Preview Newsletter
Ethicon Media Monitoring 2/14/2018
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Vaginal mesh implants: new material could reduce complications
Feb 14, 2018 | Press Association (In The Guardian)
Alternative material could replace current controversial implants, which have prompted many complaints of pain and discomfort -
Vaginal mesh implants: High demand at new Belfast unit
Feb 14, 2018 | BBC
By Marie-Louise Connolly
A specially-accredited unit has been set up in Northern Ireland to deal with women who are coping with problems resulting from vaginal mesh implants. -
Scientists develop new vaginal mesh which 'may cut complications'
Feb 14, 2018 | Sky News
By Philip Whiteside
Researchers say polyurethane could help prevent the pain suffered by thousands of women who have had surgery using polypropylene. -
Vaginal mesh: scientists develop new material which avoids serious injuries and side-effects
Feb 14, 2018 | The Independent
By Alex Matthews-King
New material is more flexible and could even promote wound healing, but campaigners warn other implants left women with serious internal injuries -
New vaginal mesh material could offer hope to thousands of women living in agonising pain
Feb 14, 2018 | The Sun
By Andrea Downey
Vaginal mesh is used to treat prolapse and incontinence, conditions often caused by childbirth -
'Plastic does not belong in the body, never mind in a woman's VAGINA': Angry campaigners slam new material that could replace controversial mesh implants
Feb 14, 2018 | The Daily Mail
By Stephen Mathews
Angry vaginal mesh campaigners have blasted the announcement of a new material that could replace the one used in the controversial implant. -
Sheffield scientists develop new vaginal mesh to help thousands of women in pain
Feb 14, 2018 | The Star
By Dan Windham
Scientists believe they have come up with an alternative to the material used in vaginal mesh implants which prompted a huge number of women to complain they had been left in severe pain. -
Med industry insurer Medmarc sues Medtronic over pelvic mesh claims
Feb 14, 2018 | Mass Device
By Fink Densford
Medtronic (NYSE:MDT) is facing a suit from its insurer Medmarc Casualty Insurance alleging that the medtech giant inappropriately handled settlements related to pelvic mesh claims and is not entitled to $17.3 million in coverage from the company. -
Appeals Court Upholds Boston Scientific Obtryx $19 Mill Loss
Feb 14, 2018 | Mesh Medical Device Newsdesk
Boston Scientific has lost its latest effort to overturn an $18.5 million loss by four plaintiffs at trial over its Obtryx pelvic mesh.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Vaginal mesh implants: new material could reduce complications
Feb 14, 2018 | Press Association (In The Guardian)
Alternative material could replace current controversial implants, which have prompted many complaints of pain and discomfort
Scientists believe they have come up with an alternative to the material used in vaginal mesh implants which prompted a huge number of women to complainthey had been left in severe pain.
Mesh treatment has been offered in cases of pelvic organ prolapse and incontinence after childbirth, but sparked controversy after many women said they felt discomfort and had difficulty walking or having sex after undergoing the surgery.
Scientists at the University of Sheffield said they have now come up with a better material following seven years of research, suggesting the use of polyurethane rather than polypropylene.
The research group said polyurethane is more suitable because it has more more elasticity and a likeness to human tissue.
They also inserted oestrogen into the new mesh in a bid to speed up the healing process after treatment.
The research, published in the Journal of Neurourology and Urodynamics, said: “We believe that we have developed a new biomaterial that will avoid complications due to a better mechanical match with the native tissues.”
Prof Sheila MacNeil, professor of tissue engineering in the department of materials science and engineering at the university, said they began their research “because it was clear that the polypropylene mesh was not fit for use in the pelvic floor”.
She said: “Over the last seven years, we have investigated a range of materials and for the past few years, we have focused our efforts on polyurethane, using the method of electrospinning to create a fine mesh which we have fabricated in layers to mimic the structure of human tissue.
“We have shown through our research that it does not provoke inflammation and retains its strength and elasticity. The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue.”
The scientists recognised their research “now needs to be further evaluated in suitable preclinical animal models”.
Guidance from England’s National Institute for Health and Care Excellence in December said that following “serious, but well-recognised safety concerns” vaginal mesh should only be used for research purposes in future.
Data from the Medicines and Healthcare Products Regulatory Agency showed that in the five years to 2017 more than 1,000 adverse incidents related to mesh implants had been reported in the UK.
About 1,500 vaginal mesh operations are carried out in the UK each year, according to the NHS, which adds that the majority of women respond well.
https://www.theguardian.com/society/2018/feb/14/vaginal-mesh-implants-new-material-could-reduce-complications
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Vaginal mesh implants: High demand at new Belfast unit
Feb 14, 2018 | BBC
By Marie-Louise Connolly
A specially-accredited unit has been set up in Northern Ireland to deal with women who are coping with problems resulting from vaginal mesh implants.
It is based at Belfast City Hospital, where dedicated clinicians can treat women with mesh-related problems.
If suitable, patients can be referred to have the mesh removed either in NI hospitals, or in England.
The mesh centre is a joint initiative between the Public Health Agency and the Health and Social Care Board.'Work in progress'
A health spokesperson told the BBC that the centre is coping with the level of demand and clinicians are talking to women affected about how best to improve the service.
Dr Christina McMaster, a consultant in public health, said it is a work in progress.
"We are now dealing with groups of women and groups of clinicians to re-establish a good partnership and making sure the information that women are given is of a kind that women understand and value and that the services are meeting the needs of these women," she said.
Over the past 10 months, the vaginal mesh story has gathered pace, with an increasing number of women revealing how mesh - used mostly to treat incontinence - has eroded inside their bodies.
In June 2017, a number of local women told the BBC how mesh implants had left them physically and mentally scarred.
Since then, an increasing number of women and men have come forward with personal stories of how mesh has created complications for their physical and mental health.'Shocking experiences'
In an interview with the BBC, the authorities said they were aware of the problem 12 months ago and are responding as best as they can.
So far, six meetings have taken place between clinicians and the two Northern Ireland-based mesh groups.
Dr McMaster described some of the women's experiences as shocking.
"The stories are very impressive and some are harrowing, but we need to remember that any surgery, any intervention, can cause difficulties," she said.
"We know we've had 6,000 people in Northern Ireland who have undergone mesh-related procedures and the numbers of those who have come forward at present are in the hundreds, which is significant."
Some of the women have said they no longer trust the local health service to remove the mesh and are insisting they travel to London instead.
Dr McMaster said that was not something unique to mesh.
"We are working closely with these women in our working groups - in fact, we have met them six times and the relationship is a very productive and positive one.
"We are working with the women and clinicians in the same room so we can hear from everyone's perspective so we can improve on the services as best we can."
Mary McLaughlin from the group Mesh Ireland said a lot more work needs to be done.
"Since the creation of the specialist centre, we know of three members who are being sent across the water," she said.
"This demonstrates that we still do not have adequately experienced specialists who perform full mesh removal surgery.
"We also don't have 3D translabial scanning services.
"The newly-formed cross-party mesh group will strengthen the voice of our mesh injured members at department level."
In August, three different letters were dispatched from various health bodies highlighting the Department of Health's stance on vaginal mesh implants advising staff, including GPs, how they should deal with complaints.
At the time, a women's support group said it welcomed the move as it was the first indication that they were being taken seriously.
Jackie Harvey, from Sling the Mesh Group NI, recently took part in a delegation led by Sinn Féin to meet the Department of Health's permanent secretary Richard Pengelly.
"I think it gets the word out there that these implants are not fit for purpose," she said.
"They are both a surgical problem and a product problem.
"[The meeting] is a step in the right direction and we are pleased."
The result of an audit into mesh implants, carried out in 2013 in Northern Ireland, is expected to be published imminently.
It is examining how women were prepared for the operation, consent issues, and any complications during the operation and immediately afterwards.
http://www.bbc.com/news/uk-northern-ireland-43047267
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Scientists develop new vaginal mesh which 'may cut complications'
Feb 14, 2018 | Sky News
By Philip Whiteside
Researchers say polyurethane could help prevent the pain suffered by thousands of women who have had surgery using polypropylene.
A different surgical material to that normally used for vaginal mesh implants could mean fewer problems for patients.
Sky News has highlighted how thousands of women in the UK have been left with chronic pain after undergoing surgery for pelvic organ prolapse and stress urinary incontinence.
Now scientists from the University of Sheffield says switching from polypropylene to polyurethane may lad to less side affects.
Polyurethane, is softer and more elastic than polypropylene and is said to be closer to human tissue.
The research also has found that a female hormone can be added to the polyurethane which stimulates tissue growth and speeds up the healing process.
Professor Sheila MacNeil, of Sheffield University's Materials Science and Engineering department, said: "For many years now, surgeons have been treating the problems of urinary stress incontinence and pelvic organ prolapse using the only synthetic material they had to hand - polypropylene.
"In certain procedures… it is beneficial to the patient and carries relatively little risk.
"However, when much bigger areas of the same material are inserted… the complication rate is frankly unacceptable.
"We have focused our efforts on polyurethane (and) we have shown through our research that it does not provoke inflammation and retains its strength and elasticity.
"The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue."
Pelvic organ prolapse and stress urinary incontinence affects half of all postmenopausal women worldwide.
Pelvic organ prolapse affects a fifth of UK women but often only becomes apparent after a women who has had children goes through the menopause.
Last month, the Government announced it was launching a full retrospective audit of all women who have had the surgery since 2005 in order to find out the scale of the complications.
The official complication rate for vaginal mesh surgery is from 1-3% but recent studies have shown it to be anything between 10% and 15%.
But one mesh complications victim said she was deeply sceptical about the new product.
Belinda Birkett, from Wilmslow, who was diagnosed with fibromyalgia after she had a mesh implant, told Sky News: "It's… outrageous. It's made mostly from glue, nail varnish and also paint.
"It's just another quick fix idea when plastics should never be put in a man or woman’s body ever."
https://news.sky.com/story/scientists-develop-new-vaginal-mesh-which-may-cut-complications-11249628
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Vaginal mesh: scientists develop new material which avoids serious injuries and side-effects
Feb 14, 2018 | The Independent
By Alex Matthews-King
New material is more flexible and could even promote wound healing, but campaigners warn other implants left women with serious internal injuries
Scientists claim to have created a flexible vaginal mesh implant which will not cause serious injuries of the kind caused by existing rigid models which left women with life-changing injuries.
The unfolding scandal over the use of plastic vaginal mesh implants, which had their approval for use in the NHS withdrawn by watchdogs in December, has led to international legal actionand the death of at least one woman.
Now scientists from the University of Sheffield have developed a new form of implant which they said avoids the harmful properties of earlier models while still being able to be surgically useful.
Using polyurethane fibres, a synthetic material used in furniture upholstery, researchers say they have created a material that is flexible and elastic and more closely resembles human tissue.
“This whole area has suffered from a lack of research because the manufacturers denied there was a problem [with the original mesh devices] and patients weren’t listened to,” said Professor Sheila MacNeil, professor of tissue engineering in the department of materials science and engineering at the university.
“Now many millions of dollars have been paid out by mesh manufacturers in compensation, and many have stopped marketing products for this use, because there are so many side-effects.
“But then surgeons look round, there’s no new material to replace it.”
A paper on their new mesh material, published in the Journal of Neurourology and Urodynamics shows it stands up to stress testing better than old models, and performed well in tests in animals.
It is also less likely to cause inflammation when implanted, and can be infused with the hormone oestrogen, which has been shown to promote wound healing.
However it would need extensive testing in clinical trials before it was used in patients.
But mesh campaigners told The Independent that they don’t feel any plastic material should be used for a vaginal implant.
Previous implants were made of the plastic polypropylene, the same material used for plastic bottles, which Professor MacNeil says “lacks the elasticity” of their new mesh and distorts under pressure.
While polypropylene had initially been approved for use in hernia repairs in the stomach, manufacturers were allowed to tweak their design – with no additional testing – and market them for treating a condition called pelvic organ prolapse.
The procedure was commonly offered to women after childbirth, where the pelvic muscles are left weakened and the internal organs can push through into the vaginal cavity.
In the UK, thousands of women are thought to have been fitted with mesh devices for this purpose, with complications reported in one in 10 of them – or as many as a third according to campaigners.
Complications occurred when the mesh shifts, or warps in the body, cutting into the internal wall leading to infections, severe pain and leaving some patients permanently disabled.
The National Institute for Health and Care Excellence (NICE) In December, which recommends treatments for use in the NHS, determined before Christmas that the evidence on the use of mesh in organ prolapse was “inadequate” ad it should not be used.
The Government has since said to will review mesh implants given to women in the UK dating back to 2005, to determine the true extent of complications.
Professor MacNeil told The Independent that she was only aware of two other teams working on implant devices for pelvic organ prolapse.
One in the US, working on a mesh made from a natural material, and another in Australia is working on a highly technical solution using the connective tissue, collagen, but these are likely to be more costly.
“I’m delighted other groups are developing these materials, the area needs more research and we ought to be one of twenty groups doing this,” Professor MacNeil added.
But Kath Sansom, founder of the group Sling the Mesh, said the harms caused by one plastic implant should be enough to show that these materials cannot be safely used in such a sensitive area.
“Poly- is key here. Whether it is polypropylene or polyurethane, it is plastic which does not belong in a human body never mind in a woman's vagina which is a clean, uncontaminated field.
“Plastic is not inert which means it can change once implanted. It can shrink, twist degrade and it is that which is catastrophic once inside women’s bodies.”
Previous mesh implants have been shown to break down inside patients, with microplastic particles passing into the body.
https://www.independent.co.uk/news/vaginal-mesh-material-latest-injuries-side-effects-scientists-sheffield-university-plastic-a8208936.html
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New vaginal mesh material could offer hope to thousands of women living in agonising pain
Feb 14, 2018 | The Sun
By Andrea Downey
Vaginal mesh is used to treat prolapse and incontinence, conditions often caused by childbirth
A NEW material developed by UK scientists could provide relief for thousands of women living in agony due to vaginal mesh implants.
Vaginal mesh is used to treat prolapse and incontinence, conditions often caused by childbirth.
But the implants, many made from polypropylene, have left some women in excruciating pain, unable to walk or have sex.
Now, scientists from the University of Sheffield, have discovered a softer and more elastic material that they believe will be better suited to the pelvic floor muscles.
The material, called polyurethane, can also release oestrogen into the surrounding area, which will help promote blood flow and speed up the healing process.
Lead author Sheila MacNei, a professor of tissue engineering at the university, said: "For many years now, surgeons have been treating the problems of urinary stress incontinence and pelvic organ prolapse using the only synthetic material they had to hand - polypropylene.
"In certain procedures, for example, when the polypropylene mesh is used as a thin strip to support the urethra and reduce the symptoms of stress incontinence, the results show it is beneficial to the patient and carries relatively little risk.
"However, when much bigger areas of the same material are inserted through the vagina to relieve pelvic organ prolapse, the complication rate is frankly unacceptable.
"Surgeons who are experts in this area have concluded that there is a need for a new synthetic material that is better suited for use in the pelvic floor.
"We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor."
Vaginal mesh has caused some women in the UK to suffer perforated organs while doctors have warned the scandal is "bigger than Thalidomide".
The 20-minute non-invasive procedure works by inserting the mesh tape through the vagina and placing it around the urethra to support it like a hammock.
More than 92,000 women in England had implants between 2007 and 2015.
One in 11 is believed to have problems.
The Government has faced calls to suspend operations using mesh implants while a “full retrospective and mandatory audit of all interventions using mesh” is carried out.
The use of vaginal mesh has been banned in Australia.
Professor MacNei added: "Over the last seven years, we have investigated a range of materials and for the past few years, we have focused our efforts on polyurethane, using the method of electrospinning to create a fine mesh which we have fabricated in layers to mimic the structure of human tissue.
"We have shown through our research that it does not provoke inflammation and retains its strength and elasticity.
"The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue."
Hundreds of women are taking legal action against the NHS and the makers of vaginal mesh implants.
The implants are prescribed on the NHS across the UK but a Scots review said use should not be routine for pelvic organ prolapse, caused by weak muscles after childbirth or ops.
https://www.thesun.co.uk/news/5569311/new-vaginal-mesh-material-could-offer-hope-to-thousands-of-women-living-in-agonising-pain/
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Feb 14, 2018 | The Daily Mail
By Stephen Mathews
Sheffield University scientists have today revealed the creation of polyurethane
Outraged victims of the procedure claim it is no different to the current material
Thousands of women have been left suicidal from the scandal-hit procedures
Angry vaginal mesh campaigners have blasted the announcement of a new material that could replace the one used in the controversial implant.
Sheffield University scientists today revealed the creation of polyurethane - which they claim is better for women suffering prolapse or incontinence.
But outraged victims who have had the procedure, which is common following childbirth, and have been left crippled by the side effects, warn it is no different to polypropylene, the current plastic material used.
Thousands of women have been left suicidal, unable to have sex or even walk from the current material, which has prompted legal action across the world.
Sling The Mesh, a campaign group calling for a ban, has almost quadrupled in size since the scandal was unearthed last April.
Its founder, Kath Sansom, has relentlessly fought for action, and her tireless fights have led to the announcement of an audit to track those affected.
Commenting on the new material, she told MailOnline: 'Poly means plastic and it is this which is causing such devastation. Plastic can shrink. It is not inert.
'Plastic does not belong in the body never mind in a woman's vagina. Women in my group have had allergic reactions, burning and pain [from mesh].'
Ms Sansom, 49, a journalist in Cambridgeshire, added: 'Everyone keeps saying how incontinence and prolapse are distressing conditions and, yes, they are.
'But they are not as distressing as women having their lives shattered as the big medical manufacturing giants rub their hands with glee.
'They have zero care for women's welfare and are just desperate to make a quick income from flogging dangerous implants with little proof of safety.'
Researchers at Sheffield's Department of Material Science and Engineering created polyurethane - which they say has a likeness to human tissue.
The new material was found to be softer and more elastic, which they said would be better suited for use in the pelvic floor, with delicate organs close.
In a 'major breakthrough', they made the material release oestrogen into surrounding pelvic tissue, which they claim speeds up the healing process.
The hormone stimulates cells to produce new tissue and form new blood vessels - regenerating the tissue.
Their creation was published in the Journal of Neurology and Urodynamics with the hope of developing a material that poses less risk to women.
It will need to go through rigorous clinical trials before it is approved. The material has only been tested on chicken membranes in the laboratory.
Professor Sheila MacNeil, who led the trial, blasted the complication rate for vaginal mesh procedures as 'frankly unacceptable'.
She said: 'Surgeons who are experts in this area have concluded that there is a need for a new synthetic material that is better suited for use in the pelvic floor.
'We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor.'
Professor MacNeil claimed surgeons have been treating incontinence and prolapse using 'the only synthetic material they had to hand'.
NHS England estimates 100,000 women have undergone the procedure since it was introduced for surgeons to treat incontinence and prolapse in the 1990s.
Health officials last month announced they will launch an audit into vaginal mesh implants to determine how many women have been affected in England.
The true rate of complications is unknown, and the Government has been accused of sweeping issues from vaginal mesh under the carpet.
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.
Sling The Mesh blasted the Government's 'weak' decision back back in December to recommend a ban on vaginal mesh implants for one procedure.
Nice, which advises the NHS, announced the surgery should only be banned for prolapse - when organs fall out of place, and not incontinence.
It is believed of the women in Sling The Mesh who have been given the controversial implant, three quarters were fitted with the device to treat their incontinence.
The Nice verdict came after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
It followed the landmark news from New Zealand that all forms of pelvic mesh would be banned - becoming the first major country to do so.
Officials in the country declared in December they would remove the controversial implants from supply and limit the use of surgical mesh products.
Tiresome fights by campaigners, backed by MailOnline, has also led to Australian health officials making a similar move for prolapse operations.
Watchdogs in the country banned the use of vaginal mesh implants for prolapse earlier in the same month after a review found benefits 'do not outweigh the risks'.
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.
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.
Mesh, introduced 20 years ago and dubbed 'gold-standard', was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
Because it did not require specialist training to implant, victims of the procedure have since begged for tougher regulations to conduct such surgery.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million (£41m) last September to a woman fitted with the implant.
Ella Ebaugh, 51, from Philadelphia, was awarded the eight-figure sum after a jury found the company to be negligent and its product defective.
http://www.dailymail.co.uk/health/article-5386803/Campaigners-slam-material-replace-vaginal-mesh.html
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Sheffield scientists develop new vaginal mesh to help thousands of women in pain
Feb 14, 2018 | The Star
By Dan Windham
Scientists believe they have come up with an alternative to the material used in vaginal mesh implants which prompted a huge number of women to complain they had been left in severe pain.
Mesh treatment has been offered in cases of pelvic organ prolapse and incontinence after childbirth, but sparked controversy after many women said they felt discomfort and had difficulty walking or having sex after undergoing the surgery.
Scientists at the University of Sheffield said they have now come up with a better material following seven years of research, suggesting the use of polyurethane rather than polypropylene.
The research group said polyurethane is more suitable because it has more more elasticity and a likeness to human tissue.
They also inserted oestrogen into the new mesh in a bid to speed up the healing process after treatment.
The research, published in the Journal of Neurourology and Urodynamics, said: "We believe that we have developed a new biomaterial that will avoid complications due to a better mechanical match with the native tissues."
Professor Sheila MacNeil, professor of tissue engineering in the department of materials science and engineering at the university, said they began their research "because it was clear that the polypropylene mesh was not fit for use in the pelvic floor".
She said: "Over the last seven years, we have investigated a range of materials and for the past few years, we have focused our efforts on polyurethane, using the method of electrospinning to create a fine mesh which we have fabricated in layers to mimic the structure of human tissue.
"We have shown through our research that it does not provoke inflammation and retains its strength and elasticity. The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue."
The scientists recognised their research "now needs to be further evaluated in suitable preclinical animal models".
Guidance from England's National Institute for Health and Care Excellence (Nice) in December said that following "serious, but well-recognised safety concerns" vaginal mesh should only be used for research purposes in future.
Data from the Medicines and Healthcare products Regulatory Agency showed that in the five years to 2017 more than 1,000 adverse incidents related to mesh implants had been reported.
Around 1,500 vaginal mesh operations are carried out in the UK each year, according to the NHS website, which added that the majority of women respond well.
https://www.thestar.co.uk/news/sheffield-scientists-develop-new-vaginal-mesh-to-help-thousands-of-women-in-pain-1-9015861
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Med industry insurer Medmarc sues Medtronic over pelvic mesh claims
Feb 14, 2018 | Mass Device
By Fink Densford
Medtronic (NYSE:MDT) is facing a suit from its insurer Medmarc Casualty Insurance alleging that the medtech giant inappropriately handled settlements related to pelvic mesh claims and is not entitled to $17.3 million in coverage from the company.
In the suit, filed in the U.S. District Court for the Eastern District of Virginia, Medmarc and subsidiary Noetic Specialty Insurance Company claim that Fridley, Minn.-based Medtronic, and its acquired subsidiary Covidien, repeatedly disregarded its obligations towards Medmarc and conditions necessary to ensure payment of judgements and settlements.
Medmarc said that Medtronic and Covidien breached four conditions that are part of the insurer’s coverage, according to court documents.
These include providing copies of bills paid and checks and drafts in payment of bills within 90 days of payment, not engaging, except at its own cost, in voluntarily making payments, assuming obligations or insuring expenses without Medmarc’s consent, cooperating with Medmarc in the investigation or settlement of claims and failing to “do nothing after loss to impair” rights Medmarc has to recover all or part of payments it makes under its policies, court documents read.
Medmarc goes on to argue that Medtronic paid higher than the average settlement value for pelvic mesh claims, saying that the company has never taken such a claim to trial and has no “reasoned basis for concluding that the average settlement value of the claims asserted against it is substantially higher than the average settlement value of claims settled by other mesh manufacturers,” according to court documents.
Medmarc is seeking to exclude itself from responsibility in the payment claims, saying that “as a result of [Medtronic]’s breach of its obligations to Medmarc, the Court should enter a judicial declaration that the claims payments made by [Medtronic] to date do not and cannot erode the SIRs in the Medmarc Policies.
The firm is also seeking a declaration that it has “no duty to indemnify [Medtronic] for settlements”, including past or present settlements for mesh claims over its breach of duties to cooperate with the firm during its investigation and during the settlements themselves.
https://www.massdevice.com/med-industry-insurer-medmarc-sues-medtronic-pelvic-mesh-claims/
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Appeals Court Upholds Boston Scientific Obtryx $19 Mill Loss
Feb 14, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, February 13, 2018~ Boston Scientific has lost its latest effort to overturn an $18.5 million loss by four plaintiffs at trial over its Obtryx pelvic mesh.
THE TRIAL
The Tyree case (here) consolidated four products liability cases against Boston Scientific (BSC) and was heard in November 2014 in the pelvic mesh multidistrict litigation currently underway.
The trial involved Jacquelyn Tyree, Carol Campbell, Jeanie Blankenship and Chris Rene Wilson. They were awarded damages ranging from $3.25 million to $4.25 million.
All were implanted with the Obtryx pelvic mesh, a ribbon of polypropylene (PP) plastic mesh placed under the urethra. All of the women had their surgery in West Virginia.
In 2015 Boston Scientific attempted to have the jury decision overturned.
The latest appeal was heard in December and decided February 7th (here) and written by Judge Wilkinson of the U.S. District Court of Appeals, of the 4th Circuit.
It states the evidence supported the jury finding that BSC negligently designed the device and failed to provide adequate warning. The appeals court also rejected the BSC argument against consolidation and upheld the punitive damages.
THE PLAINTIFFS
Among the plaintiffs, the first woman, implanted in 2011, experienced dyspareunia (painful sex). It was discovered her Obtryx pelvic mesh had eroded and portions of it were excised.
Plaintiff two was implanted in 2009. Her Obtryx pelvic mesh was “released” in 2012 since she could not urinate.
Plaintiff three had her Obtryx pelvic mesh implanted in 2010 and had a so called “sling-release procedure” in 2013 because her urethra had narrowed.
Plaintiff four was implanted in 2010 and experienced chronic pain and dyspareunia.
Originally consolidated into eleven cases for trials, six were dismissed and one was removed from consolidation, leaving the four cases. BSC wanted them tried separately, but that motion was denied.
BSC then tried to remove the evidence related to the MSDS (material safety data sheet) but that was denied. The district court did grant the plaintiffs’ motion to exclude evidence about the FDA’s 510(k) clearance process.
The trial in Charleston, WV took eleven days. The jury awarded compensatory damages of $250,000 to each of the four women and punitive damages of $1,000,000 each including future compensatory damages of $3 million to the first and second plaintiff, $3.5 million to the third and $4 million to the fourth.
Since then, BSC has reached settlements (presumably for less money) with two of the plaintiffs, while BSC proceeded with appeals in the two remaining cases.
BSC claimed the court abused its discretion by consolidating the cases in the first place, then allowing the MSDS evidence and excluding the process within the FDA which allows these medical devices on the market. BSC also challenged the punitive damage awards asserting erroneous jury instructions.
CONSOLIDATION
Trials can be consolidated under the Federal Rules of Civil Procedure 42(a), which says that actions that involve a common question of law or fact may be joined for a hearing or a trial. Consolidations also preserves time and resources and avoids conflicting rulings that could take place in individual actions.
The jury was reminded these are four separate claims and should be treated as such
In this case, all four plaintiffs were diagnosed with stress urinary incontinence (SUI) before being implanted with the Obtryx. All of the implants took place in West Virginia. In each case, the plaintiffs asserted design defect and a failure to warn under West Virginia law.
Because of the similarities they could share some she same expert witnesses and evidence.
APPEAL BY BSC
But Boston Scientific said that prejudice existed since the evidence presented only applied to some of the plaintiffs, not others.
BSC complained that omitting the clearance process by the FDA, the 510(k) regulation, omitted relevant information. Federal rules allow evidence to be omitted if it is unfairly prejudicial, confuses the issues, misleads the jury, or wastes time.
Judge Goodwin decided that the 510(k) evidence was of questionable relevance and was “inadmissible because of its potential to confuse the issues and mislead the jury.”
BSC wanted to show that meeting the criteria for FDA clearance was reasonable, which would have required experts and time to explore the FDA standard.
Discussion of the 510(k) process was also omitted in Cisson v. C.R. Bard Inc and in the Huskey v. Ethicon case.
BSC said the individual awards could imply jury confusion, but Judge Goodwin said it was not known what happened in the jury room and the separate awards indicates the jury considered the cases individually.
DESIGN DEFECT
A product is made by the manufacturer with instructions on its use.
Those are the standards for use and they should be “reasonably safe” for its intended use. When they are not, it is a design defect.
The plaintiffs showed the design was defective because of the use of Marlex polypropylene and the difficulty removing the Obtryx after implantation.
BSC argued that the evidence was insufficient because the plaintiffs’ lawyers did not establish a specific design flaw and did not provide any evidence there was a safer, alternative design.
But there was discussion during the trial of a safer alternative, when Obtryx was compared to another BSC device, there was no difference in cure rates but more groin pain among the women implanted with Obtryx.
At the time of the Tyree trial, there was a question whether West Virginia’s design defect claims required evidence of a safer design. The state’s law now requires evidence of a reasonable alternative design. (See Nease v. Ford Motor Co., 848 F.3d 219,234 (4th Cir. 2017))
FAILURE TO WARN
BSC says that the plaintiffs did not prove through expert testimony that the directions for use were inadequate, proof of a failure-to-warn.
Judge Goodwin said the Morningstar decision in the West Virginia Supreme Court of Appeals does not establish that expert testimony is required to establish a failure-to-warn claim. Instead, the jury heard evidence regarding the risks of Obtryx and risks that were not included in the directions for use.
“A jury could reasonably conclude based on this evidence that the Obtryx’s instructions were inadequate,” ~ Judge Wilkinson, 4th Circuit US Court of Appeals.
PUNITIVE DAMAGES
BSC claimed that the instructions to the jury on punitive damages used the wrong standard and should have been governed by a “clear-and-convincing-evidence” standard.
Judge Goodwin instructed the jury that they should apply the “preponderance-of-the evidence” standard, citing that the West Virginia Supreme Court of Appeals has affirmed such decisions.
A statute was later passed by the West Virginia legislature that a plaintiff establishes “by clear and convincing evidence” but it was not in effect at the time of the Tryee trial.
The appeals court decision, affirms the judgments of the district court.
BOSTON SCIENTIFIC
The same week as the Tyree case, Judge Goodwin was presiding over the first Boston Scientific bellwether trial in Miami.
It too had four plaintiffs – Eghnayem, Dortes, Nunez and Betancourt – who were all implanted with the Boston Scientific Pinnacle Pelvic Floor Repair Kit.
On November 13, 2014, the jury returned a collective award of $26.7 million to the four women. Mesh News Desk was in the courtroom for this Miami trial. See coverage here.
Pinnacle was removed from the market in May 2011, under an Immediate Recall by the FDA because the device “may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”
Obtryx II, an update to Obtryx, a pelvic mesh device to treat stress urinary incontinence, is still being marketed by Boston Scientific, along with three other mid-urethral sings made by Boston Scientific.
Boston Scientific also sells four meshes made for pelvic floor repair. ###
https://www.meshmedicaldevicenewsdesk.com/appeals-court-upholds-boston-scientific-obtryx-19-mill-loss/
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