Preview Newsletter
Ethicon Media Monitoring 4/23/2018
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Advice on Sketchy Surgery
Apr 20, 2018 | New York Times
By Herbert Rakatansky
Patients considering surgery suggested by a third party (especially from a non-physician) that has not been recommended or approved by their primary care doctor risk venturing into areas of medical practice that lack systemic quality controls. -
NHS spending hundreds of millions on care for women with vaginal mesh implants which can cause 'horrifying' complications
Apr 20, 2018 | The Independent
By Alex Matthews-King
The NHS spent “at least” £245m on follow-up hospital appointments and aftercare for women who have had vaginal mesh implants, which can cause “horrific” complications. -
UK government finally recognises the mesh scandal
Apr 20, 2018 | Medical Plastics News
By Reece Armstrong
MPs met in parliament to debate what is commonly being referred to as the biggest health scandal since thalidomide – vaginal mesh. -
Mesh campaigners to take legal action to remove their names from ‘whitewash’ report
Apr 22, 2018 | The Sunday Post
By Marion Scott
CAMPAIGNING mesh victims will take legal action to force the Government to remove their names from a “whitewash” report into the surgery blamed for leaving hundreds of Scots in agony. -
Outcry by Peterborough MP as Government refuses to suspend controversial women’s mesh implants
Apr 23, 2018 | Cambs Times
By Kath Sansom
The first Parliamentary debate into the plastic devices heard ministers from all parties tell devastating stories of women being ignored, belittled and left to suffer life changing consequences from the material used to support weakened pelvic tissues causing incontinence or prolapse. -
Health Minister agrees to meet with women affected by vaginal mesh complications
Apr 22, 2018 | The Journal
THE MINISTER FOR Health and Chief Medical Officer have agreed to meet with women who have suffered complications after surgeries using vaginal mesh devices. -
Transvaginal Mesh Lawsuit Award: $68M for Woman’s Suffering
Apr 20, 2018 | Drug Watch
By Elaine Silvestrini
A New Jersey jury ordered C. R. Bard to pay $35 million in punitive damages to a couple for the company’s actions in marketing two transvaginal mesh devices that left the woman in permanent pain. -
Plaintiffs Seek Centralization of N.J. Ethicon Multi-Layered Hernia Mesh Products
Apr 20, 2018 | HarrisMartin Publishing
Plaintiffs in New Jersey actions involving Ethicon Inc.’s multi-layered hernia mesh products are seeking multi-county litigation designation in the Bergen County Superior Court, arguing that centralization will conserve resources. -
‘The Bleeding Edge’ Review: Netflix Doc Proves That the Medical Device Industry is Destroying Lives — Tribeca
Apr 21, 2018 | Indie Wire
By Eric Kohn
Activism can take many forms — on one extreme, the empirical argument, appealing to reason above all else; on the other, the pure visceral nature of an emotional response.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Apr 20, 2018 | New York Times
By Herbert Rakatansky
Re “How Profiteers Coax Women Into Surgery” (front page, April 15):
Patients considering surgery suggested by a third party (especially from a non-physician) that has not been recommended or approved by their primary care doctor risk venturing into areas of medical practice that lack systemic quality controls.
That such surgery is to be performed in a free-standing surgery center not affiliated with a hospital is equally a serious concern.
Patients considering surgery in these instances should either seek a second opinion from an independent specialist or have the surgery performed in a large hospital that has a department of surgery with members who specialize in the condition allegedly requiring surgery.
Additionally, state medical licensing boards maintain free public online records of disciplinary actions. If there is any doubt about a doctor, these records should be checked.
HERBERT RAKATANSKY
PROVIDENCE, R.I.The writer is clinical professor emeritus of medicine at Warren Alpert Medical School, Brown University.
https://www.nytimes.com/2018/04/20/opinion/surgery.html
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Apr 20, 2018 | The Independent
By Alex Matthews-King
The NHS spent “at least” £245m on follow-up hospital appointments and aftercare for women who have had vaginal mesh implants, which can cause “horrific” complications.
An analysis by academics at the Oxford University Centre for Evidence Based Medicine (CEBM) concluded that the true costs, when accounting for lost quality of life, was likely to be far higher.
At a Commons debate on the impacts of mesh this week, MPs shared accounts from constituents about the implants, used to treat incontinence and organ prolapse, which can deform and cut into the flesh, causing agony and permanent disability.
Health minister Jackie Doyle-Price said the cases raised were “horrifying”, adding that she had serious concerns that women being offered the procedure were not given adequate information about risks, or alternative treatments that might have been more suitable.
While she said that a full public inquiry on the extent of complications from implants would be “inappropriate”, she explained that the government is looking at its response as part of a wider review.
Ms Doyle-Price added the government is “determined to do its best for women who have been badly treated in having this procedure”.
The details of an NHS audit of mesh procedures released this week showed 127,500 women have been operated on in a nine- year period. But hundreds a year are having subsequent procedures to remove implants.
Mesh campaigners said the data published by the NHS was selective and didn’t show the full extent of the problem.
Analysis of the data by Professor Carl Heneghan, director of the CEBM, found that despite these gaps – which do not include information on GP appointments or care – mesh implants are already causing significant cost.
“The costs to the NHS are considerable, despite the fact that the costs we have outlined underestimate the true costs to the NHS,” he wrote.
“Approximately 127,500 women were operated on over a nine-year period, and in the following nine years these women required about 1.35 million outpatient appointments that cost the NHS a minimum of £245m.”
As there is no information on how their quality of life has changed, or any long-term impacts on life expectancy, he said the true cost to these women can’t be estimated.
“The report does, however, tell us that the long-term complications persist and likely worsen over time,” he added.
In the Commons debate earlier this week, Labour MP Emma Hardy recounted the case of her constituent, Angie, who had previously been fit and active.
After a mesh operation following the birth of her twins and a hysterectomy operation,she is now “unable to work, in constant pain and suffering, cannot take part in sports and has problems sleeping”.
Carol Monaghan MP, from the Scottish Nationalist Party, said he constituent Karen had a mesh implant in 2009 and this had to be removed in 2013.
“She has been left severely disabled, and now has to use a wheelchair when she travels long distances,” she said.
Ms Doyle-Price said: “The tragedy of this case is that women have put their trust in the medical establishment to look after them and to make them well, and they have come out with the most debilitating, life-changing injuries.
“In many cases, these were very young women. It is very clear from the clinical guidance on these products that they should not be used as a first intervention, and should be used only in very extreme cases. We are to be very concerned about the extent to which this has been adopted.”
A recent guideline change said mesh implants should not be routinely used, but campaigners are pushing for a total ban.
https://www.independent.co.uk/news/health/vaginal-mesh-implants-nhs-cost-women-care-complications-pregnancy-incontinence-prolapse-a8314186.html
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UK government finally recognises the mesh scandal
Apr 20, 2018 | Medical Plastics News
By Reece Armstrong
MPs met in parliament to debate what is commonly being referred to as the biggest health scandal since thalidomide – vaginal mesh.
Led by Labour MP Emma Hardy, the debate referenced the recent NHS Digital audit that looked into the women adversely affected by mesh devices.
Opening the debate, Hardy gave a harrowing account of one of her constituents “who, after having incontinence following the birth of her twins and a hysterectomy, was advised to have this mesh operation. She is now unable to work, in constant pain and suffering, cannot take part in sports and has problems sleeping. I remember listening to what she said to me and feeling horrified that this had happened to her. As I have learned, she is most definitely not alone.” She said.
Hardy used the debate to call for NICE guidelines for mesh used in stress urinary incontinence (SUI) to be brought forward from 2019 to this year. She also asked for pelvic floor physiotherapy to be offered on the NHS to all new mothers as a way to offset the need for vaginal mesh devices.
Contrary to last year’s debate - in which calls to suspend the mesh were rejected alongside the need for a public inquiry, politicians agreed on a need for action.
For years now, women have campaigned against the side-effects of vaginal mesh devices, stating that the devices have caused life-changing effects such as chronic pain, organ erosion, nerve damage, psychological harm and more.
NHS Digital’s recent audit showed that at least 500 removal operations for vaginal mesh devices have been carried out by the NHS every year since 2008.
At the debate, Owen Smith, MP and chairman for the All Party Parliamentary Group for Surgical Mesh, spoke about the problem with these removals.
“Some women are left with pieces of mesh inside them, even after surgery. Those sorts of complications are clearly very worrying. They ought to have been explained properly to women, but obviously were not, in very many cases.” Smith argued.
A major point of the debate regarded how women have not been properly informed about the potential benefits and dangers of these devices. Clinical evidence on the efficacy of mesh devices has been lacking and the Medicines and Healthcare Product Regulatory Agency “has only a fraction of the knowledge of the adverse effects associated with mesh” according to Hardy.
Unfortunately the regulatory process, in which manufacturers only have to supply a small amount of evidence into the efficacy of their devices, has led to a high number of products being available on the market. The lack of data into these devices has resulted in women (and indeed clinicians) not knowing about the dangerous side-effects and the potentially devastating consequences on their health and wellbeing.
At the debate, Conservative MP Dr Sarah Wollaston stated that consent for women has to be “based on high-quality, balanced and evidence-based information, and that has been lacking”.
Perhaps most importantly, government finally started to recognise that issues stem not just from clinical practice, but from the devices themselves. In January, campaign group Sling the Mesh released a survey of over 500 women that detailed the impact that mesh was having on their lives. The survey showed that over half of the women suffer from constant urinary infections, eight out of 10 suffer pain when walking, over half suffer from incontinence and three in 10 are unable to urinate.
At last year’s debate, Jackie Doyle-Price, the Parliamentary Under-Secretary of State for Health believed that issues surrounding vaginal mesh implants were related to clinical practice instead of to the devices themselves.
Yesterday however, Doyle-Price acknowledged that the product itself has issues but noted that it was important to consider why the devices were being used, and for what reasons.
“If we are talking about some new mums, the level of risk clearly would not be outweighed by the benefits, but if we are looking at women suffering from horrendous conditions of incontinence, that is a very different debate. Again, we need to think about the broader issues. It all comes down to making sure that the guidance is properly applied and that clinicians who are recommending the use of mesh are properly making that assessment in discussion with their patients.” Doyle-Price said.
The debate highlights the true problem that are being caused by vaginal mesh devices. And whilst it may be dangerous to suggest that the devices haven’t benefitted women, the diligent campaigning done by groups such as Sling the Mesh shows that it is an issue that urgently needs addressing.
Thankfully steps are being done, and NICE is set to publish draft guidance on the use of mesh devices this year before the official guidance is published in 2019.
Ending the debate, Hardy gave thanks to the women who have campaigned to bring this issue to light.
“I end by thanking again all the fantastic women up there in the Gallery right now watching this debate. We are only talking about this now because of your bravery in coming forward and speaking out, and I thank each and every single one of you. We cannot undo the suffering you have experienced, but by speaking out and being so incredibly brave, you will stop women in the future going through what you have gone through. I and every Member who has spoken today thank you.”
https://www.medicalplasticsnews.com/news/opinion/uk-government-is-finally-recognising-the-mesh-scandal/
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Mesh campaigners to take legal action to remove their names from ‘whitewash’ report
Apr 22, 2018 | The Sunday Post
By Marion Scott
CAMPAIGNING mesh victims will take legal action to force the Government to remove their names from a “whitewash” report into the surgery blamed for leaving hundreds of Scots in agony.
The women are furious that ministers have used their names and research in the review despite their resignation from the inquiry.
Elaine Holmes and Olive McIlroy met Health Secretary Shona Robison before the review was published to demand their names come off the report after they lost faith with the review process.
They are now promising to take action after the report, which they claim was skewed in favour of mesh, and ignored evidence revealing the risks involved, was published unchanged.
The women’s exposure of the plight of victims left with life-changing, lifelong injuries because of mesh treatment led to former health secretary Alex Neil ordering suspension of its use in Scotland.
However, the official review was used to justify lifting the ban just as other countries around the world began to suspend and curtail the use of mesh. Elaine Holmes said: “Shona Robison was left under no illusion how we felt about the whitewash of a review which betrayed injured women and set up future generations to have their lives destroyed by mesh.
“We told her all our input must be removed in advance of the report being published. She assured us, in front of witnesses, that she’d heard us.
“Imagine our disgust when we discovered our names and input continued to be used to give that sham report credibility?”
The women, who campaigned for seven years to alert the world to the dangers of plastic polypropylene mesh implants to treat bladder problems and pelvic organ prolapse, have advised other governments on safety.
They say the inclusion of their names is “yet another slap in the face”.
The women resigned from the review, along with leading urogynaecologist Wael Agur, claiming vital safety evidence and warnings from around the world had been excluded, data had been altered and European guidance that all mesh should be reclassified as “high risk” was not properly acknowledged.
The women met Robison in March last year along with Chief Medical Officer Catherine Calderwood and MSPs.
They raised concerns over experts with conflicts of interest, and what they describe as a “misleading chapter’ which concludes mesh procedures are better than non-mesh- while withholding mesh complications. They also claim the report describes specific disadvantages of non-mesh procedures but not any advantages, encouraging patients towards implant surgery.
Campaigners say one type of implant, inserted “blind” using 10-inch long metal hooks causing nerve damage to 40% of patients, was wrongly described as “removable”.
Each of the four experts appointed to the review had previously received funding from mesh manufacturers, but were asked for declaration of interests going back only a year.
Consultant Paul Hilton, an independent medical witness for the NHS in the forthcoming 500 civil actions for damages by mesh patients, was not asked to disclose previous mesh industry funding.
The review failed to detail another review expert, NHS Glasgow’s lead urogynaecologist Karen Guerrero, was organising training programmes for gynaecologists sponsored and subsidised by Boston Scientific which denies allegations it used counterfeit polypropylene resin from China to manufacture implants.
Another expert, NHS Lothian consultant Voula Granitsiotis, received travel grants from mesh firms, including American Medical Systems which collapsed after announcing a £1.2 billion pay-outs.
Both NHS Glasgow and NHS Lothian, ignored Scotland’s 2014 mesh suspension and continued to implant hundreds more women.
The fourth expert, NHS Ayrshire and Arran specialist Dr Wael Agur received travel grants and support from Boston Scientific, Ethicon and CR Bard. Although he declared these, the declaration was not published.
Professor Cathryn Glazener, researcher to the inquiry, was involved in a number of multi-million pound mesh trials. Isobel Montgomery, the patient who had a “positive mesh experience”, received almost £3000 in mesh trial fees and was listed as a “grant holder”. Her declaration of interest failed to list this.
Olive McIlroy said: “We were cynically used to ‘sell’ a report biased towards mesh despite evidence that showed how dangerous it is.”
The report only recommended against “routinely” using mesh for pelvic problems, leaving the door open. It also recommended a mesh tape could be offered for bladder conditions when traditional methods that didn’t have the same devastating complications should be considered first.
Olive added: “Our own country, which under previous Health Secretary Alex Neil led the world by suspending the use of mesh, went on to ignore the hundreds of thousands worldwide who have been injured, and the £3billion paid out by manufacturers.”
The women are taking legal advice and are drawing up a legal disclaimer.
A Scottish Government spokesman said: “Both the Health Secretary and the Chief Medical Officer have great sympathy with the complications that these and other women have suffered following surgery and have personally and publically apologised to them.”
Leading civil law specialist Patrick McGuire of Thompsons Solicitors is examining the case. He said: “The women rightly feel they have been betrayed and their names used to bolster the credibility of this report, despite the fact that they disagree with so much of it and the way the review was carried out.
“We intend robustly pursuing whatever avenue is open to us.”
https://www.sundaypost.com/fp/mesh-campaigners-to-take-legal-action-to-remove-their-names-from-whitewash-report/
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Outcry by Peterborough MP as Government refuses to suspend controversial women’s mesh implants
Apr 23, 2018 | Cambs Times
By Kath Sansom
The first Parliamentary debate into the plastic devices heard ministers from all parties tell devastating stories of women being ignored, belittled and left to suffer life changing consequences from the material used to support weakened pelvic tissues causing incontinence or prolapse.
Calls were made by Dr Sarah Wollaston MP, for women to receive compensation in what she called a “wild west” of device regulation where implants were rushed to market for profit.
The debate also heard of men and women suffering hernia and rectopexy mesh complications.
Despite “ghastly complications” and shattered lives, health minister Jackie Doyle Price said the Government would not suspend mesh implants while a review is carried out into it’s long term safety.
Peterborough MP Fiona Onasanya said: “If we are hearing from women who have had mesh implants that they are not working, that they have destroyed their lives and they have debilitating painful consequences, why on earth would we try to justify not suspending the use of this mesh? It is horrendous.”
In a letter from Theresa May Fiona was told the benefits of vaginal mesh implants outweigh the risks.
Fiona said: “How can it be that people who have gone in for a day’s surgery and come out thinking, ‘my life’s going to be better —I can rock climb, mountain bike and run with my kids,’ find that they cannot move and are in constant pain?”
The controversy surrounding the use of surgical mesh debate was led by Emma Hardy MP, vice chair of the all party group on surgical mesh.
It took place just two days after the Government produced new statistics which show approximately 500 in every 13,000 women implanted with mesh are re-operated on within a decade to have it removed.
Carl Heneghan, professor of evidence based medicine at the University of Oxford, said the figures show the number of women going to outpatient clinics with mesh problems has cost the NHS a staggering £245 million in nine years.
It was the sort of treatment numbers you would expect to see among patients with multiple health problems, not among relatively young women who had been given a day case “simple” surgery, he said.
His analysis also shows women need more appointments as each year passes after-surgery, proving women get worse as time goes on, he added.
The reverse would normally be seen after successful surgery, he said.
More than 127,000 women in England have had a mesh patch or sling tape operation in the last nine years, but campaigners say that number is vastly under estimated, as NHS figures published this week miss off 10 years of data, miss private hospital information and do not include women from Scotland, Northern Ireland or Wales.
In addition, it does not include women only going to their local GP for medication.
Owen Smith MP, chair of the APPG on surgical mesh said: ‘These statistics show the scale and complexity of the problems associated with mesh is far greater than has previously been accepted.
“It cannot be right that so many women are having to return repeatedly to hospital to deal with the side-effects caused by mesh, and it cannot be cost-effective for the NHS either.
“In light of these statistics, the Government has now called in Dame Sally Davies, the Chief Medical Officer, to investigate, in addition to the appointment of Baroness Julia Cumberledge just weeks ago to look at how the scandal has been handled.
“They now need to suspend the use of mesh until the results of these twin investigations are known.”
Emma Hardy MP, said: “The Government should urgently review the financial consequences of dealing with failed mesh procedures and consider introducing post-natal pelvic floor physiotherapy for all new mothers on the NHS.
“That is standard in France, and in light of the shocking new analysis which reveals the cost of botched mesh ops, our Government should bring forward a similar programme to both support the health and wellbeing of new mothers and to save NHS money in the longer term.”
• Read the Hansard copy of the debate here.
http://www.cambstimes.co.uk/news/outcry-by-peterborough-mp-as-government-refuse-to-suspend-controversial-women-s-mesh-implants-1-5486460
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Health Minister agrees to meet with women affected by vaginal mesh complications
Apr 22, 2018 | The Journal
THE MINISTER FOR Health and Chief Medical Officer have agreed to meet with women who have suffered complications after surgeries using vaginal mesh devices.
Vaginal mesh devices are used in surgeries to treat stress urinary incontinence and pelvic prolapse, conditions women can suffer after natural childbirth. There have been thousands of reports internationally of painful complications from women who have undergone these procedures.
This includes a number of Irish women, some of whom have spoken to TheJournal.ie in the last year about their recurrent urinary infections and pain after the operations.
· Margaret Byrne said the mesh tape used in her procedure migrated and cut through her vagina. She had to undergo a number of further procedures to correct the problem.
· Lesley-Anne Stephens had the procedure when she was 36 – now at 39 she has to use a walking stick for support.
· 48-year-old Janet Roche has been told that she will probably have chronic pain for the rest of her life.
Just this week Byrne won the Eir/Age Action Silver Surfer Award, in part for her online campaigning for herself and other women who suffered these complications.
‘Unexplained pelvic pain’
Media coverage of these stories promoted Health Minister Simon Harris last year to order a report into the use of vaginal mesh devices in Ireland by the Chief Medical Officer (CMO) Tony Holohan.
Since then, campaigners from the Mesh Survivors Ireland support group have been appealing to the Minister and CMO to meet with them as part of this review process, to hear about their experiences.
This week solicitor Melanie Power, who set up the group, told TheJournal.ie that Harris and Holohan have now agreed to meet with her and a number of impacted women next month.
Among the issues she will raise is the need for the HSE to invest in specialised equipment called a ‘translabial scanner’, which will show internally whether the device has moved or started to degrade.
The HSE has previously said this equipment is not needed to assess migration, but it is being used by professionals in the UK and is also due to be introduced in Belfast. Power said making this scan available for Irish women would not cost a lot of money.
“The awful thing about this is that the scan is in every maternity hospital already. All we need is a different head on the scanner, most of the equipment is already here and they’d need to train up a sonographer in reading it,” she said.
A number of the women in the support group have travelled to the UK and paid the more than €400 for the scan themselves.
“Many ladies are baffled by what’s actually going on with them. They are being diagnosed with unexplained pelvic pain and recurrent urinary tract infections and told that’s just the menopause so they’ll have to get on with it, and they’re just being sent for pain management.
There are ladies who have had addiction issues because they’ve been on the pain medication for so long and some of them can no longer have any form of pain management because of that addiction.
Earlier this year the NHS in Britain launched an audit and the findings published this week show surgeons performed at least 500 removal operations each year for vaginal mesh and tape implants since April 2008.
The majority of these removals were after a procedure to treat stress urinary incontinence, which has up until now been considered the least risky operation using mesh devices.
Most of the vaginal mesh products used in the NHS were launched without any clinical trials. Campaigners in Ireland have said the same devices were used here.
“We need to suspend their use until we actually know what is going on,” Power said.
“It’s been 20 years of experimentation with this device and they haven’t been tracking it. They need to go back and find out what the evidence is and then make an informed decision if it should continue and on what basis it should be allowed.”
http://www.thejournal.ie/vaginal-mesh-minister-for-health-3969072-Apr2018/
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Transvaginal Mesh Lawsuit Award: $68M for Woman’s Suffering
Apr 20, 2018 | Drug Watch
By Elaine Silvestrini
A New Jersey jury ordered C. R. Bard to pay $35 million in punitive damages to a couple for the company’s actions in marketing two transvaginal mesh devices that left the woman in permanent pain.
The punitive award is on top of $33 million jurors previously ordered to compensate the couple — $23 million for Mary McGinnis and $10 million for her husband.
The combined verdicts total $68 million.
Mary McGinnis, 70, testified standing up in the trial for her lawsuit against the company, which is facing thousands of similar lawsuits around the country. McGinnis said standing was less uncomfortable and made her more able to manage her pain. She described the pain as “hot pokers all the time.”
McGinnis had the company’s mesh models named Avaulta Solo and Align TO implanted March 12, 2009, during surgery to treat her bladder’s movement, called prolapse. Within months, she started to experience erosion, which happens when mesh wears through internal tissue.Pain ‘Beyond Debilitating’
“The pain is beyond debilitating,” McGinnis testified. “It hurts so much I can’t cry…My body is always in fight or flight mode.”
Since her original surgery, McGinnis has undergone at least three more mesh removal and reconstructive operations, the most recent in February 2017.
McGinnis testified she is no longer able to be intimate with her husband, she sleeps every night with cold packs and uses a number of different therapies and methods to control her physical problems.
Her lawyer, Adam Slater, said Bard officials knew the properties of the plastic used to make the devices were dangerous to women. The supplier warned about its use in implantation. “They knew it was causing harm,” he told jurors in his summations. “They kept selling it.”
McGinnis was unaware that the product wasn’t tested, Slater said. “Mary didn’t know that she was part of an experiment.”
They could have done more research, Slater said. “They didn’t do a clinical study. And we know why…The Bard culture said, go to market.”
Drugwatch viewed the summations and recordings of other parts of the trial via Courtroom View Network.
Lori Cohen, attorney for Murray Hill, N.J-based Bard, argued during that the devices McGinnis had implanted are safe and effective. Cohen said the company followed accepted standards of care. She told jurors that her problems may have arisen because of faulty technique on the part of her surgeon.
Moreover, she suggested many of the issues may be the result of medical issues the woman had before the initial implant. McGinnis, Cohen argued, had a “significant pre-implant medical history.”
After the compensatory award was announced, Cohen told jurors that the company “has received the message and hears you…We respect you. We respect your verdict.”
She said there was “no reason” for punitive damages.
https://www.drugwatch.com/news/2018/04/20/transvaginal-mesh-lawsuit-award-68m-for-womans-suffering/
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Plaintiffs Seek Centralization of N.J. Ethicon Multi-Layered Hernia Mesh Products
Apr 20, 2018 | HarrisMartin Publishing
Plaintiffs in New Jersey actions involving Ethicon Inc.’s multi-layered hernia mesh products are seeking multi-county litigation designation in the Bergen County Superior Court, arguing that centralization will conserve resources.
In a March 14 letter, the 62 plaintiffs, all of whom allege that the Ethicon polypropylene mesh devices are defective, further argue that coordination of the actions before Judge Rachelle Harz will reduce cost, eliminate delay, and reduce the likelihood of inconsistent results.
Plaintiffs maintain there are dozens, if not hundreds of additional cases involving Ethicon’s multi-layered hernia mesh that will be filed in the near future. ...
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LetterAccess to full text unavailable – subscription required. For full story: https://harrismartin.com/article/23408/plaintiffs-seek-centralization-of-nj-ethicon-multi-layered-hernia-mesh-products/
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Apr 21, 2018 | Indie Wire
By Eric Kohn
Activism can take many forms — on one extreme, the empirical argument, appealing to reason above all else; on the other, the pure visceral nature of an emotional response. “The Bleeding Edge” oscillates between those two extremes. The latest alarming documentary from “The Invisible War” and “The Hunting Ground” director Kirby Dick is a shocking expose of the medical device industry, and while the stories of the many lives destroyed by technology resonate, the unsettling imagery of the damage caused by those devices goes much further.
Less cohesive documentary than feature-length red flag, “The Bleeding Edge” assembles a range of talking heads and upsetting case studies to target several key villains: Essure, the permanent contraceptive implant used by millions of women, has left many of them with long-lasting pain and endless surgeries as the small, snake-like device worms its way into the uterus. The “vaginal mesh” approach yields even more gruesome results. Patients operated on by the robotic surgeries of the da Vinci System often contend with extensive infections, and others with artificial hips made with chrome-cobalt devices suffer from neurological problems. Dick lays out each of these conundrums with a series of case studies, while contextualizing within the broader context of the quack medical industry.
Through an effective blend of archival footage and the testimony of contemporary experts, the movie lays out the lineage of the industry in postwar America, while rooting it in the present day. By deconstructing misleading advertisements that exploit people eager for eager solutions, Dick makes it clear just how easily people can be hoodwinked within the parameters of the law. After all, none of these dangerous medical procedures have been stopped by the Food and Drug Administration, an arm of government that operates at the whims of lobbyists and the powerful corporations fueling this $400 billion industry.
“The Bleeding Edge” has a schematic approach that doesn’t exactly make for gripping cinema, but its alarmist tone gives imbues each mini-story with unnerving immediacy. Among the more compelling subjects is Gaby Avina, a former Essure spokesperson who wrote an actual column for the company called “Ask Gaby” singing the praises of the device before — more than a decade after having the device installed herself — joining a protest group of women who suffer from its impact. Another devastating drama involves Essure victim Ana Fuentes, who struggles to cope with her mounting medical bills and large family while living a nomadic life. Then there’s the story of Tammy Jackson, who endures surgery after surgery once her vaginal mesh (designed to hold itself in place with actual scar tissue) becomes a jumbled mess described to her by one physician as “bubblegum stuck in hair.”
But that shocking description has nothing on the gnarly image of the wiry substance stuck in a bloody mass, or the story of da Vinci patient whose colon fell out. Medical students may find this parade of mortifying tales instructive; others will recoil in terror and wonder how the hell any of these procedures remain legal during such technologically-advanced times. Dick points the finger in part at Scott Gottlieb, the Trump-appointed FDA head who seems to care as much about patient safety as Scott Pruitt cares about the environment. Even worse: the absence in the movie of representatives from major household names — including Johnson & Johnson — responsible for developing these devices, all of whom declined to participate. Dick’s movie might have had deeper resonance if he’d found some defectors from the companies to elucidate their incapacity to these problems, but “The Bleeding Edge” seems less concerned with explaining why these devices come to market than simply calling attention to their harmful effects.
In that sense, it’s ideally suited for Netflix, which produced and will release the movie worldwide. Much in the way the Essure backlash stemmed from a growing Facebook group, “The Bleeding Edge” stands a good chance at enlightening more people who have been (or might be) hoodwinked. Presumably, the Netflix algorithm won’t bury it, but there’s a bigger concern with such hard-to-watch informational material: It might reach millions, but the extent of its impact will depend on how many people choose to press play.Grade: B
“The Bleeding Edge” premiered at the 2018 Tribeca Film Festival. Netflix will release it this summer.
http://www.indiewire.com/2018/04/the-bleeding-edge-review-netflix-kirby-dick-tribeca-1201955575/
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