Why Jury Trials/Verdicts Do Not Stop Medical Device Harm-for-Profit

Listen to this link: J&J defense lawyers attempt to void a $502 federal trial verdict by disassociating the 'parent' company from toxic metal-on-metal DePuy Pinnacle hips

This took place on December 7 at the New Orleans 5th District Federal Court of Appeals.

Get an Unsafe, Ineffective Medical Implant & Lose Your Civil Rights!

DeLauro Pushes to Protect Consumers from Unsafe Medical Devices

September 26, 2017 Press Release

WASHINGTON, DC (September 26, 2017) —Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).

”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.

“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”

“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”

DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.

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Washington, DC Office

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Washington, DC 20515

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Please sign and share this petition! Thank you!

https://www.petition2congress.com/ctas/the-medical-device-safety-act-hr-2164

The Medical Device Safety Act H.R. 2164

440 Messages Sent So Far

The Medical Device Safety Act 2017 H.R. 2164 #MDSA17

The Medical Device Safety Act of 2017 was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.

We are asking for your support of The Medical Device Safety Act 2017, H.R.2164, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are tens of thousands of consumers who have been harmed by, disabled by, or lost a loved one to a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA17

Disruption and Mistreatment: Healthcare CEO/Doctor

The U.S. medical system is broken. We should be listening to doctors about how to fix it

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Dr. Robert Pearl: His book offers a prescription to cure wait ails American medicine

By Patt Morrison

July 5, 2017   FiDA highlight

Dr. Robert Pearl has spent his life in medicine — most recently 18 years as executive director and CEO of Kaiser Permanente’s medical group in California, and president and CEO of its mid-Atlantic group. But it was the death of his father, and a simple medical miscommunication, that prompted him to look long and hard at an American medical system that doesn’t always deliver bang for its billions of bucks. In his book, “Mistreated, Why We Think We’re Getting Good Health Care — And Why We’re Usually Wrong,” Pearl lays out his four ways though the morass of American medical practice: integrated, not fractured care; a flat-fee capitated payment system instead of pay-per-treatment; embracing mobile and video medical technology; and most of all, care that’s led by doctors themselves.

Let me take a classic American playground taunt and turn it around: The line is, if you’re so smart, why aren’t you rich? So if the United States is so rich, and so smart, why aren’t we healthier?

This is exactly why I wrote “Mistreated,” because we spend 50% more than any other nation on the globe and our results are in the lower half. And the reason is because the American healthcare system is broken. It most closely reflects a 19^th century cottage industry. It’s fragmented, with doctors scattered across most communities, hospitals in every town.

It’s paid on a piecemeal basis; we call it fee-for-service. It uses technology from the last century. You’d never bank someplace where you couldn’t access information on your account 24/7, but if you want to get your radiology results, your laboratory results, you’d have to call the doctor’s office between 9 and 5 Monday through Friday, or go there. You can’t use video; all the modern tools are not available.

You say our results as a country are in the lower half. Can you get specific?

We’re last in the world [among the 20 most industrialized nations] when it comes to life expectancy. A girl in Seoul, [South] Korea, being born now has on average a life expectancy of 90. The same girl in the United States, 83 — seven years fewer.

We’re second to last in terms of childhood mortality.

Colon cancer — half the colon cancer deaths in the United States are preventable with proper screening, and I don’t necessarily mean a colonoscopy. It’s called a FIT test, which is basically done in the privacy of a bathroom once a year, five minutes, no bowel prep required, you can do it every year for 10 years. It’s just as good as a colonoscopy, and yet across this nation, it’s done 50 to 60% of the time. The best medical groups do it 90% of the time.

What other industry, what business can you think of that would function like American medicine today?

— Robert Pearl

Americans are dying unnecessarily. Half a million people die every year from either failures of prevention, or from medical errors, like my father, or from avoidable complications of chronic illness that simply were not addressed.

We value intervention over prevention; we value the newest advance over the things that are tried and true.

You make a distinction between malpractice and mistreatment, which can simply result from haste or error.

You’re right. I think most physicians are dedicated, smart, hard-working, knowledgeable. That is not the big problem. I’ll give you an example, again my father. He was someone who had tremendous energy. He slept four hours a night, until one day he got tired. And he had to have his spleen taken out because he had hemolytic anemia.

Now, he spent half his time in New York and half his time in Florida. His doctors in New York knew he needed to have the vaccine, the pneumococcal vaccine, to prevent the complications that often follow removal of the spleen. The doctors in Florida knew that he had to have that same exact vaccine, but they each thought the other had given it.

And that’s the system. That’s the lack of an integrated, comprehensive electronic health record. If he had had that, he would have gotten the vaccine. He didn’t die because of malpractice. He died because of a broken system.

If you were able to wave your magic stethoscope and redesign the American healthcare system, what of it would you keep and what of it would you jettison?

What I would jettison or replace is the fragmented fee-for-service, out-of-date technology, lack of leadership that we have today. I’d replace it with an integrated system with the physicians and hospitals working together as one, paid in a prepaid or capitated way, using the most modern electronic health records along with the most modern and mobile devices, things like video, secured email. And I’d put it all inside a leadership structure with physicians.

And I would have multiple groups competing to provide the best value, making information available and transparent for patients so they can make the best choice for themselves and their families.

The main thing, though, that I would keep, and I’m afraid we’re losing it, is all of the mission-driven, wonderful spirit of American medicine that’s been handed down through five millennia. I think we’re seeing right now that physicians are spending almost half of their day hunched over a computer, trying to document things for a billing system rather than looking at the patients, being able to communicate or other things. We’re asking physicians to squeeze more and more into every day with less and less time.

I think we’re reaching a breaking point where one of two things will happen: If we don’t address the concerns and transform American medicine, what we’re going to see is we’re going to devolve into a two-tier system. Not the two-tier system of today, with the poor and everyone else, but the middle class and the Medicare patients not able to get access, similar to the Medicaid patient of today.

Or we’re going to see disruption. I think if we don’t do something about American medicine, the system will simply disintegrate, dissolve, and we’ll run the risk of being disrupted, as Kodak learned.

What’s the resistance to adding technology, when technology seems to be one of the great drivers in American healthcare?

Today what you’re describing, the ability to get paid to do a video visit, for most physicians doesn’t exist. It could happen. It’s just that it doesn’t exist. And I think part of why it doesn’t exist is that insurance companies are concerned that doctors will just generate more and more and more visits whether they’re needed or not, in order to be able to bill for them.

I was struck by your point in the book that the medical system is driven by fear, and it’s not necessarily the patient’s fear of pain or death.

What happens is that in part of our brain, the reward center and the fear center, we call it lighting up, because it activates, and within fractions of a nanosecond, the perceptual side changes. And so medicine is filled with reward and fear.

The problem is that in American medicine, that same brain process leads doctors and patients to do things that don’t make sense when you look at it through the lens of objective reality. As an example: I live in Silicon Valley, and between San Jose and San Francisco, there’s 10 hospitals doing heart surgery, three of which do 200 or 300 cases a year.

That means there’s at least 65 days a year when the team’s going to be there and available, with nothing to do. It’s hard to imagine you’re going to get great results when you’re doing less than one case a day. And similarly, the cost is going to be much higher.

Take the hospital administrators, and put them in one of my classes at the Stanford graduate school of business. They’ll immediately say, bring the three together, close two of the services and have one service that does 800 or 900 a year, a much higher volume service. But what they know is they’ll lose their jobs. They know the hospitals will lose their revenue. Fear of loss — how powerful losses are compared to gains.

I talk about sepsis, which is an infection that is now the leading cause of death among hospitalized patients, a systemic infection, the same problem that my father died from. The fear there is that, what we know is that half the people who come through the hospital with sepsis are very, very sick. Everyone in the United States knows how to treat them.

But a woman named Diane Craig, one of my associates at Kaiser Santa Clara, found that half of these patients looked very sick coming in. But she also found that the other half — they were sick, because otherwise they would not be at a hospital — but they were not nearly as sick. They were often younger people, sometimes with a kidney infection or maybe a mild kind of pneumonia, and then they progress rapidly over the next couple of days, [into] that intermediate zone [where] no one quite knows what to do. And if you treat all the people in the intermediate zone, you’re going to save lots of lives.

What’s the problem? Because the intervention requires doing very aggressive treatment, and the physician is worried because some patients who might have lived will actually be harmed. And in the mind of a doctor, not all deaths are the same. I hate to say it that way. The ones they cause are far worse than the ones they could have avoided.

And so there’s an imbalance. So rather than aggressively treating the patient, they just put them in the hospital, put them on some antibiotics, and they call a consultation. It’s now no longer on their hands.

It’s not that the doctor intentionally wants to harm anyone, it’s just their fear of being the one to cause the problem.

Again, it’s how our brains change perception. Those things that we cause, the problems we cause, the deaths we cause, are significantly greater in magnitude than the ones we otherwise could have saved. It’s also why we see intervention as being so much more valuable than prevention.

You saw some of these things first-hand when your father fell ill and died.

My dad survived the first acute episode he had, but he never overcame the complications. My brother and I got called; my dad had had a bleed into his brain in Florida. We got on an airplane and we flew there. When we arrived, there were a lot of doctors at the door. There was the [ears, nose and throat] doctor who wanted to do the tracheostomy, the [gastrointestinal] doctor who wanted to put the feeding tube in place, the neurosurgeon who wanted to take a piece of bone from his skull to let his brain expand. And we looked at the X-rays — we’re both physicians — and we said no, he’s not going to get better. It’s not what he wants.

The next two and a half days he was in the hospital, we never saw a physician. There’s no [current procedural terminology] code for how doctors bill for compassion. Doctors in the fee-for-service world don’t get paid for coming by and comforting a family in its time of greatest grief.

The system is making the lives of patients worse.

And I want to add one piece: It’s making the lives of doctors worse. What we see today is one in every three doctors reports being depressed. Over half of physicians say they would not tell their children to enter into medicine. There are over 400 physician suicides every year.

And the reason is, medicine is becoming less and less fulfilling. And yet somehow, because of the context, ask most Americans and they will tell you the medical care in the United States is the best in the world, even if it’s a little expensive. The data says exactly the opposite.

How do your suggestions work when, as you pointed out in your book, about 50% of medical care costs go to 5% of people?

If you look at the 50% that go to 5% of people, you have really three groups within it: one group of people who just have a terrible, unexpected problem. A baby is born very, very premature. But the reality is, they’re not going to have another baby born premature next year.

There are some people who have severe disease, and the problem in that group is that we missed the opportunity 20 or 30 years before to actually prevent them from developing those kinds of diseases.

But the places that most people look are individuals with chronic disease, multiple chronic diseases. And that’s where I think the approach I’m describing will make the biggest difference. All these patients are seeing physicians. It’s just that when they see the physicians, the system is not focusing in a way to get that best outcome. And what do I mean by that? People often have five or six doctors. Well, are those doctors working together as one, or are they all duplicating the same kinds of things? Are the computer systems they’re using coordinated with each other? Or does everyone basically have an office-based system?

Is there a leadership structure? Doctors are not going to follow hospitals or insurance executives — they don’t trust ’em. But they will follow physicians who are well-trained, whom they know and whom they respect.

What other industry, what business can you think of that would function like American medicine today? Try to think of a business where you wouldn’t have coordination between the people who design the products, the people servicing the products, the people selling the products, where you wouldn’t have modern 21^st century computing systems so that everyone has information not just to do the care at the time, but to be able to analyze it in order to improve performance.

It just doesn’t exist in most of American medicine today.

I believe that change can best happen through the businesses of this nation, that if the businesses said, in a certain number of years — let’s say five years from now — we’re not going to purchase insurance from any organization, from any doctor, from any hospital that is not integrated, where the care is not coordinated among primary care, specialty care, inpatient care, outpatient care, where it’s not paid on a capitated or prepaid basis, where they don’t have the most modern electronic health records — I believe the American healthcare system would respond and would improve.

If we’re able to accomplish that, then my dad’s death will have served a purpose, because the result will be hundreds of thousands of patients who live who otherwise would die.

http://www.latimes.com/opinion/op-ed/la-ol-patt-morrison-robert-pearl-healthcare-20170705-htmlstory.html

Monsanto toxic chemicals, FDA corruption, 1994 and 2017

1994:   Senator Bernie Sanders

Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?

“I was rotting from the inside”: The vaginal surgery secretly destroying mothers’ lives.

MICHELLE ANDREWS

April 28, 2017  FiDA highlight

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Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.

But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.

“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.

“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”

"I had necrotic flesh in there." (Image supplied)

"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."

From there, Kim's condition spiralled.

"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."

Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".

"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."

The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.

The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".

By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.

By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.

Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".

While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.

The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.

"I felt like I was rotting from the inside," she describes.

By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.

The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.

"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.

"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."

The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.

Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.

To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.

There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)

While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.

"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."

Kim also lives with a level of anxiety she likens to post traumatic stress disorder.

"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."

If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.

When Kim found someone who had experienced what she had online, she was overwhelmed.

"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.

"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."

"I want everyone to know about it." (Image supplied)

Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".

It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.

Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.

But the aim is to do more than just have the mesh banned - it's to get justice.

"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."

And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.

If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state: 

Victoria; New South Wales/ACT; Queensland; South Australia; Western Australia; Tasmania; Northern Territory.

 http://www.mamamia.com.au/transvaginal-mesh-implants/

Johnson & Johnson shareholders: are you listening? Divest or be complicit!

Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case

POSTED:APR 28 2017 03:07PM EDT

UPDATED:APR 28 2017 03:09PM EDT  FiDA Highlight

PHILADELPHIA, PA (WTXF) - On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.

The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.

Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.

She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.

As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."

The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.

"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.

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“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”

Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”

The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.

The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.

Regulatory Watchdogs Complicit With Medical Device Industry: A Case In Mesh

NHS and medical devices regulator tried to limit scandal over vaginal mesh implants

Minutes show NHS England and MHRA worked together to try to ‘avoid media attention’ of problems faced by women

Denis Campbell and Carmen Fishwick

Friday 21 April 2017 11.19 EDT

Last modified on Friday 21 April 2017 12.43 EDT

NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.

Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency (MHRA) agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.

More than 800 women sue NHS and manufacturers over vaginal mesh implants

The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be incorporated into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.

The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by the health secretary, Jeremy Hunt – to be open and transparent over patient safety failings.

NHS England and the Department of Health both refused to comment on the minutes of the meeting.

MHRA officials said the minutes were more than six months old and the conversation noted in them was one of many conversations held during one of many oversight meetings about the issue.

The campaign, when it begins, will aim to ensure that both women and healthcare professionals know that there is no time limit on reporting complications with mesh devices. It will include engagement with the media, officials stressed. 

An MHRA spokeswoman said: “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients. MHRA strongly encourages the reporting of issues related to all medical devices. When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.”

One possible reason for the NHS to want to limit exposure of the issue could be to reduce the number of potential lawsuits faced by the health service.

More than 800 women are suing the NHS and the manufacturers of the implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.

About 11% to 12% of users have reported problems, while lawsuits in the US have already seen about $2bn (£1.5bn) paid to affected women.

Campaigners say that hundreds more women have come forward after learning of the group planning to sue.

What's your experience of vaginal mesh implants?

Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.

“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”

Data from the MHRA, which has been looking at the issue since 2011 after complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years. 

Despite the problems that have emerged the MHRA insists the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.

A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.

https://www.theguardian.com/society/2017/apr/21/nhs-vaginal-mesh-implants-scandal-suppress-media

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Hernia Mesh Harm: Canada Health

Growing concerns in Canada over surgical mesh usage, recalls

Published Monday, April 17, 2017 10:00PM EDT CTV News.ca Staff  FiDA highlight

Warning: Some of the content may be disturbing to some viewers

There is growing concern over the number of recalls of hernia mesh in Canada, as patients speak out about complications they believe are linked to the surgical device.

Patients across the country contacted CTV News after a story on health problems linked to hernia mesh aired last month.

Patient Ivan Richardson said his hernia mesh has caused him ongoing, unexplained pain.

"You couldn't even touch me, I would cry, I mean literally cry and I went to the doctor and they kept saying they couldn't find nothing," Richardson said in an interview with CTV News.

That is until one doctor cut open his abdomen. There, what was supposed to be flat plastic mesh was rolled up inside Richardson's torso.

Even with part of it removed, Richardson said he still suffers.

"It will feel like a bunch of little needles," he said. "I assume that is the edge of the plastic mesh. I'm scared to do anything anymore, really."

Figures from Health Canada show that some 12 brands of hernia mesh have been recalled or removed from the Canadian market since 2000.

Some were linked to infections and perforations. There were 185 reports of serious injury and other complications, including three deaths.

Still, studies indicate the majority of hernia mesh patients have no problems, and its use is on the rise.

Data shows mesh helps improve recovery and lowers hernia recurrence.

But Dr. John Morrison, president of the Canadian Hernia Society, warns it may be used too often given the growing questions of the harm being done to some patients. In some cases, he said, mesh may not be required.

As part of his practice, Dr. Morrison often removes mesh that's shifted and punctured organs.

"I've seen pictures of it in the bladder, I've seen mesh in the stomach," Morrison told CTV News. "The mesh can erode into other organs over a period of time."

Morrison said studies show 10-20 per cent of people are left with chronic pain.

"It is a very serious phenomenon that's happened," Morrison said.

The physician said if the pain persists longer than three months, a hernia patient should find another physician or a hernia surgeon.

Morrison called the complications an "epidemic, and unfortunately, there's no end in sight, it's going to get worse because almost all hernias are now repaired with mesh."

Dr. Morrison advises patients who are scheduled for hernia surgery to "ask their surgeon if they're going to be using mesh, ask them exactly what type of hernia they have, why the mesh is being used.

He said prior to the operation, a patient should read on the internet the effects of the mesh being used on the hernia they're having repaired.

"An educated patient is the number one thing that will solve this problem," Morrison said.

There is research underway to try to better understand these emerging complications. The research will be of vital importance to the thousands of Canadians who have hernia surgery every year.

With a report by CTV medical specialist Avis Favaro and producer Elizabeth St. Philip