Preview Newsletter
Ethicon Media Monitoring 4/18/2018
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Scale of vaginal mesh problem confirmed by NHS review
Apr 17, 2018 | The Guardian
By Hannah Devlin
Hundreds of women are undergoing surgery each year to have vaginal mesh implants removed, an NHS review has found. -
Vaginal mesh scandal: More than a third of women need trauma treatment
Apr 17, 2018 | Sky News
By Charlotte Lomas
More than a third of women who have been fitted with vaginal mesh in the last decade have returned after surgery to be treated for trauma, an audit has revealed. -
Vaginal mesh surgery: NHS releases new figures
Apr 17, 2018 | BBC News
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Hundreds of women each year need vaginal mesh implants removed, NHS audit finds
Apr 17, 2018 | The Independent
By Alex Matthews-King
Hundreds of women annually are having procedures to remove vaginal mesh implants intended to be permanent but which are linked to serious complications. -
Third Of Women With Vaginal Mesh Seek Urgent Help Due To 'Incredible Pain'
Apr 17, 2018 | HuffPost UK
By Kathryn Snowdon
More than a third of women who have undergone vaginal mesh surgery have sought urgent care in trauma units due to the subsequent pain they experience, the latest figures reveal. -
One in two women given pelvic mesh implants need treatment at hospital for complications, says Government audit
Apr 17, 2018 | Cambs Times
By Kath Sansom
As many as half of women given pelvic mesh implants have to seek further treatment for complications, according to a Government audit out today. -
Thousands of women HAVE suffered unbearable pain because of their controversial vaginal mesh implants, confirms review - but campaigners warn it 'doesn't show the true scale of the disaster'
Apr 17, 2018 | Daily Mail
By Stephen Matthews
Thousands of women have been forced to suffer unbearable pain because of their controversial vaginal mesh implants, an audit today confirmed. -
US regulators float ideas for boosting medical device safety
Apr 17, 2018 | Associate Press
By Matthew Perone
U.S. health officials on Tuesday proposed steps to improve the government's system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments. -
Doctored: mesh surgeon Richard Reid admits to writing fake patient notes
Apr 18, 2018 | Newcastle Herald
By Joanne McCarthy
PELVIC mesh surgeon and former Newcastle University associate professor Richard Reid was a man whose “first instinct was to lie to protect himself”, a tribunal was told after evidence he prepared false patient notes after a woman initiated legal action following mesh surgery. -
ConTIPI Medical develops tampon-like medical devices
Apr 17, 2018 | Globes
By Gali Weinreb
The company's first product treated incontinence while its latest insert is for pelvic prolapse.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Scale of vaginal mesh problem confirmed by NHS review
Apr 17, 2018 | The Guardian
By Hannah Devlin
Hundreds of women are undergoing surgery each year to have vaginal mesh implants removed, an NHS review has found.
The investigation by NHS Digital came after the Guardian revealed last year that the number was far higher than official figures for complication rates suggested.
The latest report shows that in each year since 2008, surgeons have performed at least 500 removal operations in England for implants that have been used to treat common complications of childbirth and pregnancy.
Over the past decade, there were 5,374 mesh removal operations in women who had initially been treated for stress urinary incontinence. Over the same period, 101,538 patients had been implanted with mesh devices to treat this problem.
NHS Digital was tasked with collating figures on to help the health service create a “clearer” national picture of the rates of complications linked to the devices.
Carl Heneghan, a professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, said the report highlighted the urgent need for proper registries on medical devices that would establish complication rates and safety far more rapidly.
Most vaginal mesh implants used in the NHS were launched without clinical trials. “Twenty years after the first device was approved, we’re only just starting to get to grips with the evidence base,” Heneghan said. “That means there’s been experimentation for 20 years.”
Vaginal mesh implants have been widely used across Europe and in the US since the early 2000s, when they started to be favoured over traditional open-surgery procedures, which took longer to perform, involved a lengthier recovery for patients and were associated with their own range of complications.
The most common kind of procedure, called a TVT implant, typically takes 30 minutes and is performed using keyhole surgery. Patients often go home the same day and trials have found impressive success rates for resolving incontinence, but some women have been left with severe complications.
In response to growing concerns about the operation’s failure rate for prolapse, the health watchdog, Nice in December banned the use of vaginal mesh to treat prolapse. The latest figures show that in the most recent year there were still more than 2,500 mesh operations for prolapse, suggesting that some surgeons have been slow to accept growing evidence of problems with the procedure.
Kath Sansom, the founder of the Sling the Mesh campaign group, said: “The government have selectively used figures in a bid to make mesh risk look low and have presented it in such a confusing way that to a non-experienced reader they will think mesh is not a problem.”
She added that the NHS Digital audit did not include private patients or women going to GPs for pain medication or antibiotics to treat urinary infections.
The health minister Lord O’Shaughnessy said: “These experimental statistics aim to provide the NHS with a clearer national picture on the use of meshes and tapes to treat urogynaecological prolapse or stress urinary incontinence.
“Given the importance of this issue, I have asked the chief medical officer, Prof Dame Sally Davies, to seek the views of relevant NHS bodies, surgical societies, and patient groups on the implications of the statistics, and report back to me within a month.”
https://www.theguardian.com/society/2018/apr/17/scale-of-vaginal-mesh-problem-official-nhs-review-removal-operations
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Vaginal mesh scandal: More than a third of women need trauma treatment
Apr 17, 2018 | Sky News
By Charlotte Lomas
More than a third of women who have been fitted with vaginal mesh in the last decade have returned after surgery to be treated for trauma, an audit has revealed.
Up to 66% have visited a specialist gynaecological centre and 34% have returned for rehabilitation and physiotherapy.
These are the findings of a full retrospective audit carried out by the NHS looking at the complication rate of vaginal mesh devices in England.
It shows more than 100,000 women had vaginal mesh inserted between 2008 and 2017 to treat stress urinary incontinence, which is common after childbirth.
During the last decade the figures show the number of women having the procedure has fallen by 48% and the rate of removal has also reduced.The national audit was commissioned in January and designed to provide better understanding of the scale of the problem with vaginal mesh, which has become the subject of global litigation after thousands of women reported chronic pain.
While campaigners welcomed the audit, they believe it does not go far enough.
Kath Sansom, founder of the campaign group Sling the Mesh, said: "The audit has not included private patients or women going to GPs for pain medication or antibiotics to treat painful urinary infections so there are thousands not included in this data.
"The report shows even eight years after mesh insertion it is still causing problems."
"This audit has no information on the devastating social and psychological impact on women - we ran a survey that shows a third of women in our group of 6,000 have had to stop work and a fifth reduce their hours due to disability or pain," she added.
Health Minister Lord O'Shaughnessy said: "These experimental statistics aim to provide the NHS with a clearer national picture on the use of meshes and tapes to treat urogynaecological prolapse or stress urinary incontinence.
"Given the importance of this issue, I have asked the Chief Medical Officer, Professor Dame Sally Davies, to seek the views of relevant NHS bodies, surgical societies, and patient groups on the implications of the statistics, and report back to me within a month."
Commenting on the findings, Owen Smith MP, chairman of the All-Party Parliamentary Group on Surgical Mesh said: "These data show that the campaign against mesh has been totally justified in our claim that large numbers of women have been damaged by mesh.
"Government has previously, repeatedly claimed that mesh was 'safe' and that just one to three percent of women suffer serious complications after surgery.
"However, their own statistics now show that around 40% of women treated with mesh are subsequently undergoing outpatient treatment for trauma or orthopaedics, 50% need further treatment for gynaecological complications and almost 10% are treated for pain in hospital outpatient clinics," he added.
Mr Smith said mesh is proving itself unsafe and ineffective in many women and doctors were therefore stopping using it.
He said: "NICE should now fast-rack its review of the mesh - still, inexplicably, not due until 2019 - while the NHS should suspend use of mesh until the results of that review are known."
In February, Health Secretary Jeremy Hunt launched a review into how the NHS responds to safety concerns raised by patients about medicines or medical devices.
In particular it will look into patient concerns about vaginal mesh along with hormone pregnancy test Primodos and epilepsy drug sodium valproate.
It will also consider whether a full investigation or a public inquiry is necessary into any of the issues.
https://news.sky.com/story/vaginal-mesh-scandal-more-than-a-third-of-women-need-trauma-surgery-11335297
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Vaginal mesh surgery: NHS releases new figures
Apr 17, 2018 | BBC News
England's most senior doctor has been told by the government to urgently respond to new data that shows how many women have had vaginal mesh surgery.
Since 2008 27,016 have had the implant - which is used to treat incontinence and prolapse - and 211 women have had it removed, data shows.
Women have complained about implants causing agony by cutting into tissue.
Chief medical officer Prof Dame Sally Davies has been told to respond to the data within a month.
Since 2008 27,016 have had the implant - which is used to treat incontinence and prolapse - and 211 women have had it removed, data shows.
Women have complained about implants causing agony by cutting into tissue.
Chief medical officer Prof Dame Sally Davies has been told to respond to the data within a month.
http://www.bbc.com/news/health-43795003
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Hundreds of women each year need vaginal mesh implants removed, NHS audit finds
Apr 17, 2018 | The Independent
By Alex Matthews-King
Hundreds of women annually are having procedures to remove vaginal mesh implants intended to be permanent but which are linked to serious complications.
An NHS audit was launched earlier this year to understand how many women may be affected by the devices in cases where they deformed after being implanted – in some cases cutting the vagina walls and causing life-threatening infections.
The findings show that since April 2008 surgeons performed at least 500 removal operations each year for vaginal mesh and tape implants, with 5,374 full or partial removals having taken place up to March 2017.
https://www.independent.co.uk/news/health/vaginal-mesh-implant-removal-nhs-audit-numbers-women-a8309276.html
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Third Of Women With Vaginal Mesh Seek Urgent Help Due To 'Incredible Pain'
Apr 17, 2018 | HuffPost UK
By Kathryn Snowdon
More than a third of women who have undergone vaginal mesh surgery have sought urgent care in trauma units due to the subsequent pain they experience, the latest figures reveal.
Forced to seek emergency help due to “incredible pain”, campaigners say many sufferers are also forced to attend multiple medical appointments before being properly diagnosed.
They say the new figures, buried deep within an experimental report published by NHS Digital, are shocking.
The statistics were released after thousands around the world reported life-changing complications from vaginal mesh, a treatment given to women who experience pelvic organ prolapse or incontinence often as a result of childbirth.
They show that nearly half of all women who had a vaginal mesh insertion in 2008/2009 have attended a trauma and orthopaedic clinic by 2016/17.
Vaginal mesh, sometimes known as “tape” or “ribbon”, is designed to support the vaginal wall and internal muscles. The figures released on Tuesday cover patients who have had a procedure for uro-gynaecological prolapse or stress urinary incontinence.
Women who have undergone the procedure have told HuffPost that they experienced severe pain when walking and sitting, leaving some unable to work. Some also said complications have had a negative impact on their mental health, leading to depression and anxiety.
Kath Sansom, founder of Sling The Mesh, a campaign group against the use of vaginal mesh, said of the findings: “The reason why a woman might be sent to a trauma and orthopaedics clinic is because... you’re in so much pain and the pain can radiate round into your hips and up into your back.”
Sansom said that many GPs may not realise at first why a woman is in such pain, sometimes misdiagnosing them with back problems.
Labour MP Owen Smith, chairman of the All-Party Parliamentary Group (APPG) on Surgical Mesh, urged the NHS to suspend the use of mesh until the product is reviewed.
Smith said: “Government has previously, repeatedly claimed that mesh was ‘safe’ and that just 1 to 3% of women suffer serious complications after surgery.
“However, their own statistics now shows that around 40% of women treated with mesh are subsequently undergoing outpatient treatment for Trauma or Orthopaedics, 50% need further treatment for Gynaecological complications and almost 10% are treated for pain in hospital outpatient clinics.”
But campaigners fear the real picture may be much worse. Not included in the statistics published are the use of private clinics, or any figures from Wales, Scotland and Northern Ireland.
Sansom said that many women will often opt for private care because the pain they are experiencing is so severe. “A lot of women in the campaign group opt for private removal because the minute the know it’s a problem they just want to get it out of them so they find the money or they borrow the money, they take out loans,” Sansom said.
“It’s a very traumatic thing when it goes wrong,” Sansom added.
She added that the NHS waiting time to see a mesh removal expert can sometimes be so long that women will cash in pensions, remortgage their homes, use their savings and do whatever they can to be seen quickly.
Factoring in the number of women who sought help privately would make a “massive difference” to the current statistics released by NHS Digital, Sansom said.
The figures reveal that overall, the number of women to have had the procedure has decreased in the last eight years. In 2016/17 there were 7,245 patients implanted with vaginal mesh – a 48% drop from the 13,990 patients recorded in 2008/09.
Sansom accused the government of “burying the information” and presenting the main findings in the report in such a way as to “make it look like mesh isn’t a problem”. The figures on outpatient trauma referrals were on page 36 out of the 46-page report.
https://www.huffingtonpost.co.uk/entry/vaginal-mesh-women-urgent-help-trauma-orthopaedic-units_uk_5ad5c164e4b0edca2cbd9e0a
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Apr 17, 2018 | Cambs Times
By Kath Sansom
As many as half of women given pelvic mesh implants have to seek further treatment for complications, according to a Government audit out today.Owen Smith MP, chairman of the all party parliamentary group on surgical mesh, said the audit shows: “The campaign against mesh has been totally justified in our claim that large numbers of women have been damaged by mesh.
“Government has previously repeatedly claimed that mesh was ‘safe’ and just one to three per cent of women suffer serious complications after surgery.
“However, their own statistics now show around 40 per cent of women treated with mesh are subsequently undergoing outpatient treatment for trauma or orthopaedic problems, half need further treatment for gynaecological complications and almost 10 per cent are treated for pain in hospital outpatient clinics.
“The data shows the number of operations using mesh has almost halved over the last decade, illustrating that doctors and patients have themselves decided to stop using mesh.
“This is precisely the opposite effect you would expect to see with a new innovative and effective treatment, the use of which would normally rise as its value was proved in clinical usage.
“Mesh is proving itself unsafe and ineffective in many women and the doctors are therefore stopping using it. That, in itself, shows the Government, NICE and the MHRA have been wrong to repeatedly defend the use of mesh.
“NICE should now fast-rack its review of the mesh, not due until 2019, while the NHS should suspend use of mesh until the results of that review are known.”
Sharon Hodgson MP said: “The Government now needs to suspend the use of surgical mesh and tape for all procedures to ensure that no more patients are harmed, make clear how many women have been injured, and investigate why so many patients were treated with these harmful products for so long.”
Sling the Mesh, launched by our newspaper, says despite the audit’s high figures, buried deep within a 50-page document, it still misses out thousands of women suffering as it does not include information from private hospitals or women in Scotland, Northern Ireland or Wales.
It misses off thousands of women just going to doctors for medication and does not take into account women who had mesh operations before 2008.
A spokesman for Sling The Mesh, with almost 6,000 members, said: “The report shows even eight years after mesh insertion it is still causing problems.
“The high figures are shocking and this is without any information on the devastating social and psychological impact on women.
“Our survey shows a third of women in our group have given up work and a fifth reduced their hours due to disability or pain and 54 per cent suffer ongoing urinary infections.”
Jackie Harvey, Of Sling The Mesh Northern Ireland, said: “If the Government has ordered a review, they should be releasing all UK figures at once.
“Problem is they have no idea how many women have been affected. No surgeon has ever reported mesh complications in Northern Ireland yet I have almost 500 women on my group.”
Karen Preater, admin of Welsh Mesh Survivors, said: “The audit is not robust enough to accurately show the scale of the mesh disaster, by cherry picking caveats they are effectively swaying the outcome.”
The audit misses off women who had a rectal prolapse and were given an operation called ventral mesh rectopexy as this operation does not have an official code where surgeons can log outcomes. The lead surgeon who trained medics across the UK in this procedure is the subject of an NHS and BBC investigation.
Health Minister Lord O’Shaughnessy said of the audit: “These experimental statistics aim to provide the NHS with a clearer national picture on the use of meshes and tapes to treat urogynaecological prolapse or stress urinary incontinence.
“Due to the importance of this issue, I have asked the chief medical officer, professor Dame Sally Davies, to seek the views of relevant NHS bodies, expert surgical societies, and patient groups on the implications of the statistics, and report back to me within a month.”
A spokesman for the Chartered Society of Physiotherapists said: ‘More evidence is emerging illustrating how mesh implants are negatively affecting the quality of life for many women.
‘Women should routinely be offered physiotherapy before, and as a possible alternative to surgery. However, due to a shortage of women’s pelvic health physiotherapists, access is inconsistent and varied across the country.
‘This must be improved, along with raising awareness among other health professionals as to the benefits of specialist physiotherapy.
‘We really need to do more to prevent these problems from developing in the first place.”
• You can read the Mesh Audit here
• A study of hospital data by an independent statistician at Newcastle University, in September 2017, said the risk of suffering complications from the most commonly used mesh sling for incontinence was at least 9.8 per cent. Read the Keltie et al study here.
http://www.cambstimes.co.uk/news/owen-smith-mesh-implants-vaginal-pelvic-audit-government-nhs-1-5480133
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Apr 17, 2018 | Daily Mail
By Stephen Matthews
Thousands of women have been forced to suffer unbearable pain because of their controversial vaginal mesh implants, an audit today confirmed.
However, while campaigners today welcomed the damning decade-long review, they stressed it 'doesn't show the true scale of the disaster'.
Health officials today urged the country's top medics to respond to the new report, which delved into data about mesh implants in England and revealed:
· The risks of complications from mesh are around the 45 per cent mark - unlike NHS assertions it is no more than three per cent
· Hundreds of women are undergoing surgery each year to have their vaginal mesh implants removed
· The risk of mesh for prolapse and incontinence are almost equal - despite health watchdogs recommending a ban on one
· The number of vaginal mesh operations for incontinence each year have halved since 2008 and have been slashed by 13 per cent for prolapse
The All Party Parliamentary Group for Surgical Mesh demanded the audit into the implants, in the hope of creating a 'clearer' picture of the scandal.
Furious experts have already dubbed the 'barbaric' procedure akin to the thalidomide scandal of the 1950s and 60s, as it has maimed thousands of women across the world.
Owen Smith, MP and chairman of the group, said: 'Mesh is proving itself unsafe and ineffective in many women and the doctors are therefore stopping using it.
'That, in itself, shows that the Government, NICE and the MHRA have been wrong to repeatedly defend the use of mesh.'
He added: 'These data show the campaign against mesh has been totally justified in our claim that large numbers of women have been damaged by mesh.
'Government has previously, repeatedly claimed that mesh was "safe" and that just one to three per cent of women suffer serious complications after surgery.
'However, their own statistics now shows that around 40 per cent of women treated with mesh are subsequently undergoing outpatient treatment.'
Sling The Mesh, a campaign group that has almost quadrupled in size since the mesh issue came to light last year,
Kath Sansom, its founder, who has battled tirelessly against the use of vaginal mesh, told MailOnline the audit was purposely confusing.
She said: 'It seems desperately unfair that campaigners have to go through so much effort to raise awareness and are then faced with picking through audits like this.
'Every step of the way campaigners fight hard to have our voices heard and taken seriously, while juggling jobs, pain and, in many cases, children.'
Commenting on the results, she said: 'The Government have selectively used figures in a bid to make mesh risk look low.
'[They] have presented it in such a confusing way that to a non-experienced reader they will think mesh is not a problem.
'It has not included private patients or women going to GPs for pain medication or antibiotics to treat painful urinary infections.'
Ms Sansom stressed the audit, published by NHS Digital, contained 'no information on the devastating social and psychological impact on women'.
She added: 'Officials have gone through a lot of trouble to come out with this 43-page report, but it doesn't show the true scale of the disaster.
What did the audit show?
The investigation, published today, showed nearly 130,000 patients had undergone a mesh procedure for incontinence or prolapse in the past decade.
It dwarfs previous NHS estimates, which suggested 100,000 women had been given mesh for both procedures since it was introduced in the 1990s.
Both procedures to implant mesh, which is made of brittle plastic and can curl, twist and cut through tissue, are common after childbirth.
Up to 44 per cent of women fitted with tape, or mesh, for incontinence will attend an appointment with trauma and orthopaedic surgeons, the audit suggests.
While this figure was even higher (46 per cent) for women fitted the vaginal mesh devices for prolapse, when organs slip out of place because of weakened muscles.
The data on prolapse comes months after health watchdog, Nice, recommended a ban on inserting the controversial devices in women with the condition.
Opened a 'can of worms'
But, the statistics, which technically show more complications from mesh used in prolapse than continence, have 'opened a can of worms'.
Ms Sansom, 49, who also happens to be a journalist, based in Cambridgeshire, said: 'The report opens up a huge can of worms.
'It shows the risks of mesh for prolapse and incontinence is roughly the same - despite a recommended ban against one type of prolapse mesh.'
The number of operations to implant vaginal mesh in women with incontinence have almost halved in the past decade, the audit revealed.While only a 13 per cent reduction was noted for mesh used in treating prolapse. The procedure is expected to take a hit next year.
And, in each year since April 2008, surgeons have performed at least 500 removal operations for tape or mesh, the audit showed.
Between 2008 and 2017 there were 5,374 total or partial removal procedures - but this could include any women who have been forced to undergo more than one surgery.
When was the audit announced?
The Department of Health and Social Care declared it would conduct an audit into vaginal mesh at the end of January.
The move, welcomed by campaigners at the time, was hoped to create a 'clearer' national picture of patients who have had mesh implants.
Health Minister Lord O'Shaughnessy today asked for the leading medics, NHS bodies and patient groups to report back to him 'within a month'.
The APPG on surgical mesh implants demanded the audit, which was expected to be completed by the end of this month April.
Chiefs have remained adamant that only three per cent of patients will experience complications of vaginal mesh, which can curl, twist and cut through tissue.
However, an array of trials into mesh - made of brittle plastic - have revealed the true rate of serious side effects is likely to be nearer the 10 per cent figure.
At least 4,800 women have suffered lacerations and nerve damage from the mesh in England, but only 1,000 have reported it to the MHRA.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more - but they have been kept silent.
Despite the risks, which have been widely publicised in recent months, most women experience no problem and doctors are adamant the procedure is beneficial.
A recommended ban
Nice's recommendation for a ban on mesh used in prolapse was announced back in December.
It came after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
All forms of pelvic mesh were banned in New Zealand back in December, and a similar move against prolapse has been made in Australia.
Vaginal mesh has been subject of various legal proceedings across the world, with figures suggesting more than 100,000 are suing manufacturers of the devices.
When did the scandal come to light?
The scandal came to light last April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some claiming the scandal could be akin to thalidomide.
At the time, 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
http://www.dailymail.co.uk/health/article-5625265/Furious-vaginal-mesh-campaigners-slam-Governments-investigation.html
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US regulators float ideas for boosting medical device safety
Apr 17, 2018 | Associate Press
By Matthew Perone
U.S. health officials on Tuesday proposed steps to improve the government's system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.
The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.
Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. But that step, like others floated by the agency, might require new guidelines or regulations. Other proposals may require additional money from Congress.
The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients. In the last decade, those have included hip replacements that failed prematurely, faulty wiring in implanted defibrillators, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.
"We want to have better tools for detecting issues that occur post-approval," FDA Commissioner Scott Gottlieb said Tuesday. "But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening."
An agency critic said the report contains few concrete changes and "many sections that will please the device industry."
"FDA's safety strategies for medical devices are still years away from effective implementation," said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. "Overall, the report indicates that the FDA's approval standards for medical devices remain completely inadequate."
The FDA's framework for regulating devices dates to the mid-1970s and has been criticized in reports from government watchdogs and independent medical experts. Only brand new devices undergo testing in patients while the overwhelming majority of devices are OK'd based on similarities to products already on the market.
In 2011, a report from the influential Institute of Medicine said the FDA should abandon its system because it provides little assurance that most devices are actually safe. The group - now part of the National Academies - is composed of medical experts who advise the federal government.
FDA officials rejected the report's conclusions, saying the system works well for the vast majority of devices.
Tuesday's report acknowledges the shortcomings of FDA's current system for detecting problems, which agency officials describe as "passive." The agency relies on reports about device problems from doctors, patients and manufacturers, but the electronic filings often contain incomplete or inaccurate information. And most device issues are not reported, according to government assessments.
That means it can take a long time to determine if the issue "represents a true safety concern," the FDA paper states.
Among other proposals laid out in the FDA's "Medical Device Safety Action Plan," the FDA will consider:
- How to quickly require additional safety requirements for certain devices, including training for doctors who work with the complex devices.
- Extra scrutiny of devices for women, following recent problems with vaginal mesh, the birth control implant Essure and surgical tools.
- New ways to encourage manufacturers to improve safety, including quicker approval for devices that appear safer than what's available.
- Requiring cybersecurity features for electronic devices like implantable heart pacemakers and defibrillators.
The agency will also ask Congress for more money for a public-private system intended to monitor insurance claims, electronic health records and other data sources for early signs of device problems. The project is estimated to cost $250 million over five years to become operational; it is now slated to receive $30 million from device manufacturers.
http://www.wboy.com/news/us-regulators-float-ideas-for-boosting-medical-device-safety/1127125038
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Doctored: mesh surgeon Richard Reid admits to writing fake patient notes
Apr 18, 2018 | Newcastle Herald
By Joanne McCarthy
PELVIC mesh surgeon and former Newcastle University associate professor Richard Reid was a man whose “first instinct was to lie to protect himself”, a tribunal was told after evidence he prepared false patient notes after a woman initiated legal action following mesh surgery.
Dr Reid “initially lied” when giving evidence about the notes, telling theNSW Civil and Administrative Tribunal a “really unlikely story” about lost records until he later “confessed that it was made up”, the barrister for the NSW Health Care Complaints Commission (HCCC), Kate Richardson, told the tribunal hearing on Friday.
Dr Reid wrote in the false notes sent to the woman’s lawyers that he warned her an Australian-manufactured pelvic mesh device was “novel” before her surgery in 2013. But in another set of notes to the woman there was no reference to the Tissue Fixation System (TFS) pelvic mesh device, the tribunal was told.
The TFS device, invented by Australian doctor Peter Petros and manufactured in South Australia by former Australian basketballer and Newcastle Falcons player Paul Zadow, was one of the first mesh products in the world to be deregistered a year later for lack of evidence backing its safe use.
Mr Zadow’s appeal against the 2014 deregistration returns to court in May.
Ms Richardson told the tribunal that in producing the false notes and initially giving evidence that they were valid, Dr Reid was “seeking to impugn the evidence of (the woman) as to what she was told and not told”.
Ms Richardson rejected Dr Reid’s submission that he panicked when he received the lawyer’s letter to produce the woman’s notes and that it was a “human reaction to panic under pressure”.
“It’s actually a dishonest reaction of someone who’s prepared to make things up,” Ms Richardson told the tribunal.
“In the witness box his first instinct was to lie to protect himself.”
Dr Reid is facing allegations he engaged in unethical and improper conduct and professional misconduct after the HCCC investigated complaints from 18 women, and also breached conditions imposed on him by the NSW Medical Council in 2011 while treating women and implanting them with pelvic mesh devices in 2013.
During submissions on Friday after several weeks of evidence in December, Ms Richardson described Dr Reid’s response to a question about how he changed his practice once the Medical Council imposed the conditions as “quite breathtaking”.
He told the tribunal he “didn’t change it at all”, she said.
“This is a practitioner who was just basically ignoring the conditions. The Medical Council thought they’d put a protective regime in place. They thought they were protecting the public by imposing the conditions and he didn’t change his practice at all,” Ms Richardson said.
She asked the tribunal to reject Dr Reid’s submission that Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines on pelvic mesh for prolapse “wasn’t intended to apply to TFS tape”.
In her submission Ms Richardson raised the case of Patient K who consented to surgery using one kind of pelvic mesh but was one of the first patients implanted with TFS by Dr Reid in mid-2013 and suffered serious and permanent injuries, without her consent.
Patient O had pelvic mesh surgery to repair a prolapse, and two further surgeries by Dr Reid within quick succession after they failed. Dr Reid did not obtain a second opinion before the surgery, as required under the Medical Council conditions. The tribunal heard evidence from several doctors critical of the repeat surgeries within a short timeframe. The woman suffered severe and permanent injuries and was sent home to self-catheterise for the rest of her life.
A second of Dr Reid’s patients was sent home with a letter to her general practitioner urging that it was “absolutely mandatory the patient continue to self-catheterise for the rest of her life”.
Ms Richardson told the tribunal Dr Reid failed to tell his patients at Sydney Private Hospital in 2013 that he was under restrictions imposed by the hospital that required him to be supervised by TFS inventor Dr Peter Petros during surgery.
While in evidence Dr Reid described the supervision as “cooperative in nature and by way of training”, it was “something imposed on him” that his patients had a right to know, Ms Richardson said.
A gynaecologist who gave evidence for Dr Reid said he did not believe women patients needed to know Dr Reid could only operate as a surgeon with a supervisor, but Ms Richardson said the evidence showed “a breathtaking lack of understanding of informed consent”.
“It’s a very old school view that doctors know best and patients don’t have a right to know information that questions the doctors’ abilities,” Ms Richardson told the tribunal.
The tribunal has reserved its decision.
https://www.theherald.com.au/story/5341823/doctored-mesh-surgeon-admits-to-writing-fake-patient-notes/
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ConTIPI Medical develops tampon-like medical devices
Apr 17, 2018 | Globes
By Gali Weinreb
The company's first product treated incontinence while its latest insert is for pelvic prolapse.ConTIPI Medical has kept a low profile since it was founded ten years ago. It was known that the company was developing a tampon-like product for treatment of incontinence, that it had signed a marketing agreement with one of the leading companies in this segment, and that it had eventually been sold for $90 million. That, however, is more or less what has been released to the public. With whom was the commercialization agreement signed? Did the product reach the market? Today, with the emergence of the "new ConTIPI," Dr. Elan Ziv, founder of both of the company's incarnations, reveals its full history and plans for the future.
Procter and Gamble disappointed
"We started in 1998," Ziv says. "A new operation had then arrived in Israel for treating incontinence, a wonderful operation called TVT, in which a device was implanted through the vagina to support the urethra. I thought that it might be possible to avoid the surgery and put a component in the vagina to support the urethra."
The first product developed by ConTIPI looked like a tampon, but when inserted, opened up inside the vagina and took the shape of a reverse tripod wrapped in unwoven cloth. The device did not restrict everyday activity, such as urination, but it was possible and desirable to remove during sexual intercourse.
ConTIPI obtained FDA approval for its product relatively quickly. It was positioned as a prescription product, and the company signed a marketing agreement with female hygiene giant Procter and Gamble. "In 2009, however, all of their prescription products business was sold to an Irish company," Ziv says. The company notified ConTIPI that it would convert the product into one that could be sold without a prescription, "but the female hygiene products division was not so interested in us," he remembers. "In 2010, we were informed that they would get around to converting the product with the FDA only in 2013."
Ziv made a tough decision for a young company that had already contracted an agreement with a large corporation. "We decided to combine forces with a corporation that had always pursued us, Kimberly Clark, Procter and Gamble's competitor."
"Globes": Did you leave a lot of angry people at Procter and Gamble?
Ziv: "You could say that."
Kimberly Clark itself was about to put a special hygienic bandage for incontinence on the market, and the combination of the products was suitable for it. "We made thousand of devices for them and financed by them, and in September 2013, when the product was ready to go to market, we sold the company for numbers a little higher than what was reported ($90 million was the initial sum, after which additional sums were received). At the same time, Kimberly Clark built a huge factory in Mexico, and it produces tens of thousands of units there."
The sale reflected a return of nine times the investment. The beneficiaries included Zeev Bronfeld, who founded the company with Ziv; Capital Point, which invested in the LN Innovative Technologies incubator, from which ConTIPI graduated; and private investors, such as Gad Somekh and Yuli Tamir.
The product is not marketed in Israel, but Ziv says that it is sold in the US market with great success. "This product is no longer ours. We get money from time to time as a milestone payment, and we're mostly glad about its success. It has no competition right now, but I'm sure that Procter and Gamble will find a way to this market at some stage."
The entrepreneurship bug thoroughly infected Ziv and his team, and that is how ConTIPI Medical was founded. The company currently deals with pelvic organ prolapse (POP) The product is still a perishable product inserted into the vagina, so the company is operating on familiar territory.
"The incontinence and POP markets are different. POP requires diagnosis by a doctor. 50% of women have some prolapse. In severe cases, you can even see the internal organ leave the vagina. The feeling is as if they are about to lay an egg." Today, if a woman suffers from pain or difficult in walking, the prevailing practice is to surgically insert a net to support the organs. The net itself, however, is anchored to tissue that is not strong. Johnson & Johnson, for example, were sued for damages inflicted on the tissue by the net and had to pay billions of dollars in damages. The reputation of surgery for the problem was stained.
There is a middle product - a pessary - a kind of rubber ring in the vagina on which the organs lean. "The problem is that it is hard to insert and remove the product without help from a doctor, and it is replaced every three months," Ziv explains.
For someone familiar with ConTIPI Medical, its solution is rather obvious - a tampon-like product inserted into the vagina, where it expands into a supporting ring. Once a prescription is obtained, the patients can operate the product by themselves. "The product can be in the vagina for up to seven days. You can take it out whenever you want in order to conduct sexual relations," Ziv says.
The product has already been approved for marketing in Europe and is in the process of trials with the US Food and Drug Administration (FDA). "All of the major companies are in touch with us. We probably won't sell to Kimberly Clark again, because they only make shelf products. It has to be a prescription product, because we want to make sure that a woman is correctly diagnosed. The product will therefore be marketed by a medical equipment company with a connection to the consumer," Ziv explains.
The company is currently raising $10-12 million. ConTIPI Medical has other products that it is not revealing yet, and is likely to develop them after this product is sold or commercialized through a marketing company.
http://www.globes.co.il/en/article-contipi-medical-develops-tampon-like-medical-devices-1001232313
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