Preview Newsletter
Ethicon 11/13
-
J&J's Ethicon cleared of liability in another federal pelvic mesh trial
Nov 11, 2017 | Reuters
By Tina Bellon
Johnson & Johnson subsidiary Ethicon was not liable for the injuries that a Texas woman blamed on the company’s pelvic mesh device, a federal jury decided on Thursday. -
Australia's pelvic mesh catastrophe has exposed a health system awash with money and influence
Nov 11, 2017 | Newcastle Herald
By Joanne McCarthy
...How much do you know about your doctor – general practitioner or specialist – before you hand over your well-being, and sometimes your life, to him or her? And where do you go to check? -
Australian pelvic mesh victims want to sue state health departments and regulators
Nov 13, 2017 | Newcastle Herald
By Joanne McCarthy
WOMEN victims of pelvic mesh surgery are investigating legal action against not only device manufacturers and surgeons, but state health departments and Australian regulators they hold responsible for failing to protect them. -
Counting the cost of mesh - women send us their monthly medication and the cost to the NHS is shocking
Nov 10, 2017 | Cambs Times
By Kath Sansom
The plastic surgical mesh implants, used to treat incontinence and prolapse, were phased in from 1997 and promoted as a cheap quick fix. -
UK To Place Further Restrictions on POP Pelvic Mesh
Nov 13, 2017 | Mesh Medical News Desk
While Australia says it will consider all vaginally- placed mesh and surgical mesh as “high risk,” news from the UK says pelvic organ prolapse (POP) mesh may be made obsolete. -
Sling the Mesh Campaign Taking Strong Steps
Nov 12, 2017 | Mesh Medical News Desk
Sling the Mesh, a campaign in the UK to have pelvic mesh removed from the market, has made enormous strides in getting the word out about transvaginal mesh, made of polypropylene to treat incontinence and pelvic organ prolapse. -
7 Ideas that Sounded Good at the Time ...
Nov 10, 2017 | MedPage Today
By Greg Von Portz
...Idea: Transvaginal mesh was created to add support for women with weakened pelvic floors and pelvic organ prolapse.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
J&J's Ethicon cleared of liability in another federal pelvic mesh trial
Nov 11, 2017 | Reuters
By Tina Bellon
Johnson & Johnson subsidiary Ethicon was not liable for the injuries that a Texas woman blamed on the company’s pelvic mesh device, a federal jury decided on Thursday.
The verdict in the U.S. District Court for the Southern District of Texas cleared Ethicon of allegations that it defectively designed the so-called Gynecare TVT-Secur device, a “miniature” mesh product used to treat female stress urinary incontinence.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/2iL3jKR
https://www.reuters.com/article/us-trump-asia/trump-vaunts-trade-progress-red-carpets-on-fruitful-asia-trip-idUSKBN1DD0FJ
https://www.reuters.com/article/us-trump-asia/trump-vaunts-trade-progress-red-carpets-on-fruitful-asia-trip-idUSKBN1DD0FJ -
Australia's pelvic mesh catastrophe has exposed a health system awash with money and influence
Nov 11, 2017 | Newcastle Herald
By Joanne McCarthy
HERE’S an exercise for the weekend.
How much do you know about your doctor – general practitioner or specialist – before you hand over your well-being, and sometimes your life, to him or her? And where do you go to check?
The likely answers are “Not much” and “Not sure”. And that’s a problem.
After more than three years writing about the pelvic mesh device catastrophe I’ve learnt the following - when things go wrong a lot turns on the notion of a patient’s “informed consent”; our whole concept of the “trust” relationship between doctor and patient needed to change with corporatised health, when patients stopped being patients and became health ‘consumers’; and there’s vast sums of money sloshing around our health system where vast sums have no business sloshing.
And another thing. Right across the health sphere there are many pretty words said and written about people and patients being at the centre of everyone’s thinking – “Building a regulatory system for the 21st century aimed squarely at protecting the public”, and “We’re committed to the establishment and maintenance of the highest possible standards of practice in women’s health”, being a couple of examples. But they’re just words.
Money is at the centre of our health system. When things go wrong you discover by just how much.
But let’s not get dispirited. It’s time for a little health consumer activism.
It tells you very little that you really need to know to distinguish quacks from the rest. I write that based on direct evidence of the complaint histories of some Australian doctors associated with pelvic mesh devices, whose public records are almost virginal in their purity.
In about 2010 the Australian Health Practitioner Regulation Agency was established to administer a national registration and accreditation scheme, working with the national boards of professions including the Medical Board, Dental Board, Nursing and Midwifery Board and Chiropractic and Chinese Medicine Boards.
It runs on a model of registrations meeting costs. In 2015/16 AHPRA collected $171 million in income to meet its $169 million in costs. Australia’s drug and medical device watchdog, the Therapeutic Goods Administration (TGA), runs on a similar model. The regulated fund the regulator, in other words.
AHPRA will tell you if your doctor/health professional is registered, date of first registration, his or her specialty area and practice address. If he or she has been the subject of a complaint process leading to conditions placed over his or her practice, those conditions will appear.
It won’t tell you why conditions were imposed, the health practitioner’s complaint history, how many matters might have been pursued in court – leading almost invariably to settlements with confidentiality clauses to keep matters out of the public realm – and once the terms of those conditions are deemed to have been met, they disappear from the register.
In other words, it tells you very little that you really need to know to distinguish quacks from the rest. I write that based on direct evidence of the complaint histories of some Australian doctors associated with pelvic mesh devices, whose public records are almost virginal in their purity. Complaints and decisions might be recorded elsewhere, but you have to know where to find them. That’s fine if you’re a journalist whose business it is to know about these things, not so fine if you’re a trusting member of the public.
Here’s why this lack of information and transparency matters.
For the past few years since the penny dropped that many pelvic mesh devices on the Australian market – particularly for women’s prolapse after childbirth – were approved with little or no evidence of safety and efficacy, the health system has responded by emphasising the need for doctors to have very specific skills and significant experience in mesh device surgery.
Then it dumped responsibility for determining which doctors were particularly mesh-skilled and experienced on women. This in a system where too many doctors have direct financial relationships with mesh manufacturers or have invented pelvic mesh devices themselves, and where it’s virtually impossible to discover a doctor’s complaint and litigation history, apart from asking the person who’s soon to be inserting a foreign object through your vagina while you’re out cold on an operating table.
Sure. You want to get your doctor offside under those circumstances, by questioning his or her expertise or litigation record. But it’s up to patients to give “informed consent”.
AHPRA and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists can’t and won’t help with information on a doctor’s complaint and litigation history. Individual hospitals credential doctors and procedures – or don’t if there are concerns – and I’ve spoken directly with former senior hospital representatives who’ve acknowledged doctors don’t tend to complain about other doctors. They just ensure they can’t do surgery at their hospitals. Not in my backyard, in other words.
Doctors’ insurance companies know everything about doctors’ complaint and litigation histories. But they’re not compelled to do anything with that information. And as an insurance company representative told a Senate inquiry in 2005, if a doctor has “many claims” against him or her, the insurer charges the doctor more in premiums. I contacted the insurer to see if it had changed its policy in the interests of protecting the public. No response.
The current Senate inquiry into the pelvic mesh catastrophe - called because women victims formed a group, the Australian Pelvic Mesh Support Group, campaigned through the Newcastle Herald and showed Senator Derryn Hinch why an inquiry was desperately needed – has confirmed how blinkered the health industry is to the influence of money. And how vulnerable the public remains without substantial reforms.
It’s time to demand them.
http://www.theherald.com.au/story/5044256/whats-up-doc/
-
Australian pelvic mesh victims want to sue state health departments and regulators
Nov 13, 2017 | Newcastle Herald
By Joanne McCarthy
WOMEN victims of pelvic mesh surgery are investigating legal action against not only device manufacturers and surgeons, but state health departments and Australian regulators they hold responsible for failing to protect them.
The Western Australian Health Department is already a focus, said solicitor Adrian Barakat of AJB Stevens Lawyers in Sydney, after women alleged a cover-up of mesh device surgical trials in WA public and private hospitals.
This followed Newcastle Herald articles revealing two senior Western Australian doctors released research papers from 2005 about surgical trials in Western Australian public and private hospitals using a pelvic mesh device invented by one of the doctors, and a secret settlement in 2013 paid by WA Health to a woman implanted with the device in a public hospital in 2003.
Although the research papers stated the trials had ethics committee approvals, WA Health said it could not locate records of ethics approvals for trials of the device.
“The majority of the cases we have at the moment are in Western Australia so that’s our focus, but we have a large number of clients and they’re from all over the country. We’re definitely looking at health departments in each state,” Mr Barakat said.
The Herald has also revealed research papers citing ethics approval of a surgical trial using the device at a Victorian public hospital. Victoria’s new health care watchdog launched an investigation in June after Health Minister Jill Hennessy was told there was no record of the trial, ethics approval or hospital credentialing of the device inventor who assisted with surgery on some of the women.
The majority of the cases we have at the moment are in Western Australia so that’s our focus, but we have a large number of clients and they’re from all over the country. We’re definitely looking at health departments in each state.Lawyer Adrian Barakat on pelvic mesh device legal action
Mr Barakat said his firm had engaged a senior barrister to advise how Australia’s drug and device watchdog, the Therapeutic Goods Administration, could be sued after multiple pelvic mesh devices were registered for use more than a decade ago with little or no evidence of safety and efficacy.
“Somebody needs to find a way to make the TGA accountable. We really think that’s one of the most important ways forward,” Mr Barakat said.
The TGA’s role in the pelvic mesh scandal led University of Canberra academics Dr Wendy Bonython and associate professor Bruce Arnold to call for a complete overhaul of the regulator, in a submission to a Senate inquiry on pelvic mesh devices.
They argued there were legislated indemnity provisions that protected the TGA from being sued for negligent performance of its regulatory functions, which was “problematic because it removes any incentive towards carefulness”.
More than 1350 Australian women are now registered in legal class actions against major mesh manufacturers Johnson & Johnson and American Medical Systems, with an unknown number of individual settlements after legal suits by women against doctors who implanted the devices.
Mr Barakat said his firm, which has successfully litigated child sexual abuse cases against institutions, would run individual cases against device manufacturers, doctors and regulators, rather than class actions.
“We’re looking at the women individually because they’ve all suffered immensely, in different ways. I’ve got women who have had to give up their businesses and jobs. Most of them have suffered in terms of their marriages. Some have lost their marriages because of this. Most of them can’t have intercourse.”
Women implanted with Intra Vaginal Sling (IVS) and Tissue Fixation System (TFS) devices have engaged the firm, along with others considering action against American Medical Systems, Boston Scientific and Johnson & Johnson.
WA Health did not respond to questions about the 2013 secret settlement or how public hospitals responded to complications experienced by women during an early pelvic mesh trial.
http://www.theherald.com.au/story/5047618/watchdog-needs-to-be-held-accountable/
-
Nov 10, 2017 | Cambs Times
By Kath Sansom
The plastic surgical mesh implants, used to treat incontinence and prolapse, were phased in from 1997 and promoted as a cheap quick fix.
But campaigners say the cost of treating women who go on to have complications is a much higher financial figure in the long term with countless prescriptions for life in a bid to manage pain, alongside visits to doctors and outpatient treatments.
A&E trips include women unable to urinate, who go into retention and become at risk of sepsis.
Women whose GPs agree to refer them for full mesh removal surgery, cost the NHS up to £12,000, with costly follow ups.
Sling The Mesh campaign asked women to send in their medication for a month to get an idea of the personal and financial costs when mesh goes wrong.
They include:
• A paramedic who had a TVT incontinence mesh tape in February 2017. Medication to ease nerve damage and pain costs £186 a month. Among it is self catheterisation sticks as since the operation she has not been able to go to the toilet again properly.
• An NHS admin who had a TVT incontinence mesh tape in 2004. She has reduced her full time hours to a lower grade at part time in order to cope. Her medication costs £180 a month and includes a faecal irrigation pump.
• A woman who had a TOT incontinence mesh tape in 2010 and has had 13 operations to try to remove it. Her pain is so bad she has tried to take her own life. She has lost her marriage, her job and her quality of life. The pain in her pelvic area and private parts is so bad that 24/7 it feels like she is being knifed and has burning hot broken glass inside her.
• A woman had a TVTO incontinence mesh in 2010. When it failed she was given another mesh, a TVT in 2016. Her pain is so bad she struggles to walk and sit. Her medication costs £140.52 a month.
• A woman who had a sacrocolpopexy mesh in 1999 and a posterior mesh repair in 2001. She works as a housing officer but is now part time because of excrutiating pain. Her medication costs £95.79 a month.
• A former NHS admin who lived a healthy, active lifestyle but now struggles with pain walking. She had a TVT incontinence mesh in 2006. Her medication costs £78.70 a month.
• One woman sent a pack of lidocaine plasters costing £72.40 a month, used in addition to a range of other nerve blockers and pain relieving tablets.
• Others sent Ovestin cream, given to thicken vaginal walls during menopause. Women are prescribed this when the plastic mesh tape slices through vaginal walls. Surgeons tell women this cream will fix their problems.
• One woman, who had prolapse mesh in 2002, sent a sample irrigation kit. Mesh has injured her insides so badly she struggles to empty her bowels and she now needs to pump herself rather than have her bowel removed in a colostomy operation.
http://www.cambstimes.co.uk/news/sling-mesh-nhs-medication-cost-tvt-tvto-tot-prolapse-1-5274896
-
UK To Place Further Restrictions on POP Pelvic Mesh
Nov 13, 2017 | Mesh Medical News Desk
While Australia says it will consider all vaginally- placed mesh and surgical mesh as “high risk,” news from the UK says pelvic organ prolapse (POP) mesh may be made obsolete.
In the United Kingdom (UK, Northern Ireland, Britain and Scotland) the National Institute for Health and Care Excellence (NICE) guidelines, due out in December, say POP mesh must only be used in a research context.
Prolift for POP repair
What may result, if this interim decision becomes a final guideline, is that unless there is upcoming research, POP mesh will not be able to be sold or used, making it highly unlikely that any doctor would implant the controversial product in a patient suffering from POP.
According to the founder of the Sling the Mesh Campaign in the UK, Kath Sansom, “This is a subtly brought in ban on vaginally placed prolapse mesh and is excellent news not just for UK women but campaigners globally as it sends a clear message to surgeons that it will not be tolerated unless it is in a research setting. I am glad that NICE has some sense.”
This news is a departure from the National Health Service working groups in England and Scotland that reported it was safe to use mesh as a last resort in a multi-disciplinary setting. A Mesh Oversight Group Report issued in July, encourages doctors to learn more about mesh implantation and for specialist centers to treat complications. It does not recommend any curtailing of the current use of mesh for POP and SUI.
Sansom says that many surgeons in the United Kingdom (as in the U.S.) believe transabdominally placed prolapse mesh is safe and will start pushing that procedure as an alternative.
“Yet it ends up in the same site in the body and has same problems of shrinkage, twisting at edges, degradation, erosion. Also, it all ends up in the vaginal vault and we know from seeing women in campaign groups globally that it all causes the same problems of excruciating pain and ruined quality of life.”
In the UK, final guidelines on the use of both stress urinary incontinence (SUI) and POP mesh will be published in 2019.
Meanwhile the National Health Service (NHS) continues to insist the risk of mesh complications is low, at 1-3%.UK To Place Further Restrictions on POP Pelvic Mesh
Prolapse by CR Bard
Mesh Medical Device News Desk, November 13, 2017 ~ While Australia says it will consider all vaginally- placed mesh and surgical mesh as “high risk,” news from the UK says pelvic organ prolapse (POP) mesh may be made obsolete.
In the United Kingdom (UK, Northern Ireland, Britain and Scotland) the National Institute for Health and Care Excellence (NICE) guidelines, due out in December, say POP mesh must only be used in a research context.
Prolift for POP repair
What may result, if this interim decision becomes a final guideline, is that unless there is upcoming research, POP mesh will not be able to be sold or used, making it highly unlikely that any doctor would implant the controversial product in a patient suffering from POP.
According to the founder of the Sling the Mesh Campaign in the UK, Kath Sansom, “This is a subtly brought in ban on vaginally placed prolapse mesh and is excellent news not just for UK women but campaigners globally as it sends a clear message to surgeons that it will not be tolerated unless it is in a research setting. I am glad that NICE has some sense.”
This news is a departure from the National Health Service working groups in England and Scotland that reported it was safe to use mesh as a last resort in a multi-disciplinary setting. A Mesh Oversight Group Report issued in July, encourages doctors to learn more about mesh implantation and for specialist centers to treat complications. It does not recommend any curtailing of the current use of mesh for POP and SUI.
Sansom says that many surgeons in the United Kingdom (as in the U.S.) believe transabdominally placed prolapse mesh is safe and will start pushing that procedure as an alternative.
Kath Sansom, Sling the Mesh Campaign
“Yet it ends up in the same site in the body and has same problems of shrinkage, twisting at edges, degradation, erosion. Also, it all ends up in the vaginal vault and we know from seeing women in campaign groups globally that it all causes the same problems of excruciating pain and ruined quality of life.”
In the UK, final guidelines on the use of both stress urinary incontinence (SUI) and POP mesh will be published in 2019.
Meanwhile the National Health Service (NHS) continues to insist the risk of mesh complications is low, at 1-3%.
AUSTRALIAN ACTION
As Australia moves to reclassify all pelvic mesh devices from moderate to “high risk” over the next 24 months, see MND story here), women in that country suffering pelvic mesh complications want to hold accountable regulators assigned with protecting the public health.
See Herald story here.
Women from Western Australia (WA) implanted with the Intra Vaginal Sling (IVS) and Tissue Fixation System (TFS) have plans to sue, not just pelvic mesh manufacturers, but the state health systems and regulators that put the medical devices on the market.
Solicitor Adrian Barakat, of AJB Stevens Lawyers in Sydney, is bringing the action with a focus on Western Australian (WA) Health Department alleging a cover-up of mesh device surgical trials in public and private hospitals.
For example, two doctors from WA, who conducted clinical trials in WA hospitals claimed they had ethics committee approvals, which cannot be confirmed.
Mr Barakat told the Herald they are looking to sue health departments in each state in Australia. Also being considered, is action against the TGA, the Therapeutic Goods Administration for clearing devices with little or no evidence of safety and efficacy.
There are more than 1,350 Australian women involved in class action lawsuits naming mesh makers Johnson & Johnson (J&J), American Medical Systems.
There is currently a six-month trial involving 700 mesh injured plaintiffs being conducted in Sydney against defendant, J&J.
https://www.meshmedicaldevicenewsdesk.com/uk-place-restrictions-pop-pelvic-mesh/
-
Sling the Mesh Campaign Taking Strong Steps
Nov 12, 2017 | Mesh Medical News Desk
Sling the Mesh, a campaign in the UK to have pelvic mesh removed from the market, has made enormous strides in getting the word out about transvaginal mesh, made of polypropylene to treat incontinence and pelvic organ prolapse.
The campaign, organized on Twitter and Facebook (see Here) has arranged a debate with Parliament in an effort to have pelvic mesh surgeries suspended.
Now organizer Kath Sansom is approaching the government with a new concern for the government health care system- the cost!
The Cambs Times editor John Elworthy, in this YouTube video from the newsroom, calls the injuries of thousands of implanted women in the UK, a “national scandal.”
The paper’s support of journalist Sansom has allowed her to report the story for two years, which also led to a debate in Parliament where MP Owen Smith has been instrumental in bringing the campaign forward.
The paper is now covering another angle on the story- the cost to consumers for pain medications.
Elworthy said some people “sent in their prescriptions to show the misery extended to these people through botched NHS procedures.”
Asking women to send in their prescription drugs to treat pain, the report concludes mesh problems are costing the National Health Service (NHS) a fortune in medication costs for pain and infection as well as tests and scans. In the UK, the government pays for health care. Patients pay for their medications.
To make the point, the paper asked women to send in their medications.
Taking bags of medications used to treat pain from the surgeries and putting a number of them is the latest tool as seen in CambTimes here in this YouTube video.
In the UK, final guidelines on the use of both stress urinary incontinence (SUI) and POP mesh will be published and finalized in 2019.
A Mesh Oversight Group Report issued in July, encourages doctors to learn more about mesh implantation and for specialist centers to treat complications. It does not recommend any curtailing of the current use of mesh for POP and SUI.
Meanwhile the NHS continues to insist the risk of complications is low, at 1-3%.
https://www.meshmedicaldevicenewsdesk.com/sling-mesh-campaign-taking-strong-steps/
-
7 Ideas that Sounded Good at the Time ...
Nov 10, 2017 | MedPage Today
By Greg Von Portz
Every profession has its misfires.
The beverage industry learned the old lesson that "if it ain't broke, don't fix it" when Coke II was released. And Apple's first foray into handheld devices, the clunky Newton, faded into obscurity in the late '90s. We often look at these flops as silly examples of companies being a little too optimistic. Hey, they sounded good at the time!
Medicine has also had some major misfires. But the reality is that when faulty or misguided devices and procedures are used on patients, it's tragic, not comic.
With the hope that manufacturers and practitioners might learn from the mistakes of the past, MedPage Today has rounded up seven medical devices that "sounded good at the time," but weren't. They're sorted according to the magnitude of their unintended bad consequences.
7. MAST pants
dea: For many years, MAST (medical anti-shock trousers) were the standard in trauma care to support circulation for patients with severe blood loss.
Clinical Reality: Clinical studies in 2000 have shown this pressurized pair of "pants" were expensive and did not increase survival.
Photo credit: Public Domain
6. Metal-on-metal hips
Idea: Metal-on-metal hips were meant to shed less debris and prevent hip dislocation.
Clinical Reality: However, the FDA warned for years that metal ions could enter the bloodstream in some patients. The agency recommended traditional metal joint in plastic socket. In 2012, Johnson & Johnson announced they would stop marketing the device.
Photo credit: U.S. National Library of Medicine
5. Absorb stent
Idea: Abbott's Absorb Bioresorbable Vascular Scaffold (BVS) was hailed as a breakthrough for stent technology when it hit European markets in 2011 and the U.S. market in 2016. The FDA still warnsagainst it.
Clinical Reality: But by 2017 with high rates of device thrombosis, Abbott pulled it.
Photo credit: Abbott
4. Morcellator
Idea: Breaking up internal masses, like fibroids, into smaller pieces for removal, the morcellator seemed to be an effective fix for non-invasive gynecological procedures.
Clinical Reality: The FDA issued an advisory in 2014 that the device may cause cancer, although the controversy is still unresolved.
Photo credit: Getty
3. Heart Sock
Idea: Early clinical trials showed promises for Acorn's CorCap, a mesh sleeve that reshaped the heart into a natural shape after heart failure.
Clinical Reality: In 2005 the FDA threw the heart sock in the laundry after surgeons found it harder to perform subsequent procedures when heart tissue grew into the mesh.
Photo credit: FDA
2. Dalkon shield
Idea: In the early 1970s, the Dalkon Shield, an IUD, was marketed by A.H. Robins company as a safe alternative to birth control pills.
Clinical Reality: Turns out a design flaw of the porous string coil caused complications like septic abortions and infections. Over 300,000 women sued, causing the manufacturer to file for bankruptcy in 1985.
Photo credit: Public Domain
1. Transvaginal mesh
Idea: Transvaginal mesh was created to add support for women with weakened pelvic floors and pelvic organ prolapse.
Clinical Reality: The FDA classified the device as high-risk, with links to adverse events including erosion through the vaginal tissue, chronic pain, infection, bleeding, pain during intercourse, and urinary problems.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested