Preview Newsletter
Ethicon Media Monitoring 12/7/2017
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J&J Loses Bid to Shrink Phila.'s Pelvic Mesh Mass Tort
Dec 6, 2017 | The Legal Intelligencer
By Max Mitchell
A central defendant in Philadelphia's pelvic mesh mass tort has lost its bid to have more than 100 cases filed by out-of-state plaintiffs tossed from the jurisdiction. -
Women harmed because vaginal mesh regulation 'not fit for purpose'
Dec 6, 2017 | The Guardian
By Hannah Devlin
Women have been exposed to unnecessary harm due to poor regulation for vaginal mesh products, medical experts have warned. -
Vaginal mesh study reveals how lax medical regulation puts women at risk
Dec 7, 2017 | The Independent
By Alex Matthews-King
Sixty-one mesh devices went to market based on "equivalence" to an older existing product, despite being made of different materials and without new evidence of their safety -
'It was supposed to help - but a mesh implant has left me fed up of life and in constant pain'
Dec 6, 2017 | Hull Daily Mail
By Patrick Daly
Angie Sykes has bravely spoken about her traumatic side-effects of a vaginal mesh operation -
'Inadequate' vaginal mesh regulations put women at risk, warn experts
Dec 7, 2017 | Sky News
By Charlotte Lomas-Farley
Experts warn that vaginal mesh implants are exposing women to much higher levels of risk than was initially thought. -
Cross-party calls for Scottish Government to review mesh scandal
Dec 6, 2017 | Holyrood
By Tom Freeman
The Scottish Government is facing calls from MSPs of all parties to revisit the findings of its review into the use of mesh implants. -
'I'm more her carer than I am lover': Husband reveals he has thought about leaving his wife after her controversial vaginal mesh destroyed their sex life, as expert warns implant is not safe
Dec 7, 2017 | The Daily Mail
By Stephen Mathews
A 65-year-old grandfather has slammed the controversial vaginal mesh procedure that has destroyed the life of his beloved wife and left her contemplating suicide. -
Inadequate Vaginal Mesh Regulation Exposed Women To ‘Unnecessary Harms’, Warn Experts
Dec 7, 2017 | HuffPost UK
By Rachel Moss
Inadequate regulatory processes for vaginal mesh products used to treat stress incontinence have exposed women to ‘unnecessary harms’, experts have warned. -
'Genuine' apology demanded for mesh-injured Kiwi women
Dec 7, 2017 | Stuff
By Megan Gattey
Women and doctors in New Zealand are demanding a formal verbal apology from The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) for surgical mesh injuries. -
'I just want this stuff out of me': Surgical mesh a silent killer of Kiwi women gallery
Dec 7, 2017 | Stuff
By Megan Gattey
Kiwi woman Renate Schutte's urinary incontinence (UI) became so severe in 2012 she "couldn't even walk around the block" without wetting herself.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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J&J Loses Bid to Shrink Phila.'s Pelvic Mesh Mass Tort
Dec 6, 2017 | The Legal Intelligencer
By Max Mitchell
A central defendant in Philadelphia's pelvic mesh mass tort has lost its bid to have more than 100 cases filed by out-of-state plaintiffs tossed from the jurisdiction.
A central defendant in Philadelphia’s pelvic mesh mass tort has lost its bid to have more than 100 cases filed by out-of-state plaintiffs tossed from the jurisdiction.
Philadelphia Court of Common Pleas Judge Arnold New ruled Tuesday afternoon that only one case pending against Johnson & Johnson subsidiary Ethicon needed to be dismissedfrom the venue as a result of the U.S. Supreme Court’s recent high-profilepronouncement in Bristol-Myers Squibb v. Superior Court of California. About 120 cases are pending in the mass tort program.
New’s two-sentence order said that any case involving an out-of-state plaintiff implanted with a Prolift +M pelvic mesh device would be tossed for lack of jurisdiction, but the order tossed only a single case. The order further denied Ethicon’s motion to dismiss cases involving all other products.
Kline & Specter attorney Shanin Specter, who is representing the plaintiffs, said in an emailed statement that the decision only tossed one case.
“We are heartened by Judge New’s ruling affirming Pennsylvania jurisdiction for all but one of the over 100 Ethicon transvaginal mesh cases,” he said. “Now our badly injured clients can continue to have us try their cases, which have been overwhelmingly successful both in Philadelphia and around the country. We will appeal the adverse ruling in the lone other case.”
A spokeswoman for J&J said in an emailed statement, “While we haven’t had an opportunity to review the entire order, we are disappointed and will consider our legal options to have this issue considered further.”
The Supreme Court’s Bristol-Myers ruling 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.
Some have referred to it as a “game-changing” decision for state-court mass tort programs, but exactly how the decision will play out as state courts begin to implement it remains to be seen.
New’s ruling marks one of the first times a Pennsylvania judge has applied Bristol-Myers to a mass tort program in Philadelphia, which has long been regarded as a hub for pharmaceutical litigation and has recently produced several multimillion-dollar verdictsfor plaintiffs in consolidated litigations, including pelvic mesh.
The jurisdictional dispute in the mesh litigation focused on the relationship between Ethicon and Bucks County biomaterials supplier Secant, which manufactured the mesh used in all of Ethicon’s products except for the Prolift +M. The type of mesh used in that product was manufactured by a non-Pennsylvania company.
Plaintiffs have argued that, given Secant’s role in making the product, venue was proper in Pennsylvania, even though Ethicon is based in New Jersey.
Ethicon, however, downplayed its relationship with Secant, and fought unsuccessfully to bar the plaintiffs from deposing a former executive about the materials the company used in its mesh products.
According to the plaintiffs, that employee’s testimony confirmed that, aside from the Prolift +M product, Secant produced 100 percent of the mesh used in all of Ethicon’s other mesh products.
https://www.law.com/thelegalintelligencer/sites/thelegalintelligencer/2017/12/06/jj-loses-bid-to-shrink-phila-s-pelvic-mesh-mass-tort/
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Women harmed because vaginal mesh regulation 'not fit for purpose'
Dec 6, 2017 | The Guardian
By Hannah Devlin
Oxford University team calls for mandatory clinical trials for invasive devices following scandal that emerged this year
.Women have been exposed to unnecessary harm due to poor regulation for vaginal mesh products, medical experts have warned.
The team, from the University of Oxford, have called for clinical trials to be made mandatory for invasive medical devices and for a registry to be created in response to the vaginal mesh scandal.
Prof Carl Heneghan at Oxford’s Centre for Evidence-Based Medicine, who led the work, said: “Many women have been subjected to great harm because regulatory loopholes allowed mesh devices to be made available in large numbers with no evidence in humans. It is now clear that regulation is not fit for purpose for the riskiest of devices, those that are implanted in the body.
“We now know that women who received mesh implants have been part of a global experiment that in many cases has gone badly wrong.
“It is unacceptable for a health professional to make judgments on what they ‘feel is a good thing to do’. What matters is what does high-quality evidence from randomised trials show, and that is over the long-term – five years at least.”
The paper, published in the journal BMJ Open, examined marketing clearance of vaginal mesh devices through the US Food and Drug Administration.
In the US, transvaginal meshes were initially class II devices, allowing them to be marketed on the basis of equivalence to existing devices. The team found 61 devices that were approved on equivalence claims and said there was no clinical-trial evidence for these devices at the time of approval.
However, many of the devices were significantly different from the original device that had gained approval, with different materials, design and method of surgical implantation. Randomised clinical trials were found to be published an average of five years after device approval, the study found.
“Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years,” the authors said.
“When evidence has been forthcoming, it has often emerged too late to inform clinical practice,” they added. “The current systems for ensuring patient safety are inadequate for medical devices.”
Concerns have been growing about the serious complications suffered by some women who have had mesh implants and about the introduction of dozens of different devices, most of which have never been assessed in a clinical trial.
In September, the Guardian reported that a vaginal mesh implant made by Johnson & Johnson had been launched without a clinical trial, and then marketed for five years after the company had learned that it had a higher failure rate than its two earlier devices.
The latest paper calls for clinical trials to be made mandatory in order for any implantable device to be marketed. It also calls for a publicly accessible registry of such devices with details of marketing status and linked evidence to the product.
Such a registry would also include details of which devices are given to which patient so if any “shortcomings” are identified then patients can be tracked down.
Later this month, England’s National Institute for Health and Care Excellence will publish guidance that is expected to recommend that vaginal mesh should no longer be used for prolapse, outside of a research context.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: “The absence of good trials for these vaginal meshes, which has been investigated carefully by these authors, shows the problem clearly. Changes in regulation are often driven by lessons learned from very bad situations, such as thalidomide, and the need for change in regard to devices is clear.”
Cathryn Glazener, emeritus professor at the University of Aberdeen, agreed that tighter regulation was needed to bring device regulation into line with the rigorous scrutiny in place for new drugs.
However, she said a distinction was needed between the use of mesh to treat incontinence, where she said evidence suggested mesh was as effective and safer in the short term than traditional non-mesh operations, and surgery for prolapse, which she said posed greater risks.
https://www.theguardian.com/society/2017/dec/06/woman-great-harm-due-loopholes-vaginal-mesh-regulation
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Vaginal mesh study reveals how lax medical regulation puts women at risk
Dec 7, 2017 | The Independent
By Alex Matthews-King
Sixty-one mesh devices went to market based on "equivalence" to an older existing product, despite being made of different materials and without new evidence of their safety
Failures in the regulation of vaginal mesh implants put women at risk of serious infection and chronic pain, experts have said.
Researchers found that lax rules on medical devices, which allow products to be approved on an “equivalence” basis if they’re similar to an already approved device, allowed 61 mesh implants to be marketed based on evidence for two older products.
While regulators have plans in place to tighten up oversight, including requiring clinical trials for each medical device in line with drug approval, these will not be fully in place until 2020.
The academics from Oxford University argue that a public registry for all invasive medical devices should be established to allow long-term follow up with patients to assure device safety.
The unfolding scandal around transvaginal mesh implants (TVM) has been branded the most serious women’s health failing since thalidomide.
Vaginal mesh implants are given to around 15,000 women every year to tackle complications following childbirth like urinary incontinence and prolapse – where the weakened pelvic muscles mean the organs can bulge into the vagina.
More than 100,000 women in the US are involved in a class action lawsuit with manufacturers after suffering complications, and legal proceedings in the UK involve around 500 hundred women with 2,000 set to join.
Complications are relatively rare, but independent academics say they are more common with the mesh implants for treating prolapse and surgical repair is likely to be more effective.
Of the 110 formally reported, mesh-related, “adverse incidents” recorded by the UK’s medical device watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), since 2005, 65 were for the device breaking off into vagina, 21 related to infections, 39 related to pain and 16 related to organ perforation.
The Independent has followed the growing public outcry on mesh implants in the wake of the Government’s refusal to ban the devices or launch a public inquiry into their use following a national report on the issue.
This week has also seen the first reported death as a result of a TVM device.
Canadian mother and mesh campaigner Chrissy Brajcic died after developing an antibiotic-resistant infection from her implant.
The paper, published in the BMJ Open today, used data for devices approved by the US Food and Drug Administration.
In an analysis, the authors said: “We traced marketing clearance for 61 mesh devices back through a chain of equivalence claims to only two unique originating devices approved in 1985 and 1996.
“We found no evidence of any new clinical trial data at the time of device approval for all of these 61 devices, with empirical evidence of effectiveness from randomised trials emerging on average five years after approval.”
It warns that this “family tree” of equivalence approvals meant devices with different designs were put on the market without safety evidence, and when the changes should have alerted regulators that equivalence wasn’t applicable.
The authors warned that in Europe devices can also be approved on equivalence grounds, with approval granted by centres across the European Union.
But, unlike the US applications, EU approvals are not public, making them “impossible to scrutinise”.
The study’s lead author said he hoped that after Brexit the UK would have a more rigorous approach that incentivised evidence backed devices and put “patient safety first”.
Professor Carl Heneghan at Oxford University’s Centre for Evidence Based Medicine said patients might wait longer for treatments and companies might “lose market share”, but added: “We could, and should though, lead the way by having regulatory systems that incentivise the production of high-quality evidence at the time of approval for implantable devices – those deemed to be the riskiest.
“In particular ensuring those devices that do make a difference and are safe are made available. And for those that aren’t safe, ensuring they do not make it onto the market in the first place.”
Later this month, England’s National Institute for Health and Care Excellence (Nice) will publish final guidance on the devices.
The watchdog could either say the devices are no longer recommended for use; that they should only be used for research purposes; or they should only be used when clinicians have had certain conversations with prospective patients about possible side-effects or complications.
Independent academics backed the plan for a registry and “tightening” regulation, especially as implanted devices are often life-long.
Professor Cathryn Glazener, retired emeritus professor at the Health Services Research Unit, University of Aberdeen, did not contribute to the paper and flagged that account for safer, and more effective, mesh implants for incontinence.
But she added: “I do agree with the authors of the article, however, that regulation of new device use needs to be tightened up, in line with the much more rigorous scrutiny already in place for new drugs.”
The MHRA, which continues to recommend mesh devices, citing “insufficient evidence” of widespread complications for a ban, said it is looking at such a registry and encouraged women to report any complications.
John Wilkinson, MHRA director of devices said: “Patient safety is our highest priority and we recognise some women do develop serious complications which can be very significant for the affected women.
“We also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions.”
https://www.independent.co.uk/news/health/vaginal-mesh-implant-women-complications-risk-oxford-university-goldacre-a8095791.html
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'It was supposed to help - but a mesh implant has left me fed up of life and in constant pain'
Dec 6, 2017 | Hull Daily Mail
By Patrick Daly
Angie Sykes has bravely spoken about her traumatic side-effects of a vaginal mesh operation
She used to be an active, karate-going mother-of-three.
But one brave west Hull woman now says she is “fed-up of life” after living with the painful side-effects of a vaginal mesh operation for six years.
Angie Sykes had an operation in 2011 to deal with longstanding incontinence issues she was experiencing.
But not only has the problem come back since the operation, the 44-year-old has been left in “constant pain” and suffers from a myriad of other ailments – all possibly linked to the surgery.
A vaginal mesh implant is a treatment given to women who experience incontinence and pelvic organ prolapse (sometimes caused by a hysterectomy).
The treatment is common in the UK, with more than 92,000 women receiving a vaginal mesh implant between April 2007 and March 2015 in England alone.
Angie, a mother-of-three, says she was not shown what the mesh looked like before her operation – and that she would have ruled the procedure out if doctors at Hull Women and Children's Hospital had let her see it.
“The word ‘mesh’ was never mentioned,” said the once active karate goer. “It was described to me as being like a tape.
“They [doctors] didn’t show me what it looked like. If they had shown me, I wouldn’t have had it done.
“I was so desperate, I would have done anything at the time. I was 37. I wanted my karate to carry on and they said I would be able to do that. I really loved doing karate – the operation seemed like the silver bullet if it meant I could carry on with that.”
Emma Hardy, MP for Hull West and Hessle, started a cross-party campaign after meeting constituent Angie to demand a suspension of mesh implants, pending a full investigation into the scandal.
The Labour MP says as many as 20 per cent of women who undergo the surgery suffer complications later on.
Angie, an avid Hull Kingston Rovers fan after growing up in the east of the city, started to experience stress incontinence – involuntarily passing urine when running, coughing or laughing – when in her early 30s.
The issue started after she gave birth to twin girls – Chloe and Victoria, now aged 21 – in 1997.
Internal complications after the twins’ pregnancy, during which she ballooned from seven to 11 stone, saw her require a hysterectomy to remove her womb when aged just 24. The ex-shop worker already had eldest daughter Chantel, now aged 25.
The karate purple belt student kept her incontinence problem a secret for years before seeking medical help.
“I was really embarrassed by it and thought, ‘Surely this shouldn’t be happening to me at my age’ and just ignored it,” she says.
After a “mortifying” episode on a dance floor, however, she decided to seek medical help.
In 2006, doctors put her on tablets and encouraged her to change her diet in an attempt to alleviate the problem, but to no avail.
After advice from a trusted surgeon, the former Heron Foods shop worker agreed to have vaginal mesh implant surgery.
The operation saw surgeons at the Women and Children's Hospital make an incision into her groin, pushing hooks through with the mesh attached. The mesh was then put in place and sewn to the inside of her groin, leaving a lump for some time, she recalls.
Angie says she was able to return to doing karate “for a few years” but had to stop again four years ago after experiencing pain. The same pain also forced her to take long-term sick leave and then later give up work altogether – a position she is still in.
She struggles to walk and experiences pain and numbness in her left leg, back aggravation and also “shooting pains” through her genitals.TIMELINE OF ANGIE SYKES MESH IMPLANT PROBLEMS
1992 – Has first child Chantel at 19-years-old
1996 – Gives birth to twins, Chloe and Victoria
1997 – Has hysterectomy at age 24 after experiencing post-natal complications
2003 – Starts menopause while in her early 30s and develops stress incontinence
2006 – Seeks medical help for an incontinence issue she had kept hidden for 3 years
2011 – Has a vaginal mesh implanted at age 38 after other medical procedures fail to stop the incontinence
2013 – Forced to stop working on medical grounds as could no longer physically fulfil her contract
2017 – Undergoes operation for prolapse and advised to consider having the vaginal mesh removed
She also reports other side-affects which she puts down to “implant illness” – where the body reacts to contact with a foreign object, such as a vaginal mesh.
Angie says she experiences dry hair, allergic reactions to metals, trouble sleeping, breathing issues and sensitivity to light ever since the implant operation.
She describes going to see Hull KR as her “one and only pleasure in life” after her family.
“I’m fed-up of this life,” she says. “I used to be really active and did karate twice a week. Now I don’t do anything.
“I’m fed-up of not working. I’m tired of being in pain and being on painkillers. I’m tired of not sleeping. I’ve even started leaking again, so it has not even properly worked.
“I’m 45 soon but I feel like I’m 100-years-old. My sex life has gone down the toilet too. It is too painful.”
Angie, who is supported by partner Ed, has been recommended by her doctor to visit a specialist surgeon in Manchester to discuss having it removed.
But she says she is unsure of the next move, having undergone an operation on her prolapse only nine months ago.
“I’m frightened of having more surgery,” she says. “Other people have said they still suffer with pain afterwards, even once they get it removed. Is it worth it then? I don’t know.”
MP Ms Hardy said the Government needed to provide answers on why women such as Angie were allowed to go through with a surgery with “such terrible risks”.
“It was obvious from our very first meeting just how much discomfort Angie was in,” she said.
“She was promised a quick and easy fix to the problems that she was having but the resulting injuries have dramatically changed her life for the worse.
“We need a full audit into the practice and if that means a public inquiry then so be it.”
Health ministers have so far ruled-out a public inquiry or a suspension of mesh implants.
NHS England, replying on behalf of NHS Hull Clinical Commissioning Group, said it had called for actions to “improve informed consent” before mesh operations are carried out in future.
A report by the Mesh Oversight Group said women should be given information leaflets about the surgery and its possible side-effects, while the consent processes should also be improved.
“Informed discussion and consent is a vital aspect of any discussion between patient and doctor when considering use of mesh,” said a spokesman for NHS England.
“A patient, their GP and surgeon must be fully informed about the potential benefits and risks of surgery.”
http://www.hulldailymail.co.uk/news/hull-east-yorkshire-news/it-supposed-help-mesh-implant-882284
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'Inadequate' vaginal mesh regulations put women at risk, warn experts
Dec 7, 2017 | Sky News
By Charlotte Lomas-Farley
Experts warn that vaginal mesh implants are exposing women to much higher levels of risk than was initially thought.
A group of medical experts have warned the regulation of vaginal mesh products is "inadequate" and devices have been brought to market without clinical trials.
Professor Carl Heneghan from Oxford University, who specialises in evidence-based medicine, has called for a patient registry to be set up to look at the long-term evidence of mesh complications.
The report, published in the British Medical Journal (BMJ), echoes the findings of a Sky News investigation in October which reported on how mesh had been used without trials and was causing harm to women on a scale bigger then Thalidomide.
The BMJ study looked at the regulation of vaginal mesh products in the US and was unable to scrutinise the approval process in Europe because of a "lack of accessibility".
Professor Heneghan and his team traced marketing clearance for 61 mesh devices and found they were based on equivalence to only two existing products that were approved in 1985 and 1996, despite important changes having been made to the models.
Their results show no evidence of clinical trial data at the time the device was approved.
The authors of the report argue "changes in design should have alerted regulators to important differences in the technological characteristics of the mesh that should have negated the use of equivalence".
"When evidence has been forthcoming, it has often emerged too late to inform clinical practice," they wrote.
"The current systems for ensuring patient safety are inadequate for medical devices.
"We think that clinical trials evidence should be mandatory for marketing authorisation of implantable devices."
In response to the increasing recognition of problems with mesh, many countries including Australia have reclassified them as high risk.
The UK watchdog NICE will soon publish new guidelines recommending transvaginal mesh should not be used to treat prolapse because of safety concerns.
Responding to the findings, the Medicines and Healthcare Products Regulatory Agency (MHRA) said that while they "recognise some women do develop serious complications… We also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions".
Earlier this year in an interview with Sky News the MHRA said: "There was no evidence from a regulatory point of view that mesh devices were inherently unsafe."
The MHRA insist the complication rate of vaginal mesh implants is between one and three percent.
That is despite latest NHS figures obtained by Sky News showing it to be at least 10%.
https://news.sky.com/story/inadequate-vaginal-mesh-regulations-put-women-at-risk-warn-experts-11159432
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Cross-party calls for Scottish Government to review mesh scandal
Dec 6, 2017 | Holyrood
By Tom Freeman
The Scottish Government is facing calls from MSPs of all parties to revisit the findings of its review into the use of mesh implants.
The use of synthetic transvaginal tapes and meshes was suspended in 2014 after some women suffered painful and crippling complications.
An independent review, which reported earlier this year, was branded a “whitewash” by campaigners after it was significantly altered before its final draft amid accusations of a conflict of interest.
Among its recommendations was that mesh implants must not be offered “routinely” to women with pelvic organ prolapse in Scotland, which the Scottish Government accepted.
SNP Alex Neil, who had commissioned the review as health secretary, labelled the final report “totally unacceptable”.
In a heated debate in the Scottish Parliament last night, Neil said: “I was absolutely clear when we appointed members of the independent review group that none of them should have a commercial interest in mesh. That did not happen.”
Health secretary Shona Robison had commissioned a further review by health academic Alison Britton, but said that an outright ban was in the power of the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Neil said the MHRA is “partly funded by the mesh manufacturers, so I do not see how it can be truly independent”.
He added: “We must ensure that any future independent review is genuinely independent. I look forward to Professor Britton’s report. We can never again have such processes tainted by suspicion such as surrounds the outcome of the review.”
Scottish Labour MSP Neil Findlay called for a new judge-led inquiry into the issue, with 400 patients now seeking damages over the implants.
“Scotland had the opportunity to lead the world on mesh – and we flunked it. The review was compromised from the outset. The SNP Government has let down mesh victims.
“This is a tragic tale of corporate power and greed, institutional arrogance by the medical establishment and government ambivalence.
“Only by refusing to give up have we got this far – and let me tell the Cabinet Secretary we aren’t going away.”
Scottish Conservative deputy leader Jackson Carlaw said the findings of the review group should be opened up to public consultation.
“There may be aspects of this scandal that are reserved and other aspects that are devolved, but for pity’s sake that can no longer be a defence against the most determined and joint close working and co-operation,” he said.
“The hourglass has run. Huge legal compensation claims the world over are landing with health services; more than 800 claims are under way in the UK. That, too, is an issue of immense concern.”
Green MSP Alison Johnstone also said the public should be allowed to respond to the review.
“We must learn from the mesh survivors and ensure that they realise that we hear their voice,” she said.
“We must leave no stone unturned in delivering justice for them and making sure that not one more life is affected by those implants.”
Robison said Scotland’s chief medical officer Dr Catherine Calderwood had written to the MHRA to highlight moves in Australia to remove the treatment.
She added: “It is important, not just for the present independent review, but for future reviews on any issue, that there is full disclosure of interests and that they are registered.
“Professor Britton will be looking at that issue along with the many other issues that have been raised about the independent review process.”
The National Institute for Health and Care Excellence (NICE) is due to issue updated guidance on use of mesh later this month.
https://www.holyrood.com/articles/news/cross-party-calls-scottish-government-review-mesh-scandal
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Dec 7, 2017 | The Daily Mail
By Stephen Mathews
· Carl Heneghan is a professor of evidence-based medicine at Oxford University
· The controversial implants can shrink, twist, curl and cut through internal tissue
· He wants them to be banned for use in humans until more evidence emerges
· John Sharman, from Reading, revealed Lynne's account of the risky implant
· The vaginal mesh has left her in unbearable pain and unable to have sex, he said
· The father-of-three sometimes contemplates leaving his marriage of 43 years
· He told MailOnline: 'I'm more of her carer than I am her lover and a husband'
A 65-year-old grandfather has slammed the controversial vaginal mesh procedure that has destroyed the life of his beloved wife and left her contemplating suicide.
John Sharman, from Reading, revealed Lynne's heartbreaking account of the scandal-hit surgery, which left her in unbearable pain and unable to have sex, following the emergence of hundreds of similar stories.
He decided to tell MailOnline of her painstaking ordeal from a man's point-of-view, which is often forgotten amid the scores of outraged women who have spoken, in an attempt to raise awareness about the topic which, up until now, has been swept under the carpet.
The father-of-three he has sometimes thought about leaving Mrs Sharman, who he has been married to for 43 years, due to the effect the mesh has had on their marriage.
Mr Sharman, who met his wife at a chess club, told MailOnline: 'It does impact your relationship and now I'm more of her carer than I am her lover and a husband.
'She has been left in constant pain which has totally altered our sex life, social life and the way we operate and what we do.'
It comes as a leading expert has warned there are inadequate regulation for vaginal mesh products which has exposed women to unnecessary harms.
Carl Heneghan, professor of evidence-based medicine at Oxford University, has previously described the mesh scandal as akin to thalidomide.
Professor Heneghan has now launched a fresh attack on mesh, asking for them to be given temporary licences that restrict them solely to use in clinical trials - and not in humans.
Writing in the BMJ Open Professor Heneghan and colleagues argue the implants can't be considered safe as they didn't undergo scrutiny in scientific studies with a follow-up of at least five years.
The implants, which can shrink, twist, curl and cut through internal tissue, have left women on the brink of suicide, unable to work and even walk.
Mr Sharman added:'It's something she will have for the rest of her life, there is no possibility of getting a pain-free life back. That's so frustrating.
'Sometimes I wonder whether if it's worth staying together, you can't help it because our relationship has changed.
'It has to change because your wife isn't the same one that you married.
'We've been together for long enough that I care enough about her, but you can never say never. But at the moment it isn't an issue.
Their sex life has been shattered
He revealed how the couple's sex life has been scuppered, going from twice a week to barely engaging in any activity beneath the sheets.
The issue arose when he felt something in the way as they had intercourse a few years ago. He could see it was hurting her.
Since then, Mr Sharman constantly worries about causing her pain.
He said: 'Even if she isn't in pain I'm always worried about hurting her if we try.
'Your sex life goes out of the window. Both of us in terms of libido have totally gone.'
'It [the mesh] probably means you don't have fun anymore at all. You've got to look after your wife.'
Her timeline of events
Mrs Sharman, 61, had the vaginal mesh surgery at Berkshire Independent Hospital in 2011 due to her mild incontinence - triggered by childbirth.
Pain almost immediately followed.
But she was not given any warnings about any possible life-long side effects other than it might perforate her bladder.
The former counsellor, who had three children, then had it partially removed at the John Radcliffe Hospital, Oxford, a year later.
It followed a year of tireless pleas to the surgeon who put in the implant, who was unable to determine what was causing her pain.
A full removal followed a year later, but the delay in removing the mesh has left her plagued by a lifetime of pain.
Mr Sharman said: 'She has contemplated it [suicide], I guess if she hadn't been a teenage counsellor then she might have had the inclination to do so.
'If she hadn't recognised in herself how to deal with it and if I hadn't been behind her then she might have gone through with it.'
Struggles to cuddle her grandchildren
The pain has impacted on Mrs Sharman's ability to be a grandmother, meaning she often struggles to cuddle her five grandchildren.
Mr Sharman said: 'It's difficult to tell a four-year-old that nanny can no longer pick them up and give them a cuddle anymore because she isn't capable.'
He said attempting to pick the youngsters up will have a detrimental effect on her, leaving her to spend the next day in bed recovering.
The couple have long campaigned for an end to vaginal mesh procedures, such as this one which has made Mrs Sharman reliant on painkillers.
Mr Sharman added: 'I know of nobody who has had a successful removal who hasn't been left with some form of pain, which is normally quite chronic.
'We are applauding all of the actions going on at the moment. It's really appalling, but hopefully we're getting somewhere.'
The couple purchased a narrowboat a few years ago. It's easier for Mrs Sharman to walk around in and gives them both an interest.
Figures suggest more than 100,000 women around the world are suing mesh manufacturers after developing serious complications from the brittle implants.
Tiresome fights by campaigners, backed by MailOnline, has since led to Australian and English health officials calling for a ban to some of the procedures.
Professor Heneghan's latest comments add fuel to the fire as outraged sufferers seek a House of Commons debate over the safety of vaginal mesh.
The comments follow the death of a 'courageous' vaginal mesh campaigner who passed away from sepsis triggered by her implant, it was reported.
Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections - as a result of her mesh.
During her final few months, she posted an array of videos detailing her struggle with the scandal-hit devices on her Facebook page.
Ms Brajcic's death followed landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
It is expected that the NHS will follow the guidance from Nice, the Government's healthcare adviser - despite not being obligated to do so.
The verdict comes after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found 'the benefits do not outweigh the risks'.
However, vaginal mesh remains a viable option for surgeons operating on women suffering from incontinence in both countries.
The scandal came to light in 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 saying the scandal could be akin to thalidomide.
At the time, it was reported that at least 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, outraged women have since begged for tougher regulations to conduct such surgery.
High-risk device in the US
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.
More than 10,000 women a year are fitted with mesh. But only 4,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more - but they have been kept silent.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million in 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-5152315/Regulation-vaginal-mesh-implants-inadequate.html
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Inadequate Vaginal Mesh Regulation Exposed Women To ‘Unnecessary Harms’, Warn Experts
Dec 7, 2017 | HuffPost UK
By Rachel Moss
100,000 women are suing manufacturers after developing serious complications.
Inadequate regulatory processes for vaginal mesh products used to treat stress incontinence have exposed women to ‘unnecessary harms’, experts have warned.
The report, published in the British Medical Journal (BMJ), follows a wave of controversy surrounding vaginal mesh.
Last month the BBC said it had seen draft guidelines from the National Institute for Health and Care Excellence (NICE) recommending that implants should not be used for routine operations.
Prior to that, MPs had debated the possible banning of vaginal mesh, following claims by women that complications from devices had left them unable to walk, work or have sex.
In the latest report, health experts argue that regulatory failings have enabled new vaginal mesh devices to be brought to market with inadequate evidence of their safety.
The report states more than 100,000 women around the world are now suing manufacturers after developing serious complications.
A vaginal mesh implant, sometimes referred to as a sling implant, is a treatment given to women who experience pelvic organ prolapse and incontinence.
It’s frequently given to women who’ve experienced complications after childbirth and involves inserting a synthetic net material in the placement of weak connective tissue or ligaments.
In light of recent debate surrounding the devices, Professor Carl Heneghan and colleagues at Oxford University’s Centre for Evidence Based Medicine looked through the history of vaginal mesh approval.
Their report highlights that in the US, vaginal mesh implants were initially class II devices meaning they were considered “lower risk”, allowing them to be marketed on the basis of equivalence to existing devices, despite “important changes”.
For example, the team traced marketing clearance for 61 mesh devices back through a chain of equivalence claims to only two unique originating devices approved in 1985 and 1996.
Their results show no evidence of any new clinical trial data at the time of device approval for all 61 devices, with empirical evidence of effectiveness from trials emerging on average five years after approval.
In the worst cases, some devices did not have any evidence of safety or effectiveness as much as 14 years after they were approved for medical use.
The researchers argue that changes in design “should have alerted regulators to important differences in the technological characteristics of the mesh that should have negated the use of equivalence”.
The report also shows that evidence consistently pointed to a lack of long term data to inform use of vaginal mesh devices. And when longer term evidence did emerge, it identified serious concerns.
In recognition of the growing problems, many countries have already reclassified mesh as high risk, and upcoming guidelines from NICE are expected to include a ruling that vaginal mesh should not be used to treat vaginal prolapse because of safety concerns.
The BMJ report also states new EU regulations, published in May 2017, mean that clinical investigations for class III and implantable medical devices will be required to provide evidence of safety and performance. However, the researchers point out that there is a three-year transition period before these rules fully come into force, in May 2020.
“We think these changes are insufficient, and the long delay in implementation does not represent a timely response to patients’ needs,” the report says.
“In our view, to be considered safe and approved for widespread use, long term implantable devices should have been evaluated in studies with follow-up of at least five years.”
The researchers have recommended the creation of a register of patients for all implantable devices to enable long term follow-up and surveillance.
The report concludes: “Such registries should include unique device identification so that any shortcomings can be more readily tracked, patterns of use monitored, and patients later judged to be at risk more easily identified.”
http://www.huffingtonpost.co.uk/entry/inadequate-regulation-for-vaginal-mesh-has-exposed-women-to-unnecessary-harms-warn-experts_uk_5a27feeee4b044d167265ed1
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'Genuine' apology demanded for mesh-injured Kiwi women
Dec 7, 2017 | Stuff
By Megan Gattey
Women and doctors in New Zealand are demanding a formal verbal apology from The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) for surgical mesh injuries.
Gynaecologist Dr Hanifa Koya said mesh-injured Kiwi women "felt experimented on" and deserved a formal apology.
"We should say sorry to them. We should accept them instead of blame-gaming, apologise and sort them out," she said.
Koya said some gynaecologists were overwhelmed by the severity of the trauma mesh-injured patients experienced, "and therefore demand urgent attention".
The "catastrophe with the meshes" has highlighted major shortfalls in medical care in New Zealand, Koya said.
"After the Cartwright Inquiry, we should never have been back here again."
WHAT WAS THE CARTWRIGHT INQUIRY?
Judge Dame Silvia Cartwright recommended reforms towards a patient-centred healthcare system by giving patients the force of law in New Zealand in 1987, which was a global first.
The Government ordered an inquiry into unethical research practices related to the treatment of cervical cancer. It resulted in significant advances in human rights and ethics in healthcare.
RANZCOG APOLOGY
Ian Page, the College's New Zealand Committee Chair, has issued a one-line apology online: "The New Zealand Committee of RANZCOG joins with the College President in saying they are sorry for the debilitating consequences suffered by some women in New Zealand following the use of mesh."
It is followed a link to the College President Steve Robson's video apology.
When Stuff asked if the New Zealand Committee would consider giving a video apology, the College said the New Zealand Committee was aware of the issue but no plans had been put in place just yet.
Advocacy group Mesh Down Under co-founder Charlotte Korte said that although the College had good intentions with Robson's apology, it had the opposite effect.
"Dr Robson did apologise initially, but unfortunately followed his statement up by saying that the benefits outweigh the risks," she said.
Korte said Robson's statement decried the severity of mesh complications.
"In essence it is just saying it is just bad luck that you have suffered, because the majority of women have been lucky enough to not have had a complication (yet)," she said.
"We feel that the RANZCOG should make a more appropriate verbal apology, one that reflects the severity of mesh complications and the harm that has been caused to so many people."
Koya agreed that the apology was not sufficient.
"Have we genuinely apologised to all who are affected? If we did, we would have done something about it urgently and helped those who were affected. We have not shown remorse but rather behaved arrogantly, in the hope that all these problems would just disappear."
Auckland University professor of obstetrics and gynaecology Cindy Farquhar said: "Our patients deserve better studies and, in the absence of evidence, better advice."
CONFLICT OF INTEREST
Koya said there was also a financial conflict of interest for some surgeons in the College using mesh products.
"A number of surgeons were involved in designing the meshes, the production of the meshes, and also as preceptors to teach other surgeons," she said.
LACK OF TRAINING CONSISTENCY
A 2017 UK survey of techniques used to perform pelvic organ prolapse repair compared variation in surgical techniques in native tissue and mesh repairs.
It concluded: "There is considerable variation between UK-based surgeons in the surgical techniques used to perform both native tissue and graft/mesh-augmented pelvic organ prolapse repairs."
Koya said the study showed "no surgeon did a similar procedure, even for a simple vaginal prolapse".
RETURN TO ETHICS
Koya said surgeons needed to revisit the code and ethics relating to how they should practise medicine.
"We need to listen to patients, show empathy, and all medicine is learnt by listening and using your own skills."
And Koya is doing that. "I care - that's the difference."
Responsibility for mesh injuries in New Zealand fell on many shoulders, Koya said.
"The surgeons, the various colleges, hospitals, Medsafe, ACC, HDC and the medical council need to ensure proper training and teaching, regulation of products, audit and oversight," she said.
"When adverse events became apparent, there has been lack of empathy and accountability in taking responsibility. We need to take responsibility now, instead of giving lip service. It is lip service right now."
Mesh-injured Kiwi woman Renate Schutte said she wanted the Ministry of Health to act.
"Our new, progressive Government needs to step up and show themselves for the leaders they are and stop further innocent women from having their lives destroyed."
DEBATE IN GOVERNMENT
Former Minister of Health Jonathan Coleman and new Minister of Health David Clark debated the issue in Parliament on December 6.
Coleman: "What does he say in reply to Newsroom's statement of 4 December that the "Labour-led Government's response to New Zealand's surgical mesh problems is not what it campaigned on", given that he promised to immediately begin work on a surgical mesh registry if elected?
Clark: I'm delighted to update the member. He will know that when he was the Minister, there was a great deal of discontent over the time it was taking to respond to the Government's select committee inquiry. One of the demands from that inquiry—the select committee recommendations—was that a registry be put in place. I will update the member shortly on even more promising progress.
In October, Clark said he wanted answers from the Ministry on the slow progress on surgical mesh injury prevention.
https://www.stuff.co.nz/national/health/99581238/genuine-apology-demanded-for-meshinjured-kiwi-women
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'I just want this stuff out of me': Surgical mesh a silent killer of Kiwi women gallery
Dec 7, 2017 | Stuff
By Megan Gattey
Kiwi woman Renate Schutte's urinary incontinence (UI) became so severe in 2012 she "couldn't even walk around the block" without wetting herself.
So she got a tension-free vaginal type (TVT) bladder sling implanted.
But five months ago, Schutte started experiencing burning leg, pelvic and groin pain. The 50-year-old is travelling to Missouri in the United States on December 15 for surgery to get the sling removed because she has no confidence in her local doctor.
"He gave me this glossy brochure [in 2012] with a woman playing tennis. And, I have to say, the reason I actually got involved in this is because I've always been a fit, active, outdoorsy kind of person."
That brochure listed three adverse reactions. But the most recent one, published in 2015, has a list of 22 adverse reactions – including death.
"I am sure that most women would not risk being in crippling pain, unable to have sex and possibly dying," Schutte said.
When Schutte asked her doctor how many successful mesh removal surgeries he had performed, she said he was evasive.
"I know for a fact he had done removals, but some of them were partial removals and the women were completely mucked up."
The surgery in the United States will cost Schutte NZ$40,000-$50,000, but she wanted to ensure she was treated by a "highly competent" doctor.
"Even if I can't get back to a fully active lifestyle, I know it can't get worse. I just want this stuff out of me."
Schutte wants the new Government to step up and prevent further women from going through similar pain. "These products need to be banned immediately, we need a mesh registry."
Doctors in New Zealand are not providing patients with adequate informed consent, Schutte said.
"It terrifies me that these procedures are still happening and women are not actually being given the full information of the risks," she said.
Gynaecologist Hanifa Koya agreed, adding that surgeons had plenty of time to inform UI patients because it is not a life-threatening condition.
"It's not surprising that people in New Zealand have lost confidence in us," she said.
"Even when there was no data on safety and efficacy, doctors chose meshes thinking it was the easy way of doing the surgery."
Koya said surgeons needed to be thorough with patients and provide informed consent, including their competence levels.
"Enough is enough. I believe in this, we have to do it properly and we have to get it right here in New Zealand."
WORST THING I'VE EVER HAD TO DO'
Koya has worked on more than 75 complex cases requiring pelvic mesh removal since 2005.
"It's the worst thing that I've ever had to do. And nobody [doctors] is coming into my theatre to learn – either to remove the meshes or how to use patients' own tissues to do proper vaginal repairs."
She has been advising against transvaginal mesh surgery at medical conferences for 15 years, but never thought she would be the one working to remove meshes from traumatised women.
"I don't have sympathy for anyone right now except the women who are suffering," she said.
Some surgeons unfairly judged mesh-injured women, Koya said, but "these are all intelligent women who just believed their doctors".
"I do not have any empathy left for any excusers at all," she said.
'LOST FIVE YEARS OF MY LIFE'
Doris Phillips, 61, can hardly eat anything because the medication she was given for her vaginal mesh surgeries left her with irritable bowel syndrome (IBS).
"I'm living on boiled potatoes and bland vegetables because I'm nauseous all the time," she said.
"I've been in the most terrible pain. I have some good days, but they're mostly bad."
Phillips developed vaginal prolapse in 2011.
When she awoke from surgery in March, 2012, she was in agony.
"I couldn't sit. It felt like I was sitting on razor wire. [The doctor] told me it would settle down after a few months, but it never did. After that, I became incontinent."
It turned out the mesh he used had been recalled in January, two months prior to her surgery. She developed IBS as a side-effect of the antibiotics and the painkillers.
"I trusted him," Phillips said. "He told me the mesh was safe. I was told I'd be back at work in four weeks. But I've lost five years of my life."
'SILENT KILLER'
Phillips' husband has done everything for her since 2012, she said.
"I have not been able to hang my own washing. I have not been able to clean my home. I cannot carry anything heavy, I cannot even carry a laptop," she said.
Her most recent surgery was performed by Koya on October 18, 2017.
"When Dr Koya went in she found the mesh was protruding through the abdominal wall into my intestines," Phillips said.
Koya removed most of the mesh from Phillips' pelvic area, but some of it remains to hold the prolapse in place. Phillips described Koya as her lifeline.
"That woman has saved my life. There were times when I felt I couldn't carry on any more," she said.
"I'll never get my health back, but I believe I will recover. I would love to go back to work and live a normal life, and do things most normal women do in their homes. I have not felt so free in six years."
Phillips said mesh was a "silent killer".
Phillips wants a total ban on surgical mesh surgeries in New Zealand.
"If I had known how I was going to suffer, I would never have done that surgery. I don't think the Government realises how serious this is."
'NO DATA'
A registry was long overdue, Koya said.
"We asked for it in 2014, it should be done. It should be compulsory that anyone who has had a device, including meshes, should have ACC treatment injury forms filled. We have no data."
Advocate group Mesh Down Under co-founder Carmel Berry was frustrated that New Zealand still had no registry and that women were still not receiving informed consent.
"We've been making a fuss about this for years."
She presented before the health select committee in 2014, suggesting an inquiry into the use of surgical mesh in New Zealand.
Auckland University professor of obstetrics and gynaecology Cindy Farquhar said a registry was absolutely necessary.
She "mostly" supported a total ban on vaginal mesh surgery.
"Certainly for vaginal mesh for prolapse. Anything that needs removing this often should not be placed via the vaginal."
Koya also supported a ban on mesh for pelvic organ prolapse, but thought UI needed closer consideration.
GOVERNMENT ACTION
New Minister of Health David Clark wants an explanation from the ministry on the slow progress.
"I can't understand why there hasn't been a [surgical mesh] registry formed and if there is a good reason I haven't heard it."
The National Government endorsed Health Select Committee recommendations to tighten regulation and monitoring of surgical mesh use in August 2016 – but the endorsement did not include a ban on mesh products.
The Royal Australasian College of Gynaecologists and Obstetricians (RANZCOG) recommended mesh implants should not be used for vaginal prolapse in November 2016.
'ALL SORTS OF TECHNIQUES'
Pelvic surgery is a "very fine art", Koya said, but doctors "are using all sorts of techniques".
"These woman have erosion into their organs – bladder, bowel, and sometimes mesh has been placed there accidentally. There are often multiple meshes sewn onto each other, and a number [of patients] have organ damage and meshes would be in the bladder or in the bowel ... it has been horrendous."
The drugs given to the women often led to addiction, Koya said. And in rare cases, the interaction of the drugs caused death.
"An unbelievable concoction of multiple potent drugs, including narcotics, are given to women."
Koya said the drugs often made patients constipated, which worsened prolapse pain.
"Their lives are total hell. Some even have kidney removal, septicemia [blood poisoning], debilitating vaginal bladder, pelvic, and nerve pains, nerve and organ damage, even deaths and post-traumatic stress disorder."
Mesh-injured women often experienced multiple symptoms at once, Koya said.
"They have no quality of life, they are unable to have sexual relationships with their partners because it is too painful, they are unable to work, and the financial loss to the individual is staggering."
DOES ACC HELP?
Patients must be able to demonstrate to ACC that a particular part of their body has been injured or harmed to receive funding.
In New Zealand, 497 women have made a treatment injury claim to ACC for mesh-related complications for surgical mesh procedures for pelvic organ prolapse and/or urinary incontinence in the past 12 years. Surgical mesh products in New Zealand have cost at least $13 million in ACC injury claims over that period.
Koya says all mesh injuries should be considered as treatment injury.
FACTS AND FIGURES
A Cohrane review in 2016 focusing on the use of transvaginal mesh for surgery in women with vaginal prolapse found women who had mesh repair were more likely to have incontinence, mesh exposure, or repeat surgery for prolapse.
The risk of repeat surgery is 5 per cent in women having native tissue repair, rising to 7 to 18 per cent in women having mesh surgery. One in 12 women who have mesh require repeat surgery for mesh exposure.
Farquhar said new interventions should always be subject to rigorous evaluation.
"Our patients deserve better studies and, in the absence of evidence, better advice."
WHAT IS SURGICAL MESH?
* A device used when providing additional support for pelvic organs and hernia repair.
* It can be absorbable or, if it is a permanent implant, non-absorbable.
* Despite complaints about mesh no recalls have been undertaken as regulators conclude the risks are minimised when product is used by surgeons with the correct training.
* Medsafe is monitoring reports relating to surgical mesh implants but has for now concluded that it is safe when used correctly.
* Surgical mesh remains approved for use by international regulators.
https://www.stuff.co.nz/national/health/99566347/i-just-want-this-stuff-out-of-me-surgical-mesh-a-silent-killer-of-kiwi-women
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