Preview Newsletter
Ethicon Media Monitoring 2/22/2018
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Review ordered into epilepsy drug, vaginal mesh and Primodos
Feb 21, 2018 | BBC
By Nick Triggle
The government has ordered a review into how UK authorities responded to concerns over three major medical problems. -
PM orders review into Primodos, vaginal mesh and epilepsy drug sodium valproate
Feb 22, 2018 | Sky News
By Paul Kelso
The Prime Minister has ordered a review of public health scandals involving the pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate. -
Jeremy Hunt announces review of vaginal mesh scandal
Feb 21, 2018 | The Independent
By Alex Matthews-King
MPs said hormone-based pregnancy test Primodos should be given its own independent public inquiry because of signs of risks were ‘covered up’ and Department of Health’s responsibility -
Jeremy Hunt launches review into handling of vaginal mesh scandal
Feb 21, 2018 | The Guradian
By Amelia Hill
Jeremy Hunt, the health and social care secretary, has launched a nine-month review into how the NHS addresses concerns about medical treatments, including vaginal mesh devices. -
May proposes inquiry into reviews of medical fears
Feb 21, 2018 | The Times
By Chris Smyth
Theresa May has called for an inquiry into how reviews of medical problems listen to patients’ concerns. -
Sling the Mesh - the campaign begun by our reporter Kath Sansom - part of Government review ordered today by Prime Minister Theresa May
Feb 21, 2018 | Cambs Times
The Prime Minister has ordered a review into three women’s health disasters – including vaginal mesh implants – the campaign begun three years ago by Cambs Times journalist Kath Sansom. -
Theresa May orders a review into scandal-hit vaginal mesh implants, 'poisonous' epilepsy drugs and controversial pregnancy test Primodos
Feb 21, 2018 | The Daily Mail
By Stephen Matthews
The Prime Minister has today ordered a review into three public health scandals that have made headlines in recent months. -
PM orders review into pregnancy test drug Primodos, vaginal mesh and anti-epilepsy drug sodium valproate
Feb 21, 2018 | itv
By Paul Brand
Theresa May has ordered a review into how the NHS addresses patient concerns about the safety and side effects of treatments. -
Review launched into concerns over Primodos, sodium valproate and vaginal mesh
Feb 21, 2018 | Press Association (In The Evening Express)
A review has been launched into patient concerns about hormone pregnancy test drug Primodos, vaginal mesh and sodium valproate. -
Government announces review into concerns over pregnancy test Primodos which led to 'baby deaths, abortions and disfigured young people'
Feb 21, 2018 | The Mirror
By Nicola Bartlett
It will examine how the NHS addresses patient concerns about side effects of treatments including vaginal mesh and sodium valproate -
What is Primodos, sodium valproate and the vaginal mesh implant?
Feb 21, 2018 | itv
The government has launched a review into how the NHS addresses patient concernsabout the safety and side effects of treatments. -
Government announces review into vaginal mesh devices
Feb 21, 2018 | Medical Plastics News
By Reece Armstrong
A review into a number of medical products that have caused public scandals has been announced by the government. -
Theresa May orders review into Primodos, vaginal mesh and epilepsy drug sodium valproate
Feb 21, 2018 | iNews
By Benjamin Butterworth
Theresa May has ordered a review into how authorities responded to concerns over three major medical issues. -
Theresa May orders public inquiry into pregnancy test drug Primodos scandal
Feb 22, 2018 | The Daily Record
By Torcuil Crichton
The UK Government have ordered a review of scandals involving the pregnancy test drug Primodos and the use of vaginal mesh implants. -
Prime Minister’s announcement on mesh devices welcomed by Deeside MP Mark Tami
Feb 22, 2018 | Deeside.com
Theresa May’s announcement today that there will be a review into the use of controversial mesh devices has been welcomed by Alyn and Deeside MP Mark Tami. -
Boston Sci Employee Found Guilty in Criminal Case
Feb 22, 2018 | MDDI online
By Omar Ford
Boston Sci is looking at $1M in fines from Italian court in relation to one of its employees financing unauthorized clinical trials.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Review ordered into epilepsy drug, vaginal mesh and Primodos
Feb 21, 2018 | BBC
By Nick Triggle
The government has ordered a review into how UK authorities responded to concerns over three major medical problems.
Baroness Julia Cumberlege has been asked to look at the pregnancy test Primodos, vaginal mesh implants and epilepsy drug sodium valproate cases.
All three have been in the news in recent months with campaigners unhappy at the official response to each.
There could even be public inquiries if they are felt necessary.
The move was announced by Theresa May at Prime Minister's Questions.
Afterwards, Health Secretary Jeremy Hunt said: "We must acknowledge that the response to these issues from those in position of authority has not always been good enough.
"Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients."Epilepsy drug in fresh safety reviewHormone pregnancy test 'no link to harm'Case studies: Mesh led to 'excruciating pain'Hundreds suing NHS over vaginal implantsWhat's the issue with mesh implants?
The government has already agreed to carry out a full audit of how many women in England have suffered complications as a result of vaginal mesh implants, while a European review is examining whether warnings about risks to unborn babies from the mother's use of sodium valproate are strong enough.
And last year, after carrying out an inquiry, the Commission on Human Medicines said the evidence did not support a "causal link" between use of Primodos and birth defects and miscarriages.
This new review will not repeat the work done previously.
Instead, it will look at:The robustness and speed of the authorities' responsesWhether regulators did enough to engage those affected to ensure their concerns were escalated and acted uponWhether there needs to be an independent system - even a public inquiry - into any of the casesWhat are these cases about?
Primodos: The hormonal pregnancy test was used in Britain between 1953 and 1975. It worked by triggering a period if a woman was not pregnant.
Before that, pregnancy tests required complicated blood tests.
It is estimated that more than one million women used the drug to test for pregnancies.
Campaigners claim it caused birth defects in their children, such as blindness, deafness, spina bifida and heart and limb defects, as well as cleft palates.
Valproate: It is considered an effective treatment for epilepsy, bipolar disorders and migraine and has been used in the UK since the 1970s.
Instructions for doctors - and, more recently, patient leaflets - say it should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the risks.
Babies exposed to valproate medicines in the womb have a 10% chance of developing physical abnormalities and a 40% chance of developing cognitive problems, such as learning disabilities and autism.
Parents who have had babies born with disabilities say they were not sufficiently warned about the risks.
Vaginal mesh implants: These are used to hold up pelvic organs to treat incontinence and prolapse.
It is estimated more than 100,000 UK women have had a mesh fitted.
But there have been reports of the implants cutting into the vagina and women being left in permanent pain, unable to walk, work or have sex.
More than 800 women are taking legal action against the NHS and mesh manufacturers.
http://www.bbc.com/news/health-43143319
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PM orders review into Primodos, vaginal mesh and epilepsy drug sodium valproate
Feb 22, 2018 | Sky News
By Paul Kelso
The Prime Minister has ordered a review of public health scandals involving the pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.
Former Conservative health minister Baroness Cumberlege will lead an examination of the circumstances in all three cases and consider whether there are grounds for wider inquiries into the failings alleged by campaigners.
Sky News last year exposed a cover-up of the impacts of Primodos, a German drug prescribed as a pregnancy test that campaigners say was responsible for causing miscarriages and abnormalities including babies born with missing limbs, brain damage and heart defects.
Research by the manufacturers acknowledged there was a one-in-five chance of birth defects, but the evidence was concealed to frustrate claimants.
Sky News has also been reporting on the impact of vaginal mesh implants for more than two years, drawing attention to women left in acute pain by the procedure, used to treat incontinence and prolapse since the 1990s.
Thousands of women are suffering complications from a "quick-fix" routine operation to cure stress urinary incontinence.
Women have been left in chronic pain, some unable to walk, work or have sex.
The official complication rate set by the medical regulator the MHRA is 1-3%, but Sky News revealed how NHS data shows the figure to be almost 10%.
The mesh is made out of polypropylene plastic and designed to be permanent so removing it is a highly dangerous operation.
Last year the use of mesh was heavily restricted in Australia and banned in New Zealand, and the National Institute for Health and Care Excellence has recommended its use be suspended in the UK.
Sodium valproate is an anti-epilepsy drug that has also been linked to birth defects in cases where it was prescribed to expectant mothers without a warning as to the potential consequences.
Documents uncovered by Sky News from the National Archive last year revealed that the dangers to pregnant women were kept from patients for decades despite evidence it could harm foetuses.
In all three cases, campaigners believe the Government response has been inadequate and have called for full inquiries.
At Prime Minister's Questions, Theresa May said she had been affected by "powerful stories" from campaigners that had highlighted "an issue with our regulatory and healthcare system",
"We are determined to address it", said the PM.
Health Secretary Jeremy Hunt later admitted that patients had at times been let down:
"We must acknowledge that the response to these issues from those in positions of authority has not always been good enough," he told the Commons.
The Health Secretary ruled out a blanket ban on vaginal mesh and also said he had "every confidence" in Baroness Cumberlege to lead the review after some MPs questioned her appointment.
Kath Sansom, from campaign group Sling the Mesh, said she was "thrilled" the review had been ordered but added that "many women's and families' lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally".
https://news.sky.com/story/pm-orders-review-into-primodos-vaginal-mesh-and-epilepsy-drug-11260421
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Jeremy Hunt announces review of vaginal mesh scandal
Feb 21, 2018 | The Independent
By Alex Matthews-King
MPs said hormone-based pregnancy test Primodos should be given its own independent public inquiry because of signs of risks were ‘covered up’ and Department of Health’s responsibility
The Government has announced a review into public health scandals caused by failings in the regulation of vaginal mesh implants, anti-epilepsy drug sodium valproate and hormone-based pregnancy test Primodos.
Announcing the review at Prime Minister’s Questions, Theresa May said in light of the harms caused to patients “we need to do better” and that responses to concerns needed to be faster.
Health and Social Care Secretary Jeremy Hunt said the failure to listen to patients whose children were born with birth defects, or who had been left in chronic pain, had “added insult to injury”.
The failings in these cases were overlooked by successive governments, and only came to light because of organised campaign efforts by patients.
In the case of vaginal mesh implants, women were left “crippled” by pain, MPs said, after plastic mesh implants, used to prevent prolapse after pregnancy, warped or deteriorated, cutting into their vagina walls.
While the epilepsy medication sodium valproate and pregnancy test Primodos, used in the 1960s and 1970s, have been linked to serious birth defects and learning difficulties.
Mr Hunt said: “Many have endured and continue to endure severe complications and a tremendous amount of pain, distress and ill health, alongside the feeling that their complaints have not reached a satisfactory resolution.”
“We must acknowledge that the response to these issues from those in positions of authority has not always been good enough.
“Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, as a result patients and their families have felt too long like they have not been listened to, making the agony of a complex medical condition even worse.”
The Government has now asked former Conservative health minister Baroness Cumberlege to review the regulatory failings in these cases, and make recommendations on how the health service responds in future.
This will include a new system for monitoring the safety of medications used in pregnancy, and stricter training and reporting requirements for doctors and pharmacists where issues are raised.
Her recommendations could also include a statutory public inquiry where patients have been harmed in these cases, as called for by campaigners and Labour, but the Government has not made this mandatory.
MPs backing a public inquiry said it was not enough to address the scandal around the hormone-based pregnancy test Primodos as part of a wider review.
On several occasions they highlighted that the use of the test in the 1960s and 1970s had been clearly implicated in birth defects and evidence of its risks was “covered up” by NHS bodies and drug companies, and previous reports had been “whitewashed”.
Sir Mike Penning, Conservative MP for Hemel Hempstead, said “there will be huge disappointment” among Primodos victims about the lack of an independent public inquiry.
“The Department of Health is fully implicated in this because these drugs were given out by GPs in GP surgeries,” he added, warning this undermined Lady Cumberlege’s ability to make recommendations and have them carried out.
Mr Hunt said there was disagreement between scientists on the risks and response in the case of Primodos, and Lady Cumberlege would have an open remit to look at these issues.
He recognised that launching a statutory public inquiry would “have implications for compensation” payouts to patients in these cases, but said this decision should not be made based on the groups with the loudest voices.
The ongoing scandal around vaginal mesh implants, which recently had their recommendation for use by the NHS withdrawn by medicines watchdogs in light of insufficient evidence, has led to legal action by thousands of women worldwide.
While the Government had announced a review, today it made clear there will be £1.1m in funding to develop a database of mesh implants and complications they caused.
Chair of the all party parliamentary group on surgical mesh implants, Owen Smith, welcomed the review but said the use of implants should be stopped immediately.
“The news of a prospective registry is also hugely welcome, and is one of the key things we’ve been asking for,” he said.
“I’m pleased that the Government has listened and this registry, together with the recently announced retrospective audit currently being undertaken, will provide us with a better understanding of problems related to mesh.”
“It is a shame however that NICE is still unable or unwilling to bring forward its review into the safety and efficacy of mesh and that the Government will not suspend mesh until the reviews have been undertaken, as has happened in New Zealand.”
Lady Cumberlege said: “I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed.
“It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.”
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Jeremy Hunt launches review into handling of vaginal mesh scandal
Feb 21, 2018 | The Guradian
By Amelia Hill
Jeremy Hunt, the health and social care secretary, has launched a nine-month review into how the NHS addresses concerns about medical treatments, including vaginal mesh devices.
Speaking in the House of Commons, he admitted the government had failed to respond adequately to a series of public health scandals caused by the side-effects of medical treatments, citing the surgical mesh scandal as a key example.
The review will also look at the regulation of the hormone pregnancy test drug Primodos and the anti-epilepsy drug sodium valproate.
The review, led by the former Conservative health minister Baroness Cumberlege, will also consider whether there are grounds for wider inquiries into the failings alleged by campaigners.Guardian Today: the headlines, the analysis, the debate - sent direct to you
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Hunt admitted responses to the issues “have not always been good enough”. Pledging to come up with a quicker and more balanced system, he admitted that the stress and frustration felt by campaign groups on these issues had often “added insult to injury”.
“We must acknowledge that the response to these issues from those in positions of authority has not always been good enough,” he said.
“Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse,” he said.
In the past decade, more than 100,000 women have had vaginal mesh surgery to treat urinary incontinence, which is common after childbirth, according to NHSfigures. But there is disagreement about the scale of problems linked to the devices, with campaigners saying women have been exposed to unacceptable risks.
Most mesh devices were launched without clinical trials, meaning the complication rates were never established prospectively.
Official guidance has suggested the figure is 3-5%, but recent research has suggested the true complication rate could be between 10-15% and a Guardian investigation found that up to 1 in 15 women subsequently require partial or full removal of their implant.
Last month, a full retrospective audit of women who have undergone vaginal mesh surgery was launched by the government to establish how many have experienced complications following the procedure.
The Labour MP Owen Smith, who set up the all-party parliamentary group on surgical mesh implants that looked into the safety of mesh devices, welcomed the review but criticised the government for failing to suspend the use of mesh until after the review has concluded, as has happened in New Zealand.
The shadow health secretary, Jonathan Ashworth, agreed, saying the review “falls short of the calls for a full public inquiry that campaigners have been (demanding)”.
Kath Sansom, the founder of the campaign group Sling the Mesh, pointed out that women have had to fight for years to get their voices heard, “often being dismissed as mad, hysterical or a minority suffering”.
“So many women’s and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally,” she said. “We were human guinea pigs.”
https://www.theguardian.com/society/2018/feb/21/jeremy-hunt-launches-review-into-handling-of-surgical-mesh-scandal
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May proposes inquiry into reviews of medical fears
Feb 21, 2018 | The Times
By Chris Smyth
Theresa May has called for an inquiry into how reviews of medical problems listen to patients’ concerns.
The prime minister said that she wanted to see a “faster, more understanding response to patients” after criticism of how official reviews were conducted.
The investigation will look at whether independent inquiries, full public reports or other forms of review are the best way to respond to future considerations of side-effects from treatments.
It comes after campaigns involving three treatments used by the NHS. Primodos, a hormone pregnancy test used until 1978, and sodium valproate, an epilepsy medication, were both subject to claims of birth defects, while the use of vaginal mesh to treat incontinence and prolapse has led to painful side-effects.
In response to a question about Primodos, Mrs May told the Commons: “Concerns raised by campaign groups, not just about Primodos but some other issues like vaginal mesh and sodium valproate, I think have highlighted that there is an issue with our regulatory and healthcare system, and we are determined to address it.
“I was very struck by the stories, the powerful stories, I heard. We do need to see a faster, more understanding, response to patients when they raise concerns.”
An expert review last year concluded that there was not enough evidence to conclude that Primodos caused birth defects, while the European Medicines Agency is reviewing whether warnings about the use of sodium valproate in pregnancy were good enough. The government has also agreed to an audit into how many women have suffered complications as a result of vaginal mesh.
The latest inquiry will ask whether any further action is needed on the three treatments. It will also look at whether regulators’ response to concerns was good enough and how well they communicated with patients.
Jeremy Hunt, the health secretary, said: “We must acknowledge that the response to these issues from those in positions of authority has not always been good enough. Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse.
“From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many. I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”
Baroness Cumberlege, who will lead the review, said: “It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.”
Campaign groups have given a mixed reaction to the latest review. A spokeswoman for Sling the Mesh said that patients had been used as “human guinea pigs” and dismissed as mad or hysterical. “We are delighted that at last a review is to be carried out but also deeply saddened that so many women’s and families’ lives have been shattered,” she said. “These are three huge women’s health disasters.”
Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, had reservations, however. She said: “We are disappointed that the three campaigns are being reviewed together. We are not prepared to support this proposal without consultation and agreed terms of reference.”
Martyn Day, an SNP MP, said those affected will be “somewhat sceptical that the government may have today just announced a review of reviews”. He added: “Everyone needs the confidence that this won’t turn into simply a government whitewash.”
https://www.thetimes.co.uk/article/may-proposes-inquiry-into-patients-medical-fears-qszj822w6
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Feb 21, 2018 | Cambs Times
The Prime Minister has ordered a review into three women’s health disasters – including vaginal mesh implants – the campaign begun three years ago by Cambs Times journalist Kath Sansom.
Ms Sansom was glued to the internet at Prime Minister’s Question Time today after being alerted to the likely of an imminent and major announcement by Theresa May.
The PM didn’t fail her.
Mrs May said she was ordering a review not only into vaginal mesh – and what has gone horribly wrong- but the review would also consider the pregnancy drug Priomodos and Valproate.
Her statement comes amid an admission that the regulation system has failed patients.
Ms Sansom has been a persistent opponent of Government inaction on mesh – her Facebook group has grown to more than 5,600 members and she has been a frequent lobbyist at the House of Commons and House of Lords whenever the issue has been raised.
Only two weeks ago around 50 members of the group, led by Ms Sansom, travelled from across Britain to join a protest outside the House of Lords.
They called on the Government to hear their voice with a slogan: ‘100 years of votes for women, now hear our voice, Sling the Mesh’.
Today’s announcement marks a significant development in the ‘Sling the Mesh’ campaign but Ms Sansom believes the fight will, and must, continue.
“Mesh implants can shrink, twist and degrade slicing into internal tissues and organs, causing agonising pain,” she said.
Of the other issues forming part of the Government review, she said Primodos was given to 1.5 million pregnant women from the 1950s and was withdrawn form the market in 1978. It caused birth defects.
Valproate was given for epilepsy or for women suffering bi-polar disorder. Campaigners say 20,000 children now suffer disabilities which can then be passed on in the next generation.”
Grouping together the common theme of the suffering caused to so many people, the Prime Minister said “There are very powerful stories. There’s an issue with our regulation in the health care system.
“We need to do better. I was very struck by the stories I have heard.”
Shortly after PMQs, Health and Social Care Secretary Jeremy Hunt admitted: “There are three areas of potential medical error.”
“Serious concerns have been raised by patients and their families about vaginal mesh linked to crippling and ongoing pain.
“I pay tribute particularly to campaigners for their resolute determination to campaign on behalf of others.”
He said that patients and families “have spent too long not being listened to”.
Mr Hunt said that the stress and frustration felt by campaign groups on these issues had often “added insult to injury” as he pledged to come up with a quicker and more balanced system.
“We must acknowledge that the response to these issues from those in positions of authority has not always been good enough,” he said.
“Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse.”
The Health Secretary said that Conservative peer Baroness Cumberlege would lead the review.
He also announced a number of measures in relation to Primodos, sodium valproate and vaginal mesh, though ruled out a blanket ban on vaginal mesh specifically
Ms Sansom’s campaign group later released a statement thanking the Prime Minister for her intervention, pointing out that “every woman who has had a mesh implant is a ticking time bomb.
“Mesh implants can shrink or twist years later, slicing into internal tissues, nerves and organs. So if a woman has had a good outcome now there is no guarantee she will be good for her lifetime.
“We are delighted that at last a review is to be carried out but also deeply saddened that so many women’s and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally.
“We were the human guinea pigs. These are three huge women’s health disasters. The people who benefited most were the share holders and big CEOs.
“It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering.
“Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence.
“Every woman affected by Primodos, Valproate or mesh implants has suffered personal tragedies that can never be compensated for.”
Baroness Julia Cumberlege will lead to the review, announced by Mrs May.
She said: ‘I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed.
‘It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.’
MP Emma Hardy called for more support for victims, she asked for the Government to look into the way devices get on to the market and added it is not just about surgeon training.
She said: “It’s the product itself that is faulty.”
MP for NE Cambs Steve Barclay, also a health minister, said: “There was an important step forward in the campaign to address the concerns of patients who have suffered from vaginal mesh implants, with a statement today in the House of Commons from the Secretary of State for Health.
“It is welcome that these issues are now receiving such national attention and being subject to detailed review. I will continue to flag the concerns of patients specifically within the Department of Health.”
http://www.cambstimes.co.uk/news/government-announce-review-into-mesh-implants-primodos-and-valproate-1-5403628
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Feb 21, 2018 | The Daily Mail
By Stephen Matthews
· Thousands of furious victims have been affected by the 3 controversial issues
· Baroness Julia Cumberlege will lead the review, announced by Mrs May today
· The review will look into how the authorities responded to any concerns raised
· Public inquiries into each issue could be undertaken, if the Government sees fit
The Prime Minister has today ordered a review into three public health scandals that have made headlines in recent months.
Theresa May announced the Government will look into vaginal mesh implants, epilepsy drug sodium valproate and pregnancy test Primodos.
Thousands of furious victims have been affected by the controversial issues, which have left women on the brink of suicide and caused serious birth defects.
Baroness Julia Cumberlege will lead the review, which was announced by Mrs May during Prime Minister's Questions this morning.
Mrs May told MPs that she wanted to see a 'faster, more understanding response to patients when they raise concerns'.
While Health and Social Care Secretary Jeremy Hunt has admitted the reaction to the scandals has 'not always been good enough'.
The review will delve into how the authorities responded to concerns raised by those affected and establish whether fears were raised upon.
Public inquiries into each of the three issues - which MailOnline has repeatedly raised awareness of - could be undertaken, if the Government sees fit.
Campaigners have announced their 'delight' over the news, which has come after years of relentless fights for justice and 'often being dismissed as mad'.
Mrs May was asked about Primodos specifically by Tory former minister Sir Mike Penning, who has campaigned on the issue.
The Prime Minister replied: 'I recognise that there are many individuals whose lives have been affected by this. There are very powerful stories of these individuals.
'I know this has been of concern across the whole of this House and the concerns raised by campaign groups, not just about Primodos but some other issues like vaginal mesh and sodium valproate, I think have highlighted that there is an issue with our regulatory and healthcare system, and we are determined to address it.
'I've been clear that we need to do better. I was very struck by the stories, the powerful stories I heard.
'We do need to see a faster, more understanding response to patients when they raise concerns.
'If [Sir Mike] can be a little patient, [Health Secretary Jeremy Hunt] will be making a statement this afternoon setting out his plans to the House for a review on these issues.'
Mr Hunt said: 'Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of three products used by the NHS.
'The response they have received from those in positions of authority has not always been good enough.
'From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many.
'I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.'
Mr Hunt also announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.
Baroness Cumberlege said: 'I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed.
'It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.'
Commenting on the news, chair of the All Party Parliamentary Group on Surgical Mesh Implants, MP Owen Smith said he was 'delighted'.
'Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future.
'The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary.
'Mesh devices should be seen against that history of medicalisation and miss-selling and should be subject to the most stringent clinical trials before being deployed in surgery.'
Kath Sansom, founder of Sling The Mesh, a campaign group calling for a ban on mesh, said: 'We are delighted that at last a review is to be carried out but also deeply saddened that so many women's and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally.
'We were the human guinea pigs. These are three huge women's health disasters.
'The people who benefited most were the share holders and big CEOs. It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering.
'Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence.
'Every woman affected by Primodos, valproate or mesh implants have suffered personal tragedies that can never be compensated for.'
But Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said: 'We are disappointed that the three campaigns are being reviewed together.
'We are not prepared to support this proposal without consultation and agreed terms of reference.'
http://www.dailymail.co.uk/health/article-5417545/PM-orders-review-three-controversial-issues.html
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Feb 21, 2018 | itv
By Paul Brand
Theresa May has ordered a review into how the NHS addresses patient concerns about the safety and side effects of treatments.
In particular, it will look into concerns raised about potentially harmful effects of the hormone pregnancy test drug Primodos, vaginal mesh and anti-epilepsy drug sodium valproate.
Mrs May told MPs at Prime Minister's Questions she wanted to see a "faster, more understanding response to patients when they raise concerns".
The review will be led by Baroness Julia Cumberlege and will also consider whether any further action is required, including whether a full investigation or an inquiry is necessary.
In a Commons statement, Health and Social Care Secretary Jeremy Hunt said responses to the issues raised "have not always been good enough".
What are the main issues that have raised safety concerns?
It has been claimed the hormone-based pregnancy test Primodos led to miscarriages and birth defects during the 1960s and 1970s.
Mr Hunt told the Commons it was prescribed to more than 1.5 million women before being withdrawn from use in 1978.
Anti-epilepsy drug sodium valproate, has been "definitively linked to autism and learning disabilities in children when taken during pregnancy," Mr Hunt said.
Vaginal mesh implants, often used to address complications after childbirth, have also been linked to "crippling and life-changing side-effects," he added.
Mr Hunt said that the stress and frustration felt by campaign groups in relation to the issues raised had often "added insult to injury".
He also pledged to come up with a quicker and more balanced system.
"We must acknowledge that the response to these issues from those in positions of authority has not always been good enough," he said.
Mr Hunt said the review will also consider the processes followed by the NHS and regulatory bodies after patients report their concerns - including how they communicate with patients.
"Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of three products used by the NHS - the response they have received from those in positions of authority has not always been good enough," Mr Hunt said.
"From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many."
Mr Hunt also announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.
Shadow health secretary Jonathan Ashworth said Labour's 2017 manifesto called for an inquiry into medical devices and product licensing and regulation.
He said: "We do offer this review our support, though we note it falls short of the calls for a full public inquiry that campaigners have been (demanding)."
Mr Ashworth also said women and children affected deserved full compensation and support, and asked if the Government would establish a compensation fund.
"Isn't it time they were given a full apology, surely it's the very least they deserve?" he added.
What has been the reaction to the review?
A spokeswoman for the campaign group Sling the Mesh said: "We are delighted that at last a review is to be carried out but also deeply saddened that so many women's and families' lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally.
"These are three huge women's health disasters."
Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said: "We are disappointed that the three campaigns are being reviewed together.
"We are not prepared to support this proposal without consultation and agreed terms of reference."
Clare Pelham, chief executive of the Epilepsy Society, said it was "delighted" a review was now taking place and new measures introduced.
"Over 28000 women with epilepsy take this drug every day and these measures (when implemented) should dramatically reduce the number of babies born with avoidable disabilities.
"Our hearts go out to all the mothers since 1974 who have taken sodium valproate during their pregnancy in ignorance of the risk to their unborn baby. It is a tragedy for any baby to be born with an avoidable disability."
http://www.itv.com/news/2018-02-21/pm-orders-review-into-pregnancy-test-drug-primodos-vaginal-mesh-implant-and-anti-epilepsy-drug-sodium-valproate/
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Review launched into concerns over Primodos, sodium valproate and vaginal mesh
Feb 21, 2018 | Press Association (In The Evening Express)
A review has been launched into patient concerns about hormone pregnancy test drug Primodos, vaginal mesh and sodium valproate.
Health and Social Care Secretary Jeremy Hunt announced that Baroness Julia Cumberlege will lead a review into how the NHS responds to safety concerns raised by patients about medicines or medical devices.
In particular it will look into concerns raised about the three health issues.
It will also consider whether any further action is required, including whether a full investigation or a public inquiry is necessary.
Mr Hunt said the response to the issues “has not always been good enough”.
And during Prime Minister’s Questions, Theresa May said: “Concerns raised by campaign groups – not just about Primodos but some other issues like vaginal mesh and sodium valproate – have highlighted that there is an issue with our regulatory and healthcare system and we are determined to address it.
“I have been clear that we need to do better.
“We do need to see a faster, more understanding response to patients when they raise concerns.”
Mr Hunt said the review will also consider the processes followed by the NHS and regulatory bodies after patients report their concerns – including how they communicate with patients.
He also announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.
“Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of three products used by the NHS – the response they have received from those in positions of authority has not always been good enough,” Mr Hunt said.
“From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many. I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”
A spokeswoman for the campaign group Sling the Mesh said: “We are delighted that at last a review is to be carried out but also deeply saddened that so many women’s and families’ lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally.
“We were the human guinea pigs.
“These are three huge women’s health disasters.
“It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering. Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence.”
But Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said: “We are disappointed that the three campaigns are being reviewed together.
“We are not prepared to support this proposal without consultation and agreed terms of reference.”
Clare Pelham, chief executive at Epilepsy Society, said: “Our hearts go out to all the mothers since 1974 who have taken sodium valproate during their pregnancy in ignorance of the risk to their unborn baby. It is a tragedy for any baby to be born with an avoidable disability.
“We are therefore impressed that the Government has decided to set up a review led by Baroness Cumberlege and to learn lessons. And pleased with Jeremy Hunt’s commitment that the Baroness will be reporting to ministers not to the MHRA (Medicines and Healthcare products Regulatory Agency).”
Epilepsy Action deputy chief executive Simon Wigglesworth added: “Today’s announcement marks a major breakthrough for the thousands of women with epilepsy who’ve campaigned for change around sodium valproate.
“Their lives have been irreparably damaged by the risks involving this drug and it’s only right these families get the justice they deserve.”
https://www.eveningexpress.co.uk/news/uk/review-launched-into-concerns-over-primodos-sodium-valproate-and-vaginal-mesh/
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Feb 21, 2018 | The Mirror
By Nicola Bartlett
It will examine how the NHS addresses patient concerns about side effects of treatments including vaginal mesh and sodium valproate
The Government have announced a review into how the NHS addresses patient concerns about side effects of treatments after a high profile campaign over hormonal pregnancy test Primodos.
Theresa May told MPs at Prime Minister's Questions that she wanted to see a "faster, more understanding response to patients when they raise concerns".
Health and Social Care Secretary Jeremy Hunt announced that Baroness Julia Cumberlege will lead a review how the NHS responds to concerns raised by patients about medicines or medical devices.
In particular, it will look into concerns raised about the hormone pregnancy test drug Primodos, vaginal mesh and sodium valproate.
It will also consider whether any further action is required into the issues, including whether a full investigation or an inquiry is necessary.
Mr Hunt said the response to the issues "have not always been good enough".
Today Sir Mike Penning, who has campaigned for justice for the Primodos vicitms, asked the prime minister if progress has been made on the issue.
He told the House of Commons: "These people went to their GPs in good faith and were given a drug which has ended up with loss of life of their baby, abortions and disfigured young people being born."
The Prime Minister replied: "I recognise that there are many individuals whose lives have been affected by this. There are very powerful stories of these individuals.
"I know this has been of concern across the whole of this House and the concerns raised by campaign groups, not just about Primodos but some other issues like vaginal mesh and sodium valproate, I think have highlighted that there is an issue with our regulatory and healthcare system, and we are determined to address it.
"I've been clear that we need to do better. I was very struck by the stories, the powerful stories I heard.
"We do need to see a faster, more understanding response to patients when they raise concerns."
Following PMQs , the health and social care secretary announced the review in a statement to the House of Commons.
Mr Hunt said that the stress and frustration felt by campaign groups on these issues had often "added insult to injury" as he pledged to come up with a quicker and more balanced system.
"We must acknowledge that the response to these issues from those in positions of authority has not always been good enough," he said.
"Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse."
The Health Secretary said that Conservative peer Baroness Cumberlege would lead the review.
He also announced a number of measures in relation to Primodos, sodium valproate and vaginal mesh, though ruled out a blanket ban on vaginal mesh specifically.
https://www.mirror.co.uk/news/politics/government-announces-review-pregnancy-test-12064254
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What is Primodos, sodium valproate and the vaginal mesh implant?
Feb 21, 2018 | itv
The government has launched a review into how the NHS addresses patient concernsabout the safety and side effects of treatments.
In particular, it will look into concerns raised about the hormone pregnancy test drug Primodos, vaginal mesh and anti-epilepsy drug sodium valproate.
It will also consider whether any further action is required into the issues, including whether a full investigation or an inquiry is necessary.Primodos
What is Primodos? Primodos is a Hormonal Pregnancy Test that first became available in the UK in 1959. Around 1.5 million women in Britain were given the drug during the early stages of pregnancy.
How does it work? The pill contains a synthetic version of two hormones, progesterone and estrogen. It works by triggering menstruation when there is no pregnancy.
Why is Primodos controversial?
It was withdrawn from the the market in 1978 for "commercial reasons". Families say the drug is responsible for causing birth defects including missing limbs, brain damage and miscarriages.
A campaign group, the ‘Association for Children Damaged by Hormone Pregnancy Tests’, took the manufacturer of Primodos, Schering (now Bayer), to court in the 1970s.
However, the casual link between the drug and birth abnormalities has always been an uncertain factor. A review by the Commission on Human Medicines found there was no "casual link" between Primodos and the birth defects, meaning the drug is not the cause of birth defects and that the association between the two could be linked to other factors.
A new report published earlier this month in Scientific Reports, Nature, highlighted fresh evidence proving that the drug is linked to "developmental abnormalities". The study, lead by Aberdeen University scientist, Neil Vargesson, was done using zebrafish embryos.
"Further work in mammalian model species are now required to build on these findings and determine if placental embryos also are affected by synthetic sex hormones," Vargesson and team stated in the study.Sodium valproate
What is sodium valproate?
Sodium valproate is used to treat epilepsy alongside acting as a mood stabiliser for bipolar disorder.
How does it work? It is thought to prevent epileptic fits by calming excessive electrical activity in the brain.
Why is it controversial? Birth defects caused by the drug could pass down generations. Scientists proved this in an experiment on mice where behavioural changes in the first generation were seen in the third generation of mice who had not been exposed to the drug in the womb.
What is the current advice?
Sodium valporate is listed on the NHS website as an anti-epilepsy drug, directing users to seek the advice of their doctor before taking it as it can "harm an unborn baby."
Vaginal mesh
What is the vaginal mesh?
It is an implant used to treat incontinence and pelvic organ prolapse, which affects up to half of women who have had children. This can result in urine leaking when they cough or sneeze.
How does it work?
The mesh is inserted surgically through an incision in either the vagina or the abdomen wall in the hopes that it will support weakened organs and repair damaged tissue.
Why is it controversial? More than 800 women took legal action against the NHS last year deeming the mesh as "barbaric treatment." One in 15 women who had the implants needed surgery to remove the mesh following traumatic complications.
What is the current advice? The mesh should only be used in research circumstances according to guidelines from The National Institute for Health and Care Excellence.
https://www.itv.com/news/2018-02-21/what-is-primodos-and-sodium-valproate/
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Government announces review into vaginal mesh devices
Feb 21, 2018 | Medical Plastics News
By Reece Armstrong
A review into a number of medical products that have caused public scandals has been announced by the government.
Speaking during prime minister’s questions, Theresa May stated that a review into health scandals including primodos, vaginal mesh and sodium valproate would be undertaken.
When asked about the situation by Conservative MP Mike Penning, the prime minister responded saying: “The concerns raised by campaign groups about not just primodos, but issues such as vaginal mesh and sodium valproate, have highlighted that there is an issue with our regulatory and healthcare system, and we are determined to address it. I have been clear that we need to do better. I was very struck by the powerful stories I heard. We need to see a faster, more understanding response when patients raise concerns.”
Health and social care secretary, Jeremy Hunt, announced shortly after prime minister’s questions that a review would be undertaken by Conservative peer Julia Cumberlege.
In his statement, Hunt said: “The response they have received from those in positions of authority has not always been good enough. From primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many."
In relation to vaginal mesh products, Hunt stated that the products had been linked to “crippling, life-changing side-effects”.
“We must acknowledge that the response to these issues, in those in positions of authority, has not always been good enough.” Hunt stated.
The review will take nine months and will examine the safety of the medical devices mentioned during Jeremy Hunt’s statement.
Hunt mentioned that a full ban of vaginal mesh products was not an option as “clinical experts here and abroad agree that when used appropriately, many women gain benefits from this intervention”.
He went on to announce that an audit will be produced investigating the links between patient data and outcomes and that £1.1 million will fund a vaginal mesh database to help improve clinical practice and identify issues.
In response to the announcement, founder of vaginal mesh campaign group, Sling the Mesh, Kath Sansom, said: “If a woman has had a good outcome it is only “for now”. Any woman who has had mesh is a ticking time bomb as the product can shrink or twist years down the line. No amount of surgeon training can counteract that.
“It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering. Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence. Every woman affected by primodos, valproate or mesh implants have suffered personal tragedies that can never be compensated for.”
“We are delighted that the government has announced a review into Mesh, primodos and valproate. but also deeply saddened that so many women’s and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally. We were the human guinea pigs. These are three huge women’s health disasters. The people who benefited most were the share holders and big CEOs.”
Commenting on the news, Chair of the APPG on Surgical Mesh Implants, Owen Smith said: “I am delighted that the government has listened to our concerns about the safety of mesh devices and has agreed to conduct this review. Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future.
“The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary. Mesh devices should be seen against that history of medicalisation and miss-selling and should be subject to the most stringent clinical trials before being deployed in surgery.
“The news of a prospective registry is also hugely welcome, and is one of the key things we’ve been asking for. I’m pleased that the government has listened and this registry, together with the recently announced retrospective audit currently being undertaken, will provide us with a better understanding of problems related to mesh.”
“It is a shame however that NICE is still unable or unwilling to bring forward its review into the safety and efficacy of Mesh and that the government will not suspend mesh until the reviews have been undertaken, as has happened in New Zealand.”
https://www.medicalplasticsnews.com/news/government-annoucnes/
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Theresa May orders review into Primodos, vaginal mesh and epilepsy drug sodium valproate
Feb 21, 2018 | iNews
By Benjamin Butterworth
Theresa May has ordered a review into how authorities responded to concerns over three major medical issues.
Former Conservative health minister Baroness Julia Cumberlege has been asked to look at the vaginal mesh implants, pregnancy test Primodos and epilepsy drug sodium valproate cases.
All have been reported to have serious side effects for users and campaigners have long called for official inquiries.
Mrs May announced that a formal review is to be carried out into all three issues at PMQs.
Health Secretary Jeremy Hunt said: “We must acknowledge that the response to these issues from those in position of authority has not always been good enough.
“Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients.”Vaginal mesh
Thousands of women have said vaginal mesh left them in chronic pain and unable to lead their normal lives.
It is estimated more than 100,000 women have had the implants, which are used to hold up pelvic organs to treat incontinence and prolapse.
A full government review is set to identify the extent of the problems caused, with most women thought to have no serious issues following the procedure.
Concern over the treatment was raised in recent years, with more than 800 women currently suing the NHS.
The National Institute for Health and Clinical Excellence has already said that the practice should effectively be banned.
New Zealand became the first country in the world to completely ban the mesh in December 2017.
New Zealand’s medical body Medsafe said: “As a consequence of the Australian TGA review of surgical mesh for urogynaecological use, and subsequent regulatory action, there is a case for Medsafe to question the safety of certain devices.”
Australia became the first country to take action when it restricted the use of mesh in prolapse surgery in November.Primodos
Hormonal pregnancy test Primodos was used in Britain between 1953 and 1975, and worked by triggering a period if a woman was not pregnant.
Campaigners claim it caused birth defects in children – such as blindness, deafness, spina bifida and heart and limb defects, cleft palates and even that it was responsible for miscarriages.
More than one million women are estimated to have used the German drug.
Manufacturers’ research acknowledged that there was a one-in-five chance of birth defects, according to Sky News.Valproate
The drug was used as treatment for epilepsy, bipolar disorders and migraine and has been used in the UK since the 1970s.
Recently, advice has urged people to not use the drug during pregnancy, unless there is no safer alternative available.
Babies exposed to valproate medicines in the womb are said to have a 10 per cent chance of developing physical abnormalities and a 40 per cent chance of developing cognitive problems, such as learning disabilities and autism.
Parents and campaigners say they were not properly made aware of the risks.
https://inews.co.uk/news/health/theresa-may-orders-review-primodos-vaginal-mesh-epilepsy-drug-sodium-valproate/
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Theresa May orders public inquiry into pregnancy test drug Primodos scandal
Feb 22, 2018 | The Daily Record
By Torcuil Crichton
Health Secretary Jeremy Hunt said the government has not done enough.
The UK Government have ordered a review of scandals involving the pregnancy test drug Primodos and the use of vaginal mesh implants.
The move comes as a major victory for campaigners and the Daily Record.
We exposed a cover-up of the impact of German-made Primodos, which caused miscarriages and birth abnormalities.
Our sister paper the Sunday Mail campaigned on vaginal mesh implants which left women treated for incontinence and prolapse in acute pain.
Theresa May said a review of the two scandals and the use of the anti-epilepsy drug sodium valproate will be led by former Tory health minister Baroness Cumberlege.
The UK Government also said they would consider whether there are grounds for wider public inquiries into the failings.
And Health Secretary Jeremy Hunt admitted that the Government’s response to the health scandals “has not always been good enough”.
Campaigners welcomed the move but were disappointed the three matters were being reviewed together.
May told the Commons: “Concerns raised by campaign groups – not just about Primodos but some other issues like vaginal mesh and sodium valproate – have highlighted that there is an issue with our regulatory and healthcare system and we are determined to address it.
“I have been clear that we need to do better. We need to see a faster, more understanding response to patients when they raise concerns.”
Hunt said the review will also consider the processes followed by the NHS and regulatory bodies after patients report their concerns.
He added: “Families have had to spend too much time and energy campaigning for answers in a way that added insult to injury for many.
“I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”
A spokeswoman for campaign group Sling the Mesh said: “We are delighted that at last a review is to be carried out but also saddened that so many women’s and families’ lives have been shattered.”
Marie Lyon, of the Association for Children Damaged by Hormone Pregnancy Tests, said: “We are disappointed the three campaigns are being reviewed together.”
https://www.dailyrecord.co.uk/news/politics/theresa-orders-public-inquiry-primodos-12067454
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Prime Minister’s announcement on mesh devices welcomed by Deeside MP Mark Tami
Feb 22, 2018 | Deeside.com
Theresa May’s announcement today that there will be a review into the use of controversial mesh devices has been welcomed by Alyn and Deeside MP Mark Tami.Mr Tami and the late Alyn and Deeside AM Carl Sargeant campaigned on behalf of an affected constituent Maxine Cooper to suspend the use of mesh.
Mesh operations are supposed to fix prolapse and incontinence however women who have had them have reported long-term devastating side effects.
The Deeside MP called the use of mesh a “national scandal” at a Westminster debate last October.
Campaigners have long called for a public inquiry into the use of mesh after it was revealed that more than 800 women are taking legal action against the NHS and the makers of vaginal mesh implants.
Mark Tami welcomed the commitment, especially as the Government had previously responded by saying the problem lies not with the product, but with the procedure, and failed to commit to a public inquiry or suspension of the product.
Mark Tami said; “This is a bitter sweet moment for me because it is fantastic that the Prime Minister is finally recognising the need for change, however it is bitter in the fact that it took so long for these women to be heard.
These women must be listened to during the review so we can learn from what they have been through and proper processes must be put in place to stop this happening in the future.
The pockets of shareholders and CEOs of medical device companies have been lined for long enough and it is good to see the Government finally putting patients before profits.
It is a shame that the the product will not be suspended until the reviews have been undertaken, however this is certainly a step in the right direction and is a credit to the hard work put in by campaigners.”
http://www.deeside.com/prime-ministers-announcement-on-mesh-devices-welcomed-by-deeside-mp-mark-tami/
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Boston Sci Employee Found Guilty in Criminal Case
Feb 22, 2018 | MDDI online
By Omar Ford
Boston Sci is looking at $1M in fines from Italian court in relation to one of its employees financing unauthorized clinical trials.
Boston Scientific faces $1 million in fines after an Italian court found one of its employees guilty in a criminal case, according to an SEC filing.
On Feb. 23, 2015, the judge for the Court of Modena (Italy) ordered a trial for the Marlborough, MA-based company and three of its employees as well as numerous other defendants charged in criminal proceedings.
Those charges arise from allegations that the defendants made improper donations to certain healthcare providers and other employees of the Hospital of Modena in order to induce them to conduct unauthorized clinical trials, as well as related government fraud in relation to the financing of such clinical trials, the company said.
In its regulatory filing, Boston Scientific said on Dec. 1, 2015, the Brazilian governmental entity known as the Administrative Council of Economic Defense (CADE) served a search warrant for the offices of its Brazilian subsidiary, as well as on the Brazilian offices of several other major medical device makers, in furtherance of an investigation into alleged anti-competitive activity with respect to certain tender offers for government contracts.
The company went on to say that on June 20, 2017, CADE, through the publication of a “technical note,” announced that it was launching a formal administrative proceeding against Boston Scientific’s Brazilian subsidiary, Boston Scientific do Brazil Ltda.
In its filing, Boston Scientific said it would "continue to deny these allegations" and "defend itself vigorously."
Litigation and lawsuits can be commonplace for large medtech companies, and Boston Scientific has certainly had its share throughout the years.
The firm is currently involved in litigation with Redwood City, CA-based Nevro, a neurostimulation specialist. In the lawsuit, Nevro alleges patent infringement related to its Senza and HF10 spinal cord stimulation systems.
Boston Scientific spent most of 2016 duking it out with Edwards Lifesciences over two patents related to transcatheter aortic valve replacement (TAVR) technologies.
The lawsuit was specifically over Edwards's Sapien 3 TAVR, introduced in the United States in 2015. The suit, filed in California, was aimed at a handful of Edwards's catheter delivery systems and a crimping tool used with the Sapien 3.
In 2015, Boston Scientific paid $600 million to Johnson & Johnson to settle the lawsuit the latter brought against the Massachusetts company over its purchase of Guidant in 2006.
J&J alleged that Guidant had breached the merger agreement it had when Boston Scientific became another bidder.
The lawsuit charged that Guidant allowed Abbott to conduct due diligence on a business unit that Abbott would buy to help Boston Scientific resolve any potential antitrust issues in its purchase of Guidant.
Perhaps the most significant lawsuits Boston Scientific faced came from women injured by the company’s Pinnacle and Advantage Fit vaginal mesh products. In 2014, Boston Scientific spent $1.036 billion in lawsuit expenses, of which $485 million was held in qualified settlement funds for mesh product liability settlement.
During that time, Boston Scientific was near the top of the medical device industry as far as legal bills were concerned.
https://www.mddionline.com/boston-sci-employee-found-guilty-criminal-case
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