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Ethicon Media Monitoring 10/12/2018
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British mesh investigation paints 'hair raising' picture of 'scandal'
Oct 12, 2018 | Newshub
By Aine Kelly-Costello
A British investigation reveals how vaginal mesh implant manufacturers, regulators and the medical profession have all been complicit in causing thousands of women unnecessary pain and ongoing complications over the past 20 years. -
Investigation exposes 'scandal' that has left thousands of women irreversibly harmed
Oct 11, 2018 | Medical Xpress
An investigation by The BMJ reveals how vaginal mesh implant manufacturers "aggressively hustled" their products into widespread use, how regulators approved them "on the flimsiest of evidence" and how the medical profession failed to set up registries that might have picked up problems far sooner. -
What we must learn from mesh
Oct 11, 2018 | British Medical Journal
By Fiona Godlee
What can we learn from the shameful story of vaginal mesh? -
What new mesh guidance means for future patients and the 'victims' whose lives have been ruined
Oct 11, 2018 | Wales Online
By Mark Smith
Mesh operations should only be carried out “as a last resort” for women suffering from incontinence and prolapse, a health body has concluded. -
Grandmother living in agonising pain from mesh 'life sentence' calls for apology
Oct 12, 2018 | The Press
By Cate Broughton
Marie Knibb had two surgeries to implant mesh. She then needed 15 more to take it out. -
Women Patients Urge Surgeons Not To Use Mesh Material
Oct 11, 2018 | WBBM NewsRadio (Blog)
By Michele Fiore
Women who say they were injured by the implantation of polypropylene pelvic mesh rallied outside the Hyatt Regency Hotel Thursday.
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British mesh investigation paints 'hair raising' picture of 'scandal'
Oct 12, 2018 | Newshub
By Aine Kelly-Costello
A British investigation reveals how vaginal mesh implant manufacturers, regulators and the medical profession have all been complicit in causing thousands of women unnecessary pain and ongoing complications over the past 20 years.
The two reports by investigative journalist Jonathan Gornall, published by the British Medical Journal, claim manufacturers "aggressively hustled" the products into circulation, that regulators approved them "on the flimsiest of evidence," and that conflicts of interest have been ubiquitous since the product's inception in 1998.
The polypropylene mesh sling or tape, originally designed to surgically treat stress urinary incontinence and pelvic organ prolapse, replaced a daunting operation involving an average of seven days in hospital and a long recovery period, one report explains.
But, since that time, evidence of poorly managed regulatory procedures and lasting pain and complications for women has steadily increased.
Side-effects can include pain, urinary tract infection, trouble urinating, discharge, bleeding and pain during sexual intercourse, among others.
The reports say the product's life got off to a rocky start when its inventor - Swedish Ulf Ulmsten, in 1997 was paid $1 million in advance of a study to test the safety and effectiveness of a type of vaginal mesh by medical multinational Johnson and Johnson.
Jonson and Johnson deny the payment was linked to the study's outcome.
While Medsafe has restricted the supply of vaginal mesh for gynaecological procedures in New Zealand as of January 4 this year, surgical mesh can still be used in other operations including hernia surgery, a Medsafe spokesperson told Stuff.
Stuff reports ACC paid $13 million across 810 claims for surgical mesh-related injuries in the 12 years to June 2017, and a press release from advocacy group Mesh Down Under states ACC reports such claims to have increased by 34 percent in the year to June 2018, bringing the total to more than 1000.
Carmel Berry, co-founder and leader of Mesh Down Under says the report is just one more reason change is needed in New Zealand.
"The British Medical Journal article that was published this week is an exposé of the culmination of many years of medical colleges, regulators and manufacturers deflecting responsibility for patient harm and in many cases ignoring patient claims," she says.
However, she says some progress is being made.
"We heard just yesterday that Hon James Shaw (Acting Associate Minister of Health) has agreed to our proposal that the Ministry provides an opportunity for all New Zealanders affected by surgical mesh (and that includes men with hernia mesh as well as women, and their families) to be heard via a national 'roadshow'."
Ms Berry says Mesh Down Under will discuss logistics with the Ministry next week.
https://www.newshub.co.nz/home/world/2018/10/british-mesh-investigation-paints-hair-raising-picture-of-scandal.html
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Investigation exposes 'scandal' that has left thousands of women irreversibly harmed
Oct 11, 2018 | Medical Xpress
An investigation by The BMJ reveals how vaginal mesh implant manufacturers "aggressively hustled" their products into widespread use, how regulators approved them "on the flimsiest of evidence" and how the medical profession failed to set up registries that might have picked up problems far sooner.
It also names prominent individuals—all on mesh guidelines committees—who take money from mesh manufacturers for various activities including research grants, speaker honorarium and consultancy, as do the medical royal colleges, creating a potential for bias. And even where payments are declared, it is very hard to unpick their value, and there is no obligation on clinicians to declare their interests.
Altogether, this "hair raising" story offers lessons for the entire medical community, manufacturers and regulators, says author andinvestigative journalist, Jonathan Gornall.
Vaginal mesh implants were introduced in 1998 as a quick and easy way to treat stress urinary incontinence and pelvic organ prolapse in women. Twenty years on, their use in the NHS is suspended pending the findings of a major government review—and companies are facing tens of thousands of compensation claims.
In a series of special reports published today, Gornall charts the rapid rise of mesh in the UK and tracks down some of the doctors who warned of the consequences of mass launching a product on flimsy evidence.
He also tracks the failure of the surgical profession to register patients getting mesh implants, despite warnings from NICE and others dating back to 2003.
It wasn't until February 2018 that Jeremy Hunt, the former health secretary, announced that his department would be investing £1.1m "to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues." If all of [these warnings] had been heeded, "today's mesh crisis might have been largely averted," argues Gornall.
In a second report, Gornall goes in search of Ulf Ulmsten, the Swedish obstetrician who invented mesh, and uncovers how the original evidence was mired in a multimillion pound deal, industry funded research, and undisclosed conflicts of interest.
Gornall describes how, in March 1997, Ulmsten was paid $1m by global medical giant Johnson and Johnson ahead of a study to test the effectiveness and safety of his new tension-free vaginal tape (TVT) procedure.
While Johnson and Johnson deny allegations that the payment was conditional on the study proving successful, and rejected any suggestion that this had compromised the results of that trial, Gornall questions whether this was 'wallet driven' research.
Finally, Gornall reports on the NHS surgeons, professional bodies, royal colleges and medical conferences that benefit from corporate funding and how this financial involvement is hidden from patients. He describes how, despite government guidance on conflicts of interests, it remains difficult to unpick industry funding of clinicians in the UK—and specialists in vaginal mesh are no exception.
But it isn't only individual clinicians who have financial links with industry, says Gornall, who cites links between some of the leading mesh device companies and several royal colleges, including the Royal College of Surgeons and the Royal College of Obstetricians and Gynaecologists.
The UK Pelvic Floor Society, whose members use synthetic meshes for prolapse and incontinence surgery, is also supported by Shire, Cook Medical, Medtronic, THD, and BK Medical, he adds.
But regardless of the perceived or actual effect of such extensive industry influence within specialist branches of the medical profession, none of this information is freely or easily available to the public in the UK, argues Gornall.
The UK trails far behind the US in putting the relationship between doctors and industry in plain sight, he writes. Without legislation, he believes that "it is all too easy for patients to draw conclusions harmful to public confidence in the healthcare system."
In an editorial, Chris Allan and colleagues at Newcastle University warn that Europe's new device regulations "will fail to protect the public, unless they are reinforced."
They argue that the new rules, which come into force on 26 May 2020, "require further tightening to protect public safety." At the very least, for all high risk devices, national authorities such as Medicines and Healthcare products Regulatory Agency (MHRA) in the UK "should take over conformity assessments to reduce commercial conflicts of interest," they write.
And they say clinical studies of both efficacy and effectiveness "should be a condition of pre-market approval," and all data including clinical studies and investigations "should be available to everyone, ending differential rights of access for regulators and the public."
Dr. Fiona Godlee, The BMJ's Editor in Chief and Professor Carl Heneghan of Oxford University's Centre for Evidence Based Medicine, say the postmarketing assessment of vaginal mesh has been "a shameful episode in the history of implantable devices."
Surgeons, manufacturers, regulators, and governments have all played their part in this failing, they write in an editorial. "Mandated national registries are needed for all implantable devices, to protect patients, improve outcomes, reduce costs, and identify best practice. Another mesh tragedy is otherwise inevitable."
https://medicalxpress.com/news/2018-10-exposes-scandal-left-thousands-women.html
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Oct 11, 2018 | British Medical Journal
By Fiona Godlee
What can we learn from the shameful story of vaginal mesh? That thousands of women have been irreversibly harmed; that implants were approved on the flimsiest of evidence; that surgeons weren’t adequately trained and patients weren’t properly informed; that the dash for mesh, fuelled by its manufacturers, stopped the development of alternatives; that surgeons failed to set up mesh registries that would have identified complications sooner; and that the National Institute for Health and Clinical Excellence and the UK regulators let them off the hook (doi:10.1136/bmj.k4137, doi:10.1136/bmj.k4164). As our editorial says (doi:10.1136/bmj.k4231), unless mandatory national registries are now established another mesh tragedy is inevitable.
The mesh story tells us something else: the extent to which surgeons, researchers, and professional bodies are entangled with the device manufacturers. This is nothing new. Indeed discussion of it will be as tediously familiar to most readers of The BMJ as it is to us editors. But we make no apology for raising it again. Why? Because of the evidence that researchers’ conclusions and clinicians’ decisions are influenced in favour of their sponsors’ products. If this were not the case, why would manufacturers spend the money? GlaxoSmithKline has just confirmed the usefulness of paid opinion leaders by reinstating payments to clinicians who speak and write about its products (doi:10.1136/bmj.k4157).
So I have two questions. First, should clinicians and researchers take money from industry? My answer is no. We don’t allow judges or journalists to take money from the people they are judging or reporting on. Doctors should be equally independent in their advice to patients. This is why, uniquely among the major medical journals, The BMJensures that the authors of clinical education articles and editorials are free from relevant financial interests (doi:10.1136/bmj.g7197). As for industry sponsored research, we welcome the call by Paula Rochon and colleagues for journals to ensure that academic authors retain full control of the process (doi:10.1136/bmj.k4224).
Second, given that doctors and researchers do take money from the industry, should the details be readily available to patients and the public? My answer is yes. Jonathan Gornall found this wasn’t the case with mesh (doi:10.1136/bmj.k4164), despite NHS guidance on declaration of financial interests. NHS trusts are catching up with their responsibilities, but slowly. The Association of the British Pharmaceutical Industry’s database is voluntary and therefore ultimately ineffectual. The device industry’s equivalent body, the Association of British HealthTech Industries, has refused to take even this baby step. The GMC has been asked to establish a register of doctors’ interests (doi:10.1136/bmj.h396) but shows no signs of doing so.
In the US the Sunshine Act hasn’t solved the problem (doi:10.1136/bmj.k4151) but it has put doctors on notice (http://bit.ly/2C94j6G). Other countries should follow this lead.
https://www.bmj.com/content/363/bmj.k4254
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What new mesh guidance means for future patients and the 'victims' whose lives have been ruined
Oct 11, 2018 | Wales Online
By Mark Smith
Mesh operations should only be carried out “as a last resort” for women suffering from incontinence and prolapse, a health body has concluded.
The National Institute for Health and Care Excellence (Nice) has issued new draft guidance which states that clinicians should offer non-surgical options before any mesh procedures take place.
The organisation has also called for a national database to be set up to record all procedures involving the use of surgical mesh or tape to “help with future decision-making”.
But mesh victims believe the draft guidance doesn’t go far enough and have called for the operations to be banned altogether.
Mesh implants have devastated the lives of thousands of people across the UK and left many in permanent pain, unable to walk, work or make love to their partners.
Made out of plastic and typically used in women after childbirth, the devices are implanted to support organs such as the vagina, uterus, bowel, bladder or urethra.
But complications appear to be rife in the UK with women reporting severe and constant abdominal and vaginal pain following the surgery while others have experienced incontinence, infections, and bleeding.
Now Nice has changed their guidance which could substantially reduce the number of mesh operations taking place.
Sir Andrew Dillon, chief executive of Nice, said: “Our independent advisory committee looked at a range of evidence for interventions for urinary incontinence and pelvic organ prolapse in women and made a series of detailed recommendations using the best evidence currently available.
“It is important that every woman is supported to make decisions that are right for her, consents to a procedure, and fully understands the benefits and risks of the procedure being offered before consenting to it.
“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 patient then she should be referred to one who can.
“Surgeons must also record any intervention using surgical mesh/tape in a national database.
“The guideline committee was asked to look at a range of interventions and examine the evidence for them. Importantly our recommendations offer women a range of options for treatment that don’t involve the use of surgical mesh/tape.”
Carolyn Churchill, who had a mesh implanted into her seven years ago in a bid to combat her stress incontinence, said the device stopped her walking properly and ruined a 14-year relationship with her partner.
She fears many women will continue to have the mesh procedure.
“Many of us feel that the campaign to ban mesh has taken a huge step backwards,” said the Nantgarw resident.
“This opens the doors for many more people to be abused surgeons who don’t have the skills to repair with natural tissue.
"By banning mesh it will open the flood gates for compensation.”
Kath Sansom, of campaign group Sling the Mesh, added: “Ideally we want all pelvic mesh banned. The risks are too great.
“It is totally unacceptable that women come out of a ‘simple little operation’ with shattered lives.
“One in seven women in Sling The Mesh have lost their marriages because of mesh. Seven in 10 have lost their sex life. Eight out of 10 suffer pain so great it affects their daily life.
“More than half suffer ongoing urinary infections. Not surprisingly many are suicidal and six in 10 are on antidepressants.
“Sling The Mesh has nearly 7,000 members. Sadly many thousands have been harmed in the last 20 years. This guidance should have come a long time ago.”
The concerns with mesh are not isolated to just woman.
Former supermarket manager Peter Corbett, who had a mesh inserted following a hernia, said the procedure and subsequent removal of the implant has left him struggling to walk or play with his grandchildren.
His wife Dawn Corbett, from Llwydcoed, Aberdare, said of the new guidance: "I think it’s a good solution but it still does not answer the question of why it was used in the first place.
"It also doesn’t solve the problem that many men are suffering, like my husband who had a hernia repair with the mesh."
The non-surgical options for urinary incontinence advised by Nice include:
Lifestyle interventions
Physical therapies
Behavioural therapies
Medicines
While the non-surgical options for pelvic organ prolapse include:
Lifestyle modification
Topical oestrogen
Pelvic floor muscle training
Pessary management
The draft guideline also recommends how complications associated with surgical mesh surgery should be assessed and managed.
Nice says consultants at specialist centres should develop individualised investigation plans for each woman with suspected or confirmed mesh-related complications.
Complications related to the device should also be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and details of the complications should be collected in a national registry.
In July a national “pause” was announced by the UK Government on the use of the devices to treat stress urinary incontinence and prolapse where the mesh is inserted through the vaginal wall.
Nice says this will remain in place until a number of conditions are met including:Registering all operations and any complications on a national databaseSurgery being performed by specialist surgeons based at specialist centres
Chairman of the All-Party Parliamentary Groups on surgical mesh implants, Owen Smith MP, said: “This is a welcome U-turn from Nice, who in their 2016 guidelines for mesh did not recommend any other treatment options for stress urinary incontinence and in fact stated that complications from mesh were ‘infrequent’.
“While I am pleased that Nice is now taking action to advise against mesh as a first-line treatment this announcement is well overdue. I have called on them to get on and urgently publish these guidelines for the last two years and I’m glad they have finally listened.
“This news is also a complete vindication of the thousands of women injured by mesh surgery who have campaigned tirelessly to get the procedure halted.
“I believe that the announcement of these guidelines, along with the Department for Health’s current suspension of mesh surgery, will mean the end of mesh surgery for incontinence other than for a handful of women for whom all other options have been ruled out.”
https://www.walesonline.co.uk/news/health/what-new-mesh-guidance-means-15261794
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Grandmother living in agonising pain from mesh 'life sentence' calls for apology
Oct 12, 2018 | The Press
By Cate Broughton
Marie Knibb had two surgeries to implant mesh. She then needed 15 more to take it out.
The 57-year-old Canterbury mother and grandmother lives with agonising pain in her pelvic area and right leg, bladder failure, nerve damage, insomnia, depression and Post Traumatic Stress Disorder (PTSD).
Knibb and other New Zealanders who suffered from mesh botch-ups are calling on the Government to follow Australia's lead and apologise.
On Wednesday, Australia's Health Minister Greg Hunt responded to a Senate inquiry into vaginal mesh accepting, in principle, 11 of 12 recommendations to improve safeguards against mesh-related harm.
"On behalf of the Australian Government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes," he said.
In an open letter to Acting Associate Minister for Health James Shaw, support group Mesh Down Under said an apology would make "a massive difference to all those concerned".
A British Medical Journal investigation this week revealed vaginal mesh devices were "aggressively hustled" by manufacturers despite "flimsy" evidence of safety, surgeons were inadequately trained and governments failed to track complication rates.
Shaw said a nationwide roadshow by the Ministry of Health was planned "to hear from survivors and their experiences".
"...I expect to get advice back about what would be the most meaningful and sincere way for the government to apologise."
After a decade of suffering mesh-related injuries Knibb wants New Zealand surgeons and the Government to listen and learn.
"Mesh has to stop being used. Surgeons need to be monitored and given further teaching and need to give their patients other options."
Five months after surgery in May, Knibb's bladder has not healed. Every visit to the toilet is excruciating and leaves her nauseous.
A weakened right leg from nerve damage has made walking difficult and she recently bought a motorised scooter.
Knibb's mesh nightmare started in 2008 when she sought help for a minor prolapsed bowel.
A gynaecologist told her he could do a "simple" mesh procedure and complications were very rare.
She signed a consent form which advised there was a risk of erosion, bleeding and infection, but her surgeon again assured her these were rare.
Knibb says no alternatives to the surgery were suggested.
Within six weeks she developed a constant aching pain in her buttock and burning in the groin but this was attributed to a back injury.
Her surgeon denied the pain was from mesh.
In 2010 the same surgeon diagnosed a bladder prolapse and implanted two more mesh devices.
Following this procedure she developed terrible pain while urinating. The implanting surgeon checked for mesh erosion and found none.
He suggested a hysterectomy and this went ahead but failed to improve the symptoms.
"Two years of hell later" she went to another urologist who found mesh had eroded into her bladder.
"It felt like I had barbed wire in me, cutting into me."
In 2012 and 2013, three major operations went ahead to remove all of the mesh.
But the pain worsened and by January 2015 Knibb developed chronic depression.
"I was almost suicidal thinking...is this the way I'm going to be for the rest of my life?
"I'd had three surgeries within 12 months and it was all just quite hideous. I'd had to have so much time off work and that led to guilt and it just really got to me at that point."
In 2016, Knibb was forced to quit her job as an academic administrator. She sought a second opinion with a surgeon in Wellington who found further mesh erosion in her bladder.
Further surgeries went ahead to remove more mesh.
But surgeons were unable to remove all of it without risking major, life-threatening complications, Knibb said.
"You just can't ever be mesh-free, it's a life sentence. I don't believe there is a surgeon in New Zealand who can guarantee they can remove it all successfully."
https://www.stuff.co.nz/the-press/107745117/Grandmother-living-in-agonising-pain-from-mesh-life-sentence-calls-for-apology
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Women Patients Urge Surgeons Not To Use Mesh Material
Oct 11, 2018 | WBBM NewsRadio (Blog)
By Michele Fiore
Women who say they were injured by the implantation of polypropylene pelvic mesh rallied outside the Hyatt Regency Hotel Thursday.
They picked that site because nearly 2,000 urogynecologists were attending their annual conference there.
The women say they have suffered life-altering complications from the procedure, which is done to alleviate any urinary incontinence or provide help for a fallen bladder.
Ongoing issues they say include reoccurring urinary infections, autoimmune diseases, inflammation, and possible bladder cancer.
One of the physicians at the conference, Dr. Margaret Mueller of Northwestern, says a "sling procedure for stress incontinence" is a common procedure. She said mesh is a durable material.
The American Urogynecologic Society met with the group of protesters and listened to their concerns.
https://wbbm780.radio.com/articles/women-patients-urge-surgeons-not-use-mesh-material
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