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Ethicon Media Monitoring 4/26/2018
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Wagstaff Cartmell Settling Ethicon Transvaginal Mesh Cases
Apr 26, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
While Johnson & Johnson and its Ethicon division appear to be the last holdouts to any transvaginal mesh settlements, one midwest law firm seems to be settling its cases with the healthcare giant. -
This shocking story shows why Devon hospitals are chosing to stop using vaginal mesh implants
Apr 26, 2018 | Devon Live
By Anita Merritt
Hospitals in Devon have confirmed they are no longer using vaginal mesh implants which are intended to be permanent but have been linked to serious complications such as that experienced by a Devon woman who was bedridden for three months and remains in constant pain. -
Dispatch from Tribeca #3: The Bleeding Edge
Apr 25, 2018 | Bright Lights Film Journal
By Claire Baiz
Two weeks ago, under a concoction that my anesthesiologist dubbed “a Michael Jackson cocktail,” I had a medical device removed from my body. -
What causes urinary incontinence after childbirth, how common is it and what treatments are available?
Apr 25, 2018 | The Sun
By Rebecca Flood
MILLIONS of women give birth every year but having a baby can cause long-term complications and side-effects.
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Wagstaff Cartmell Settling Ethicon Transvaginal Mesh Cases
Apr 26, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
While Johnson & Johnson and its Ethicon division appear to be the last holdouts to any transvaginal mesh settlements, one midwest law firm seems to be settling its cases with the healthcare giant.
According to an April 19th motion, Thomas Cartmell of Wagstaff & Cartmell of Kansas City, MO., filed an unopposed Motion for Qualified Protective order to keep confidential a Master Settlement Agreement with Ethicon signed by the parties April 16, 2018.
There is no information on how many Ethicon cases will be resolved by this agreement. Cartmell is one of the few law firms remaining that is still involved in litigating transvaginal mesh cases.
The order keeps third party payors information confidential to aid in the “efficient processing and administration of the Settlement Agreement.”
Providio MediSolutions is the lien resolution administrator responsible for identifying and resolving all liens that “have been or may be asserted by Federal Medicare in each state, the US Department of Veterans’ Affairs, the US Department of Defense, Tricare and Indian health services. The information is necessary to resolve all liens in these cases. Normally HIPPA assures information is private and not to be shared.
Ethicon continues to have the largest number of product liability cases filed in the multidistrict litigation (MDL) gathered in Charleston, West Virginia before Judge Joseph Goodwin. The healthcare giant will face a grouping of product liability cases, Wave 7, in upcoming litigation in that court in an effort to resolve the remaining cases.
Judge Goodwin recently announced that transvaginal mesh cases with “mesh-in-place” only, that is that have not had a removal, will be dismissed without prejudice, meaning they can be refiled sometime in the future.
Judge Goodwin has repeatedly announced he wants to move along the transvaginal mesh MLD to clear cases from his courtroom where they have been filed since 2012.
Currently there are more than 104,000 defective product/product liability cases filed in that court against seven mesh makers.
https://www.meshmedicaldevicenewsdesk.com/wagstaff-cartmell-settling-ethicon-transvaginal-mesh-cases/
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This shocking story shows why Devon hospitals are chosing to stop using vaginal mesh implants
Apr 26, 2018 | Devon Live
By Anita Merritt
Hospitals in Devon have confirmed they are no longer using vaginal mesh implants which are intended to be permanent but have been linked to serious complications such as that experienced by a Devon woman who was bedridden for three months and remains in constant pain.
Mesh treatment has been offered in cases of pelvic organ prolapse and incontinence after childbirth, but has since sparked controversy after many women said they felt discomfort and had difficulty walking or having sex after undergoing the surgery.
Details of an NHS audit released this month 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 claim the data published by the NHS was selective and didn’t show the full extent of the problem, and they are calling for its use to be suspended for prolapse.
Data from the Medicines and Healthcare Products Regulatory Agency has showed that in the five years up to 2017, more than 1,000 adverse incidents related to mesh implants had been reported in the UK.
A study of NHS figures by Professor Carl Heneghan of Oxford University, has revealed the cost in outpatient appointments alone for women going back suffering mesh problems in the last nine years is £245m.
Guidance from England’s National Institute for Health and Care Excellence in December said that following “serious, but well-recognised safety concerns” vaginal mesh should only be used for research purposes in future.
DevonLive asked all acute hospitals in Devon whether they still used vaginal mesh implants and if not, how long it had been for.
Torbay Hospital, Mount Stuart Hospital in Torquay, the Royal Devon & Exeter Hospital and North Devon District Hospital all confirmed the implants were not being used. Plymouth NHS Trust failed to respond.
Among those whose lives have been changed beyond recognition since receiving a vaginal mesh implant is a 56-year-old mum grandmother of Torquay, who has asked to remain anonymous.
As well as living with a condition called Fibromyalgia which causes pain all over the body, she suffered a pelvic organ prolapse in 2011 when she was aged 49.
She was treated with mesh implant surgery which left her in excruciating pain and resulted in her being bedridden for three months during which time an operation to remove the mesh was unsuccessful.
It has resulted in her having to give up work and she now suffers from pain, depression and chronic fatigue.
She now can’t sit or stand for long, and is only able to walking using a mobility aid.
She recalled: “I was told I needed a simple 20 minute operation using mesh and I would be back to work in six weeks. However, as soon as I came around after the operation I knew something wasn’t right because I was screaming out in pain.
“I was told it was a difficult procedure because of adhesions and heavy bleeding. Following the surgery I had infections and heavy bleeding then after several days in hospital I returned home.
“I was bedridden for several months due to the pain. I was in and out of hospital with infections, bleeding and pain. After seven weeks I had an examination by the consultant and he informed me the mesh had eroded through my vagina wall. It was at this point he decided it would be best to remove the mesh.
“During the operation the hooks that held it in place were so deeply imbedded that they could not be removed. I then returned home and remained in my bed due to the pain.
“After a period of about three months I attempted to return to work and lead a normal life but unfortunately for me I haven’t been to regain the life I had before. Over the past six years the consultant has referred me to pain management which they have tried to relieve with injections.
“I have nerve damage now due to the operation for which I take strong pain killers and antidepressants just to get through the day.
“Since the operation my fibromyalgia has flared up due to the stress, pain, depression and anxiety. I also suffer chronic fatigue and reluctantly had to give up work three years ago.
“I now have days where I can’t get out of bed due to pain and fatigue, and I walk with a walking aid to support me. The grandchildren have seen a drastic change in me and it breaks my heart not being able to interact with the like I used to.
“My fourth grandchild came along a few months before my operation and all he knows me as is ‘poorly nana’. Due to this operation I can’t sit or stand for long. If I go out I have to take a specialist cushion with me. Everything people take for granted in everyday life I can’t do anymore.
“If I had known then what I know now about the outcome of this polypropylene mesh damaging my body - and my life - I would never have had it done. Many thousands of women and men have been damaged by this mesh. There are many in wheelchairs or use walking aids, their homes and their jobs.
“Many have also lost their partners because the intimacy with them has had to stop. Some men can’t cope with this so they leave their partners. I am so lucky to have a wonderful supportive husband who has stood by me with all of the difficulties I have been through and which are still on going.
“It is very hard on him as well and I feel so guilty some days for what he has to put up with.
“I’m not the happy, live life to the full person I once was.
“To people out there with prolapses, hernia’s etc, please think twice about having this operation. The mesh is made out of polypropylene plastic which shrinks in the body, breaks up and can cut into organs, bladder, bowels and leave permanent damage. I, along with 6,000 members who belong to Facebook support group Slingthemesh after being harmed by the mesh, are calling for a suspension of mesh implants until a review by the government into its safety is published.”
The issue was debated last Thursday, April 19, at the House of Commons. The debate was led by Kingston upon Hull West and Hessle MP Emma Hardy who is calling for a suspension of the controversial vaginal mesh implants until a government review is completed.
Among those who spoke was Torbay MP Kevin Foster.
He said: “I have been very concerned to meet constituents who are living in pain and discomfort following operations using synthetic mesh. I welcome the review which has been ordered and would urge NICE to bring forward new guidance as quickly as it can.
“While the case I highlighted in the commons did not follow treatment at Torbay Hospital, I am pleased to note the suspension of using synthetic mesh in vaginal surgery which has been put in place.”
Manufacturers of the mesh implants are facing legal action in the UK and overseas.
Mark Harvey, head of specialist personal injury at law firm Hugh James, said: “Hugh James represents over a 100 women who have suffered horrendous pain following the failure of mesh in their pelvic organ prolapse treatment.
“Our investigations reveal a situation in which mesh manufacturers provided a remedy that wasn’t needed and didn’t work. The NHS and NICE reviews have confirmed that the very significant risk of failure of this treatment considerably outweighed any benefit it could provide when compared with traditional conservative repair.
“Moreover, this adverse risk-benefit profile seems rarely to have been communicated to patients in advance.”
Among Devon’s hospital’s no longer carrying out the procedure is Torbay Hospital.
A Torbay and South Devon NHS Foundation Trust spokesperson said: “We are committed to listening to our patients and the public to ensure that we’re continually providing the highest quality of care possible. Due to concerns of the general public regarding this type of surgery, as well as some updated NICE recommendations, we voluntarily stopped using the meshes in October 2017. Before we removed the meshes as a surgical option for our patients last year, we had been significantly reducing the number of procedures being carried out using these meshes - well before the NICE recommendations were made.
“As a trust, we have decided to stop using the meshes indefinitely and we are currently offering our patients the more traditional surgery options. However, we are closely monitoring the evidence and development of alternatives so that we can ensure that we are at the forefront of any future surgical developments.”
They have also been halted at Mount Stuart Hospital in Torquay.
A spokesperson said: “Following guidance from The National Institute for Health & Care Excellence’s (NICE) interventional procedure advisory committee in December 2017, consultants practising at Mount Stuart Hospital no longer carry out transvaginal mesh repairs of anterior or posterior vaginal wall prolapses, and we have no plans to reintroduce its use at the hospital.
“Providing the highest quality of care to all our patients remains of utmost importance to Mount Stuart Hospital.”
In Exeter, the use of them has not be common but are now also not used.
Rowenna Rutherford, Exeter cystic fibrosis service manager and gynaecology cluster manager at the Royal Devon and Exeter Hospital said: “At the RD&E over the last 15 years we have undertaken very few vaginal repairs with the use of synthetic mesh in women presenting with prolapse, preferring instead to use the traditional non-mesh repair.
“While mesh for prolapse has not been widely used in Exeter, the RD&E was involved in an ethically approved multi-centre randomised controlled trial called PROSPECT (PROlaspe, Surgery: Pragmatic Evaluation and randomised Controlled Trials), whose results were published in the Lancet in 2017 and showed no overall benefit for the use of mesh.
“The trust no longer uses synthetic mesh in vaginal prolapse repairs.”
In North Devon it was confirmed the mesh was not used, but no response was received how long that had been for.
Darryn Allcorn, director of nursing, quality and workforce at Northern Devon Healthcare NHS Trust, said: “It’s really important to us that our patients receive high quality care that follows the latest best practice guidance. We do not use mesh in this type of surgery.”
Campaigners are hopeful the decisions made by hospitals in Devon is also being repeated across the country.
Mum of two Kath Sansom, of Sling the Mesh, said: "We are delighted that Torbay Hospital has taken this important step of suspending these controversial mesh implants for women. It is heartening to see that surgeons are listening to patient voice and realising these implants can cause devastating, life changing complications.
"This will allow a measure of protection for women in the Torbay area and surrounding towns and villages.
"Sling the Mesh is calling for the implants to be suspended UK wide until a Government review into risk is completed. We are also calling for NICE guidelines due out in 2019, to be brought forward.
"More importantly we are calling for pelvic floor physiotherapy to be offered as standard to women after having babies so they learn how to properly restore their core to prevent problems of incontinence or prolapse after babies. This happens in France and in our opinion is a simple solution to staying healthy for life."
https://www.devonlive.com/news/devon-news/shocking-story-shows-devon-hospitals-1497421
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Dispatch from Tribeca #3: The Bleeding Edge
Apr 25, 2018 | Bright Lights Film Journal
By Claire Baiz
Two weeks ago, under a concoction that my anesthesiologist dubbed “a Michael Jackson cocktail,” I had a medical device removed from my body.
A surgeon in South Bend, Indiana, pulled a threaded metal stick that held my foot in the proper position after bunion surgery. The bone is healed, and the metal was working its way (shudder) out the top of my foot, so like a pin on a grenade, I had it pulled.
I’m still hobbling, but after seeing The Bleeding Edge, I’m glad my foot didn’t explode.
I am one of 70 million Americans who have been implanted with metal, plastic, polymers, pacemakers, corneas, and more in the past decade. Most of us are wheeled to the OR with a high level of trust for the protocol that brought these devices into our operating rooms.
In the first few minutes of The Bleeding Edge, two-time Academy Award-nominated filmmakers Kirby Dick and Amy Ziering (The Hunting Ground, The Invisible War) offer a quick disclaimer, mentioning all the good things medical devices can do.
It’s the last nice thing they have to say.
The medical device industry is rigged to maximize profit, minimize safety, and – when things go wrong – to marginalize victims and silence the voices that might prevent further harm.
With a title like The Bleeding Edge, I expected disturbing images (there weren’t as many as I was bracing for, because the stories alone are horrific). I wasn’t surprised by the smug attitude of industry executives caught on tape, or the complacency of people in power.
The problem with The Bleeding Edge isn’t the gripping, well-paced, seamlessly produced, scary-as-hell content.
My concern is, in this crowded world of worthy causes, will the documentary produce enough buzz to generate reform.
This is the kind of cogent, well-researched exposé that, if activists weren’t tearing their hair out over Syria, North Korea, Bob Mueller’s investigation, Scott Pruitt’s cone of silence, global climate change, rampant gun violence and lettuce poisoning, there might enough of an uproar to generate real reform.
Especially now, how much outrage can a 99-minute Netflix documentary expect to generate? If enough people watch it, if enough tough questions go unanswered, there might be an election-year push for progress.
The Bleeding Edge highlights case histories of four types of victims: women who suffered permanent damage from Essure – a device marketed as a “simple, nonsurgical, permanent birth control,” an orthopedic surgeon from Alaska who suffered a mental meltdown after his metal-on-metal hip implants began leaching cobalt into his nervous system, a pelvic mesh patient who has lost track of how many surgeries she’s had to remove floating fragments (18? 19?), and several women who display remarkable dignity, considering their insides fell out, days after having DaVinci robots perform remote hysterectomies.
Filmmakers Dick and Ziering let each victim tell their own story, not sparing the ripple effects on spouses, children, and careers. The presentation isn’t sappy or exploitive. It’s real life. We feel their pain.
None of these devices – from the eroding hip replacement to the pelvic mesh that stiffened internal organs – underwent rigorous testing, or required human trials, before they went into our bodies.
Like 96% of all medical devices on the market today, they were “grandfathered in” as part of the Medical Device Regulation Act of 1976.
As long as a manufacturer can point to a device that they claim is “substantially equivalent” to one that’s been legally marketed, it qualifies for PMA (Premarket Approval) under a provision called 510 (K). Even if, the documentary claims, the originally approved device was dangerous or ineffective.
If, somehow, it can be traced back to 42-year-old technology, as far as the Food and Drug Administration is concerned, it’s good to go (inside you).
There’s also a sick symbiosis between doctors and manufacturers’ sales reps, who offer legal kickbacks to surgeons.
I was upset to hear in passing that, while patients are under anesthesia, a salesperson from Johnson & Johnson, Stryker, or Medtronic is probably in the operating room looking over a surgeon’s shoulder offering installation suggestions, or maybe discussing a deep-sea fishing junket off the Gulf Coast.
Former FDA commissioner David Kessler (1990-1997) looks straight into the camera and admits, “We built a system that doesn’t work.”
Why has the US Food and Drug Administration gone along with this dangerous protocol for so long? Because the $400 billion medical device industry is one of the most powerful – and one of the more quiet – influencers in Washington, D.C.
The Bleeding Edge claims the industry’s lobbying arm, Advamed, bleeds green into campaign coffers, to the tune of $64 million in 2017 alone.
Current Commissioner of Food and Drugs Scott Gottlieb, MD, is a prime example of the industry/regulator revolving door. A former attorney for big device-maker Bayer, Gottlieb was accused of conflict of interest during his confirmation hearings. He was confirmed after offering to recuse himself from rulings that involved his former employer (and investment partner) for the first two years of his tenure.
As that sinks in, the audience is treated to photos of other former industry executives, alongside their positions with the FDA, and a frightening segment about whistleblowing research scientists who lost their jobs after suggesting that CT scanners, which can emit the equivalent of hundreds of X-rays in a single scan, might be better off with warning labels.
It may be no coincidence that three of the four nightmare scenarios Kirby Dick selected for his “doc doc” could only happen to women. I can’t help but wonder how the DaVinci robot executives would have reacted if, instead of a hysterectomy patient emerging from the bathroom with two feet of her colon in her hand, men began to report that their penises were falling off after surgery.
Though the documentary’s indictment of government and industry is damning, Dick and Ziering don’t mention one person who bears direct responsibility for the medical device nightmare. His name is Steve Austin.
The FDA isn’t the only one who is complacent when it comes to medical devices. Americans were conditioned, from an early age, to trust them implicitly, thanks to the character played by Lee Majors in the 1973-78 TV series The Six Million Dollar Man. (If ABC-TV revived the show, it would be The $48 Million Man.)
If anyone deserves a kickback from medical device manufacturers, it’s Austin, the fictional astronaut who lost his right arm, both legs, and his left eye in an experimental airplane accident. That incredibly popular TV show, and its spinoff, The Bionic Woman, convinced my entire generation that if something inside our bodies goes on the fritz – a hip joint, a bum knee, foggy vision – there’s a good chance that American ingenuity, dedicated government scientists, and selfless physicians could slice us open, replace the missing or defective part, and make us BETTER than we were before our mishap or disease.
The trouble with the FDA is that it’s working with regulations that were enacted back when The Six Million Dollar Man was still in production.
http://brightlightsfilm.com/dispatch-from-tribeca-3-the-bleeding-edge/#.WuFymL6FPIU
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Apr 25, 2018 | The Sun
By Rebecca Flood
MILLIONS of women give birth every year but having a baby can cause long-term complications and side-effects.
The human body changes immensely during pregnancy and post-birth, and for some women there are lingering issues which persist long after they’ve had their child.What causes urinary incontinence after childbirth?
One side-effect of having a baby is urinary incontinence.
There are different variations of incontinence, including stress, urge, overflow and total incontinence.
Various factors can increase the chances of urinary incontinence, including having a vaginal birth.
The use of forceps or other interventions can also trigger it as they can injure pelvic nerves and muscles.
Stress incontinence can be caused by the weakening, or damage to, the pelvic floor muscles or urethral sphincter, which both control urination.
Urge incontinence is often the result of over activity of the detrusor muscles which control the bladder.
Pregnancy and menopause can also trigger it, along with weak bladder muscles, overactive bladder muscles and nerve damage.
Overflow incontinence is usually caused by an obstruction in the bladder or a blockage, which prevent it emptying fully.
Total incontinence can stem from a spinal injury, a bladder fistula or some people are born with it.
For women who have given birth, the most likely form of incontinence they suffer is stress induced.How common is it?
The NHS says that: “After having a baby, it's quite common to leak a bit of pee if you laugh, cough or move suddenly.”
The National Childbirth Trust (NCT) says almost half of women experience urinary incontinence.
But despite it being a common problem, their research found a third of women, 33 per cent, were embarrassed to discuss the issue.
And nearly half, 46 per cent, were not comfortable talking about it with their friends.
And the Baby Centre claims that around a third of women will experience urinary incontinence in the first year after having their baby.What treatments are available?
Initially it is likely your GP will prescribe some exercises to help with the condition.
Pelvic floor exercises can help with bladder control, which involve exercising, and ultimately tightening, your pelvic floor.
These exercises help strengthen the muscles around your bladder, vagina and anus.
The NHS says: “Your pelvic floor muscles are the muscles you use to control the flow of urine as you urinate.
“They surround the bladder and urethra, the tube that carries urine from the bladder outside the body.
“Weak or damaged pelvic floor muscles can cause urinary incontinence, so exercising these muscles is often recommended.”
If non-surgical treatments don’t work, there are surgical options.
The most common type of incontinence for women post-birth, stress incontinence, can also be treated by medication duloxetine.
This has side-effects and your GP will prescribe it if they think this is the best option.
There are surgical procedures which include the tape procedure, transobturator tape procedure (TOT) and retropubic tape procedure or tension-free vaginal tape procedure (TVT).
There is also the option of a colposuspension, which has two forms open colposuspension and laparoscopic (keyhole) colposuspension.
Women can undergo a sling procedure, have urethral bulking agents injected, or have an artificial urinary sphincter fitted.
For more information on pregnancy and your post-birth body visit the NHS website.
https://www.thesun.co.uk/fabulous/6137935/urinary-incontinence-childbirth-causes-common-treatments-available/
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