Preview Newsletter
Ethicon Media Monitoring 7/25/2018
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Ireland to pause use of transvaginal mesh after 'understandable public anxiety'
Jul 24, 2018 | The Journal.ie
By Paul Hosford
Health Minister Simon Harris has announced that his department’s Chief Medical Officer (CMO) has requested the HSE stop the use of all procedures involving transvaginal mesh devices in public hospitals. -
Health Minister orders temporary suspension of vaginal mesh implants
Jul 24, 2018 | News Health
By Eilish O'Regan
The use of a controversial medical device used to control urinary incontinence and organ prolapse in women has been temporarily suspended, Health Minister Simon Harris announced today. -
Is the promise of £125,000 tempting 'cash-hungry' medics to back vaginal mesh? Victims accuse private surgeons of wanting to 'double their salary' by fitting the controversial implants
Jul 24, 2018 | Daily Mail
By Stephen Matthews
Hundreds of private surgeons have been accused of being 'cash-hungry' by pushing women to undergo barbaric vaginal mesh surgery. -
Use of transvaginal mesh devices put on pause, says Minister for Health
Jul 24, 2018 | Irish Times
By Sorcha Pollak
The chief medical officer for the Department of Health has requested that all procedures involving transvaginal mesh devices be paused unless it is “clinically appropriate” or “safe” to use the device, the Minister for Health has said. -
Health Minister Suspends Vaginal Mesh Ops Following Calls
Jul 25, 2018 | Midlands 103
By Ben Finnegan
The Health Minister has announced a pause in the use of transvaginal mesh devices. -
500 Women Have Ethicon Mesh Cases Dismissed
Jul 24, 2018 | Mesh Medical Device News Desk
By Jane Akre
At one time the multidistrict litigation (MDL) had more than 104,000 product liability cases filed over allegedly defective pelvic mesh. -
Wilkie overwhelmingly confirmed as VA Secretary
Jul 24, 2018 | Politico - Morning eHealth
By Mohana Ravindranath
Morning eHealth correspondent Darius Tahir caught an advance screening of Bleeding Edge, a documentary indicting some of the safety pitfalls of the medical device industry, Monday night. -
The voices of women must be heard when it comes to healthcare – Mary Lou McDonald TD
Jul 24, 2018 | An Phoblacht
By Callum Smyth
Sinn Féin leader Mary Lou McDonald TD along with Dáil Health spokesperson Louise O’Reilly TD and Assembly spokesperson on Mental Health Órlaithí Flynn MLA today launched Sinn Féin’s all-Ireland women’s healthcare policy document entitled ‘A Vision for Women’s Healthcare’. -
Afraid Of The Doctor? 'The Bleeding Edge' Says Maybe We Should Be
Jul 24, 2018 | Forbes
By David Alm
The Bleeding Edge, a new Netflix documentary directed by Kirby Dick, does for the medical device industry what Supersize Me did for McDonald's. -
This documentary isn’t even out yet, but it’s already changing birth control
Jul 25, 2018 | Metro
By Meagan Morris
"People think pharma's got power," journalist Jim Spencer says in the documentary The Bleeding Edge. "No no no, the medical device industry has much more power than pharma." -
Netflix’s The Bleeding Edge Exposes the Horrors of FDA-Approved Medical Devices
Jul 24, 2018 | LA Weekly
By April Wolfe
Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. -
Netflix pic aims to highlight danger of medical devices
Jul 24, 2018 | Medical Plastics News
Featuring devices such as Essure birth control, transvaginal mesh implants, metal-on-metal hips and the DaVinci surgical robot, a theme of the film looks at how ledical devices make their way onto the market untested.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Ireland to pause use of transvaginal mesh after 'understandable public anxiety'
Jul 24, 2018 | The Journal.ie
By Paul Hosford
HEALTH MINISTER SIMON Harris has announced that his department’s Chief Medical Officer (CMO) has requested the HSE stop the use of all procedures involving transvaginal mesh devices in public hospitals.
The pause on the use of the mesh will cover the management of Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP) where it is safe to do so.
This announcement follows a review by the Department of Health together with the HSE and the Health Products Regulatory Agency (HPRA), of the decision by health authorities in England and Northern Ireland to pause the use of mesh in those countries until a set of conditions to mitigate the risks of injury are met.
Thousands of women across the world have suffered complications after having a vaginal mesh device implanted. These devices, made with polypropylene – a type of plastic – are used in surgeries to address stress urinary incontinence and pelvic prolapse, conditions women can suffer after natural childbirth.
These complications include chronic pain and recurrent urinary tract infections and have been life-changing in many cases. Some women have reported that the mesh device moved and eroded through the walls of their vaginas, causing pain and resulting in further surgeries to remove sections of the mesh.
A statement from Minister Harris said:
“There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS.
“It is important that this be addressed as comprehensively as possible. A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.”
Melanie Power, solicitor and the founder of the Mesh Survivors Ireland support group said:
“Mesh Survivors Ireland are relieved that finally there is a recognition of the appalling and life altering injuries caused by mesh for both stress urinary incontinence and pelvic organ prolapse. women had to take to the streets and discuss their most intimate issues in media in order for these complications to be recognised. We look forward to meeting with Minister Harris in August to hear the pathways that will be put in place for women with mesh complications as currently women are paying privately to go to the UK for treatment.”
This pause should remain in place until the HSE confirms implementation of recommendations relating to training, informed consent and the development of an agreed dataset of mesh procedures.
Patients affected by the cancellation will be contacted by the HSE as soon as possible to advise them that their surgery has been postponed. Concerned patients are advised to contact their consultant.
http://www.thejournal.ie/transvaginal-mesh-paused-4145882-Jul2018/
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Health Minister orders temporary suspension of vaginal mesh implants
Jul 24, 2018 | News Health
By Eilish O'Regan
The use of a controversial medical device used to control urinary incontinence and organ prolapse in women has been temporarily suspended, Health Minister Simon Harris announced today.
He said the use of vaginal mesh implants will be "paused "in HSE-funded hospitals, in cases where it is clinically appropriate and safe to do so.
The announcement follows a review by the Department of Health together with the HSE and the Health Products Regulatory Agency (HPRA) of a similar decision by health authorities in England and Northern Ireland.
It came on foot of a recommendation UK's Independent Medicines and Medical Devices Safety Review (IMMDS).
The pause will continue until a set of conditions to mitigate the risks of injury are met, he said.
"There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received, and this has been heightened by recent developments in the NHS. It is important that this be addressed as comprehensively as possible.
"A pause on the use of mesh procedures, pending confirmation by the HSE that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.”
He said there is no concurrent change in the evidence base concerning these devices.
"It is widely accepted that for many women suffering the distressing symptoms of urinary incontinence in particular that surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional surgical procedures.
"The recommendations of the IMMDS to NHS England arose because of a lack of certainty or confidence that critical clinical governance measures to assure the safety of mesh procedures are demonstrably in place. The Department considers that similar concerns in relation to the visibility and consistency of such measures apply equally in the public health system here.
"This pause should remain in place until the HSE confirms implementation of recommendations relating to (i) Surgical Training, (ii) Informed Consent and (iii) the Development of an agreed Dataset of Mesh Procedures. The Department has also written to the Institute of Obstetricians and Gynaecologists, the Royal College of Surgeons in Ireland and the Continence Foundation of Ireland requesting that they assist the HSE in progressing these recommendations on an urgent basis.
"Patients affected by the cancellation will be contacted by the HSE as soon as possible to advise them that their surgery has been postponed. The duration of their cancellation will be related to the duration of the pause and every effort will be made to keep this to a minimum. Patients with concerns are advised in the first instance to contact their Consultant’s clinic.
NHS England has put down conditions that by March next year surgeons only undertake the operations for incontinence using the mesh if appropriately trained and a registry set up to keep track of any complications.
Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women.
However, in some women, they have been allegedly shown to erode and disintegrate, slicing through organs and vaginal walls to cause paralysis, chronic pain, sepsis, loss of sex life and even organ failure.
The manufacturers of the implants Johnson and Johnson defended their safety record saying all such devices have pros and cons.
Melanie Power, solicitor for a group of Irish women, Mesh Survivors Ireland, who claim side effects, wrote to Mr Harris asking him to take the same decision here as in the UK.
https://www.independent.ie/irish-news/health/health-minister-orders-temporary-suspension-of-vaginal-mesh-implants-37151409.html
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Jul 24, 2018 | Daily Mail
By Stephen Matthews
Hundreds of private surgeons have been accused of being 'cash-hungry' by pushing women to undergo barbaric vaginal mesh surgery.
Campaigners have today unearthed data that reveals urogynaecologists can 'double their salaries' by offering the controversial procedure in their own clinics.
Calculations by prominent group Sling The Mesh show surgeons can earn an extra £125,000 by giving four women mesh each week privately.
Vaginal mesh, made of brittle plastic that can curl, twist and cut through tissue, has been branded the 'biggest medical scandal' since thalidomide.
Thousands of women have been maimed by the controversial implants globally, left on the brink of suicide, unable to work and reliant on wheelchairs.
A landmark NHS audit in April confirmed that thousands of women have been forced to suffer unbearable pain because of their controversial vaginal mesh implants.
Tireless fights by campaigners, backed by MailOnline, were rewarded last week, when officials declared a temporary ban on mesh being used to treat incontinence.
But the British Society of Urogynaecologists, made up of NHS and private surgeons with 'flashy websites', attacked the decision as going against the NHS' own rulebook.
'Meshed up' victims claim the stance of the surgeons, who they describe as 'misogynistic bullies', is 'because they fear their luxurious lifestyles may take a hit'.
Number crunching by Sling The Mesh shows private urogynaecologists can earn nearly £125,000 extra a year by operating on four women with mesh each week.
It believes four operations is a feasible amount, as before the scandal emerged the risky procedure was hailed for taking just 20 minutes.
Gynaecological surgeons - who earn in the region of £90,000 - can receive fees of £589 for privately fitting TVT – the most common type of mesh, according to Bupa.
This means, in theory, they could pocket £2,356 a week or £122,512 a year, if they had no holidays and each women paid for the procedure.
Sling The Mesh argued this figure could be on the low end, as many surgeons may find time to fit more women with TVT each week, and charge for consultations.
In contrast, gynaecological surgeons can receive £548 for privately fitting a Burch colposuspension, another method to treat incontinence, which takes three hours.
Kath Sansom, founder of the 6,300-strong Sling The Mesh group, attacked the BSUG for, what she feels could be, choosing money over the safety of thousands of women.
She told MailOnline: 'If you look through some of the members in the group, you can see plenty of surgeons have flashy websites for their own private practice.
'By implanting a TVT into four women each week, they can pretty much double their salary doing private hospital work. They’re cash-hungry.
'It’s pretty obvious that their position on vaginal mesh is ... down to them living in fear that their luxurious lifestyles may be taken away from them.
'They don’t want to lose their opportunities for paying the mortgage off early, driving a flash car, luxury holidays, or settling school fees.
'Their aggressive denial that mesh is a problem smacks of misogyny and continues to undermine the severity of suffering.
'They are riding rough shod over patient experience with a "we know best attitude" and giving bad advice to the Government on the safety of mesh implants.'
The BSUG's parent group, the Royal College of Obstetricians and Gynaecologists, said it was 'committed' to ensuring the safety of women.
A spokesperson said last week: 'The RCOG is committed to working with others to meet the conditions set out by the review.’
But, in a statement issued after the decision to immediately suspend the use of mesh for incontinence, the BSUG declared it 'strongly opposes'.
In a letter, signed by its chair Professor Jonathan Duckett, it wrote: 'This decision is not based on any scientific logic or thinking.
'This is the single most researched incontinence procedure in the world, and to therefore place a suspension on its use contradicts all the research, scientific evidence and guidance issued by national bodies.
'This procedure has been the mainstay of surgical treatment for women with stress incontinence over the last 20 years.'
It added the decision 'goes against several key principles of the NHS constitution, including its accountability to the public, communities and patients it serves'.
Baroness Julia Cumberlege, leader of the review into vaginal mesh for incontinence, called for the immediate suspension of the implants last Monday.
It is not a complete ban, but a halt to implementing mesh until a list of five strict conditions laid down by 'appalled' reviewers have been met.
But victims hope it sets the groundwork for an outright ban, as the review has so far found no evidence the benefits of mesh outweigh the severity of human suffering.
Baroness Cumberlege described the ordeal of hundreds of women who were brave enough to speak out about their mesh ordeal as 'compelling'.
Both the Department of Health and Social Care and NHS England accepted her recommendations, which included a list of five criteria that need to be met for the pause to be lifted, including reporting every procedure to national database.
But the BSUG, which has around 500 members, claims to have 'achieved and fulfilled' the criteria listed by Baroness Cumberlege.
The full recommendations of the review, announced by former Health and Social Care Secretary Jeremy Hunt in February, is expected to be publicised next year.
A BSUG spokesperson told MailOnline: 'The BSUG represents urogynaecologists in the UK and remains committed to providing women with the safest and most effective treatments for a range of conditions.
'It is committed to patient safety and believes that any decision regarding treatment for women must be based on sound and rigorous evidence.
'Synthetic tapes for stress urinary incontinence are an effective treatment for women who suffer from this debilitating condition and for some women may be the only feasible option.'
Health watchdogs Nice already announced the controversial surgery should only be banned for prolapse - when organs fall out of place, and not incontinence.
Sling The Mesh attacked that decision, announced in December, as they estimated around three quarters of women were given vaginal mesh to treat incontinence.
And the group also urged officials to add a suspension onto the use of rectopexy mesh, used for rectal prolapse, amid evidence it can also maim women.
A Government audit that delved into the effects of mesh, released in April, shone a light onto the true scale of disaster caused by vaginal mesh.
The risks of complications from mesh were shown to be around the 45 per cent mark - unlike the previous assertions by the NHS it is no more than three per cent.
The dangers of mesh for prolapse and incontinence, common medical issues after childbirth, were almost equal, despite Nice only recommending a ban on the former.
All forms of pelvic mesh are already banned in New Zealand after a landmark move in December, and a similar move against use in the treatment of vaginal mesh for prolapse has been made in Australia.
The Scottish Government put in place a suspension in the use of mesh for SUI in 2014, following years of campaigning by outraged victims.
Vaginal mesh has been subject of various legal proceedings across the world, with figures suggesting more than 100,000 are suing manufacturers of the devices.
Despite the risks, widely publicised over the past year, most women experience no problem and doctors are adamant the procedure is beneficial.
The scandal came to light last April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some claiming the scandal could be akin to thalidomide.
At the time, 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
http://www.dailymail.co.uk/health/article-5951611/Is-promise-125-000-tempting-cash-hungry-medics-vaginal-mesh.html
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Use of transvaginal mesh devices put on pause, says Minister for Health
Jul 24, 2018 | Irish Times
By Sorcha Pollak
The chief medical officer for the Department of Health has requested that all procedures involving transvaginal mesh devices be paused unless it is “clinically appropriate” or “safe” to use the device, the Minister for Health has said.
In a statement released on Tuesday, Simon Harris said his department’s chief medical officer had requested that the HSE refrain from using the device, which is used to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP), following a review by the Department of Health, the HSE and the Health Products Regulatory Agency.
The announcement comes a fortnight after the UK government accepted a recommendation to temporarily ban the use of vaginal mesh implants for women with urinary incontinence until March 2019. The Independent Medicines and Medical Devices Safety Review found that the use of the mesh must be stopped until steps had been taken to mitigate the risks to patients.
“There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS, ” said Mr Harris. “A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.”
The minister noted that it was widely accepted that the use of the synthetic mesh for women suffering from symptoms of SUI has provided a “more effective and less invasive form of treatment than traditional surgical procedures”. He said the UK National Health Service recommendations arose because of a “lack of certainty or confidence that critical clinical governance measures to assure the safety of mesh procedures are demonstrably in place”.
“The Department considers that similar concerns in relation to the visibility and consistency of such measures apply equally in the public health system here.”
The pause in using the mesh will remain in place until the HSE confirms it has implemented recommendations relating to surgical training, informed consent and the development of an agreed dataset on mesh procedures, said Mr Harris. The statement from the department underlined that the pause was “not a blanket ban on relevant procedures” and that for some patients the use of mesh may be the only viable treatment option.
Members of the Mesh Survivors Ireland group met with the minister last month to call for a suspension of the mesh device and to discuss how the treatment of women suffering from SUI or POP could be improved. “Irish women deserve the same care as those in the UK,” said Melanie Power, founder of Mesh Survivors Ireland after the meeting. “Until the government take action to suspend mesh for stress urinary incontinence, Irish women will continue to be subjected to the risk of lifelong disabling complications from a procedure often described to patients as gold standard and a quick-fix.”
Surgical mesh is a medical device made from a synthetic material has been in use since the 1950s to repair abdominal hernias and since the 1990s in treating male and female SUIs, female POPs and bowel disorders.
POP, which affects women who have given birth, is when one of more of the organs in the pelvis slips down from their normal position and bulge into the vagina. SUI is the unintentional loss of urine and occurs when the muscles that support the bladder weaken.
Patients in Ireland affected by the cancellation of the procedure are due to be contacted by the HSE and any patients with concerns are advised to contact their consultant’s clinic.
https://www.irishtimes.com/news/health/use-of-transvaginal-mesh-devices-put-on-pause-says-minister-for-health-1.3575463
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Health Minister Suspends Vaginal Mesh Ops Following Calls
Jul 25, 2018 | Midlands 103
By Ben Finnegan
The Health Minister has announced a pause in the use of transvaginal mesh devices.
It comes as the NHS committed to immmediately stopping the procedure in the UK two weeks ago.
The material is used to manage Stress Urinary Incontinence or Pelvic Organ Prolapse, but has been criticised for painful side affects such as cutting through a womans vaginal wall.
Midlands woman Veronica is a member of Mesh Survivors Ireland, she had recently shared her story with Will Faulkner on Midlands Today;
http://www.midlands103.com/news-centre/health-minister-suspends-vaginal-mesh-ops-following-calls/
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500 Women Have Ethicon Mesh Cases Dismissed
Jul 24, 2018 | Mesh Medical Device News Desk
By Jane Akre
At one time the multidistrict litigation (MDL) had more than 104,000 product liability cases filed over allegedly defective pelvic mesh. Johnson & Johnson and its Ethicon division were the largest among seven mesh makers. But women who never had their mesh removed will not be marching forward with their cases, at least for now.
500 Women Dismissed Without Prejudice
Judge Joseph Goodwin, who, for six years has overseen pelvic mesh litigation from his Charleston, West Virginia federal courtroom, on July 19 issued orders that dismiss 500 women from the Ethicon (Johnson & Johnson) roster. The notice does not appear with Judge orders but was placed in each individual case electronically.
They will not be dismissed permanently.
Women who have not had their Ethicon mesh removed (revised), will have the defective product cases dismissed without prejudice. They will have five years to refile their cases against Ethicon and Johnson & Johnson, if they do decide to have a mesh revision or removal.
Judge Goodwin, has made it very clear he wants to pare down the list of 104,000 cases in his court – the largest mass tort ever filed in one courtroom.
Ethicon is the mesh maker with the most cases before Judge Goodwin and 55,000 if you consider the global count of women who have filed defective product lawsuits against the healthcare giant.
The latest order removes just Ethicon cases.
MESH IN PLACE
Last spring, Ethicon announced it would no longer compensate women with a “mesh in place” from its TVT line of products used to treat stress urinary incontinence (SUI).
The reason? The medical devices were still on the market and in fact, a well-compensated medical society refers to these mesh devices, used to treat SUI as the “Gold Standard” despite the fact that they have been found to be defectively designed in a court of law (Huskey).
Standing firm, Ethicon motioned the court for Judge Goodwin to sort out the “mesh in place” women.
The reason she had not undergone a mesh removal didn’t really matter.
Maybe she had died and her estate was carrying on her claim. Maybe she could not undergo anesthesia because her health had deteriorated. She may be fighting cancer. Maybe she was deathly afraid of any more pelvic surgeries.
Maybe the mesh wasn’t causing her any problems or not enough to undergo sometimes brutal surgery.
Any “mesh in place” Ethicon case on the attached order filed July 19, would be dismissed “without prejudice,” meaning it could be refiled if she ever did attempt a mesh removal within five years.
The upside for the judge, who was age 76, was that he would be one step closer to retiring and ending the nightmare of 104,000 women before him, all wanting their day in court.
ETHICON ORDER
Last March, Ethicon motioned the court (ECF 5313) on how to rid itself of non-revision cases.
Executing the plan came from Judge Goodwin April 13, in the form of Pretrial order #293. First it defined the Ethicon Gynecare TVT marketed products that the order covered:
Gynecare TVT Retropubic (TVT) or Abdominal (TVT-A) System, Gynecare TVT Obturator System (TVT-Obturator), Gynecare TVT Abbrevo Continence System (TVT-Abbrevo), and/or Gynecare TVT Exact Continence System (TVT-Exact), (hereinafter collectively “the Ethicon Gynecare TVT Products”).
Even though some of these products had been litigated successfully in favor of the plaintiff, those had been revision cases. Judge Goodwin thought rather than lingering in the MDL for years, a future revision might eventually set a much-needed value for the case.
“The court is well aware of the issues in this litigation and believes there is significant value to the plaintiffs who have not undergone a revision surgery not being required to go forward with a case at this time when there is the possibility that they could be at risk of a surgery in the future.”
DISMISSED CASES
L.T of West Virginia is one of the 500 women who has had her case dismissed.
She was implanted with the TVT –O September 1, 2010 by Dr. Connie Perkins at Greenbrier Valley Medical Center in Ronceverte, WV. An unnamed “friend,” who answered her phone, said she has opted not to have her mesh removed. In fact, because it was not working and incontinence had returned, she opted to have another mesh implanted last May.
Judy Perry, now Tuckette, lives in West Virginia and was implanted with a TVT-O (“TVT-Oturator” is misspelled in the prefab short form), on June 24, 2008 at the Charleston Area Medical Center, by Dr. Uzay Yasar.
“There is some pain but not enough to require surgery” she tells MND.
She reserves the right to have some form of revision within the five years of dismissal. She knows it may be necessary.
OTHER QUALIFYING PROCEDURES
While Ethicon limited a refiling to a “medically necessary Revision Surgery,” Judge Goodwin broadened the definition of “revision” surgery offering other “qualifying procedures” that could substitute for a full mesh removal.
“For purposes of this order only, Ethicon agrees that plaintiffs who, although their treatment does not qualify as Revision Surgery within five years after the election, have more than one (1) in office revision of the mesh and who also have concomitant treatments of trigger point injections, vaginal physical therapy or utilization of vaginal Valium, that are demonstrated to be necessary by 6 contemporaneous medical records and that are performed by a competent, licensed physician who is neither retained nor funded by a plaintiff’s lawyer or a litigation funding entity for purposes of performing such procedures or treatments, nor where the litigation funding company has a relationship with the physician or the facility (or any related entity), will be treated the same as those plaintiffs who have a Revision Surgery within the five year period, as described above; however, the applicable statute of limitations shall begin to run upon the completion of the second of such multiple qualifying procedures.”
Nine of the 500 women were among the 150 plaintiffs set for trial in Charleston before Judge Goodwin August 14, part of the Wave 7 of women who will have their Ethicon cases tried at the same time.
https://www.meshmedicaldevicenewsdesk.com/500-women-have-ethicon-mesh-cases-dismissed/
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Wilkie overwhelmingly confirmed as VA Secretary
Jul 24, 2018 | Politico - Morning eHealth
By Mohana Ravindranath
MEDICAL DEVICE DOCUMENTARY COMING TO NETFLIX: Morning eHealth correspondent Darius Tahir caught an advance screening of Bleeding Edge, a documentary indicting some of the safety pitfalls of the medical device industry, Monday night. The documentary details some patients’ negative experiences with devices such as Bayer’s Essure and Johnson and Johnson’s vaginal mesh.
The documentary focuses its ire on FDA and the medical device industry, but Darius was struck by a scene in which patients suffering from complications from Essure crash an ob/gyn conference. It’s a little shocking how much condescension they face from their interlocutors. The film will premiere on Netflix on July 27; it’s made by the authors of The Hunting Ground.https://www.politico.com/newsletters/morning-ehealth/2018/07/24/wilkie-overwhelmingly-confirmed-as-va-secretary-295130
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The voices of women must be heard when it comes to healthcare – Mary Lou McDonald TD
Jul 24, 2018 | An Phoblacht
By Callum Smyth
Sinn Féin leader Mary Lou McDonald TD along with Dáil Health spokesperson Louise O’Reilly TD and Assembly spokesperson on Mental Health Órlaithí Flynn MLA today launched Sinn Féin’s all-Ireland women’s healthcare policy document entitled ‘A Vision for Women’s Healthcare’.
Speaking at today’s launch in Dublin City Centre, Teachta McDonald highlighted the many injustices suffered by women in Ireland in the field of health.
The Dublin Central TD said: “From the outrageous wrongdoings of thalidomide and symphysiotomy in the past, to the unfolding vaginal mesh implant scandal and the CervicalCheck scandal, women have suffered in the provision of healthcare in this State.
“When it comes to safeguarding women’s health and wellbeing, history shows a litany of practices and policies where an appalling combination of official, whether clinical, clerical, or political, ignorance and arrogance not only led to women enduring injustice and injury but also the duration of that ill treatment being wilfully prolonged.”
The Sinn Féin policy document looks at how gender massively influences health, amongst other things, and that lessons must be learnt from the mistakes of the past and present.
Teachta McDonald continued: “The voices of women must be heard when it comes to healthcare. We are advocating a health system that is sensitive to and reflects gender differences.
“While always being cognisant of the wrongs of the past, it is imperative that current discrimination is tackled, not only through progressive policy planning, but through action at all levels of our health systems.
“We do not claim to have identified all the issues in the delivery of health services for women across Ireland. Nor do we claim to have advocated all the solutions.
"What we have done is produce a document which outlines Sinn Féin’s vision for women’s health care in Ireland, a vision that is based on the principles of fairness and equality which we can all work towards together."
You can read the document in full here.
http://www.anphoblacht.com/contents/27424
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Afraid Of The Doctor? 'The Bleeding Edge' Says Maybe We Should Be
Jul 24, 2018 | Forbes
By David Alm
The Bleeding Edge, a new Netflix documentary directed by Kirby Dick, does for the medical device industry what Supersize Me did for McDonald's. As a society, we may not have sworn off Big Macs completely after Morgan Spurlock's 2004 film came out, but we certainly thought twice about putting them in our bodies. The Bleeding Edge wants us to do the same any time a doctor recommends necessary medical implants, like hip replacements and drug-eluting stents, but also elective ones such as permanent birth control and breast augmentations.
As vital as such devices can be, the film reports, they face little to no regulation and scant testing, and are sometimes favored over superior products simply because their manufacturers make it worth a doctor's while to use them instead of something better, safer, and even, in some cases, more affordable. This can lead to complications that could ruin a patient's life, or worse, end it altogether.
The Bleeding Edge focuses on five people who suffered grave consequences from taking the advice of doctors who may not have meant harm, but whose familiarity with a given device was no more advanced than the industry's at large. That is, they were pretty unfamiliar, but that didn't prevent them from conducting the procedures on patients who amounted, essentially, to human guinea pigs.
One of the film's subjects, an orthopedic surgeon himself, received a hip replacement only to have it disintegrate inside his body and turn the surrounding tissue to pulp. Another is a 40-something mother who got a transvaginal mesh implant after experiencing urinary incontinence following the birth of her daughter; the mesh melded with her organs and caused excruciating pain and abdominal bleeding. Removing it was described as being akin to getting bubblegum out of hair, or plying a crowbar out of concrete. The other three are all women who received the vaginal contraceptive Essure, from Bayer, which is supposed to trigger inflammation in the fallopian tubes, causing them to scar and seal shut, permanently. But the device can break and fragment, migrate into other parts of the reproductive system, and cause everything from autoimmune disease to neurologic disorders.
While complications like these are rare, and acknowledged by the manufacturers, they may not be as rare we we're led to believe. Secondary subjects in the film report that they were instructed during Essure's clinical trials to indicate that they were "very satisfied" with the procedure merely because they had not gotten pregnant; the bleeding and pain and tremors were seen as incidental. Some of these women have fought to get Essure taken off the market, with success throughout Europe, but it remains on the market in the U.S., where lobbying groups wield enormous power in Washington, particularly at the Food and Drug Administration, or FDA.
The FDA, according to numerous insiders interviewed for The Bleeding Edge, maintains far looser standards for medical devices than it does for drugs, food or anything else that enters our bodies, in part because of some eyebrow-raising affiliations between the FDA and the very medical device manufacturers it purports to oversee. Moreover, medical devices, according to Dr. Michael Carome, director of the Public Citizen Health Research Group, amount to a $300 billion industry.
"People think pharma's got power," says the journalist Jim Spencer in the film. "No no no, the medical device industry has much more power than pharma." Or, in the more nefarious words of Scott Whitaker, CEO of the lobbying group Advanced Medical Technology Association, "We have more power in this room than most governments around the world." Whitaker delivered that claim as a boast, during his keynote at an industry conference, as mostly aging, white men sat in the audience, nodding.
And things aren't getting any better. Under President Trump, the FDA has slashed regulations even further, so that medical devices can make it to the market faster. Good for industry, but very, very risky for patients.
The Bleeding Edge might sound alarmist and anti-business, a leftist polemic against Trump and his policies, and even medical innovation itself. On the contrary, it's so well reported and sourced that it transcends partisan politics to objectively emphasize, through statistics and testimonials, the long-term costs of prioritizing short-term gains over the wellbeing of millions of people.
It may not make you fear your doctor -- and nor should it -- but you will likely find yourself asking a lot more questions before going under the knife.
The Bleeding Edge opens in theaters and begins streaming on Netflix this Friday.
https://www.forbes.com/sites/davidalm/2018/07/24/afraid-of-the-doctor-the-bleeding-edge-says-maybe-we-should-be/#66956300a832
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This documentary isn’t even out yet, but it’s already changing birth control
Jul 25, 2018 | Metro
By Meagan Morris
"People think pharma's got power," journalist Jim Spencer says in the documentary The Bleeding Edge. "No no no, the medical device industry has much more power than pharma."
As it turns out, filmmakers have power, too: Bayer announced that it was pulling the birth control device Essure from the market, just ahead of the documentary’s July 27 debut.
And for good reason: The device — a metal coil used by women as an alternative to tubal ligation — is heavily profiled in the film, and not in a good way.What is The Bleeding Edge about?
In The Bleeding Edge, Academy Award-nominated filmmakers Kirby Dick & Amy Ziering take a deep dive into the profitable — and seedy — world of medical devices where it seems that patient safety takes a back seat to profits.
The film follows the stories of five people who experienced serious — and even life-threatening — consequences after medical devices were implanted into their bodies. One of the patients, an orthopedic surgeon, received a hip implant that disintegrated in his body and damaged the surrounding tissue. Another woman, in her 40s, had a transvaginal mesh implanted after the birth of her daughter, but the mesh adhered to her organs, causing severe pain and bleeding. Getting it out was even worse.The controversy about Essure
The other three women profiled in The Bleeding Edge had the Essure device inserted. The device — like some IUDs — is designed to trigger inflammation in the fallopian tubes which, in turn, causes them to scar and seal shut.
In 2017, Bayer told The Washington Post that more than 750,000 Essure devices had been sold around the world and sales "continue to grow."
"Hundreds of thousands of women who’ve received Essure … successfully achieved permanent contraception without having to go through an invasive surgical procedure," Patricia Carney, director of U.S. medical affairs for Bayer Women’s Healthcare, told the newspaper.
But as the Post points out, the U.S. Food and Drug Administration has received more than 16,000 reports about adverse events related to Essure — and it’s illegal in many other countries outside the United States.
The reason: Women — like the three profiled in The Bleeding Edge — experienced problems when their Essure devices broke and migrated to other parts of the reproductive system, causing neurologic disorders and autoimmune diseases.
Bayer pulling Essure from the market before The Bleeding Edge premieres is "a gratifying affirmation of the power of documentary," the filmmakers said in a statement released by Netflix.
"This is exactly why we do this work: This film has already changed policies and changed history."
https://www.metro.us/body-and-mind/health/the-bleeding-edge-essure-pulled-from-market-bayer
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Netflix’s The Bleeding Edge Exposes the Horrors of FDA-Approved Medical Devices
Jul 24, 2018 | LA Weekly
By April Wolfe
Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. Prepare to be scared shitless of vaginal mesh or high-tech surgery robots. Through a series of personal stories from both qualified medical professionals and laypeople, the film explores just what exactly the word “complications” means on a device’s warnings. In the cases Dick investigates, those complications become a ripple effect of lives ruined by untested but FDA-approved devices.
The film, which premieres Friday, July 27, on Netflix, traverses the spectrum of medical devices but opens and closes on one particular item, Essure, a metal coil that’s inserted into the Fallopian tubes for sterilization purposes. We meet a mail carrier from upstate New York whose doctor sold her on Essure years ago. As the documentary jumps around to different people, devices and experts, we return again and again to the horrifying story of this mail carrier, who came to find that her body was rejecting the coil, which led to her nearly bleeding to death. Another woman, a Latina account executive with four children, relays a frighteningly similar story, only with the added layer of racism; her doctor told her he assumed Latinas just bled more than white women did. Neither woman’s story takes a turn for the better, but it’s the Latina woman whose entire life — and the lives of her daughters — gets smashed all because of one doctor not taking her concerns seriously.
Dick seems to anticipate that viewers — just like doctors — may be conditioned to think women exaggerate their pain, so at the 15-minute mark of the film he jumps into the story of a respected older white male doctor who got a cobalt hip joint and began suffering from neurological issues. These were so severe that he had a complete mental breakdown in a hotel room, smashing things and scrawling cryptic messages on the walls. He begins questioning established medicine’s embrace of cobalt implants; upon the removal of his, every neurological issue he had developed disappeared. If a completely healthy man with medical training can go so quickly from zero to delusional, what of the millions of other Americans with cobalt in their bodies? What of the injured vets already fighting PTSD who live with an implant that could be poisoning them? What are the metal plates and screws in my own ankle made of, and why didn’t I know to ask?
The director backs up all these anecdotes with some hard facts about the FDA approval process for medical devices, which — even according to a former head of the department — is a broken system. The medical device industry is the least understood and regulated under the FDA umbrella. Dick exposes so much that I yelled “Oh my God!” multiple times while watching. There is nothing more upsetting than listening to a charming Southern woman say the words, “My colon’s falling out!” Worse yet are the profit-hungry companies that have been able to slide by unnoticed for so long. Here’s hoping The Bleeding Edge gets the right attention on a decidedly unsexy topic.
https://www.laweekly.com/film/the-bleeding-edge-explores-how-medical-devices-can-damage-the-body-despite-fda-approval-9678028
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Netflix pic aims to highlight danger of medical devices
Jul 24, 2018 | Medical Plastics News
Featuring devices such as Essure birth control, transvaginal mesh implants, metal-on-metal hips and the DaVinci surgical robot, a theme of the film looks at how ledical devices make their way onto the market untested.
Speaking to Drugwatch, director Kirby Dick said: “We want the public to be aware. We want the public to protect themselves. We want these medical device companies to do right by the public,” director Kirby Dick told Drugwatch at the New York City premiere.
“They claim to be operating in the public’s interest. We see examples — millions of examples — when they are not, so hopefully this film will cause them to change their approach.”
The film is due to stream on Netflix later this month, keep an eye out on Medical Plastics News for a review of the title.
https://www.medicalplasticsnews.com/news/netflix-pic-aims-to-highlight-danger-of-medical-devices/
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