Preview Newsletter
Ethicon Media Monitoring 4/5/2019
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Pa. Appeals Court Affirms State's Jurisdiction Over Pelvic Mesh Mass Tort
Apr 4, 2019 | Law.com
By Max Mitchell
An intermediate Pennsylvania appellate court has rejected a Johnson & Johnson subsidiary’s efforts to have all out-of-state plaintiffs dismissed from the pelvic mesh litigation in Philadelphia. -
Pennsylvania Will Accept Out-of-State Mesh Cases
Apr 4, 2019 | Mesh Medical Device News Desk
By Jane Ekre
Please has yielded $146 million in verdicts for mesh injured women. -
Life after vaginal mesh surgery
Apr 5, 2019 | BBC
By Caroline Briggs
The health watchdog has suggested controversial vaginal mesh implants should be offered again on the NHS. -
Vaginal mesh implants offered on the NHS again
Apr 4, 2019 | Pulse
By Lea Legraien
Controversial vaginal mesh implants have been made available on the NHS again after being temporarily suspensed. -
Surgical options must be ‘last resort’ for stress incontinence
Apr 4, 2019 | OnMedica
By Louise Prime
Doctors should offer women with stress urinary incontinence the full range of non-surgical options before exploring any surgical operations such as mesh or tape, the National Institute for Health and Care Excellence (NICE) now recommends. -
Vaginal mesh campaigners condemn lifting of ban on ‘vile procedure’
Apr 4, 2019 | Devon Live
By Anita Merritt
Vaginal mesh campaigners who have suffered life-changing injuries in Devon have slammed new guidelines which will allow the ban of the ‘vile procedure’ to be lifted once certain conditions are met. -
Connah's Quay woman left shocked by NICE decision on surgical mesh
Apr 5, 2019 | Leader Live
By Joe Robinson
A FLINTSHIRE woman left disabled following a surgical mesh implant has spoken of her disgust that a healthcare watchdog says the NHS could overturn the suspension on its use. -
WATCH: Woman tells of her ordeal after mesh surgery - went from being fit young mum to being suicidal
Apr 5, 2019 | Health24
A 50-year-old woman shares her ordeal after she underwent mesh surgery for what she describes as mild stress incontinence - but the aftermath took such a toll that she became suicidal. -
$2.3 million to improve safety of pelvic floor surgery
Apr 5, 2019 | Mirage News
The Liberal National Government will invest $2.3 million over three years to improve health outcomes for the more than 20,000 women who undergo pelvic floor surgical procedures each year. -
Still Time to Participate in MDL Satisfaction Survey for Pelvic Mesh Plaintiffs
Apr 4, 2019 | Mesh Medical Device News Desk
By Jane Akre
t is not too late to participate in a survey and confidentially share your thoughts on how the multidistrict litigation (MDL) has been working for you.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Pa. Appeals Court Affirms State's Jurisdiction Over Pelvic Mesh Mass Tort
Apr 4, 2019 | Law.com
By Max Mitchell
An intermediate Pennsylvania appellate court has rejected a Johnson & Johnson subsidiary’s efforts to have all out-of-state plaintiffs dismissed from the pelvic mesh litigation in Philadelphia.
A three-judge Superior Court panel on Wednesday determined that ties between Ethicon, a J&J subsidiary that is the main defendant in the pelvic mesh litigation in Philadelphia, and Secant, a Pennsylvania-based company that was involved in manufacturing the mesh product at issue, were sufficient to establish jurisdiction in the Keystone State in the wake of recent U.S. Supreme Court precedent affecting jurisdiction for out-of-state plaintiffs. The decision affirmed a ruling from the Philadelphia Court of Common Pleas.
The Superior Court’s unanimous ruling relied heavily on a decision the court made last year in Hammons v. Ethicon, which is another pelvic mesh case. That ruling from June was also the first instance that a Pennsylvania appellate court waded into the effects of the U.S. Supreme Court’s high-profile 2017 decision in Bristol-Myers Squibb v. Superior Court of California, which made clear that out-of-state plaintiffs can’t sue companies where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury.
A key part of Ethicon’s argument regarding jurisdiction was that it had a limited contractual relationship with the Bucks County-based company Secant, which manufactured and then supplied to the defendant the Prolene filaments Ethicon used to create the allegedly problematic pelvic mesh products.
But, relying on Hammons, Superior Court Judge Paula Francisco Ott said Wednesday in the court’s 14-page opinion in In re Pelvic Mesh Litigation that evidence showed Ethicon took a “hands-on approach” in dealing with Secant, providing detailed specifications for knitting the mesh and traveling to Pennsylvania to observe the mesh-making process.
“The design of the mesh, and in particular its inelasticity, is an important issue in this litigation,” Ott said. “Ethicon’s direct oversight of the knitting of the mesh in Pennsylvania, coupled with its reliance on clinical studies performed by a Pennsylvania gynecologist, is sufficient to bring Ethicon within the jurisdiction of this commonwealth.”
Ethicon is facing about 90 lawsuits in Philadelphia, where the company has been repeatedly hit with multimillion-dollar verdicts, including the $12.85 million awarded in Hammonsand a $41 million verdict awarded in January in Emmett v. Ethicon.
The decision marks the third time the Superior Court has addressed whether the out-of-state claims should be dismissed from Pennsylvania for lack of jurisdiction. Along with the Hammons ruling, the court also addressed the question in Carlino v. Ethicon. Appeals in both of those cases are pending before the Pennsylvania Supreme Court.
In an emailed statement, Shanin Specter of Kline & Specter, who is representing the plaintiffs, referred to Ethicon’s recent unsuccessful efforts to have the judge who presided over several trials, including Emmett, removed from handling pelvic mesh cases.
“We are gratified by the Superior Court’s reconfirmation of jurisdiction,” Specter said, but added he and his clients “remain concerned” by what they view as “Johnson & Johnson’s repeated judge-shopping and court-shopping.”
An Ethicon spokeswoman did not return a message seeking comment.
https://www.law.com/thelegalintelligencer/2019/04/04/pa-appeals-court-affirms-states-jurisdiction-over-pelvic-mesh-mass-tort/
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Pennsylvania Will Accept Out-of-State Mesh Cases
Apr 4, 2019 | Mesh Medical Device News Desk
By Jane Ekre
Please has yielded $146 million in verdicts for mesh injured women.
A three-judge panel on Wednesday cleared the way for more cases to be tried there.
Pelvic mesh plaintiffs who live outside Pennsylvania will be able to pursue pelvic mesh claims in the Keystone State against Johnson & Johnson (Ethicon). A three-judge Superior Court panel cleared the way Wednesday.
Law 360 has the story, by subscription only.
Pennsylvania, specifically the Philadelphia Court of Common Pleas, has been an especially favorable court to plaintiffs yielding about $146 million in verdicts to the mesh-injured women.
The precedent was set by the Hammons case.
Hammons, an Indiana resident, appeared before the Philadelphia jury in December 2015 and was awarded nearly $13 million.
The compensation included $7 million in punitive damages due to the injuries she suffered from the Prolift pelvic mesh device, which was implanted with in 2009.
Ethicon, argued that the Indiana woman’s case should never have been heard in Pennsylvania claiming it was the wrong jurisdiction for Hammons to bring a civil lawsuit.
Dr. Greg Vigna, MD JD
Dr. Greg Vigna, who consults with pelvic mesh cases and especially pudendal nerve damaged women from a pelvic mesh implant, believes this is good news for plaintiffs.“This is excellent news for my newly injured sling clients as my team looks to file catastrophic pudendal and obturator neuralgia cases in state courts across the country now that the MDL is closed. “We appreciate the work Kline-Specter has done and continues to do. Pennsylvania obviously will be a frequent venue going forward for my clients who may be best served with their case governed under Pennsylvania Product Liability law rather than their state of implantation.”
Patricia HammonsIn an 82-page decision, filed June 19, 2018, Superior Court Judge Victor P. Stabile told the company to pay the damages.
Hammons was represented by Shanin Specter of Kline Specter, a Philadelphia law firm.
Her complaint, filed in May 2013, included not just Ethicon, but Secant Medical and Secant Medical LLC, a manufacturer of surgical mesh located in Perkasie, Pennsylvania, lending credence to Pennsylvania as the proper venue for this civil action.
Proper Venue
Plaintiffs argue Johnson & Johnson works with Secant Medical Inc., a Pennsylvania-based company that manufactured its implants. That gives plaintiffs the jurisdiction in Pennsylvania.
Ethicon (Johnson & Johnson) had tried to have about 70 mesh cases toss from Pennsylvania based on a U.S Supreme Court decision (Squibb v Superior Court of California) that disallows judge shopping unless there is a link to a particular venue.
See Case #652 EDA 2018 before the Pennsylvania Superior Court, Pelvic Mesh litigation.
https://www.meshmedicaldevicenewsdesk.com/pennsylvania-will-accept-out-of-state-mesh-cases/
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Life after vaginal mesh surgery
Apr 5, 2019 | BBC
By Caroline Briggs
The health watchdog has suggested controversial vaginal mesh implants should be offered again on the NHS.
Use of vaginal mesh was halted across the UK last year amid safety concerns.
But, on Tuesday, the National Institute for Health and Clinical Excellence said the "limited evidence" meant "the true prevalence of long-term complications following surgery with mesh is unknown".
Here, BBC News talks to some of the women who say their lives were radically changed by the procedure.
Mel Semple lives in Newcastle with her husband, Ronnie, her three youngest children, and three dogs.
As a result of childbirth, Mel experienced mild incontinence, limited to when she was coughing or sneezing, and was fitted with vaginal mesh on the advice of a doctor.
The incontinence had been nothing more a nuisance, a disorder common to millions of women following childbirth.
It did not dominate or dictate her lifestyle - but, within weeks of the procedure, that would change.
Mel stopped being the active, healthy mother her family knew, and became a mass of pain, exhausted by the slightest effort.
Before long, her day-to-day life had become dominated by the simplest functions of her body.
Her incontinence became worse and she felt at constant risk of wetting herself.
As a drastic measure, she started to limit her fluid intake - and began to develop bladder infections, for the first time in her life.
One was so severe that she was admitted to hospital.
Today, Mel has to measure every journey by the distance to the nearest toilet.
It means she often finds it easier to stay at home - and her life has become more isolated.
On those days where she does venture out, she has to limit what she can drink.
A hot tub in the back garden provides relief from the constant pains in her hips and pelvis and from the fibromyalgia with which she was recently diagnosed.
A survey by the Sling The Mesh campaign group suggests a third of women fitted with vaginal mesh now have this debilitating condition - way above the national average.
Pressing surgeons for an operation to reverse the procedure, Mel spent most of the summer confined to her bed, unable to leave the house.
To get the go-ahead for the operation, she had to endure numerous visits to hospital for a series of scans and tests. Many are invasive, some are humiliating.
A Tens machine - often used by women in labour - provides some relief from the constant pain in her hips.
Family life has been placed under strain.
When her children were small, their lives were spent outdoors - cycling, walking and enjoying long adventures in the countryside.
Today, Mel's daughter is surprised when her mother is well enough to get out of bed.
Prescribed with powerful painkillers, such as Gabapentin and Pregabalin - drugs sometimes used by cancer patients, Mel has long been used to a daily intake of pills.
But the side-effects are "horrendous".
Instead, she has turned to alternatives such as cannabis oil in an attempt to manage her chronic pain.
Mel lives for her "better" days, when the pain subsides and her "brain fog" lifts.
On these days, Mel is able to get out of bed and tries her best to lead a normal life.
But her health and regular hospital appointments have come to dominate her existence, as she struggles to manage her condition and to be a mother to her children.
Jackie Cheetham, from Pickering, North Yorkshire, lives every day of her life in agonising pain.
This pain - like "being cut inside by a cheese wire" - began in 2006, shortly after she was fitted with vaginal mesh as part of a surgical treatment for incontinence.
For months, doctors dismissed her pain as psychosomatic - and she attempted to take her own life.
One in 20 women who responded to a recent survey by the Sling The Mesh campaign group said they had attempted suicide, with many more having suicidal thoughts.
After nearly 13 years, Jackie is unable to walk long distances - or to sit for any length of time.
She relies on a stick daily - and has to use a mobility scooter for long journeys.
The correspondence relating to her case runs to hundreds of pages.
In over a decade of discussion between health professionals, Jackie says her GP has been the only one who has consistently fought her corner.
Doctors initially told her mesh complications were one in a million, she says.
Others refused to believe the extent of her suffering.
And some even advocated that she should be sectioned under the Mental Health Act.
Her children are now grown up but they spent their childhood concerned every day for their mother's mental and physical wellbeing.
Jackie believes the experience has had a long-lasting effect on them.
Gill Hedley, from Newcastle, had mesh fitted in a procedure called a rectopexy, following a bowel prolapse.
She says the side-effects left her unable to work and she had to give up her house.
Gill's mesh was eventually removed but in doing so the surgeon had to remove Gill's rectum and part of her intestine.
She has been left with a permanent stoma and faces more surgery to close the incision wound, still open two years after the initial operation.
It has to be packed and dressed three times each week.
Gill says the problems caused by her mesh have had a profound and damaging effect on her mental health.
Kath Sansom, a journalist from Cambridgeshire, was a keen mountain biker and high board diver.
Four years ago, she had mesh surgery following the birth of her youngest child.
Within weeks, she says, an intense burning sensation in her vagina and severe leg pains left her "a wreck".
Kath founded the campaign group Sling The Mesh in 2015, after she discovered that women from across the world had experienced similar problems.
Every week, many more contact her with their stories. The campaign's Facebook group now has more than 7,300 members.
Kath runs the operation from her living room, often working late into the night.
Members' stories frequently reduce her to tears.
https://www.bbc.co.uk/news/in-pictures-47777782
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Vaginal mesh implants offered on the NHS again
Apr 4, 2019 | Pulse
By Lea Legraien
Controversial vaginal mesh implants have been made available on the NHS again after being temporarily suspensed.
The Government suspended the use of vaginal mesh on the NHS in July 2018 following an investigation carried out by the BBC in 2017. The investigation revealed that more than 800 women were taking legal action against vaginal mesh makers and NHS England, following complications such as the impossibility to walk and having suicidal thoughts.
However, new NICE guidance released this week revealed that it is now appropriate to offer implants to women suffering stress urinary incontinence and pelvic organ prolapse, as long as they are 'fully informed' about the risks and certain criteria are met.
Although NICE said in its guidance it 'acknowledged the public concern about the risks of these procedures, especially those involving the insertion of mesh products', it argued 'women should not be denied effective surgical options'.
It said: 'Instead, women should be fully informed and supported by their doctor to make the right decision about their treatment, taking into account the benefits and risks of all the options as well as any individual social or psychological factors that might affect their decision.
'The committee agreed that a patient decision aid could help women better understand the different surgical options and promote shared decision making.'
Labour MP Owen Smith told BBC Victoria Derbyshire that NICE has been ignoring the 'overwhelming, anectodal experience' from women who have come forward.
He said: 'The Government conducted its own study, as a result of the pressure we had been putting on for years, add found there was wide scale evidence of people having suffered all manner of harms, especially after five to seven years.
'For NICE now to effectively say 'we should just carry on regardless" is, I think, is flying over the evidence'.
NICE director for the centre for guidelines Dr Paul Chrisp said: 'The patient decision-making aids developed by NICE in association with patients, clinicians and professional bodies will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure.
'It will ensure each woman is able to decide, with the help of her clinician, which option is best for her. This might include the decision not to have surgery at all.'
He added: 'Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can.
'Surgeons must also record any intervention using surgical mesh/tape in a national database.'
http://www.pulsetoday.co.uk/news/all-news/vaginal-mesh-implants-offered-on-the-nhs-again/20038515.article
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Surgical options must be ‘last resort’ for stress incontinence
Apr 4, 2019 | OnMedica
By Louise Prime
Doctors should offer women with stress urinary incontinence the full range of non-surgical options before exploring any surgical operations such as mesh or tape, the National Institute for Health and Care Excellence (NICE) now recommends. Obstetricians and gynaecologists have welcomed the new guidance, as well as the patient decision aids and related user guides that NICE has published, which they said would help women and clinicians to make an informed choice about the best possible treatment for their individual circumstances.
Last July the government announced a period of "high vigilance restriction" on the use of a group of procedures in England, including vaginally inserted mesh and tape to treat stress urinary incontinence and pelvic organ prolapse, following a recommendation by Baroness Cumberlege, who is chairing an independent review of surgical mesh procedures and has heard from women and families affected by them.
In its final guidance on management of urinary incontinence and pelvic organ prolapse in women, NICE recommends that the full range of non-surgical options, including lifestyle interventions, physical therapies and medicines, should be offered to women with these conditions before any surgical operations are explored.
In addition to reiterating recommendations from its previous (2006/2013) guidance – including advising women with overactive bladder to trial caffeine reduction, advising women with urinary incontinence or overactive bladder and a high or low fluid intake to modify their fluid intake, advising women with urinary incontinence or overactive bladder who have a BMI greater than 30 to lose weight, suggesting pelvic floor muscle training, and offering at least six weeks’ bladder training as first-line treatment to women with urgency or mixed urinary incontinence – NICE now recommends that doctors “offer a trial of supervised pelvic floor muscle training of at least three months’ duration as first-line treatment to women with stress or mixed urinary incontinence”.
Furthermore, NICE now recommends that if women and their doctors explore surgical options, and if it is agreed to use surgical mesh/tape, doctors must fully inform women of the risks, and offer follow up within six months of surgery.
NICE also includes detailed guidance on the assessment and management of complications associated with surgery. It recommends that for women who report new-onset symptoms after having mesh surgery for urinary incontinence or pelvic organ prolapse, doctors should evaluate whether the symptoms might be caused by a mesh-related complication – and refer women with a suspected mesh-related complication to a urogynaecologist, urologist or colorectal surgeon for specialist assessment.
In their joint statement the Royal College of Obstetricians and Gynaecologists and The British Society of Urogynaecology said: “Stress urinary incontinence and pelvic organ prolapse are common and often debilitating conditions for which women must have access to a range of safe and effective treatment options.
“We therefore welcome NICE’s final guidance on the management of these conditions, which recommends that the full range of non-surgical options should be offered to women before any surgical procedures.
“We also fully endorse the patient decision aids published by NICE which are important resources for women and clinicians that will help them to understand all treatments available, as well as the benefits and risks associated with each option. These will support women and clinicians to make an informed choice about the best possible treatment for their individual circumstances.”
They added: “It is important to note that the high vigilance restriction remains in place for the use of mesh. While the period of high vigilance continues, healthcare professionals should continue to follow any restrictions.” -
Vaginal mesh campaigners condemn lifting of ban on ‘vile procedure’
Apr 4, 2019 | Devon Live
By Anita Merritt
Vaginal mesh campaigners who have suffered life-changing injuries in Devon have slammed new guidelines which will allow the ban of the ‘vile procedure’ to be lifted once certain conditions are met.
The controversial implants can be offered again on the NHS in England once certain conditions are met, health watchdog NICE has said.
Women in Devon have previously shared their stories of how the use of vaginal mesh, which is used to ease incontinence and to support organs, has left them unable to walk, work or have sex.
Mum-of-two Susan Morgan, is now virtually a recluse at her home in Brixham because she has no control over her bladder and remains in constant pain from the vaginal mesh trans vaginal tape (TVT), which she says feels like a chemical burn and cheese wire inside her body.
As well as the horrific impact the surgery has had on her health, Susan has lost her successful career, partner and all the other things she took for granted in life.
Since then she has been relentlessly campaigning to stop the use of vaginal mesh implants, and last July celebrated an initial victory when the government announced it has called for a pause in the use of mesh implants until a set of conditions is met.
NICE have now said operations must be performed by specialist surgeons at specialist centres before their reintroduction.
All instances - and outcomes - of vaginal mesh operations should also be recorded on a national database "to help with future decision-making", it said.
The NHS is not compelled to act on the guidelines - which are for England only - and the "pause" on vaginal mesh surgery remains in place.
But services are expected to take NICE recommendations into account when planning and delivering care.
Under the new guidelines, each patient would receive a "decision aid" - detailing all the latest evidence on available treatments - and mesh implants would be used only after non-surgical options, such as lifestyle changes and pelvic floor training, had failed.
NICE said the "limited evidence" meant "the true prevalence of long-term complications following surgery with mesh is unknown".
Susan says she is horrified the concerns of thousands of women have suffered injuries following mesh surgery are being ignored.
She said: “This a slap in the face to the thousands of seriously injured women that suffer severe and painful complications as a result of this vile procedure. We have lost our sex lives, partners and careers. Our bladders, urethras and vaginas have been injured causing mind blowing pain.
“I have been in this pain now for 10 years and I am a mere shadow of my former self. Every day is a struggle, but my life now is about supporting mesh injured women and this announcement is profoundly upsetting.
“I have had the pleasure to meet Baroness Cumberlege and her very compassionate review team where they gave five conditions to be met before the pause on mesh could be lifted, and shamefully these conditions have not been met.
“The government called for this review and at the very least NICE should have waited until the review team had concluded. NICE clearly has not reflected on the mesh tragedy across the country and not truly considered the patients that have been catastrophically injured, and why it happened.
“Just one point from NICE which show weakness is the reference to multidisciplinary (MDT) teams, but this only happens in NHS hospitals. What about the private patients and with no mention of nurse/ RGN continence advisers? This does not take into consideration the pressure that the patient will be placed under yet again by the doctor to accept these devices.”
Baroness Cumberlege CBE, chair of the Independent Medicines and Medical Devices Safety Review said: “We will examine the NICE guideline published.
Our position is very clear. Last July, we recommended, and NHS England and the Department of Health & Social Care agreed to, an immediate pause in the use of mesh for stress urinary incontinence.
“We made the recommendation because we had already by then heard from many women, all of who had suffered terribly following their mesh procedures, and continue to do so.
“Since then, we have met many hundreds more women across the country who face the same situation. The scale and intensity of this tragedy is truly shocking, lives have been ruined.
“We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. Those conditions have not yet been met, and it is clear to us that it will be some considerable time before they are.
“This means that now and for the foreseeable future mesh should not be used to treat stress urinary incontinence either in the NHS or the independent sector.
“A restriction in the use of vaginally inserted mesh for pelvic organ prolapse has also been put in place. Abdominally inserted mesh to treat pelvic organ prolapse has, since the introduction of the pause, been subject to an NHS high vigilance regime to address safety concerns.
“We expect both the restriction and the high vigilance regime to continue. We are in the midst of our review and expect to publish our report with recommendations later this year.”
An official at England's Department of Health and Social Care said: "NICE's new guidelines and patient decision aids on managing urinary incontinence and pelvic organ prolapse will help women make more informed choices about their treatment.
"The use of vaginal mesh was paused to ensure that patients receive a high-quality and consistent service.
"Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant."
https://www.devonlive.com/news/devon-news/vaginal-mesh-campaigners-condemn-lifting-2719444
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Connah's Quay woman left shocked by NICE decision on surgical mesh
Apr 5, 2019 | Leader Live
By Joe Robinson
A FLINTSHIRE woman left disabled following a surgical mesh implant has spoken of her disgust that a healthcare watchdog says the NHS could overturn the suspension on its use.
Connah's Quay resident Maxine Cooper, 56, has been undergoing treatment for four years following major health complications after she received a surgical mesh implant after pregnancy in 2010.
And she has told of her shock and horror at the news that The National Institute for Health Care and Excellence (NICE) says the block on the use vaginal mesh can be lifted with changes.
Mesh is a generic name for metallic or polymeric (plastic) implantable surgical devices used as a scaffold to reinforce weaknesses in tissue or bone throughout the human body.
There are several common conditions which it is used to treat, including stress urinary incontinence, a condition caused by a complication in pregnancies.
But a number of complications can and have been shown to arise after having mesh implanted. Patients can suffer from internal injuries to neighbouring organs, blood vessels and nerves, which in turn can leave people with severe illnesses and disabilities. These are life altering conditions and in the worst-case scenario may result in death.
NICE announced earlier this week that any future operations must be performed by specialist surgeons at specialist centres before their reintroduction.
All instances - and outcomes - of vaginal mesh operations should also be recorded on a national database "to help with future decision-making", it said.
The NHS is not compelled to act on the guidelines - which are for England only - and the "pause" on vaginal mesh surgery remains in place.
But it is expected to take NICE recommendations into consideration when planning and delivering care methods.
Despite the numerous cases like Ms Cooper's, NICE said the "limited evidence" meant "the true prevalence of long-term complications following surgery with mesh is unknown".
And the news comes as a huge blow for women mesh has affected, like Maxine Cooper, who successfully campaigned for its embargo.
Ms Cooper said: "It's absolutely disgusting that NICE is even contemplating bringing it back. Every woman left disabled by mesh who's told their story must be being ignored.
"It's not as if it's just one or two isolated cases, it's thousands of women whose lives have been changed forever because of this operation.
"If the suspension on its use is lifted, I am willing to stand outside hospitals and warn women about what potentially awaits them.
"Why anyone, with the amount of cases of it going wrong, would be willing to play Russian roulette with their life I don't know.
"I would give anything to go back to before my operation and decide on another form of treatment."
Ms Cooper organised a fundraising night last Friday with acclaimed psychic medium and clairvoyant James Byrne partly in aid of Mesh UK, a charity supporting women affected and campaigning for a permanent ban on the use of surgical mesh.
And despite the evening being a resounding success, with over £1700 raised on the night, a hallmark of the extent mesh has changed Ms Cooper's life is that she was in so much pain during the evening she could barely sit through.
She said: "I gave a little speech at the start of the night as I had organised it, but I was so ill that I couldn't really enjoy it. The pain is just excruciating, but I'm just glad so much money was raised."
https://www.leaderlive.co.uk/news/17552881.connahs-quay-woman-left-shocked-by-nice-decision-on-surgical-mesh/
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Apr 5, 2019 | Health24
A 50-year-old woman shares her ordeal after she underwent mesh surgery for what she describes as mild stress incontinence - but the aftermath took such a toll that she became suicidal.
Urinary incontinence is not only a condition that can cause a great deal of embarrassment, but it can potentially be life-ruining. There are treatment options, many often including the surgical procedure where vaginal mesh is implanted.
But this surgery comes with its own set of risks and can include a host of side-effects such as pain and infection, not to mention a far-reaching effect on intimacy.
In this video, Jackie Cheetham, a 50-year old woman, shares her agony after receiving the mesh implant procedure. She explains that she always suffered from mild stress incontinence, from the age of 15.
But after childbirth, the condition worsened and she sought help from a GP when the incontinence started getting in the way of her marathon training. She was referred to a hospital, where the procedure was described as a quick same-day surgery. She woke up with groin pain and was told that it will get better.
But over the weeks, the pain progressed to her bladder. She spent next few months in and out of hospital as the pain gradually got worse.
She lost her job, and her house - and found herself bed-ridden and unable to play with her kids. It all took such a toll that Jackie tried to commit suicide.
Her ordeal isn't the first. Health24 previously reported on other patients who experienced several complications such as unbearable pain and nerve damage.
https://www.health24.com/Medical/Incontinence/News/watch-woman-tells-of-her-ordeal-after-mesh-surgery-went-from-being-fit-young-mum-to-being-suicidal-20190405
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$2.3 million to improve safety of pelvic floor surgery
Apr 5, 2019 | Mirage News
The Liberal National Government will invest $2.3 million over three years to improve health outcomes for the more than 20,000 women who undergo pelvic floor surgical procedures each year.
Government funding will support the establishment of a Pelvic Floor Surgery Clinical Quality Registry to collect information about the safety of medical procedures and transvaginal surgical mesh devices which are used in the treatment of pelvic organ prolapse and stress urinary incontinence.
In time, the registry will be able to provide benchmarked, risk-adjusted feedback to drive continuous improvement.
The registry will also be used to ensure all patients and surgeons can be contacted as quickly as possible in the event of an identified risk or issue with a particular device.
An estimated 150,000 Australian women have had mesh devices implanted since 1998, when they were first approved for supply in Australia.
For many women, procedures involving mesh devices have been beneficial. However over the past decade there has been an increase in the number of patients reporting complications.
The establishment of the registry follows a Senate inquiry that reported its findings in March 2018.
The Senate inquiry provided a number of recommendations including the enhancement of post-market surveillance and the preparation of material to guide an effective informed consent process.
I acknowledge the strength of the women who spoke at the public hearings, recounting deeply private and often traumatic experiences.
All Australians expect and deserve a high quality healthcare system. The Australian Government is committed to ensuring the safety of all patients and restoring the confidence of affected women in our healthcare system, now and into the future.
The proposal for the registry was developed in close consultation with prominent clinicians, the Australian Commission on Safety and Quality in Health Care, and Monash University.
In particular I would like to thank Professor Helen O’Connell, Director of Surgery and Head of Urology at Western Health in Victoria, and Dr Oliver Daly, the clinical lead for Urogynaecology at Western Health, for their efforts.
The registry has received in-principle support from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, UroGynaecological Society of Australia, Urological Society of Australia, Colorectal Surgical Society of Australia and Royal Australasian College of Surgeons.
Australians deserve and expect a high quality healthcare system.
The Liberal National Government is committed to a system that is professional, that ensures informed consent by patients and delivers better health outcomes.
The Australian Government’s full response to the Inquiry is on the Health Department’s website at www.health.gov.au/internet/main/publishing.nsf/Content/government-responses
https://www.miragenews.com/23-million-to-improve-safety-of-pelvic-floor-surgery/
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Still Time to Participate in MDL Satisfaction Survey for Pelvic Mesh Plaintiffs
Apr 4, 2019 | Mesh Medical Device News Desk
By Jane Akre
t is not too late to participate in a survey and confidentially share your thoughts on how the multidistrict litigation (MDL) has been working for you.
More than 104,000 pelvic mesh cases were consolidated in one court in Charleston, West Virginia to expedite the settlements and to hear bellwether trials to set relative values of these cases, filed against seven manufacturers.
From your comments here and online, expedite is far from what has actually happened.
This is a chance to make use of legal channels to let the MDL committee know what has or has not worked for you, the plaintiff.
Feedback is vital to making things better.
Professor of Law, Elizabeth Burch would like your participation in this:
University of Georgia School of Law Procedural Justice Study, Confidential Study for Plaintiffs involved in Women’s Health MDLs
Burch, a law professor at the University of Georgia School of Law is conducting a project that gives plaintiffs a chance to confidentially discuss their experience with the justice system. That includes the lawyers, the judges and any third-party funders. Many have already participated and Professor Burch is very thankful.
She is not in any way affiliated with or related to any of the law firms, either side sand she does not consult for anyone. There have been some unsubstantiated rumors to that effect. She is funded solely by the University of Georgia.
She tells Mesh News Desk:
“I’m hoping that it will give them a voice. I’m working with Margaret Williams, who’s full time job is at the Federal Judicial Center, but who is writing under her Vanderbilt University affiliation. She’s a talented statistician, and our hope is to turn the study into a widespread in-depth look at the procedural justice issues (if the data shows they exist, of course) that litigants face in the mass harms.”
Burch even provides her phone number so you can be reassured about confidentiality and the purpose of the survey. Otherwise the MDL system will continue what it’s always done, amassing huge numbers of cases into one court to get them through the system. If it didn’t work for you, perhaps you can pay it forward and help others.
Thank you in advance!
The link is here.
https://www.meshmedicaldevicenewsdesk.com/17472-2/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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