was completed this year which recommends that access to SNS for urinary dysfunction should be increased so that more clinically suitable patients can benefit from this treatment locally.
“This recommendation has been accepted by the National Specialist Services Committee and will now be considered by NHS board chief executives.”
Around £250,000 a year was previously allocated to treat bladder patients with the pacemaker device, but last year that was raised to £400,000 with 20 new patients treated last year.”
Claire said: “I don’t care who does this procedure or where they are based, all I care about is that it is done before I have to make the choice of losing both organs because I can no longer go on living like this.”
Chief medical officer Catherine Calderwood said: “We take concerns around surgical mesh very seriously.
“While it is not appropriate to comment on individual cases, my sympathies rest with those who have ongoing health problems linked to these procedures.”
-
Panorama set to lift the lid on the vaginal mesh implant scandal
Dec 11, 2017 | Wisbeh Standard
By Kath Sansom
The documentary will lift the lid on what is called the biggest global health crisis since Thalidomide.
BBC Panorama investigation reveals global medical companies failed to fully inform doctors of the extent of risks posed by its vaginal mesh implants.
The investigation comes amid growing anger among campaigners that today surgeons are still not warning women about mesh risks.
In UK hospitals surgeons insist they do not use “the mesh in the media” to fix incontinence but are using a “tape” - yet this tape is made of plastic mesh.
For women worried about prolapse they tell them they use a different mesh.
They believe they can do that because they insert it through the tummy and not the vagina to get round guidelines, due out any day soon, banning the use of transvaginal prolapse mesh.
Campaigners say this breaks ethics rules.
Panorama will reveal that Ethicon, a subsidiary of multi billion dollar Johnson and Johnson, failed to update doctors with risks for its leading transvaginal meshes.
NHS figures given to BBC Panorama show there have been more than 6,000 procedures for removals or partial removals of vaginal mesh in England and Wales in the last decade.
Sling The Mesh says that figure is much lower than the true picture as it does not take into account hundreds of women who get snips of mesh tapes that have poked their way through vaginal walls.
These procedures are carried out in outpatient departments who do not have to send their figures to NHS HQ.
Also it does not show the number of women having mesh removal in private hospitals.
Pelvic mesh implants have been surgically fitted into millions of women globally since the late 1990s to help cure incontinence or pelvic organ prolapse.
Campaigners say nobody has a clue of the true number suffering as surgeons deny mesh causes their health problems and less than 40 per cent record problems.
Another issue is industry influence on surgeons like Linda Cardozo , who appears on Panorama saying mesh is an effective treatment option for the vast majority.
Dr Cardozo has written scores of studies on mesh use, including one that insists women have a healthy sex after pelvic mesh surgery.
Sling The Mesh, which has 4,800 members, says at least 2/3 of women in its Facebook support group lose their sex life.
Dr Cardozo is a consultant to four medical industry giants and to a UK based company that promotes innovation - medical speak for testing new products in humans.
She also gets research grants from another medical giant.
BBC Panorama says it has discovered Ethicon launched a mesh implant called the TVT Secur in 2006 after testing it in just 31 women for five weeks, and in sheep.
It was intended to be the company’s safest and most effective pelvic floor mesh product but was withdrawn in 2012.
Professor Carl Heneghan warned some surgeons are now insisting prolapse mesh operation risks are higher than incontinence mesh.
But he said: “Surgeons are using the same evidence with the same quality issues that underpinned mesh in prolapse to say everything is alright with incontinence mesh.
“It is the same issues; lack of Equivalence, trials done by manufacturers, lack of long term evidence and the losses to follow up which are high.”
The company told Panorama: “While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives.”
Dr Cardozo, from the Royal College of Obstetricians and Gynaecologists, said: “You cannot operate without complications occurring in a small minority of cases. You are never aware of complications that may occur years later and that doesn’t just occur with these tapes and meshes.”
Ethicon says pelvic mesh has helped improve the quality of life for millions of women with serious, debilitating conditions.
The MHRA, the UK medical devices regulator, told Panorama it recognises some women develop serious complications, and many women gain benefit from these surgical procedures.
Professor Carl Heneghan warned some surgeons are now insisting prolapse mesh operation risks are higher than incontinence mesh.
But he said: “Surgeons are using the same evidence with the same quality issues that underpinned mesh in prolapse to say everything is alright with incontinence mesh.
“It is the same issues; lack of Equivalence, trials done by manufacturers, lack of long term evidence and the losses to follow up which are high.”
Sling The Mesh says part of the controversy is that women are treated with a total lack of respect from surgeons who deny mesh is an issue.
Some of the worst things surgeons have said to women presenting with mesh problems include:
• Do you think all this research is good for your mental well being?
• One surgeon told a campaigner ‘you have a beautiful vagina.’
• One surgeon said “we will try and make your quality of life comfortable.” But she never heard from him again.
• A woman was told she was obese and to lose weight as her symptoms would go.
• One surgeon said the women was born with the problem. The fact that pain started instantly after operation is purely coincidence.
• A woman told her surgeon that she was in so much pain when she moved my legs. He replied, don’t move them then.
• When the sharp edges of the mesh cut her partner during sex the surgeon told her it can’t be the mesh you must have something else sharp in there.
• One surgeon said “You’ve been reading too much Daily Mail and the Internet.”
• A consultant said: “I can assure you the tape is fine, I have done thousands of these operations. It’s media hype.”
• After collapsing with a massive bleed and vomiting blood one surgeon said: “Do you get anxious around doctors?”
• I told a male surgeon of my chronic groin, leg and pelvic pain. He suggested gymnastics, practising the splits would do me good.
• One woman was told it’s just one of those things. You’re just going to have to live with the pain.
• After telling her GP she hadn’t been intimate with her partner for six years as it was too painful, he printed out an online brochure for a device to make her “feel tight and wanted again.”
• One surgeon said: “It’s not like it’s life threatening is it.”
• A consultant said: “I think this woman is obsessed with her vagina and should hurry back to work”.
• A neurologist said a campaigner had to push through the pain and retrain her brain.
• BBC Panorama: The Operation That Ruined My Life. BBC One, 7.30pm, Monday 11th December.
http://www.wisbechstandard.co.uk/news/panorama-sling-mesh-implant-tvt-secur-tot-tvto-linda-cardozo-rcog-1-5315604
-
Hundreds of women suffered because 'truth about dangerous mesh implants was withheld'
Dec 10, 2017 | The Herald Scotland
By Andrew Whitaker
HUNDREDS of women unnecessarily suffered devastating health complications from mesh implants because key facts about the dangers of the procedure were withheld, it has been claimed. Former health secretary Alex Neil said that misleading briefings from officials meant action over the implants was not taken earlier.
The use of synthetic transvaginal tapes and meshes was suspended in 2014 by Neil after a number of women suffered painful and crippling complications. Neil said that if he had even known three months earlier, several hundred women in that period could have been spared the pain and trauma.
Speaking to the Sunday Herald, he said civil servants "let me down badly", adding: "If I'd known just three months earlier, I would have suspended the procedure and I think that would probably have made a difference to a few hundred in that time alone."
The suspension came after Neil launched a review of the procedure in his role as health secretary. However, after leaving government, Neil blasted the findings of the probe that he set up as “totally unacceptable”.
Neil said that as a minister he had not been told “the whole truth” about the extent of the scandal, claiming he had been given unreliable information by his officials. Neil added that he was forced to conduct his own investigation because of unconvincing briefings. Neil said that research led him to subsequently suspend mesh implant procedures.
Crucially, Neil said he could have taken action to suspend the surgery earlier if he had been given the full facts. Neil made the dramatic intervention during a Holyrood debate.
He said: “I am going to be open, honest and very transparent. It took me longer to commission the independent inquiry than I might have taken. Why? It was because, to be quite frank, I was – very unusually – not convinced by the information on the matter with which I was provided by official advisers when I was health secretary.
“On no other matter did I have any reason for doubt, but I increasingly felt that I was not being told the truth, the whole truth and nothing but the truth. I ended up doing a lot of research into the subject myself.
"The more I researched, the more I became convinced that we had to do something: at the very least, we had to suspend the procedures until we were much more sure about their safety. I am glad that we did that.”
Campaigners against the use of mesh implants said they were "dismayed and disgusted" at the publication of the review into the procedure's risks, which they claimed had been "watered down".
Olive McIlroy and Elaine Holmes, who resigned from the review group set up to investigate the use of mesh implants, said they felt "utterly betrayed" by the publication.
The suspension Neil imposed is still formally in place and has never been lifted. However, figures published in December 2016 showed hundreds of operations have been performed since. Last night, Neil said: "It's ridiculous that after parliament supported a suspension that this is still happening. Those allowing this should be brought to book."
Meanwhile, Labour MSP Neil Findlay demanded to know whether the same officials were still in place advising ministers. Findlay also asked whether they were advising the current health secretary Shona Robison.
He said: “This is very serious revelation by a former minister. Here we have Alex Neil being honest enough to say that he believed he was being misled by civil servants and special advisers over the mesh scandal. We now need to know who these people are and whether or not they are still in position and advising Shona Robison on this very same issue.”
However, a Scottish Government spokesman defended the conduct of civil servants. The Scottish Government spokesman said: “Civil servants have consistently acted to the highest professional standards on this issue, providing information and advice to ministers on the basis of the evidence, accurately presenting all the options and facts around surgical mesh.”
http://www.heraldscotland.com/news/homenews/15712501.Hundreds_of_women_suffered_because___39_truth_about_dangerous_mesh_implants_was_withheld__39_/
-
Dec 8, 2017 | Holyrood
By Tom Freeman
Civil service advice on mesh implants was not “the whole truth” felt former health secretary Alex Neil
Former health secretary Alex Neil has claimed he had to do his own research into mesh implants while a minister because he had not been told “the whole truth” about the issue by advisers.
During a Holyrood debate, Neil, who was health secretary between 2012 and 2014, also criticised “commercial interests” in the independent inquiry into the use of synthetic transvaginal tapes and meshes to treat stress incontinence.
There are 420 women in Scotland with pending civil action for damages after being left with painful and crippling complications after the procedure.
Neil told MSPs he had had to do his own research into the issue as a minister because he did not trust what he had received from his advisers.
“I was - very unusually - not convinced by the information on the matter with which I was provided by official advisers when I was health secretary,” he said.
“On no other matter did I have any reason for doubt, but I increasingly felt that I was not being told the truth, the whole truth and nothing but the truth.
“I ended up doing a lot of research into the subject myself.
“The more I researched, the more I became convinced that we had to do something: at the very least, we had to suspend the procedures until we were much more sure about their safety. I am glad that we did that.”
Labour MSP Neil Findlay asked Neil if the advisers in question were the same ones advising the current health secretary.
“I have no idea,” Neil replied. “For the record, I was absolutely clear when we appointed members of the independent review group that none of them should have a commercial interest in mesh. That did not happen; I am very critical of that.”
In response to the allegations, a Scottish Government spokesman said: “Civil servants have consistently acted to the highest professional standards on this issue, providing information and advice to ministers on the basis of the evidence, accurately presenting all the options and facts around surgical mesh.”
The independent inquiry was launched in 2014 by Neil but it was published under his predecessor Shona Robison.
The report was labelled a “whitewash” by campaigners after its conclusions were altered in the final draft after the resignation of expert Dr Wael Agur.
MSPs of all parties have called on the Scottish Government to revisit its findings.
https://www.holyrood.com/articles/news/snp-msp-alex-neil-felt-he-%E2%80%9Cwas-not-being-told-whole-truth%E2%80%9D-civil-servants-when-he-was
-
Medsafe brings in surgical mesh restrictions
Dec 11, 2017 | New Zealand Herald
A long list of surgical mesh products can no longer be supplied in New Zealand for transvaginal surgeries after hundreds of patients were injured, some left in agony, following their operations.
Medsafe said it had made the decision to ban the supply of the mesh for operations such as pelvic organ prolapse and stress urinary incontinence following a similar move in Australia.As in Australia, surgical mesh will still be able to be used here for other surgical conditions such as hernia repair.
The use of the mesh has cost ACC at least $13 million in injury payouts in the past 12 years.
Most New Zealand suppliers have told Medsafe that by early next year they will limit supply so it cannot be used for those purposes.
The decision from Medsafe, New Zealand's medical regulatory body, follows a similar decision made last week in Australia.
The Medicines Act 1981 allows Medsafe to require suppliers to provide safety information about their devices.
Under section 38, Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd requesting safety information or confirmation that the companies will comply with the Australian requirements.
Suppliers must either confirm they will comply with the requirements of the Therapeutic Goods Administration in Australia, or to supply information supporting continued use for these indications within the next 45 days.
All four companies said they intended to comply with the requirements by January 4 and have indicated they do not intend to push for continuing use of the mesh in transvaginal operations.Medsafe's spokesman said meanwhile suppliers could not knowingly provide the mesh for urogynaecological surgery.
"If there was a situation where a surgeon already had some of this product, discussed it with patient and got their informed consent, it could still be used," he said.
A surgeon or DHB could also purchase the mesh products from overseas although that was unlikely, he said.
"The steps Medsafe is taking are the strongest possible under the current law."
Associate Minister of Health Julie Anne Genter welcomed the move, saying it was an important step in restoring people's faith in the New Zealand medical system.
"Hundreds of women in New Zealand have seen their health and lives compromised because of surgical mesh, and I gladly welcome changes to restrict usage," Genter said.
"This will prevent further harm to women being caused by surgical mesh."
List of affected products
Boston Scientific NZ Ltd
• Xenform Soft Tissue Repair Matrix
• Advantage
• Lynx
• Obtryx
• Obtryx II
• Solyx
• Uphold Life
• Upsylon
Culpan Medical
Coloplast – 9 models
Endotherapeutics NZ Ltd
• TOA Sling
• TVA Sling
• Multi Purpose Sling
• BSC Mesh
• EndoGYNious
• Ophira Minisling
Johnson & Johnson Medical NZ Ltd
• GYNEMESH PS soft mesh
• Gynecare TVT Device
• Gynecare TVT W/Abdominal
• Gynecare TVT Obturator
• TVT Abbrevo
• TVT Exact Retropubic system
http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11957630
-
Medsafe bars surgical mesh in some operations
Dec 11, 2017 | Radio New Zealand
ACC has paid out more than $13 million in injury claims to hundreds of patients who had problems with the mesh in the last decade.
Some of the injuries include the mesh eroding in the body, binding with other tissue, and causing extreme pain.
The mesh is also the subject of thousands of lawsuits in the United States.
This afternoon, Medsafe said the mesh would no longer be able to be used for the repair of pelvic organ prolapse or stress urinary incontinence.
Stewart Jessamine, from the Ministry of Health, said New Zealand was the second country to restrict the use of mesh, after Australia did so last month.
"There's no doubt that for women who have had these surgeries this has been a tragedy at a personal level in up to 10 to 12 percent of women who've had mesh used in this way."
Mr Jessamine said the mesh would still be used for hernia repairs.
Carmel Berry, the co-founder of advocacy group Mesh Down Under, is welcoming the news.
She said it was what her organisation had been asking for since 2014.
But she said there was still more work to be done, including a register for the mesh that will still be used.
https://www.radionz.co.nz/news/national/345958/medsafe-bars-surgical-mesh-in-some-operations
-
Medsafe introduces surgical mesh restrictions
Dec 11, 2017 | New Zealand Doctor
Medsafe is taking action in New Zealand to remove from supply and effectively limit the use of certain surgical mesh products used for urogynaecological indications.
Medsafe has already contacted suppliers in New Zealand and most of them have already indicated by early next year that they will be taking the same steps here to limit supply, as they are in Australia.
As a consequence of the Australian TGA (Therapeutic Goods Administration) review of surgical mesh for urogynaecological use, and subsequent regulatory action, there is cause for Medsafe to question the safety of certain devices.
Medsafe is using powers under the Medicines Act 1981 to require suppliers to provide safety information about their devices.
Under section 38, Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd requesting safety information or confirmation that the companies will comply with the Australian requirements.
Medsafe understands from its communications with these companies that they intend to comply with the requirements by 4 January 2018.
As in Australia, surgical mesh will still be able to be used for other surgical conditions such as hernia repair in New Zealand.
As is also the case in Australia, Medsafe’s response is effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence rather than a limit on use of surgical mesh for other types of surgery.
Products affected
Boston Scientific NZ Ltd
Xenform Soft Tissue Repair Matrix
Advantage
Lynx
Obtryx
Obtryx II
Solyx
Uphold Life
Upsylon
Culpan Medical
Coloplast – 9 models
Endotherapeutics NZ Ltd
TOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
Johnson & Johnson Medical NZ Ltd
GYNEMESH PS soft mesh
Gynecare TVT Device
Gynecare TVT W/Abdominal
Gynecare TVT Obturator
TVT Abbrevo
TVT Exact Retropubic system
https://www.nzdoctor.co.nz/article/undoctored/medsafe-introduces-surgical-mesh-restrictions
-
Medsafe effectively bans surgical mesh for pelvic operations
Dec 11, 2017 | Newstalk ZB
Surgical mesh has effectively been banned for use in pelvic organ prolapse in New Zealand.
The material's often used for childbirth injuries, but women on both sides of the Tasman say it causes serious pain and has been blamed for hundreds of complications.
Ministry of Health spokesperson Dr Stewart Jessamine told Larry Williams Medsafe has asked mesh suppliers to either stop distribution for certain conditions or prove that their product is safe.
"We're always cautious about the use of the word 'ban', but effectively the companies are agreeing no longer to sell these products for these reasons in New Zealand from the 4th of January."
The move puts us in the same boat as Australia, and surgical mesh will still be allowed for use on conditions like hernia repair.
http://www.newstalkzb.co.nz/on-air/larry-williams-drive/audio/dr-stewart-jessamine-surgical-mesh-effectively-banned-in-nz/
-
Medsafe removes surgical meshes from supply in New Zealand
Dec 11, 2017 | Stuff
By Cate Broughton
Surgical mesh used for some gynaecological procedures will be removed from New Zealand's supply by January 4, Medsafe has announced.
Suppliers of the controversial products were required to follow the ban announced by the Australian Therapeutic Goods Authority (TGA) on November 29, after a review of the most recent research and clinical evidence which found the benefits did not outweigh the risks for patients.
Surgical mesh is a medical device used mainly to reinforce weak abdominal and pelvic muscles. It is most often used to treat pelvic organ prolapse, incontinence and hernias, but complications causing severe pain and disability have been found to occur in 10-12 per cent of pelvic organ prolapse procedures.
Medsafe has written to four companies – Boston Scientific NZ, Culpan Medical, Endotherapeutics NZ and Johnson & Johnson Medical NZ – requesting safety information or confirmation the companies would comply with the Australian requirements.
"Medsafe understands from its communications with these companies that they intend to comply with the requirements by January 4, 2018."
Medsafe's action was taken with authority under Section 38 of the Medicines Act 1981, which requires suppliers to provide safety information about their devices, an authority spokesman said.
Surgical mesh would still be able to be used for other surgical conditions, such as hernia repair, the spokesman said.
Mesh Down Under advocacy group member Charlotte Korte said the news was like "an early Christmas present".
"We have been campaigning for so long and the previous Government did nothing, but [Health Minister] David Clark has actioned this straight away."
Korte said the action would protect Kiwis from suffering horrific complications and daily pain as a result of mesh eroding and cutting into nerves.
"It's a win for all the future patients that could be affected."
Korte and fellow campaigners and mesh sufferers Carmel Berry and Patricia Sullivan presented a petition to Government asking for a ban of surgical mesh products in 2014.
A Health Select Committee inquiry was held that year and recommendations released in 2016. The previous government endorsed the recommendations, but Mesh Down Under found little action was being taken to implement them.
Berry said she wrote to the Ministry of Health asking for it to action under Section 38 of the Medicines Act, but said she was not listened to.
Berry, who has suffered acute pain for a decade after a 2004 procedure with GYNEMESH PS soft mesh, said hearing about Medsafe's action was overwhelming and emotional.
Associate Minister of Health Julie Anne Genter welcomed the change and said it was needed to restore faith in the health system.
"People need to be able trust that when they go to the health system they will get assistance and aid to help them. Today's step is an important in restoring faith in our medical system to do the right thing.
Genter said it was a "first step" in a process to ensure products like surgical mesh safe for all New Zealanders.
Those harmed by mesh and living with injuries needed to be provided with care and support.
"We absolutely have a responsibility to look after women who have been affected negatively and there will be a response that ACC has to take for what is effectively a medical injury."
Ministry of Health director of protection, regulation and assurance Dr Stewart Jessamine said Medsafe had required significant evidence before taking action to limit supply of the products.
New Zealand operated a post-market regulation system and relied on evidence from the international community to determine.
The results of a large UK study released six to eight weeks ago and further information supplied by the TGA had proven the risks were too high for some of the products.
Jessamine said the work of Charlotte Korte, Carmel Berry and Patricia Sullivan from Mesh Down Under had been critical in helping the Ministry improve the safety of mesh patients.
"I cannot stress the importance of the work they did."
Jessamine said there was more work to do to ensure women affected by complications of mesh received the right care from the medical community.
He said governments needed to learn from the tragedy of mesh injuries.
"It's time for regulators globally to look at how we assess the safety of devices and put the safety of patients at the centre of the issue."
LIST OF PRODUCTS AFFECTED
Boston Scientific NZ
Xenform Soft Tissue Repair Matrix
Advantage
Lynx
Obtryx
Obtryx II
Solyx
Uphold Life
Upsylon
Culpan Medical
Coloplast – 9 models
Endotherapeutics NZ
TOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
Johnson & Johnson Medical NZ
GYNEMESH PS soft mesh
Gynecare TVT Device
Gynecare TVT W/Abdominal
Gynecare TVT Obturator
TVT Abbrevo
TVT Exact Retropubic system
https://www.stuff.co.nz/national/health/99754231/medsafe-removes-surgical-meshes-from-supply-in-new-zealand
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested