Preview Newsletter
Ethicon Media Monitoring 8/21/2018
-
Holyrood committee calls for a ban on mesh implants
Aug 21, 2018 | BBC News
The use of mesh implants by the NHS in Scotland should be banned, a parliamentary report has concluded. -
Hundreds of women continue to undergo mesh operations despite Scottish goverment's 'ban'
Aug 21, 2018 | HeraldScotland
By Stephen Naysmith
More than 750 women had mesh procedures in the three years since the Scottish Government called for use of the controversial medical technique to be suspended, it has emerged. -
Mesh implant procedures should end in Scotland, report says
Aug 21, 2018 | The Scotsman
By Catriona Webster
The use of mesh implants in the Scottish health service should stop, a parliamentary report has concluded. -
Report calls for total ban on the use of mesh implants
Aug 21, 2018 | STV News
The use of mesh implants in the Scottish health service should stop, a parliamentary report has concluded. -
Parties in AMS pelvic mesh class action promise streamlined approach
Aug 20, 2018 | Lawyerly
By Miklos Bloza
Lawyers on both sides of the class action against American Medical Services over pelvic mesh implants have taken steps to ensure the case proceeds with... -
The regulation of medical devices is flawed and another scandal is inevitable: health advocates
Aug 21, 2018 | ABC News.au
By Alison Branley and Sophie Scott
More catastrophic failures of medical devices are "almost guaranteed" to happen because there's been no significant reforms to the way Australia regulates such implants, health advocates say.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Holyrood committee calls for a ban on mesh implants
Aug 21, 2018 | BBC News
The use of mesh implants by the NHS in Scotland should be banned, a parliamentary report has concluded.
A review into the controversial procedure last year set out new conditions on its use but the findings were criticised by campaigners.
Holyrood's petitions committee said it had "serious concerns" about the review's credibility and urged ministers to take stronger action.
The Scottish government said a number of steps were being taken.
It said "serious consideration" would be given to the findings and health boards were expected to implement the committee's recommendations.What's the issue with mesh implants?Immediate stop to NHS mesh operations
Over the past 20 years, more than 100,000 women across the UK have had transvaginal mesh implants, which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), often after childbirth.
The mesh, usually made from synthetic polypropylene, is intended to repair damaged or weakened tissue.
While the vast majority of women suffer no side-effects, others have reported chronic and debilitating pain, with some being left unable to walk.
Concerns were first brought to the attention of the Holyrood's petitions committee in 2014 by campaigners who complained that complications were frequently under-reported by doctors.Guidance ignored
The Scottish government urged all health boards to stop using the procedure until more evidence was gathered - and set up an independent review to look into safety concerns.
But the guidance was widely ignored - BBC Scotland revealed in December 2016 that hundreds of operations had been carried out since the "suspension".
And the final draft of the safety review, published in March 2017, was itself mired in controversy.
While it laid out strict criteria for use of the procedure, it did not recommend an outright ban.
Campaigners, including Elaine Holmes and Olive McIlroy, who lodged the original petition with the parliament on behalf of the Scottish Mesh Survivors campaign, branded it a "whitewash".
They resigned from the review, as did expert clinician Dr Wael Agur.
Holyrood's petitions committee said it was worrying that an interim draft of the safety review report was modified before the final version was published.
"We have serious concerns about the credibility of the final report as a basis for informing both clinicians and patients to make fully informed decisions," it said in a report published on Tuesday.The committee expects a positive response from the Scottish governmentAngus MacDonald, Deputy convener
The committee said its preference was for "the use of mesh devices to treat SUI and POP to cease in Scotland".
The report criticised the continued use of the procedure in Scotland despite the request for a moratorium.
The Scottish government said the total number of mesh operations had fallen considerably since it requested that health boards suspend the use of transvaginal mesh in 2014.
It said the number of operations for SUI in the six months to March 2018 was at 5% of the previous rate.
Deputy convener Angus MacDonald called for stronger guidance from the Scottish government.
"The committee expects a positive response from the Scottish government, particularly given we're awaiting the review of the review from Professor Alison Britton which will hopefully shed some more light on this extremely upsetting saga," he said.Designated centres
A Scottish government spokesman said the chief medical officer would develop designated centres able to treat the "very few" women who have no choice but procedures using a mesh, while also overseeing an audit of all procedures in Scotland in future.
The Scottish government pointed out it had no power to enforce a ban the use of mesh, which is a matter for the Medicine and Healthcare products Regulatory Agency (MHRA).
"The MHRA is the regulator of medical devices across the UK, and responsibility for the agency is reserved to Westminster.
"The Scottish government cannot therefore ban mesh. We have, however, repeatedly raised concerns about mesh with the MHRA when they have been brought to our attention and, were the agency to issue a medical device alert in relation to it, health boards would be fully expected to act on it."
The spokesman added: "All boards are fully expected to implement the recommendations of the independent review.
"The Scottish government's request that they suspend use of transvaginal mesh will remain in place until the chief medical officer is satisfied that they have been implemented, and all necessary safeguards are in place."
Mesh implants - timeline
April 2014
- Campaigners lodge a petition at the Scottish Parliament, calling for a suspension of mesh implant surgery.
June 2014
- Women, some of them in wheelchairs, give evidence to Holyrood's petitions committee about the debilitating consequences of their surgery. Health secretary, Alex Neill asks Scotland's health boards to suspend the use of mesh while an independent review is carried out.
October 2015
-New health secretary, Shona Robison, apologises to women affected and says the suspension will remain in place.
December 2016
- Figures obtained by BBC Scotland reveal that 404 women have received mesh and tape implants since the health secretary called for the suspension in June 2014.
March 2017
- Patient representatives Olive McIlroy and Elaine Holmes resign from the independent review group, claiming its final report has been watered down. The review says the procedure should not be used routinely for pelvic organ prolapse cases, and for incontinence, women should be given full information about the risks before making their decision.
May 2017
- Shona Robison asks Prof Alison Britton of Glasgow Caledonian University to conduct a review of the independent review
July 2018
- NHS England says the use of mesh implants will be "paused" until strict new conditions are met but will remain as a treatment of last resort for some patients
https://www.bbc.com/news/uk-scotland-45246761
-
Hundreds of women continue to undergo mesh operations despite Scottish goverment's 'ban'
Aug 21, 2018 | HeraldScotland
By Stephen Naysmith
More than 750 women had mesh procedures in the three years since the Scottish Government called for use of the controversial medical technique to be suspended, it has emerged.
The figures reveal the extent to which health boards have ignored the request by then health secretary Alex Neil in 2014, when he said boards should stop treating women using the procedure.
A report today by the Scottish Parliament’s Public Petitions Committee will renew calls for ministers to follow the lead of the UK Government, which ordered a halt to mesh operations in July.
Transvaginal Mesh is used to treat a number of conditions including pelvic organ prolapse (POP) and stress urinary incontinence, by using a polypropylene net-like implant to support organs, including the bladder.
However, thousands of women have suffered life-changing complications from the treatment, leaving some in chronic pain or even given hysterectomies in a bid to alleviate their symptoms.
The committee’s report will also criticise a “perceived lack of urgency” on the part of the Scottish Government about making sure patients are appropriately informed.
Figures published by current health secretary Jeane Freeman have revealed the extent to which the controversial implants are still being used by health boards. Around 1200 procedures were carried out in the year prior to the ban. While this has dropped dramatically, women were treated with mesh tape insertion – for urinary incontinence – 696 times between 2014 and 2017, and on 54 occasions women had operations to insert mesh implants for POP.
An independent review commissioned by the Scottish Government was criticised as a whitewash when it was published last year, after an entire chapter was omitted from the final version amid concerns that details of negative effects experienced by patients were downplayed. Key participants resigned and disowned the findings.
Alison Britton, professor of healthcare at Glasgow Caledonian University, has now been commissioned to review the Independent Review.
The report says use of mesh should be suspended in Scotland until confidence in the review can be restored, and also expresses alarm that many women were not believed when reporting complications to medical professionals. MSPs on the committee have been considering a petition lodged in April 2014 by Elaine Holmes and Olive McIlroy on behalf of the Scottish Mesh Survivors’ ‘Hear our Voice’ campaign.
Johann Lamont MSP, the Committee’s convener, said evidence sessions for the report had been “incredibly emotional, with the physical and mental impact plain to see”. She added: “We urge the Scottish Government to respond to our recommendations and the concerns of women.”
Angus MacDonald MSP, deputy convener of the Committee, said the Scottish Government should act on the findings and said Professor Britton’s report “will hopefully shed some more light on this extremely upsetting saga.”
Mesh expert Dr Wael Agur, of the University of Glasgow school of medicine – who resigned from the independent review group – said: “I believe the figures underestimate the number of women still undergoing this treatment. I don’t think women are being told that there are serious concerns and risks with these procedures.
“Having led the way on this Scotland is now trailing behind England. Alex Neil did what he could given the limited information at the time. But given what we now know about the seriousness of the damage done to women by this practise the safest thing to do is suspend it,” he said.
http://www.heraldscotland.com/news/16587515.hundreds-of-women-continue-to-undergo-mesh-operations-despite-scottish-goverments-ban/
-
Mesh implant procedures should end in Scotland, report says
Aug 21, 2018 | The Scotsman
By Catriona Webster
The use of mesh implants in the Scottish health service should stop, a parliamentary report has concluded.
Holyrood’s Public Petitions Committee has urged the Scottish Government to halt the use of such procedures, used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
The committee said they had “serious concerns” about the final report of an independent review into the use of mesh, which last year concluded that mesh must not be offered “routinely” to women with pelvic organ prolapse.
The review was announced by the Scottish Government in 2014, with health boards requested to stop the procedure until its conclusion. Its final report was branded a “whitewash” by campaigners, including Elaine Holmes and Olive McIlroy, who lodged the original petition with the parliament on behalf of the Scottish Mesh Survivors campaign.
They resigned from the review amid the controversy, as did expert clinician Dr Wael Agur.
Professor Alison Britton has been commissioned to conduct a review of the review, which is due to report later this year.
After considering evidence taken on the issue, the committee said its preference was for “the use of mesh devices to treat SUI and POP to cease in Scotland”.
The report criticised the continued use of the procedure in Scotland despite the request for a moratorium. “We have serious concerns about the credibility of the final report as a basis for informing both clinicians and patients to make fully-informed decisions,” the report said.
MSPs said they shared the concerns raised by mesh survivors “about the transparency and true independence” of the review and warned of the potential for the final report to be used “to justify the lifting of bans on mesh in other jurisdictions”.
The committee said that if Prof Britton’s review revealed significant flaws, the final report “must be regarded as lacking credibility to the extent that it requires to be revisited”.
Convener Johann Lamont praised the “courage and commitment” of Ms Holmes and Ms McIlroy and urged the Socttish Government to respond to the concerns.
“Seeing and hearing the experiences of the many women we have heard from during our consideration of this petition was incredibly emotional, with the physical and mental impact plain to see,” she said.
“One of the most important things to come out of this report was the extent to which women were not believed when they were highlighting their concerns to the medical profession, ultimately resulting in there being no record of their concerns.”
Deputy convener Angus MacDonald said the report had cross-party support.
He said: “The committee expects a positive response from the Scottish Government, particularly given we’re awaiting the review of the review from Professor Alison Britton which will hopefully shed some more light on this extremely upsetting saga.”
Scottish Labour MSP and mesh campaigner Neil Findlay said: “Mesh survivors, and myself, said the review was a whitewash. The committee’s damning report confirms it as such.
“It is now time for those MSPs and the Scottish Government to ensure these mesh survivors are not failed again.” A Scottish Government spokesman said “serious consideration” would be given to the findings and health boards were expected to implement its recommendations.
The Chief Medical Officer would develop designated centres able to treat the “very few” women who have no choice but procedures using a mesh, while also overseeing an audit of all procedures in Scotland in future, he added.
But he said: “The MHRA is the regulator of medical devices across the UK, and responsibility for the agency is reserved to Westminster. The Scottish Government cannot therefore ban mesh.
“We have, however, repeatedly raised concerns about mesh with the MHRA when they have been brought to our attention and, were the agency to issue a medical device alert in relation to it, health boards would be fully expected to act on it.”
https://www.scotsman.com/news/mesh-implant-procedures-should-end-in-scotland-report-says-1-4787190
-
Report calls for total ban on the use of mesh implants
Aug 21, 2018 | STV News
The use of mesh implants in the Scottish health service should stop, a parliamentary report has concluded.
Holyrood's Public Petitions Committee has urged the Scottish Government to halt the use of such procedures, used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
The committee said they had "serious concerns" about the final report of an independent review into the use of mesh, which last year concluded that mesh must not be offered "routinely" to women with pelvic organ prolapse.
The review was announced by the Scottish Government in 2014, with health boards requested to stop the procedure until its conclusion.
Its final report was branded a "whitewash" by campaigners, including Elaine Holmes and Olive McIlroy, who lodged the original petition with the parliament on behalf of the Scottish Mesh Survivors campaign.
They resigned from the review amid the controversy, as did expert clinician Dr Wael Agur.
Professor Alison Britton has been commissioned to conduct a review of the review, which is due to report later this year.
After considering evidence taken on the issue, the committee said its preference was for "the use of mesh devices to treat SUI and POP to cease in Scotland".
The report criticised the continued use of the procedure in Scotland despite the request for a moratorium.
"We have serious concerns about the credibility of the final report as a basis for informing both clinicians and patients to make fully-informed decisions," the report said.
MSPs said they shared the concerns raised by mesh survivors "about the transparency and true independence" of the review and warned of the potential for the final report to be used "to justify the lifting of bans on mesh in other jurisdictions".
The committee said that if Prof Britton's review revealed significant flaws, the final report "must be regarded as lacking credibility to the extent that it requires to be revisited".
Convener Johann Lamont praised the "courage and commitment" of Ms Holmes and Ms McIlroy and urged the Scottish Government to respond to the concerns.
Scottish Labour MSP and mesh campaigner Neil Findlay said: "Mesh survivors, and myself, said the review was a whitewash.
"The committee's damning report confirms it as such.
"It is now time for those MSPs and the Scottish Government to ensure these mesh survivors are not failed again."
A Scottish Government spokesman said "serious consideration" would be given to the findings and health boards were expected to implement its recommendations.
The Chief Medical Officer would develop designated centres able to treat the "very few" women who have no choice but procedures using a mesh, while also overseeing an audit of all procedures in Scotland in future, he added.
But he said: "The MHRA is the regulator of medical devices across the UK, and responsibility for the agency is reserved to Westminster.
"The Scottish Government cannot therefore ban mesh.
"We have, however, repeatedly raised concerns about mesh with the MHRA when they have been brought to our attention and, were the agency to issue a medical device alert in relation to it, health boards would be fully expected to act on it."
https://stv.tv/news/scotland/1427946-report-calls-for-total-ban-on-the-use-of-mesh-implants/
-
Parties in AMS pelvic mesh class action promise streamlined approach
Aug 20, 2018 | Lawyerly
By Miklos Bloza
Lawyers on both sides of the class action against American Medical Services over pelvic meshimplants have taken steps to ensure the case proceeds with...
Access to full text unavailable – subscription required.
Story can be found here: https://www.lawyerly.com.au/parties-in-ams-pelvic-mesh-class-action-promise-streamlined-approach/
-
The regulation of medical devices is flawed and another scandal is inevitable: health advocates
Aug 21, 2018 | ABC News.au
By Alison Branley and Sophie Scott
More catastrophic failures of medical devices are "almost guaranteed" to happen because there's been no significant reforms to the way Australia regulates such implants, health advocates say.
The warning comes after the ABC revealed dozens of women who have suffered complications from a permanent contraceptive device called Essure have signed up to be part of a class action against pharmaceutical giant, Bayer.
Since then, the law firm Slater and Gordon has been contacted by more than 300 individuals seeking to join the class action, and at least 100 women have joined a Facebook group called Essure Problems Australia.
Chief executive of the consumer group Health Issues Centre, Danny Vadasz, said device regulation in Australia was so flawed at every step of the chain that another device scandal was inevitable.
"The real tragedy is that those failures almost guarantee that this will happen again with another device in another circumstance," he said.
Australia has faced a number of medical device scandals in recent years.
Many women have been left in chronic pain after being implanted with trans-vaginal mesh, which is used for incontinence and pelvic prolapse.
It was the subject of a Senate inquiry after thousands of women reported problems as a result of fundamental flaws in the products' design.
Prior to that, there were health scandals involving PIP and Cereform breast implants, DePuy hip implants, and faulty cardiac stents.
Each time it's been unclear how many devices were implanted across the country and who had what product.
In some cases, it has led to the creation of device-specific registries, but Mr Vadasz said it was clear a national registry for all implants was needed.
"The sad conclusion that we have to draw is that the variety of institutions that are in place to protect the general public are actually there to protect the institutions themselves and the people within the institution."
The Australian Medical Association (AMA) said the history of medical devices in Australia showed a "strong case" for more funding for the regulator, the Therapeutic Goods Administration (TGA).
"If they're not in a position … to look at the evidence and to make the correct decisions to protect the Australian public, then we need to give them those resources," the AMA's Michael Gannon said.
"We need to find that balance between not denying people access to often lifesaving treatments now and making sure that patient safety and clinical quality use is prioritised."
A spokeswoman for the TGA said its "top priority" was patient safety, and the Federal Government reviewed regulations for medical devices between 2014 and 2016.
"The TGA is implementing the recommendations that were supported by the Government," she said.
A spokesman for the Medical Technology Association of Australia (MTAA) said the Government's recent review was considered the most thorough ever done.
He added that while device registries could be helpful, they could also be expensive and the MTAA would instead welcome medical device data included in My Health Record — an online summary of healthcare information.
Whether it's breast or dental implants, plates, pins or cardiac stents, chances are you know somebody who has medical technology keeping them together.
For example, just over 28,000 stents were inserted into Australians in 2017-18, and about 4,800 Cereform breast implants were sold in Australia between 2009 and 2014.
A key issue for regulators is knowing exactly how many of each make and model are implanted — there's no central database of information.
Mustafa Jamnagarwala has two stents in his arteries after experiencing severe chest pain a year ago at age 36.
"I was rushed to my GP and the GP saw my heartbeat and it was resting 140 [beats per minute]," he explained.
Mr Jamnagarwala doesn't know what make or model his stents are, and wasn't given any paperwork about it.
Amy Maulder had breast implants three years ago but said she already regretted the decision because of ongoing questions over the safety with various brands and reports of leaking, and even cancers, associated with some products.
"I had thought about it for 10 years before I decided to get them [but] honestly I wish I had waited a couple more because with all the information that's coming out these days, it does make you think twice."'Ridiculously low' bar for approvals
Mr Vadasz described the process for getting a medical device approved as a "ridiculously low" bar that often relied on clinical trials conducted by manufacturers.
"Nobody can feel confident that a medical device has gone through a rigorous process … to the point where the public can feel safe and confident that they are not going to be facing adverse outcomes," he said.
He said an important issue was the role of the medical technology industry, which often provided technicians to assist in procedures and train doctors to use devices.
"You're dealing with sales and marketing people, you're not dealing with clinical professionals," he said.
In response, Dr Gannon said the AMA would like to see more transparency when it came to use of medical technology representatives in clinical settings but it was "the responsibility of doctors to manage that relationship in a professional way".
A TGA spokeswoman said makers were obligated to report problems with devices and failing to do so could lead to that product's approval being suspended or cancelled.
"TGA is continuing to work with medical practitioners and consumers in reporting of adverse events, including through workshops and information provided to consumer groups, healthcare and dental professionals," she said.
"Manufacturers are required [from December 2018] to provide patient information leaflets and implant cards with their devices.
"The leaflets are required to include information about symptoms to be aware of and where to report adverse events, including to the TGA."
When it came to the TGA, Mr Vadasz said while it did issue an alert on Essure, it was not proactive in informing the general public.
"We think that's indicative of the total lack of duty of care on the part of the TGA," he said.
A TGA spokeswoman said it published a hazard alert on its website and sent out an email, it also wrote to doctors who had implanted an Essure with extra information. This was in addition to the maker, which alerted hospitals that had bought the product.
http://www.abc.net.au/news/2018-08-21/health-advocates-warn-another-medical-device-scandal-inevitable/10143162
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested