Preview Newsletter
Ethicon Media Monitoring 10/10/2018
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Vaginal mesh implants: Australia apologises for 'decades of pain'
Oct 10, 2018 | BBC News
The Australian government has issued a national apology to women affected by a vaginal mesh scandal, acknowledging decades of "agony and pain". -
Federal Health Minister issues national apology over transvaginal mesh implants
Oct 10, 2018 | RACGP
By Amanda Lyons
Many women in Australia who were already traumatised by severe injury sustained during childbirth – an estimated 10,000–15,000 – have been further traumatised by a material proposed for use as a surgical solution to their problems: transvaginal mesh. -
Govt Apologises To Thousands Of Women Mutilated By Transvaginal Mesh
Oct 10, 2018 | Pedestrian
By Sam George-Allen
Health minister Greg Hunt has publicly apologised to the thousands of Australian women who have been maimed and disabled by transvaginal pelvic mesh implants. -
The Thousands Of Women Who Suffered From Pelvic Mesh Just Got An Apology
Oct 10, 2018 | Buzzfeed
By Gina Rushton
"On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes," Hunt said when releasing details of the government's response to a Senate inquiry into the implants. -
Mesh: Layla Moran backs new guidance on 'national scandal'
Oct 9, 2018 | The Oxford Times
The National Institute for Health and Care Excellence (NICE) has published draft guidance stating that clinicians should offer non-surgical options for stress urinary incontinence or pelvic organ prolapse before mesh operations. -
National apology over pelvic mesh implants
Oct 10, 2018 | The Northern Daily Leader
Thousands of Australian women whose lives have been ruined by vaginal mesh implants have received an apology from the federal government. -
Health minister Greg Hunt’s apology for ‘historic agony and pain’ of pelvic mesh surgery
Oct 10, 2018 | Newcastle Herald
By Joanne McCarthy
Pelvic mesh victims have called for a complete ban on the use of pelvic mesh implants in Australia after Federal Health Minister Greg Hunt apologised to women for the “historic agony and pain” of mesh surgery. -
Greg Hunt apologises to women affected by 'horrific' transvaginal mesh scandal
Oct 10, 2018 | The Guardian
By Melissa Davey
The health minister Greg Hunt has issued a national apology on behalf of the government to women affected by the transvaginal mesh scandal. -
Mesh implants: Government issues national apology over 'agony and pain' caused by device
Oct 10, 2018 | ABC News.au
By Sophie Scott and Alison Branley
Health Minister Greg Hunt has issued a national apology to the many women whose lives have been ruined by the debilitating effects of pelvic mesh implants. -
Use mesh implants for stress urinary incontinence only as last resort, says NICE
Oct 9, 2018 | British Medical Journal
By Zosia Kmietowicz
Surgical mesh or tape should be used to treat stress urinary incontinence or pelvic organ prolapse only after all non-surgical options have been reviewed, the UK National Institute for Health and Care Excellence has said in draft guidance. -
Vaginal mesh should be the last resort, health officials say
Oct 9, 2018 | Metro
By Martine Berg Olsen
Vaginal mesh should only be offered to women as a last resort, health officials have said in a U-turn recommendation. -
LAST DITCH ATTEMPT Vaginal surgical mesh ops to treat incontinence should ONLY be used as last resort
Oct 10, 2018 | The Sun
By Miranda Larbi
Vaginal mesh should only be offered to women as a last resort, health bosses have stated in a new draft document. -
Surgical mesh last resort for prolapse or incontinence
Oct 9, 2018 | On Medica
By Louise Prime
Surgical mesh or tape should be considered only as a last resort for women with stress urinary incontinence or pelvic organ prolapse when all other non-surgical options have failed or are not possible, the National Institute for Health and Care Excellence (NICE) advised this morning. -
Mesh implant became broken, twisted, and embedded in woman’s muscle
Oct 9, 2018 | Great Yarmouth Mercury
By Geraldine Scott
A Norfolk woman whose vaginal mesh had broken, twisted, and become embedded deep into a muscle said she wished she never had the procedure. -
Pelvic mesh implant inquiry: victims take class action
Oct 10, 2018 | Daily Telegraph
Australia has been rocked by the shocking discovery pelvic mesh devices intended to address incontinence and organ prolapse in women were causing...
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Vaginal mesh implants: Australia apologises for 'decades of pain'
Oct 10, 2018 | BBC News
The Australian government has issued a national apology to women affected by a vaginal mesh scandal, acknowledging decades of "agony and pain".
Mesh implants are at the centre of health scandal affecting women around the world, prompting lawsuits in the UK, US, Canada and Australia.
In March, an Australian inquiry found that the devices had ruined many lives.
The medical implants were used to treat pelvic organ prolapse and incontinence after childbirth.
More than 700 women in Australia have joined a class action against one manufacturer, Johnson & Johnson, but lawyers say up to 8,000 women may have been affected.
Health Minister Greg Hunt said on Wednesday: "On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes.
"This has been an issue, over some decades in many cases, and on our time and our watch."Mesh led to 'excruciating pain'What's the issue with mesh implants?Hundreds of UK women sue over 'barbaric' treatment
The Senate inquiry estimated that about 150,000 women in Australia were fitted with mesh implants in the past two decades, in many cases to help treat complications post-childbirth.
'Devastating impact'
The net-like fabric can be attached into the wall of the vagina to act as a scaffold to support organs, such as the bladder, to keep them in the right place to help manage incontinence or prolapse.
Negative effects reported after surgery have included bleeding, nerve and tissue damage, perforated organs and mesh eroding into the vagina.
The inquiry found that many women had suffered chronic and debilitating pain, leaving a "devastating impact" on their lives, relationships and careers.
It also noted that those suffering had often struggled to have their condition identified or for their pain to be taken seriously by doctors - worsening distress.
Mr Hunt said the government supported nearly all recommendations made by the inquiry, including improving regulation of medical devices.
The nation banned two mesh devices last year, after they were classified as "high risk", but still allows some mesh products to be used.
https://www.bbc.com/news/world-australia-45806324
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Federal Health Minister issues national apology over transvaginal mesh implants
Oct 10, 2018 | RACGP
By Amanda Lyons
Many women in Australia who were already traumatised by severe injury sustained during childbirth – an estimated 10,000–15,000 – have been further traumatised by a material proposed for use as a surgical solution to their problems: transvaginal mesh.
The Senate launched an inquiry earlier this year into the use of transvaginal mesh implants in Australia, and its final report delivered a scathing assessment of the health system’s failure to protect women from the implants’ catastrophic effects. Meanwhile, more than 700 women have launched a class action against Johnson & Johnson, manufacturer of transvaginal mesh products.
The Federal Government is today due to table a response to the Senate Inquiry, and Federal Health Minister Greg Hunt has acknowledged the debilitating effects of the mesh with a national apology.
‘On behalf of the Australian Government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes,’ he told the ABC.
Patient groups have advocated for compulsory reporting by all health practitioners of side-effects of any implantable devices. However, Minister Hunt has stated that although the Government is supportive of this measure, it lacks the powers to impose it on the states and territories. Instead, it proposes a voluntary national register to become operable in 2019.
The Government will also make further proposals at the next meeting of the Council of Australian Governments, which will include the creation of permanent Medicare payment items for the removal and treatment of pelvic mesh, and asking the states and territories to conduct and audit of pelvic mesh products.
Minister Hunt does not anticipate resistance from the states and territories to these recommendations, saying that, ‘Too many women have suffered too much for too long’.
The Therapeutic Goods Administration has banned the use of transvaginal mesh products for the treatment of pelvic organ prolapse, but select mesh products remain available for use for other conditions, albeit only by qualified surgeons.
However, many women and consumer health groups would like to see mesh products banned altogether until their safety can be conclusively proven.https://www.racgp.org.au/newsGP/Professional/Federal-Health-Minister-Greg-Hunt-issues-national
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Govt Apologises To Thousands Of Women Mutilated By Transvaginal Mesh
Oct 10, 2018 | Pedestrian
By Sam George-Allen
Health minister Greg Hunt has publicly apologised to the thousands of Australian women who have been maimed and disabled by transvaginal pelvic mesh implants.
Urogynaecological meshes, also known as transvaginal meshes, are inserted as treatment for pelvic prolapse or urinary incontinence. Thousands of women have reported “devastating complications” from the insertion of the mesh, from vaginal bleeding and pain to “erosion“, when the mesh protrudes through tissue and into surrounding organs, wearing holes in the body as it moves.
A senate inquiry found that the women suffering with the implants had been ignored, let down and dismissed by health professionals and regulatory bodies, saying:
The committee was deeply concerned by the accounts it has received of women’s experiences at the hands of medical practitioners.
The inquiry found that most women were not told about possible complications from the mesh, or informed that the polypropylene implant was permanent and non-absorbable.
During the release of the details of the government’s response to the inquiry, Greg Hunt said:
On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes.
A voluntary national register of women who have been adversely affected by mesh implantation will be set up by the government, and the sellers of the mesh will now be required to supply information leaflets and cards with each sale. Surgical mesh products have also been moved from the “medium to high risk” product category to “high risk”, and surgical repair of prolapse and mesh removal items will be added to the Medicare Benefits Schedule.
About 150,000 Australian women are estimated to have had transvaginal mesh implanted. For a long time, the adverse effects went underreported, which the inquiry says led to a “false indication of the safety” of the mesh. A class action lawsuit against manufacturer Johnson and Johnson is ongoing.
https://www.pedestrian.tv/health/government-apology-transvaginal-mesh/
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The Thousands Of Women Who Suffered From Pelvic Mesh Just Got An Apology
Oct 10, 2018 | Buzzfeed
By Gina Rushton
"On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes," Hunt said when releasing details of the government's response to a Senate inquiry into the implants.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
The inquiry concluded earlier this year that the thousands of Australian women suffering "devastating complications" from transvaginal mesh implants had been "ignored" and "let down" by health professionals and regulatory bodies, and the surgery should only be performed as a "last resort".
Hunt said on Wednesday the government would work with states and territories to establish a voluntary national register of women who have had the devices implanted and experienced adverse effects.
“The committee was deeply concerned by the accounts it has received of women’s experiences at the hands of medical practitioners,” the inquiry, which began in July last year, reported in March.
Surgeons should be required to obtain “informed consent” from patients receiving transvaginal mesh implants, and medical regulators must record adverse side effects properly, the inquiry wrote in its 13 recommendations.
Hunt said the government was already taking recommendations on board by requiring device sellers to supply leaflets and cards, moving all surgical mesh products from a "medium to high risk" to "high risk" product category, making it "easier to report" adverse events to the Therapeutic Goods Administration, and introducing new Medicare Benefits Schedule items for the surgical repair of pelvic organ prolapse and removal of mesh.
The inquiry estimated about 150,000 women in Australia have undergone transvaginal mesh procedures.The underreporting of adverse events associated with transvaginal mesh products had provided a “false indication of the safety” of the devices, the inquiry's report said.
There were more than 150 patient submissions made to the inquiry, the most heartbreaking of which you can read here, and almost all of them claimed there was no informed consent or awareness of the possible complications.
Almost every submission details a complication after the mesh was inserted.
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, the Senate inquiry heard in August last year.
Half of the women who experienced adverse physical and psychological side effects after receiving a vaginal mesh implant have also suffered from a relationship breakdown after the procedure, the inquiry also heard.
The committee heard from doctors, hospitals and device manufacturers, including Johnson & Johnson, which in January withdrew from the market the controversial devices at the centre of a class action against it.
This isn't Hunt's first apology on women's health.
In December last year, Hunt said sorry to women who had suffered from endometriosis, a painful condition where the tissue similar to that which normally lines the inside of the uterus grows externally, typically on ovaries, fallopian tubes, or pelvic organs.
The condition affects an estimated 600,000 Australian women every year, and research suggests there is an average of seven and a half years between a woman seeing a doctor and actually getting an endometriosis diagnosis.
He apologised that nothing had been done sooner, and announced the government would provide $160,000 in immediate funding to investigate better treatments for endometriosis patients.
https://www.buzzfeed.com/ginarushton/pelvic-mesh-implants-apology-australia-greg-hunt?origin=shp
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Mesh: Layla Moran backs new guidance on 'national scandal'
Oct 9, 2018 | The Oxford Times
The National Institute for Health and Care Excellence (NICE) has published draft guidance stating that clinicians should offer non-surgical options for stress urinary incontinence or pelvic organ prolapse before mesh operations.
Ms Moran said she had been contacted by a number of her constituents about 'botched and unnecessary' procedures.
She said: “This guidance is a step forward and should be adopted quickly.
“The only positive I can see from this national scandal is that more women are now aware of the dangers. Too many women in our county have had to bravely come forward with horror stories in order to be taken seriously.”
At least 15 women in Oxfordshire are seeking damages from Oxford University Hospitals NHS Foundation Trust over mesh-linked procedures, while nationwide thousands of women have reported serious issues issues with the implants.
There are a number of different types of mesh operations, but the Trust insist that transvaginal tape - one of the most common procedures - is 'highly effective'.
Last month the Baroness overseeing a national review into mesh hit out at the ‘terrible harm’ endured by Oxfordshire women, after a hearing in Wallingford.
https://www.oxfordtimes.co.uk/news/16971275.mesh-layla-moran-backs-new-guidance-on-national-scandal/
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National apology over pelvic mesh implants
Oct 10, 2018 | The Northern Daily Leader
Thousands of Australian women whose lives have been ruined by vaginal mesh implants have received an apology from the federal government.
Health Minister Greg Hunt on Wednesday acknowledged the pain and suffering of those caught up in what turned out to be a global medical scandal.
"On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes," he told the ABC on Wednesday.
"My message to them is your voice has been heard, and not just heard but acted upon."
Vaginal mesh implants have been given to about 8000 Australian women since the 1990s to treat pelvic floor damage.
Many were treated for stress incontinence and prolapse, often after giving birth, resulting in chronic and debilitating pain and the inability to have sex.
The federal government has now tabled its response to a Senate inquiry, which heard horror stories from women who had the implants.
It supports, or supports in principle, 12 out of 13 committee recommendations which included mandatory reporting of adverse effects on women, more information about the risks of implants and better training for doctors and surgeons.
The government's central response is to work with the states and territories to set up a voluntary national register of mesh recipients recording the issues they experienced.
"I would like to see it set up by the end of 2019, if not the middle of the year," Mr Hunt said.
Patient lobby groups want to make it compulsory for health practitioners to report side-effects of implantable devices.
While the federal government supports this, it cannot act because it would be outside its powers.
"We will encourage the states and territories to adopt mandatory standards," Mr Hunt said.
The federal government has also established Medicare benefit payments for the removal of pelvic mesh implants and related treatments.
Medicare items have also been changed to restrict the use of the mesh in surgeries for pelvic organ prolapse.
The states and territories are being asked to conduct an audit of the devices.
"I would be surprised if any state or territory resisted the steps that we have taken," Mr Hunt said.
"Too many women have suffered too much for too long."
But the federal government did not support a recommendation to retrospectively audit pelvic mesh procedures, citing policy and implementation issues.
Labor said the important thing now is that the scandal is not repeated and those women who suffered are supported.
"Many women will however continue to deal with the health consequences of their mesh implant for the remainder of their lives," opposition health spokeswoman Catherine King said.
https://www.northerndailyleader.com.au/story/5694515/national-apology-over-pelvic-mesh-implants/
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Health minister Greg Hunt’s apology for ‘historic agony and pain’ of pelvic mesh surgery
Oct 10, 2018 | Newcastle Herald
By Joanne McCarthy
Pelvic mesh victims have called for a complete ban on the use of pelvic mesh implants in Australia after Federal Health Minister Greg Hunt apologised to women for the “historic agony and pain” of mesh surgery.
Peak consumer health bodies around Australia welcomed the apology but said the lack of funding to help affected women, and the failure to hold authorities responsible for the scandal to account, were “glaring” absences from the Federal Government’s response on Wednesday to a Senate report into pelvic mesh.
“We congratulate the Minister for recognising that these women have waited too long for validation from a system that treated them as unreliable witnesses to their own pain and suffering,” said Health Issues Centre chief executive Danny Vadasz.
“But ‘sorry’ is just a good first step. It doesn’t in itself deliver a happy ending. The Minister is relying on system reform through institutional self-regulation. Expecting the various bodies that failed their duty of care to pick up their game without addressing their accountability is an empty hope.”
On Wednesday Mr Hunt acknowledged “horrific outcomes” for many Australian women.
“On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes,” he said.
The Senate inquiry and report identified failures across the health system leading to “catastrophic” results for an unknown number of women implanted with devices for more than three decades.
The Senate report recommended a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements” to doctors and teaching hospitals, mandatory reporting of adverse events by doctors, a registry for all high risk implantable devices, a more comprehensive monitoring scheme for devices approved for use in Australia, and government agency oversight of a more effective informed consent process by doctors.
Mr Hunt said the government supported, or supported in principle, 12 of the 13 recommendations, but stopped short of a retrospective audit of transvaginal mesh procedures since the devices were introduced in Australia. Transvaginal mesh devices are polypropylene supports implanted into a woman via the vagina after complications following childbirth, including incontinence and prolapse.
The audit was strongly supported by pelvic mesh victims and public health groups after evidence health authorities did not know how many women had received implants, and how many were experiencing significant problems following mesh surgery.
The Newcastle Herald has reported since 2014 on women across Australia being ignored for decades when they have reported complications following mesh surgery.
On Wednesday Mr Hunt said the inquiry raised awareness about serious and longstanding impacts reported by some women following mesh-related procedures.
“I acknowledge the strength of the women who spoke at the public hearings, recounting deeply private and often traumatic experiences. The inquiry identified how we can recognise and support the women affected, and make improvements to Australia’s health care system,” he said.
“Our main aim and collective efforts are focused on restoring affected women’s confidence in our healthcare system, now and into the future.”
He said the government had already strengthened pre-market assessment of surgical mesh products by identifying them as high risk, had enhanced post market surveillance, introduced new Medicare items for the removal of mesh and launched a new Therapeutic Goods Administration web hub for consumers and professionals to find information about mesh.
Carolyn Chisholm, who launched the first support group for pelvic mesh women in 2014, said she appreciated the recognition of pelvic mesh as a national scandal and the minister’s apology, but said all mesh had to be removed from the market.
“I appreciate the recognition but these products should be banned altogether to prevent the possibility of more women’s lives being ruined. If only Greg Hunt would acknowledge this, then that would be progress,” Ms Chisholm said.
https://www.theherald.com.au/story/5694693/ministers-apology-for-historic-agony-and-pain-of-mesh-surgery/?cs=305
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Greg Hunt apologises to women affected by 'horrific' transvaginal mesh scandal
Oct 10, 2018 | The Guardian
By Melissa Davey
The health minister Greg Hunt has issued a national apology on behalf of the government to women affected by the transvaginal mesh scandal.
The government will on Wednesday table its response to the Senate inquiry into transvaginal mesh procedures, which found many women experienced great difficulty finding medical practitioners who would accept that the symptoms they were experiencing as a result of the mesh were as severe as they claimed. Their struggles to find support and treatment had devastating impacts on their lives.
The biggest lesson from the vaginal mesh saga? Doctors must listen to women
The government will support 12 of the 13 recommendations made by the inquiry. Recommendation 11, which calls for a retrospective audit of transvaginal mesh procedures since the devices were introduced in Australia, has been noted by the government but not committed to.
“On behalf of the Australian government I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes,” Hunt said.
“This has been an issue over some decades in many cases, so in our time and on our watch we recognise the problem and we’re moving to take sweeping action to repair it.”
It is the second time in less than 12 months that the minister has apologised for the way women have been treated by the medical system. In December, Hunt apologised to women with endometriosis, a chronic disease affecting more than 600,000 Australian women which historically had little research attention. Endometriosis can be crippling and occurs when tissue similar to the lining of the uterus grows outside the uterus, causing inflammation, pain and in some cases, infertility. Yet diagnosis takes an average of eight to nine years.
The inquiry into transvaginal mesh examined financial or other incentives provided to medical practitioners to use or promote transvaginal mesh implants, the lack of data available on how many procedures were performed, and the type and incidence of health problems women have experienced. Its findings, delivered in March, were scathing: “We feel that women have been let down by their doctors, by the manufacturers of mesh and by the Therapeutic Goods Administration [TGA] as the regulator,” the inquiry found.
The TGA banned the use of transvaginal mesh implants in November 2017. Only select mesh products can continue to be used by specialists in exceptional circumstances.
Most short-term clinical trials have found high efficacy and low complication rates for the most common mesh implants used for incontinence, but there is a growing body of evidence that efficacy is lower and complication rates are higher when certain meshes are used to repair pelvic organ prolapse. Complications can include mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and are difficult to treat.
The government’s response to the inquiry will include introducing measures to improve patient information. Medical device companies will be required to supply leaflets with details of each device implanted. Mesh products will also be reclassified from medium-to-high risk to high risk, and post-market surveillance will be strengthened to make it easier for patients to report adverse events to the TGA.
New medicare item numbers will also be introduced for the surgical repair of pelvic organ prolapse and removal of mesh.
In a statement Hunt said he had written to state and territory health ministers seeking their cooperation to implement inquiry recommendations that extended beyond the direct responsibility of the commonwealth.
“I acknowledge the strength of the women who spoke at the public hearings, recounting deeply private and often traumatic experiences,” he said. “Our main aim and collective efforts are focused on restoring affected women’s confidence in our healthcare system, now and into the future.”
https://www.theguardian.com/society/2018/oct/10/greg-hunt-apologises-to-women-affected-by-horrific-transvaginal-mesh-scandal
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Mesh implants: Government issues national apology over 'agony and pain' caused by device
Oct 10, 2018 | ABC News.au
By Sophie Scott and Alison Branley
Health Minister Greg Hunt has issued a national apology to the many women whose lives have been ruined by the debilitating effects of pelvic mesh implants.
Speaking as he released details of the Government's response to a Senate inquiry into vaginal mesh, Mr Hunt said he wanted to acknowledge the pain and suffering of those at the centre of the medical scandal.
"On behalf of the Australian Government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes," he said.
"My message to them is your voice has been heard, and not just heard but acted upon."
The ABC has obtained details of the Government's response to the inquiry, which is expected to be tabled today.
Mr Hunt said the Government would work with states and territories on setting up a voluntary national register of women who have had mesh devices and anything that went wrong.
"I would like to see it (the register) set up by the end of 2019, if not the middle of the year," he said.
Patient groups had wanted it to be made compulsory for all health practitioners to report side-effects of any implantable device.
Mr Hunt said while his Government supported such a move, it was outside federal powers to do so.
"We will encourage the states and territories to adopt mandatory standards," he said.
There's been a mixed response from women and consumer health groups who continue to lobby for all mesh products to banned.
At the moment many items have been pulled from shelves and only select products can be used by qualified surgeons.
Mother of two Joanne Villani said she had witnessed some reforms by regulators, but many problems she experienced more than a decade ago still persisted.
"Women are still not being believed by their doctors," she said.
"Doctors are still implanting mesh and telling women it's new mesh and it is the same mesh.
"I would like mesh to be banned until it's been shown to be safe. If it's not shown to be safe, then it should never be used again."
Senator Derryn Hinch pushed for the Senate inquiry, calling mesh "one of the biggest medical scandals" in Australian history.
Among the other actions the Federal Government will take are:Permanent Medicare payment items for the removal and treatment of pelvic meshAsking states and territories to conduct an audit of pelvic mesh
Mr Hunt said he would raise the issues with his counterparts at the next health COAG meeting.
"I would be surprised if any state or territory resisted the steps that we have taken," he said.
"Too many women have suffered too much for too long."'I've friends who probably won't make it': patient
For Ms Villani it was not that pelvic mesh stopped her being able to have intercourse with her husband, it was the broader impact it had on their relationship.
"We actually split up for quite some time. It's nothing my husband did or thought," she said.
"It was very hard when he felt guilty and I felt guilty. It caused strain."
The mother-of-two left the family home for some time because of the problems mesh caused in her relationship.
She has now returned to her partner because they "just want to be together", but said their partnership would never be the same.
It is just one way Ms Villani said mesh has "totally altered my life" after her doctor suggested it to treat prolapse and incontinence following the birth of her son.
She recalled her surgeon seemed quite excited about the product at the time and believed he was on the "cutting edge" of new techniques.
"It didn't quite work the way they expected," she said.
"I went back to the surgeon on a number of occasions to discuss problems I was having and I was basically told it was in my head."
Eleven years on, she said her situation had improved little.
"I have pain all the time," she said.
"I'll have to give up my job eventually. My financial future is also affected. I've been extremely depressed and anxious."
Ms Villani said the worst part was that she was "not the only one".
"Some women are expecting to die from their complications," she said.
"I've friends who probably won't make it."Patient advocates call for regulation of devices
And while Ms Villani welcomed the Government's reforms to regulation and reporting, she said it did very little to help women who were continuing to struggle with debilitating side-effects from the product.
"I have friends who are talking about suicide. So we all need help," she said.
"I would like to believe the Federal Government is serious about reform but what I see is a lot of this comes down to money.
"Money isn't the issue, we are the issue."
Patient advocates had been hoping for much tighter regulations of implantable devices, so that a scandal like pelvic mesh could not happen to other patients in the future.
Health Issues Centre chief Danny Vadasz said the Minister's apology would provide much-needed validation to women who had long been told their problems were in their heads.
He welcomed the push for mandatory reporting, but said it relied on doctors listening to their patients.
"What we found in a lot of cases [was] women believed they had an adverse outcome but their practitioners didn't," Mr Vadasz said.
"You can only effectively mandate something if there's an agreement on what constitutes an adverse result."
He said the states and territories, to date, had not made an audit of past mesh cases a priority, but "hopefully with the Minister's encouragement they will put this on the front burner".
Mr Hunt said discussions were also underway to include implantable devices on the My Health record, if a patient chose.
But he said it would not be mandatory and the Government wanted to make sure that the My Health record system "was an entirely voluntary system".
Mr Vadasz did not think the My Health record was an adequate avenue for a registry of devices because it had "sufficient problems of its own".
"Complicating one problem by introducing the problems of another isn't a way of coming up with an overall solution," he said.
The Health Issues Centre was also hoping to see stricter credentialing around which surgeons were allowed to implant mesh.
"I haven't heard anything yet that suggests there's going to be tighter control of clinical trials that would enable a high degree of confidence in products that find their way to market," Mr Vadasz said.
"I think people still need an explanation about why the various regulatory systems that are supposed to protect the public failed."
http://www.abc.net.au/news/2018-10-10/mesh-implants-government-issues-apology-to-women/10355546
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Use mesh implants for stress urinary incontinence only as last resort, says NICE
Oct 9, 2018 | British Medical Journal
By Zosia Kmietowicz
Surgical mesh or tape should be used to treat stress urinary incontinence or pelvic organ prolapse only after all non-surgical options have been reviewed, the UK National Institute for Health and Care Excellence has said in draft guidance.
When mesh or tape is used, the procedures and any related complications should be recorded in a national database to help with future decisions about its use, it said.
The safety of mesh implants has been brought into question by thousands of women around the world, many of whom are taking legal action against manufacturers, including in the UK.
In July the use of surgical mesh for stress urinary incontinence was suspended in England by the life peer Julia Cumberlege,2 just days after she began taking evidence from women affected by mesh as part of an independent review.3 The government set up the review in February after pressure from campaigners and MPs,45 who said that increasing numbers of women were reporting complications after mesh surgery, including debilitating pain, infection, inflammation, loss of sex life, and mobility problems.
NICE said that the suspension of the use of mesh in England should remain in place until the national database for registering operations and complications was up and running and when all operations could be performed by specialist surgeons based at specialist treatment centres.
All women who have surgery for urinary incontinence or prolapse that uses mesh or tape should be fully informed of the possible risks and be offered a follow-up appointment within six months, says NICE.
The draft guidance also recommends that surgeons develop an individualised investigation plan for each woman with suspected or confirmed complications from mesh, which should be reported to the Medicines and Healthcare Products Regulatory Agency as well as being collected in the national registry.
Women with suspected complications should be referred to a urogynaecologist, urologist, or colorectal surgeon for specialist assessment, while women with a confirmed complication or unexplained symptoms should be seen by a consultant at a regional centre specialising in the diagnosis and management of surgical mesh or tape related complications.
Owen Smith MP, chair of the all parliamentary group on surgical mesh implants, said that the advice against using mesh as a first line treatment was long overdue. “This is a welcome U turn from NICE, who in their 2016 guidelines for mesh did not recommend any other treatment options for [stress urinary incontinence] and in fact stated that complications from mesh were ‘infrequent,’” he said.
Kath Sansom, from the campaigning group Sling the Mesh, said that mesh should be a third line option treatment and be offered only after medical and other surgeries failed, as is planned for Scotland. “That way it is a belt and braces approach so that mesh truly is the last resort,” she said. “Our ideal scenario is to see pelvic mesh stopped. Full stop. The risks are too great. It is totally unacceptable that women come out of a ‘simple little operation’ with shattered lives.
“One in seven have lost their marriages because of mesh. One in seven have lost their sex life. Eight in 10 suffer pain so great it affects their daily life. More than half suffer ongoing urinary infections. Unsurprisingly many are suicidal, and six in 10 are on antidepressants.”
Linda Millband, head of medical negligence at Thompsons Solicitors, the firm acting for more than 280 mesh clients, said she was concerned that private hospitals will ignore the guidance, just as they have not acted on Cumberlege’s advice to halt surgery.
She said, “NICE has recommended a limited register for mesh related operations, whereas we support the call by Sling the Mesh for a complete register of not only those who are due to have mesh surgery but all those operated on in the past. Only then will the true scale of this medical scandal be revealed.”
https://www.bmj.com/content/363/bmj.k4242
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Vaginal mesh should be the last resort, health officials say
Oct 9, 2018 | Metro
By Martine Berg Olsen
Vaginal mesh should only be offered to women as a last resort, health officials have said in a U-turn recommendation.
A new draft guideline from the National Institute for Health and Care Excellence (Nice) states that those who suffer from stress urinary incontinence or pelvic organ prolapse should be offered a full range of non-surgical options before an operation is considered.
The mesh scandal has seen thousands of women complain of being left in constant pain after having the implants, which have been offered to treat pelvic organ prolapse and incontinence after childbirth.
In July, a ‘pause’ was put in place on some mesh procedures in England until certain conditions are met – including the publication of the new Nice guideline.
Nice has issued its latest draft guideline with formal guidance expected in April next year.
Campaign group Sling The Mesh has welcomed the new guideline but said ‘they do not go far enough’.
Kath Sansom from the group said: ‘Our ideal scenario is to see pelvic mesh stopped. Full stop. The risks are too great. It is totally unacceptable that women come out of a “simple little operation” with shattered lives.
‘One in seven have lost their marriages because of mesh. One in seven have lost their sex life. Eight out of 10 suffer pain so great it affects their daily life. More than half suffer ongoing urinary infections. Unsurprisingly many are suicidal and six in 10 are on anti-depressants.’
The draft document states that women should explore all other possible options before considering the surgery.
The non-surgical options for urinary incontinence include lifestyle interventions including caffeine reduction, modifying fluid intake and weight loss; physical therapies such as pelvic floor muscle training; behavioural therapies such as bladder training programmes; or medication.
Non-surgical options for pelvic organ prolapse include lifestyle modifications including avoiding heavy lifting and preventing constipation, pelvic floor muscle training and pessary management, according to Nice.
The draft guideline states that surgical interventions using surgical mesh also known as tape should only be considered when non-surgical options have failed or are not possible.
Sir Andrew Dillon, chief executive of Nice, said: ‘It is important that every woman is supported to make decisions that are right for her, consents to a procedure, and fully understands the benefits and risks of the procedure being offered before consenting to it.
‘If a surgeon cannot provide a full range of choices to the patient, then she should be referred to one who can. ‘Surgeons must also record any intervention using surgical mesh/tape in a national database.’
Meanwhile a national database should be set up to record all procedures involving the use of surgical mesh/tape in operations for stress urinary incontinence or pelvic organ prolapse, Nice added.
Women should be fully informed about the risks and be given a follow-up appointment six months after surgery to check for any side effects.
The draft guideline also recommends how complications associated with surgical mesh or tape surgery should be managed.
https://metro.co.uk/2018/10/09/vaginal-mesh-should-be-the-last-resort-health-officials-say-8019224/
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Oct 10, 2018 | The Sun
By Miranda Larbi
Vaginal mesh should only be offered to women as a last resort, health bosses have stated in a new draft document.
They've been prescribed previously to treat pelvic organ prolapse and incontinence after childbirth.
The guideline, from the National Institute for Health and Care Excellence (NICE), comes after hundreds of women sued the NHS earlier this year, saying that the mesh ops had left them unable to walk or have sex.
Typically those who seek treatment for this are over the age of 50 who have had several children, are overweight or suffered a vaginal tear.
Complaints include persistent pain, sexual problems, mesh exposure through vaginal tissues and occasionally injury to nearby organs, such as the bladder or bowel.
Problems are usually caused by the mesh eroding and breaking down into smaller pieces which move.
Back in July, vaginal mesh ops were paused until certain conditions were met - including the publication of NICE's guidelines.
The Medicines and Medical Devices Safety Review said at the time that "we must stop exposing women to the risk of life-changing and life-threatening injuries".
Now the NICE draft document has said that women should try a range of techniques before a mesh is even considered.
Non-surgical options for urinary incontinence include lifestyle changes like reducing the amount of caffeine and fluids consumed, and losing weight.
Pelvic floor muscle training, behavioural therapies for bladder training and medication are all also options.
Pelvic organ prolapse can also be treated without surgery by getting women to avoid any heavy lifting, reducing the risk of constipation, and getting them to do pelvic floor muscle training.
Mesh implants, these new guidelines insist, should only be offered after these no-surgical options have failed or aren't possible.
And it says that women should be made fully aware of the risks having the surgery can come with.
Sir Andrew Dillon, chief executive of Nice, said: "It is important that every woman is supported to make decisions that are right for her, consents to a procedure, and fully understands the benefits and risks of the procedure being offered before consenting to it.
"Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape.
"If a surgeon cannot provide a full range of choices to the patient, then she should be referred to one who can."
He went on to say that all procedures involving the use of surgical mesh or tape in operations for these issues should be recorded, with a follow-up appointment six months after surgery to be check for any side effects.
"Surgeons must also record any intervention using surgical mesh/tape in a national database."
But not everyone believes that these draft guidelines go far enough.
Kath Sansom of the campaign group Sling The Mesh said: "Our ideal scenario is to see pelvic mesh stopped. Full stop. The risks are too great.
"It is totally unacceptable that women come out of a 'simple little operation' with shattered lives.
"One in seven have lost their marriages because of mesh. One in seven have lost their sex life. Eight out of 10 suffer pain so great it affects their daily life.
"More than half suffer ongoing urinary infections. Unsurprisingly many are suicidal and six in 10 are on anti-depressants."
https://www.thesun.co.uk/fabulous/7450189/vaginal-surgical-mesh-operations-should-only-be-used-last-resort/
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Surgical mesh last resort for prolapse or incontinence
Oct 9, 2018 | On Medica
By Louise Prime
Surgical mesh or tape should be considered only as a last resort for women with stress urinary incontinence or pelvic organ prolapse when all other non-surgical options have failed or are not possible, the National Institute for Health and Care Excellence (NICE) advised this morning. NICE insisted that wherever surgical mesh/tape could be an option, there is almost always another recommended intervention that does not involve its use – and if a surgeon cannot provide a full range of choices to the patient, then they should refer her to another who can.
In its draft guidance published for consultation this morning, NICE insisted that women should be offered a full range of non-surgical options for stress urinary incontinence or pelvic organ prolapse before any operations. It said there are several non-surgical options for both urinary incontinence and pelvic organ prolapse, that should be considered before surgery. Its recommended non-surgical options for urinary incontinence include:
lifestyle interventionsphysical therapiesbehavioural therapiesmedicines.Recommended non-surgical options for pelvic organ prolapse include:
lifestyle modificationtopical oestrogenpelvic floor muscle trainingpessary management.NICE said that in the cases where it is agreed to use surgical mesh/tape, women must be fully informed of the risks. For surgery for incontinence this information should cover differences in type of anaesthesia, expected length of hospital stay, surgical incisions and expected recovery period; and where mesh is to be used in prolapse surgery, it should cover what type of mesh will be used and whether it is permanent, as well as the uncertainty about long-term complications associated with mesh and about the proportion of women affected.
It also called for a national database to be set up to record all procedures involving the use of surgical mesh/tape in operations for stress urinary incontinence or pelvic organ prolapse, to help with future decision making.
NICE chief executive Sir Andrew Dillon commented: “It is important that every woman is supported to make decisions that are right for her, consents to a procedure, and fully understands the benefits and risks of the procedure being offered before consenting to it.
“Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the patient, then she should be referred to one who can.
“Surgeons must also record any intervention using surgical mesh/tape in a national database.
“The guideline committee was asked to look at a range of interventions and examine the evidence for them. Importantly, our recommendations offer women a range of options for treatment that don’t involve the use of surgical mesh/tape.”https://www.onmedica.com/newsarticle.aspx?id=922c0444-c0ed-436e-bb99-b5ee4ad32384
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Mesh implant became broken, twisted, and embedded in woman’s muscle
Oct 9, 2018 | Great Yarmouth Mercury
By Geraldine Scott
A Norfolk woman whose vaginal mesh had broken, twisted, and become embedded deep into a muscle said she wished she never had the procedure.
It comes as health officials said vaginal mesh should only be offered to women who have explored all other possible options.
A new draft guideline from the National Institute for Health and Care Excellence (Nice) states that those who suffer from stress urinary incontinence or pelvic organ prolapse should be offered a full range of non-surgical options before an operation is considered.
But for Lorraine Lodge, from Great Yarmouth, the guidance comes too late as her mesh - known as a TVTO - was fitted at the James Paget University Hospital in Gorleston in 2015.
The mesh scandal has seen thousands of women complain of being left in constant pain after having the implants, which have been offered to treat pelvic organ prolapse and incontinence after childbirth.
In July, a “pause” was put in place on some mesh procedures in England until certain conditions are met - including the publication of Nice guidelines on the use of mesh for stress urinary incontinence.
Ms Lodge, 52, has just had her mesh removed at University College London Hospital.
Speaking from her hospital bed she said: “It had broken in three places, it was twisted, it was embedded deep into a muscle – and had apparently been put in too tight in the first place.
“Now all of the mesh has gone, I already feel so much better. Even though I’ve had serious surgery, the pains in my hips have gone and it isn’t painful to lay down any more.
“I know it’s going to take time to recover but this is a start, a very good start. If I’d have known about the complications, I would never have said ‘yes’ to a pelvic mesh implant.”
Before having the mesh fitted, Ms Lodge worked as a community carer, went to the gym, and had a reputation of being the first on the dance floor on a night out.
She had mild incontinence, which she understood would be fixed by the mesh procedure.
But she said as soon as she came around from surgery something was not right.
She said: “I was having problems from the word ‘go’ with horrible pains in my legs and groin. Initially, I was told it was from the way my legs were positioned during the surgery.
“It felt as though my legs were being stung with stinging nettles, a similar sensation to pins and needles. Over time, it got worse and my health deteriorated.”
In October last year her legs gave way at work. Since, she has been housebound and can only get out with a mobility scooter.
Ms Lodge realised others were suffering complications after watching a documentary about mesh on the television last year.
She joined the Sling the Mesh Facebook group, and met others going through a similar ordeal. Later, she set up a local Norfolk and Suffolk meshies branch.
At the moment, there are 41 members who support one another and arrange get-togethers.
A government tour of the UK to speak to women experiencing complications from pelvic mesh implants will be in Cambridge on Monday, October 15 in the afternoon
And Ms Lodge is encouraging women from Norfolk to go and even arranging transport.
She said: “We need to get the word out there that all mesh - hernia, pelvic and rectopexy – is bad and the stuff is completely ruining people’s lives. Not just patients, their families and loved ones as well.
“We also need to meet others who are experiencing complications, and let them know they are not alone. “
The Independent Medicines and Medical Devices Safety Review hearing for pelvic mesh implants is being held in at the Homerton Conference Centre between 1pm and 3pm.
Travel expenses can be reimbursed as part of the review, which family members and loved ones may also attend. Participants will need to submit all travel receipts, with economy or standard class used on public transport whenever possible.
Those unable to attend can email their experiences to reviewteam@kcl.ac.uk. A free counselling service is also available for anyone who needs support as a result of participating in the review.
Kath Sansom, of the Sling The Mesh campaign group and a journalist from March, said: “The pain this procedure can cause is indescribable.
“I’ve been in contact with women who are suffering serious complications from pelvic mesh implants. This procedure was promoted as a quick fix for urinary stress incontinence and prolapse – but the plastic can twist, shrink, go brittle and degrade inside the body.
“It can attach and slice through organs causing chronic pain, sepsis, loss of sex life and for some women they need to have their bladder or bowel removed. Women contact our group daily feeling suicidal from the pain pelvic mesh implants have caused them.”
Today The National Institute for Health and Care Excellence (NICE) has issued its latest draft guideline on the management of urinary incontinence and pelvic organ prolapse in women, with formal guidance expected in April next year.
The draft document states that women should try a range of techniques before mesh is even considered.
The non-surgical options for urinary incontinence include lifestyle interventions including caffeine reduction, modifying fluid intake and weight loss; physical therapies such as pelvic floor muscle training; behavioural therapies such as bladder training programmes; or medication.
Non-surgical options for pelvic organ prolapse include lifestyle modifications including avoiding heavy lifting and preventing constipation, pelvic floor muscle training and pessary management, Nice said.
The draft guideline states that surgical interventions using surgical mesh/tape should only be considered when non-surgical options have failed or are not possible.
Meanwhile a national database should be set up to record all procedures involving the use of surgical mesh/tape in operations for stress urinary incontinence or pelvic organ prolapse, NICE added.
Ms Sansom, who also had the mesh implant in March 2015, but since has had it removed due to the complications, said: “These draft guidelines are to be welcomed but they do not go far enough.
“Our ideal scenario is to see pelvic mesh stopped. Full stop. The risks are too great. It is totally unacceptable that women come out of a ‘simple little operation’ with shattered lives.
“One in seven have lost their marriages because of mesh. One in seven have lost their sex life. Eight out of 10 suffer pain so great it affects their daily life. More than half suffer ongoing urinary infections. Unsurprisingly many are suicidal and six in 10 are on anti-depressants.”
http://www.greatyarmouthmercury.co.uk/news/implant-broke-and-twisted-inside-great-yarmouth-woman-s-body-1-5728857
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Pelvic mesh implant inquiry: victims take class action
Oct 10, 2018 | Daily Telegraph
Australia has been rocked by the shocking discovery pelvic mesh devices intended to address incontinence and organ prolapse in women were causing...
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Story can be found here: https://www.dailytelegraph.com.au/newslocal/stgeorge-shire-standard/pelvic-mesh-implant-inquiry-victims-take-class-action/news-story/963c9402f7a3f5ba40db178f2256d0a7
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