Preview Newsletter
Ethicon Media Monitoring 7/30/2018
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J&J Unit Can't Skip To En Banc Hearing In Pa. Mesh Appeal
Jul 27, 2018 | Law 360
By Matt Fair
A Pennsylvania appeals court has refused to allow a Johnson & Johnson subsidiary to skip straight to an en banc hearing as it challenges a $13.7 million verdict over injuries a New Jersey woman suffered after receiving what a jury agreed was a faulty pelvic mesh implant. -
'Ban the implant that left me in crippling pain and took away my sex life, my dignity and the job I loved'
Jul 28, 2018 | Manchester Evening News
By Sam Yarwood
When paramedic Julie Gilsenan underwent a commonplace procedure last year, she had no idea of the hell it would cause her. -
Stevenage patient’s relief after government suspends surgical mesh op which left her in agony
Jul 27, 2018 | The Comet
By Louise McEvoy
Mesh implants provide additional support when repairing weakened or damaged tissue, but more and more patients have been coming forward suffering complications, and class actions have been brought against manufacturers around the world. -
Ordinary Kiwi women finalists in Women of Influence awards
Jul 29, 2018 | Stuff.co.nz
By Leah McFall
There's a multiple gold medal-winning athlete, a secretary of defence and an acting coach to Hollywood stars among the finalists announced today in the 2018 Women of Influence Awards. -
Editorial – Seeing sense: Medical device ban
Jul 27, 2018 | Limerick Post
The decision this week by Health Minister Simon Harris to listen to the voices of hundreds of women and halt the use of a medical device that is destroying their lives is to be welcomed. -
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Jul 27, 2018 | Mass Device
By Nancy Crotti
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. -
The Bleeding Edge Profiles Victims of Medical Devices
Jul 27, 2018 | Mesh Medical Device News Desk
By Jane Akre
The fallout from lax federal regulation over medical devices and the harm done to patients, is the focus of a new documentary, The Bleeding Edge, which premiers today on Netflix. -
Bayer hits back at new Netflix medical device documentary
Jul 27, 2018 | Reuters
By Tina Bellon
Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety. -
"We are Guinea pigs": Filmmakers on the risks of medical devices
Jul 27, 2018 | CBS News
Medical companies are responding to a new documentary that claims the health care industry's loose regulations on medical devices are putting patients at risk. -
What the Netflix Documentary ‘Bleeding Edge’ Gets Right About the Dangers of Medical Devices in America
Jul 27, 2018 | TIME
By Alexandra Sifferlin
A new Netflix Original documentary sheds light on a topic that’s opaque to many: the medical device industry in America. -
The dangerous reality of medical devices exposed in new film
Jul 27, 2018 | Think Progress
By Amanda Gomez
The pharmaceutical industry has recently come under intense scrutiny for driving the opioid epidemic, insurance companies and hospitals are faulted for rising health care costs, and even the insurance “middlemen” (pharmacy benefit managers) recently got called out by President Donald Trump for their role in high drug prices. -
Why Are Medical Devices So Expensive? 'The Bleeding Edge' Reveals The Outrageous Costs Of Some Dangerous Devices
Jul 27, 2018 | Romper
By Mishal Ali Zafar
High healthcare costs are a point of contention in practically every political debate in today's era. Netflix’s new documentary, The Bleeding Edge, investigates one major healthcare expense — medical devices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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J&J Unit Can't Skip To En Banc Hearing In Pa. Mesh Appeal
Jul 27, 2018 | Law 360
By Matt Fair
A Pennsylvania appeals court has refused to allow a Johnson & Johnson subsidiary to skip straight to an en banc hearing as it challenges a $13.7 million verdict over injuries a New Jersey woman suffered after receiving what a jury agreed was a faulty pelvic mesh implant.
The J&J unit — Ethicon Inc. — asked the state’s Superior Court to consolidate the case alongside a recently decided mesh appeal to allow an en banc panel to weigh arguments that out-of-state plaintiffs should not be allowed to bring claims against the company in Pennsylvania.
But the Superior Court ruled Thursday that the New Jersey-based Ethicon could not bypass the typical appeals process in Pennsylvania, which involves a hearing before a three-judge panel before potential consideration by the court en banc.
The request for en banc consideration came as part of a broader fight that Ethicon has been waging in pelvic mesh cases in Pennsylvania over the impact of a recent U.S. Supreme Courtdecision limiting the ability of state courts to hear claims from out-of-state residents.
In that decision — Bristol-Myers Squibb Co. v. Superior Court of California — the justices ruled that BMS did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood-thinner Plavix.
Since then, Ethicon has launched renewed attacks on whether Philadelphia County can exercise jurisdiction over the claims filed by out-of-state plaintiffs in a mass-tort program designed to consolidate a glut of mesh-related claims against the company.
The Superior Court got a chance to weigh in last month as it issued a decision finding that Ethicon’s links with a Pennsylvania-based company it contracted with to help manufacture its mesh products was sufficient to give the state jurisdiction over claims from non-Pennsylvanians.
Ethicon then asked for the en banc rehearing of the decision, which upheld an almost $13 million verdict awarded to Indiana resident Patricia Hammons, but the petition remains pending.
In the meantime, Ethicon asked the Superior Court at the beginning of July to consolidate the Hammons case en banc with an appeal it launched in May 2016 challenging the $13.7 million damage award to New Jersey resident Sharon Carlino in another mesh case.
The company argued that consolidating the appeals into a single en banc hearing for consideration of the jurisdictional issue would promote judicial efficiency.
Carlino, however, countered the motion by noting that two of the three judges assigned to the panel in her case had also been on the panel in the Hammons case, and suggested that Ethicon could be engaged in improper “judge-shopping.”
While the panel did not issue an opinion explaining its reasons, it shot down Ethicon’s petition Thursday.
Shanin Specter, an attorney with Kline & Specter PC, praised the decision in a statement to Law360.
“We are glad Superior Court is making J&J play by the rules,” he said.
In addition to the Hammons and Carlino cases, Ethicon is pursuing one additional avenue to challenge Pennsylvania’s ability to retain jurisdiction over the out-of-state plaintiffs in the mesh litigation.
The challenge stems from a motion asked the supervising judge of the pelvic mesh mass-tort in Philadelphia County to reconsider a 2015 ruling greenlighting claims from non-Pennsylvania litigants.
While the judge agreed to reconsider the decision in light of the BMS ruling, he ultimately agreed that Ethicon’s business ties with Pennsylvania were sufficient for state courts to hear claims over the mesh products.
Ethicon is also appealing that ruling to the Superior Court.
Ethicon declined to comment Friday.
Carlino is represented by Shanin Specter, Lee Balefsky, Charles “Chip” Becker, Kila Baldwin and Ruxandra Laidacker of Kline & Specter PC, and Adam Slater of Mazie Slater Katz & Freeman.
Ethicon is represented by D. Alicia Hickok and William Carr of Drinker Biddle & Reath LLP, Stephen Brody of O’Melveny & Myers LLP, and Julie Callsen of Tucker Ellis LLP.
The case is Sharon Carlino v. Ethicon Inc. et al., case numbers 1129 EDA 2016 and 1294 EDA 2016, before the Pennsylvania Superior Court.https://www.law360.com/articles/1067776/j-j-unit-can-t-skip-to-en-banc-hearing-in-pa-mesh-appeal
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Jul 28, 2018 | Manchester Evening News
By Sam Yarwood
When paramedic Julie Gilsenan underwent a commonplace procedure last year, she had no idea of the hell it would cause her.
An implant that was meant to improve her life rapidly stripped her of the job she loved, her sex life, and left her in excruciating pain.
She is one of thousands of women who have had a vaginal mesh sling fitted to ease incontinence.
Urinary incontinence is a hugely common problem, and in a lot of cases things such as pelvic floor exercises or bladder training can help to improve symptoms.
But for some women, surgical treatment is advised.
For some, having a ‘sling procedure’, which uses synthetic mesh to support the bladder, has been an effective quick-fix.
But, for others, complications resulting from the treatment, which takes minutes, have been catastrophic.
Being unable to walk and unable to have sex are just some of the symptoms been reported by women like Julie.
Other women say the mesh has sliced into them, causing internal injury.
“It has had a hugely detrimental affect on me and my mental health,” Julie, 42, who works for the North West Ambulance Service said.
“Before this I was running 5k every day, I was fit and healthy. After my surgery I was in so much pain, I couldn’t exercise or have sex with my husband, I put on weight, I felt depressed.
“My little boy turned around and told me he didn’t want a birthday party because I couldn’t do fun things anymore.
“He’d gone from having a mum who was the first one up a mountain dragging him up behind me, to seeing me drugged up on painkillers on the couch. It was no quality of life and I’ve never been the same again because of it.”
Julie is now among campaigners calling for a total ban on sling procedures involving vaginal mesh.
Earlier this month, the procedure was suspended by NHS England following safety concerns. However, days ago, a new report by the British Society of Urogynaecology (BSUG) – taking data from 2013 – described the midurethral synthetic slings as ‘safe and effective as a treatment option’.
The claim has horrified campaigners such as mum-of-five Julie. On the advice of doctors, she underwent the procedure in February last year because of mild stress incontinence, but found it made the problem worse - each time she left the house, she would panic, terrified in case she couldn’t find a toilet.
“You trust them,” she added. “You trust what doctors have to say.
“I was only supposed to be in for a day, but when they put the mesh in they perforated my bladder. I had a catheter in and had to stay overnight.
“I was in so much agony. The next day I had to go home with a catheter in, that itself was painful. I had it in for three weeks and then I was forced to self-catheterise.
“I couldn’t go back to being a paramedic on an ambulance, I couldn’t do that on the road.
“I started to question what was wrong with me, why was I like this? And then I found the Sling the Mesh campaign.”
Sling the Mesh was launched in 2015 in a bid to raise awareness of the risks caused by the procedure.
It now represents more than 6,000 women affected by the complications, and runs an online support group.
In December last year, Julie finally had the mesh removed.
“It took 20 minutes to put in, then four hours to get it out. I spent three days in hospital”, she said.
“The cheese wire cutting pain in my groin has gone, but it has left me with nerve damage, I have a pain in my leg and a numbness in my groin.
“I now work in the call centre for the ambulance service, and although I enjoy it, I miss my job on the road.
“I worked so hard to get to the position I was in and that was taken away from me.
“Aside from the pain, there is a huge impact on your mental health, you feel trapped inside your own body and the pain just wears you down.”
Mandy Bridge, a 51-year-old from Rossendale, was crippled with pain for six years by vaginal mesh.
“If I leaned or bent over I could feel it sticking into me”, she told the M.E.N. “My legs would go numb down the back. It was a horrible feeling.
“I’d struggle to walk up stairs, I’d do a few steps then have to sit down for a bit before I could get up and do some more.
“It affected holidays, I remember we went for a friend’s birthday to the Lake District.
“One day we went for a walk and there were 20 people at the top of the hill stuck waiting for me because I couldn’t get up because of the mesh. I was so embarrassed.”
Mandy, who was a professional dancer, began suffering with stress urinary incontinence following the birth of her second child.
In the mid-90s, her gynaecologist recommended she undergo a procedure – known as a urethral buttress – to treat the problem.
“It lasted for around 15 years,” she added.
“I went back to my doctor in 2012 to see about having it done again, and that’s when I was told about the mesh and how it was this new treatment and how it was much better.
“I had no concerns – there was no reason to at the time – and I had it put in under local anaesthetic.
“Straight away I could feel it sticking in me, stabbing me.
“I couldn’t walk with the pain, I told the nurses and they just gave me drugs and sent me home.
“A week later I went back to the hospital, I kept telling them it was sticking in me, I couldn’t stand the pain.
“They just gave more drugs and said it would calm down, it was just the nerves getting used to the mesh.”
Over the next six years, Mandy continued to complain to her doctor about the mesh. She was referred on to other clinicians, but nothing ever came from it.
She even had to have surgery to remove a superficial cyst which she says was caused by the material sticking out through the exit wound of her stitches.
Eventually, after years of agony and visits to the GP, Mandy was referred by her hospital in Lancashire to a surgeon in London that could remove the device.
“Within minutes of the surgeon examining me she was amazed how I was even able to walk and said she wanted to take it out straight away,” Mandy added.
“It’s a two-part surgery, and there’s about a three-month healing time in between.
“I had my first surgery in May.
“Afterwards I felt like crying – it was the first time since 2012 that I hadn’t been in pain, I hadn’t had that feeling of something sticking into me.
“It was a huge relief.
“I walked upstairs for the first time and I stood there and thought, ‘wow, I just did that’.”
Mandy says she realises that not all women have experienced trouble with the mesh, but says it is vital those who have are listened to.
“In my case I think it was put in wrong,” she added.
“I know other people have had it and it works for them and I understand that, but there’s a lot of people who have been fine for five or so years, and it’s only now it’s started to affect their body.
“From day one I knew something wasn’t right with mine, but then a year ago I started vomiting for no reason and I was told it was because I was reacting to the plastic from the mesh.
“I’m so relieved that it’s nearly over.”
Kath Sansom, founder of the Sling the Mesh campaign, criticised the recently published BSUG report, which described sling procedures treatments as ‘safe and effective’, as ‘seriously flawed’.
She said the audit only looked the short term effects, from six weeks to three months.
“This is one of the big problems with the mesh disaster and many other medical issues like this”, Kath said.
“The questionnaires used to ask patients how they are doing, and now don’t actually give them the chance to tell their stories of any new onset of pain or other chronic conditions.
“It deliberately doesn’t these questions, and therefore does not pick up any negative impacts the operation may have.
“If you dont ask the questions you don’t get the answers.
“The BSUG audit is the most shambolic piece of so-called research I’ve ever seen. More than half the data on how women are doing is missing.
“Add to this that the mesh operation is a cheap, quick fix that has been very popular in private hospitals.
“This audit also doesn’t capture any private hospital data.”
A spokesperson for the BSUG said that it was committed to patient safety and believes that any decision regarding treatment for women must be based on sound and rigorous evidence.
They say synthetic tapes for stress urinary incontinence are an effective treatment for women who suffer from this debilitating condition, and for some it may be the only option.
Their recent report, which analysed women who underwent the procedure in 2013, found that 92 per cent of women were ‘very much better or much better’ at their follow up visit, which was undertaken between six weeks and 12 months.
And the body said that less than two per cent of women suffered pain which persisted for more than 30 days after the procedure, and that 3.7 per cent of women experienced complications following surgery from more than 30 days.
The spokesperson added: “BSUG is looking into whether longer term outcomes, as well as failure and recurrence rates of stress urinary incontinence surgery, can be assessed from this cohort of patients from 2013.
“BSUG takes each and every complication caused by mesh implants very seriously and encourage our members to report every complication to the Medicines and Healthcare products Regulatory Agency (MHRA).”
They said the BSUG is now working with the review panel, NHS England and other partners to provide women with the safest and most effective treatments.
https://www.manchestereveningnews.co.uk/news/greater-manchester-news/ban-implant-left-crippling-pain-14956647
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Stevenage patient’s relief after government suspends surgical mesh op which left her in agony
Jul 27, 2018 | The Comet
By Louise McEvoy
Mesh implants provide additional support when repairing weakened or damaged tissue, but more and more patients have been coming forward suffering complications, and class actions have been brought against manufacturers around the world.
Carole Davies, who lives in Stevenage, had a tension-free vaginal tape operation due to a prolapsed bladder in 2007.
Mesh made of prolene – a synthetic material – was inserted to replace tissue that had weakened and caused the pelvic organs to prolapse.
Carole, 72, says she has been in terrible pain ever since. She cannot stand for long or walk far.
In February, then-health secretary Jeremy Hunt announced a review into the use of vaginal mesh. He said: “Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects. The response from those in positions of authority has not always been good enough.”
The review is ongoing, but has called for an immediate suspension of the use of surgical mesh to treat stress urinary incontinence until conditions to mitigate the risks of injury are met, including that surgeons are appropriately trained.
The Department of Health and Social Care and NHS England have agreed these conditions should be met by March 2019.
Baroness Cumberlege, who is leading the review, said: “I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly. We had to act now.
“We must stop exposing women to the risk of life-changing and life-threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment.
“At this stage in our review we are not recommending a ban.”
Carole, a member of campaign group Sling the Mesh, said: “It’s a great start, but the fight hasn’t finished yet. Mesh shouldn’t be used for anything, including hernias, the vagina or the bowel.
“The suspension is still a triumph though. Obviously it’s too late for me, but it will stop others from suffering. If it just helps one person, then it’s worth it.”
http://www.thecomet.net/news/sling-the-mesh-campaigner-carole-davies-from-stevenage-is-delighted-baroness-cumberlege-has-suspended-surgical-mesh-implants-1-5622145
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Ordinary Kiwi women finalists in Women of Influence awards
Jul 29, 2018 | Stuff.co.nz
By Leah McFall
There's a multiple gold medal-winning athlete, a secretary of defence and an acting coach to Hollywood stars among the finalists announced today in the 2018 Women of Influence Awards.
Sophie Pascoe, Helene Quilter and Miranda Harcourt join 83 New Zealanders shortlisted not only for their achievements but their positive influence, in categories spanning business, the arts and community leadership.
Today's finalists also feature less prominent women, forced by extraordinary circumstances to push themselves in ways they'd never imagined possible. Charlotte Korte is one of them.
The softly-spoken Titirangi mother of two might insist she's unremarkable. But in 2010, her life was forever changed by what should have been a routine operation.
"If I'd known eight years ago where I would end up now, I would have laughed," she admits. "I was an active mum; I was a teacher; I loved the outdoors, yoga, going out. When I look back and at my life now, it's considerably changed."
Korte developed complications from an implant of surgical mesh – a polypropylene medical device treating urinary stress incontinence and vaginal prolapse in women, which can also be used in hernia procedures.
The mesh has become internationally notorious and its use banned or restricted in some countries because of the severity of problems it can cause patients, including chronic pain, incontinence and painful intercourse.
Korte's experience led her to connect with Carmel Berry and Patricia Sullivan, and in 2012 they formed the support and advocacy group Mesh Down Under. They began with six members; today, there are over 600. It's become the ardent patient voice in the public debate about mesh.
"I've met so many amazing people through this," says Korte. Some are horribly injured; there have been suicides. The courage of survivors compels her to keep campaigning. "They keep getting up and keep going. That's inspired me to go on."
Korte has turned lobbyist in the six-year battle to protect people from mesh harm. She has co-presented a petition to a parliamentary select committee; argued with a surgeon on radio; spoken to an Australian Senate inquiry, and heavily criticised politicians and health officials for failing to act decisively.
"It's funny, because I'm terrified of public speaking," she laughs. Her passion for the issue makes her brave but emotionally, it's exhausting.
"This is a really hard job. There's been many a time we wanted to give up. We're tired. I've had enough of campaigning. I want to put some strategies in place to fix things."
Women of Influence judge, Stuff CEO Sinead Boucher says this year's line-up of finalists notably includes unsung influential women, like Korte, whose stories are rarely told.
"It is powerful that they are being recognised not for individual achievement, but for influence – the impact they have on others around them.
"In this year where we celebrate 125 years of suffrage, it means a lot to me to see so many examples of women making an enormous difference in the lives of others."
So, how does Korte feel to be recognised in the public policy category of the Women of Influence Awards?
"I'm stunned, actually," she says, making clear she'd accept a win on behalf of the three-strong Mesh Down Under team. "The main reason I do what I do is to prevent what happened to me and my family from happening to anyone else."
From boutique to big deal
Angela Meyer is many things, and one of them is irrepressible.
In the early 2000s the Wellington marketing and communications professional set up the comedy dance troupe Real Hot Bitches, the Man Bank dating site, and later wrote a memoir about the time she, her husband and toddler son set sail across the Pacific.
Today she's a finalist in the Women of Influence business enterprise category for her emergence as a corporate change-maker.
As co-founder of the female-led creative agency Double Denim and the Ace Lady Network with Anna Deans, Meyer has gone from boutique to big deal – recently winning the New Zealand Labour Party as a client.
Their work challenges brands, companies and political parties to connect with, cater to and care about New Zealand women, whose power as consumers, employees and cultural influencers has been underestimated for too long.
It's overwhelming women who decide what to buy in New Zealand, says Meyer. They're an economic force, yet they're insecure. A quarter feel unloved, most feel anxious and unsafe, and many are experiencing abuse or know someone who is.
"I literally had my head in my hands asking, what is going on?" she says of Double Denim's deep-dive research into Kiwi women.
"It also made me go, there's a massive opportunity here, for our clients, for us, for the country, to actually address this and ask: how can we make people feel loved, connected and valued?"
It's out with sexist advertising, or employers paying only lip service to equal opportunity. Corporate culture needs to change, as does policy, language, and advertising.
"What if gender equality was an everyday reality?" Meyer will ask clients. She warns them they need to be honest with the female market and respect it, because in the era of #MeToo and social media, a backlash could be swift and merciless. "If you're not ahead of this curve, you're going to be left behind."
It's Double Denim's policy to collaborate with professional women. It contracts their services, puts them in touch with each other and shares expertise.
When only a tiny percentage of the world's creative agencies are female owned makes Double Denim "outrageously unusual", says Meyer. But their time has come, and it's galvanising entrepreneurial women inspired by Double Denim's example.
"The impact is showing, not telling – and demonstrating you can do it."
https://www.stuff.co.nz/life-style/105797955/ordinary-kiwi-women-finalists-in-women-of-influence-awards
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Editorial – Seeing sense: Medical device ban
Jul 27, 2018 | Limerick Post
THE DECISION this week by Health Minister Simon Harris to listen to the voices of hundreds of women and halt the use of a medical device that is destroying their lives is to be welcomed.
Undoubtedly his judgement in the matter was swayed to a great extent by concerns raised by Dooradoyle solicitor Melanie Power and the women she represents.
But a tiny, cynical doubt raises the question about how much louder these women might have had to shout had another Limerick woman, Vicky Phelan, not spoken first?
The Ministerial order to suspend the use of trans vaginal mesh to treat incontinence in women follows a similar order a few weeks ago in the UK.
This is only a suspension but there is little doubt in the minds of the members of Mesh Survivors Ireland that it will become an outright ban once the facts and the testimonies come to light.
The pain and suffering that women have endured because these devices are slicing into vital organs and becoming enmeshed with their own body parts is indescribable.
But what is almost worse is the attitude of some members of the medical profession as reported to Ms Power.
Woman say they have been dismissed, sidelined, insulted when they spoke about the effects of this device on their intimate relationships. Some were even told they were suffering psychological problems when they described real pain and suffering.
Which was richly ironic, considering we don’t even have a scan in this country capable of seeing the plastic mesh device once it has been implanted.
Clinicians were willing to believe their own suppositions rather than listen to their patients. Up to the moment the Minister called halt on Tuesday, women were still being scheduled for the procedure to insert this device.
Medical practitioners are still defending its use on the basis that it helps solve incontinence – an embarrassing problem certainly, but much less distressing than a sliced kidney.
The real cost of clinical deafness and blindness has yet to be counted.
https://www.limerickpost.ie/2018/07/27/editorial-seeing-sense-medical-device-ban/
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Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Jul 27, 2018 | Mass Device
By Nancy Crotti
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today.
The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial hips, and women whose surgeons used Intuitive Surgical’s da Vinci robotic arm to perform hysterectomies. It focuses on the efforts of women who had Essure implants to get the device off the market through Facebook groups, picketing of medtech conferences, and one-on-one conversations with physicians and lobbying members of Congress.
Facebook group founder Angie Firmalino recounts her experience following removal of Essure. “Blood exploded out of me,” she says. “It looked like a horror scene.”
Award-winning filmmakers Kirby Dick and Amy Ziering, of “The Invisible War” and “The Hunting Ground” also followed Ana Fuentes, a mother of four who says that she started wearing diapers to contain her excessive bleeding following implantation with Essure. Her doctor told her that Latinas bleed more than other women. Fuentes’ husband left and she eventually lost her job due to excessive medical appointments. After she and the girls became homeless, Fuentes placed them in foster care.
Orthopedic surgeon Stephen Tower blames high cobalt levels from his metal artificial hip for neurological problems and a mental breakdown. Tower, who had revision surgery with a plastic-and-ceramic hip, now speaks to groups of physicians on the hazards of metal hips.
The film also includes criticism of the industry and the FDA by watchdog groups, doctors and former FDA officials. It dissects the 510(k) approval process, pointing out that predicate devices that have been recalled still count toward approvals.
“FDA does a credible job with the vast majority of products,” former FDA commissioner David Kessler says in the film. “The problem we have is, when it comes to medical devices, we built a system that doesn’t work.”
Introduced in 1976 at the request of the medtech industry seeking speedier, less expensive approvals than required for a premarket approval or PMA, the 510(k) process allows for FDA clearance of “substantially equivalent” devices with less research.
“That provision, which was meant as an exception — in essence, a little loophole —
that exception became the rule,” Kessler says. “So, the vast majority of devices today, regrettably, are regulated under this framework.”“There’s a lot of problems with that 510(k) system,” adds Rita Redberg, MD, a cardiologist and editor of JAMA Internal Medicine. “That’s how metal-on-metal hips got on the market.”
The filmmakers also slam the industry for its focus on innovation. “They wheel out patients and they say, ‘This person wouldn’t be alive today if it wasn’t for this innovative product,’” says Deborah Cohen, associate editor of the British Medical Journal. “It’s all very glossy. It’s a slick machine.”
“Just because you have a new technology doesn’t mean it’s innovation,” adds Redberg.
“Too often you hear people say, ‘Oh, you’re going to stifle innovation. They’re not talking about stifling innovation. They’re talking about … putting untested devices on the market. That’s not innovative.”When the filmmakers take aim at medtech lobbyists, AdvaMed president Scott Whitaker counters, “We want to make sure that new medical innovations get to patients and help save lives, improve the human condition, eliminate suffering and make this world a better place. That’s what we all agree on, right?”
The FDA, Bayer, Johnson & Johnson, and Intuitive Surgical declined to be interviewed for the film. AdvaMed and the companies did not immediately respond to MassDevice’s request for further comment.
J&J issued a statement to the filmmakers saying, “Your assertion that our ‘vaginal mesh and hip products have had a negative impact on the health of patients’ is untrue.” In a lengthy email to MassDevice, an FDA spokeswoman said no one at the agency had seen the film, although the agency did provide “extensive responses to the filmmakers’ questions.”
“Regardless of which process is followed, FDA strives to permit marketing of only those devices with a favorable benefit-risk profile,” the email response says. “However, not all information regarding benefits and risks for a given device are generally known before the device reaches the market… This is why the FDA uses a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices, including analyzing reports of problems that are submitted to our public database, reviewing results from Post-Approval Studies, and evaluating the available clinical literature.”
The statement also pointed to the FDA’s efforts at building its collaborative National Evaluation System for Health Technology (NEST) to “link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims. Full implementation of NEST will improve surveillance, signal management and mandated postmarket studies, and has the potential to support studies designed to answer specific device safety questions,” the statement said.
Bayer removed Essure from markets outside the U.S. in 2017. In March 2018, the FDA said it was evaluating the nearly 12,000 adverse event reports it received in 2017 about Essure, a 136% increase over the number of reports logged in 2016. Since its U.S. approval in 2002, the FDA has received a total of 26,773 adverse event reports on Essure.
In April 2018, the FDA required Bayer to add a boxed warning to the Essure label and advised physicians to explain the potential risks of the device to women. Bayer pulled Essure from the U.S. market July 20, 2018, one week before today’s documentary debut.
“Evaluating the postmarket safety of Essure continues to be a top priority for the FDA, and we expect Bayer to meet its postmarket obligations concerning this device,” the agency’s statement continued. “Ensuring the safety and effectiveness of medical products is a core part of our consumer protection role.”
Near the end of the film, Firmalino and other women visit members of Congress to explain how Essure affected them and thousands of other women.
“Women just seem to be expendable, don’t they,” says U.S. Rep. Louise Slaughter (D-NY). Slaughter died in March 2018.
“That’s how we’re starting to feel,” responds one member of the group. “We’re disposable.”
https://www.massdevice.com/netflixs-the-bleeding-edge-blasts-medtech-fda/
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The Bleeding Edge Profiles Victims of Medical Devices
Jul 27, 2018 | Mesh Medical Device News Desk
By Jane Akre
The fallout from lax federal regulation over medical devices and the harm done to patients, is the focus of a new documentary, The Bleeding Edge, which premiers today on Netflix.
Image: Scene from The Bleeding Edge
Mesh-injured Tammy Jackson, is followed through the film along with her family. Her pelvic mesh implant was among the medical devices, 95% of which are cleared for sale and marketing by a loophole in Food and Drug Administration safety, known as the 510(k).
Pelvic mesh, Essure birth control and metal-on-metal hips all entered the market after assurances from manufacturers that they were safe and effective.
Most medical devices are considered moderate risk or class II by the agency, even if they are to be implanted permanently. Unlike drug reviews, which involve clinical trials and years of research to assure safety, the FDA relies on the honesty and integrity of the device maker that theirs is similar enough to a device already marketed, even if that “predicate” device has been recalled from the market for problems.
“When it comes to medical devices, we built a system that doesn’t work for proper regulation,” says David A. Kessler, former FDA commissioner. Director Kirby Dick tells the New York Times that the multi-billion dollar medical device industry has exploited those flaws.
The film looks at the revolving door between the FDA and the industries it oversees. Leave the federal agency, get a cozy job with industry, revolve back into a government position.
It’s job security for the few, but at what cost?
Jackson is one of hundreds of thousands of women implanted with vaginal mesh, “which costs about $25 to bring to market, and they sell for about $2,000” says urogynecologist, M. Tom Margolis, MD.
Attorney Adam Slater who successfully represents hundreds of mesh injured women, also featured in the film.
At one time there were more than 104,000 defective product lawsuits filed in one federal court in the U.S. alone against seven mesh makers – Johnson & Johnson, American Medical Systems, Boston Scientific and C.R. Bard, among them. In the case of all of the medical devices mentioned in the documentary, there was no long-term data before the devices were put on the market.
Most pelvic meshes used to treat stress urinary incontinence (SUI) are still on the market, while the larger mesh, all polypropylene, used to treat prolapse, have been reclassified as high-risk or class III. That essentially means the bar is raised on proving safety. As a result, most prolapse meshes are no longer on the market.
No matter what medical device, when scientists, working for industry, voice internal dissent that the product is not ready for market, a plaintiff’s lawyer says, “the marketing is always going to win out.”
The film features Ana Fuentes, who was implanted with an Essure birth control device, made by Bayer. The mother of four is not unable to work because of the complications she continues to experience.
Angie Firmalino, who founded Essure Problems on Facebook, says even though Bayer announced last week it would remove Essure from the market, more work needs to be done. “That was a win,” she tells MND.
Implanted in 2011 she started the Facebook group two years after she was implanted to warn friends.
It originated as a support group, but grew virally online as more and more women found each other and shared their experiences.
Public pressure was a deciding factor in the removal of Essure.
Essure problems took excerpts from the FDA’s expert panel meeting and created YouTube Videos. “The more people saw the angrier they got,” says Firmalino.
Then Erin Brockovich got involved and the Essure group sent volumes of emails to the FDA and continued to research data within the agency to come to the convincing conclusion that Essure should not have been marketing.
No word on how many women have been implanted with Essure. Bayer says 750,000 kits have been sold worldwide, but Firmalino says they don’t know if that translates into women implanted.
Stephen Tower, a physician who was implanted with a chrome-cobalt prosthesis hip, was poisoned which led to a mental breakdown.
Conflicts of interest are addressed with an ominous warning the dangers of devices will grow over time. Medical companies paid doctors more than $2 billion in 2016 to use their implantable devices, says the film.
“The medical device industry has incredible power in Washington, D.C.”
“They don’t really care,” says one patient.
“The only good thing is knowing I’m not alone,” says Jackson.
https://www.meshmedicaldevicenewsdesk.com/the-bleeding-edge-profiles-victims-of-medical-devices/
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Bayer hits back at new Netflix medical device documentary
Jul 27, 2018 | Reuters
By Tina Bellon
Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety.
The company, in a statement released Thursday night, said the documentary “The Bleeding Edge,” which debuted on the streaming site on Friday, lacks scientific support and cherry-picked facts to present an inaccurate and misleading picture of Bayer’s permanent birth control device Essure, one of the products spotlighted in the film.
“This does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device,” Bayer said.
Nexflix did not immediately respond to a request for comment.
Bayer last week announced it would phase out Essure in the United States after discontinuing sales elsewhere in 2017, a move it said was not related to safety concerns. Bayer said studies overwhelmingly showed Essure to be safe.
A small metal coil inserted into a woman’s fallopian tubes, Essure triggers scarring to permanently prevent pregnancy.
Bayer currently faces over 16,000 U.S. lawsuits related to Essure from women who claim the implants caused injuries like excessive bleeding, abdominal pain and allergic reactions.
The documentary features several women who say they were injured by Essure and accuse Bayer of having concealed its knowledge about potential risks.
The documentary also focuses on Johnson & Johnson’s metal-on-metal hip and pelvic mesh implants, saying the company knew the products to be unsafe but proceeded to market them anyway.
J&J did not immediately respond to a request for comment. The company in the past has said it stands by the safety of both devices, adding that surgeons are properly informed about potential complications.
The J&J devices featured in the documentary were cleared by the FDA under less stringent procedures than its formal approval process, exempting manufacturers from having to submit clinical data on device safety.
Essure was approved in 2002 following the FDA’s most stringent device review process, but the documentary said Bayer evaded critical safety questions at the time.
The FDA in a statement said it has not yet seen the documentary but that it strives to allow devices with favorable benefit-risk profiles to be marketed.
“Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice,” the FDA said, adding that it uses postmarket data to monitor the safety and effectiveness of devices.
The agency is currently monitoring Essure in postmarket studies.
https://www.reuters.com/article/us-netflix-bayer-medical-devices/bayer-hits-back-at-new-netflix-medical-device-documentary-idUSKBN1KH27F
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"We are Guinea pigs": Filmmakers on the risks of medical devices
Jul 27, 2018 | CBS News
Medical companies are responding to a new documentary that claims the health care industry's loose regulations on medical devices are putting patients at risk. The filmmakers of "The Bleeding Edge" spoke with patients suffering apparent complications from devices such as cobalt hip replacements and the Essure permanent birth control device.
Essure's manufacturer, Bayer, recently announced it would stop selling the birth control product in the U.S. at the end of year due to declining sales. In a statement to CBS News, Bayer reminded women with the Essure device, "the safety profile of the device remains positive and unchanged." It says "the film presents an inaccurate and misleading picture of Essure."
Bayer argues the film may encourage women "to pursue risky and unnecessary surgery to remove the device." The FDA also responded to the Essure claims and said the "evaluating the post-market safety of Essure continues to be a top priority."
The filmmakers behind "The Bleeding Edge," Kirby Dick and Amy Ziering, joined "CBS This Morning" to discuss what they were "shocked" to learn while making the documentary and respond to companies that have condemned the film.
"It's not just the devices we actually show in our film, it's actually devices across the board. The system is flawed and it puts patients unnecessarily at risk and that's why we made this film," Ziering said.
Ziering said the term "medical devices" refers to a wide range of products – cat scans, x-rays, ultrasounds, hip implants – any interaction with technology in the medical industry. The filmmakers say that industry is using its lobbying power to keep regulation as low as possible.
"Ninety-eight percent of devices can be approved for sale without any studies in humans, meaning we are Guinea pigs and we don't know it," Ziering said.
In Bayer's response to the film's claims about Essure, the drug maker cites "40 published studies involving approximately 200,000 women over two decades," which are not discussed in The Bleeding Edge." Asked to address the omission of those studies, Dick said, "Most studies are actually funded by industry and as a result they're very, very biased. And one of the big problems with a lot of these studies is Essure's implanted for life but these studies often followed women only for a short time, a year, year and a half, and a lot of these symptoms come up five, 10, 15 years later."
"We save lives with every viewing. It has information you simply can't get anywhere else....Every screening people say thank you. Doctors thank us. they didn't know this information," Ziering said.
Statements to CBS News regarding "The Bleeding Edge" from the FDA, Bayer (reproduced here in part), Johnson & Johnson, Essure and the Advanced Medical Technology Association are published below:FDA
The FDA has not had the opportunity to see this documentary, but we did provide extensive responses to the filmmakers' questions, part of which we are providing below. We are not aware of whether any of the information we provided was used in this project to provide a more balanced viewpoint of medical devices. If your segment addresses additional points from the film, please let us know as we would be happy to provide additional comments to address any inaccuracies in the film.
The mission of Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is to assure that patients and providers have timely and sustained access to high-quality, safe, and effective medical devices and safe radiation-emitting products. Within CDRH, the FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests and relatively simple devices such as tongue depressors and elastic bandages. Medical devices are classified based on the risks associated with the use of the device. Devices are classified as Class I, Class II, or Class III, Class I being the lowest risk and Class III the highest risk.
There are various processes that the FDA uses to review information about medical devices before they can be marketed in the U.S. Regardless of which process is followed, the FDA strives to permit marketing of only those devices with a favorable benefit-risk profile. However, not all information regarding benefits and risks for a given device are generally known before the device reaches the market. Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice. This is why the FDA uses a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices, including analyzing reports of problems that are submitted to our public database, reviewing results from Post-Approval Studies, and evaluating the available clinical literature. We can also order companies to conduct postmarket surveillance studies of a class II or class III device if we have new concerns about a product's safety. In the long term, we are in the process of building a collaborative National Evaluation System for health Technology (NEST). NEST will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims. Full implementation of NEST will improve surveillance, signal management and mandated postmarket studies, and has the potential to support studies designed to answer specific device safety questions.
ESSURE
On Friday, July 20, 2018, FDA Commissioner Scott Gottlieb released a statement regarding Bayer's decision to halt Essure sales in the U.S. market and our continued commitment to review postmarket use of Essure and keeping women informed.
Evaluating the postmarket safety of Essure continues to be a top priority for the FDA, and we expect Bayer to meet its postmarket obligations concerning this device. Ensuring the safety and effectiveness of medical products is a core part of our consumer protection role; the FDA has taken many steps in recent years with respect to Essure including issuing an order in April to restrict the sale and distribution of the device.
Note that as the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. Before the April sales restriction, we conducted a thorough review of our database and medical literature; we convened an expert panel to discuss new concerns; we ordered Bayer to conduct a new post-market surveillance study to better evaluate the safety profile of the device when used in the real world; and we required Bayer to add a boxed warning to the labeling and a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks.
Regarding your question about the number of medical device reports received, over the past several years, the FDA has been examining the number of adverse event reports associated with the use of Essure. As of December 31, 2017, the FDA had received 26,773 medical device reports related to Essure.
JOHNSON & JOHNSON
At Johnson & Johnson, providing safe and effective products is always our top priority. Pelvic mesh has helped to improve the quality of life for millions of women with stress urinary incontinence and pelvic organ prolapse. Scientists from around the world who have conducted and reviewed independent research on pelvic mesh continue to recommend it as an important treatment option for women.
Our decision to voluntarily recall the ASR Hip System in 2010 was made after reviewing new data as part of the company's ongoing surveillance of post-market data we conduct for all of our devices. The company's decisions leading up to the recall of the ASR Hip System and our subsequent actions, reflect our company's ongoing commitment to patients.
ADVANCED MEDICAL TECHNOLOGY ASSOCIATION
Kirby's film does a disservice to the hundreds of millions of patients worldwide who have benefited from medical technology. The filmmakers could have crafted a thoughtful and balanced piece that explores the latest in medical innovation, including the risks and benefits of any medical technology and how to help patients make informed choices. Instead, they chose the easy route with an irresponsible film that might cause patients to forgo what could be life-saving procedures. Where are the voices of the millions of patients who can see, hear, walk and live normal, healthy everyday lives thanks to medical technology?
BAYER
Bayer today released a Fact Check of The Bleeding Edge, which premieres on Netflix on July 27, devotes significant time to Essure, the only FDA-approved non-incisional form of permanent birth control, and is now the subject of media coverage by The New York Times, CBS News, and others. This Fact Check is based on Bayer's review of the film's premiere at the Tribeca Film Festival on April 21, 2018 and is intended to encourage a science-based conversation about Essure. Bayer also is reminding women with Essure that the safety profile of the device remains positive and unchanged.
As a leader in women's healthcare, Bayer believes strongly that women and their physicians should make reproductive health decisions based on sound science. In contrast, the portrayal of Essure in The Bleeding Edge lacks scientific support, despite the fact that Bayer provided the producers with extensive scientific information on Essure before the completion of the film. The
film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the Food and Drug Administration's (FDA) determination that Essure's benefits outweigh its risks and disregarding the appropriate warnings that accompany the device. The film also relies on many conflicted sources without disclosing their potential biases. This does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device.Notably, the film's only reference to scientific data regarding Essure is the 2018 Bouillon study published in the Journal of the American Medical Association ("JAMA"), which its producers cite out of context and portray in its least favorable light. Taken as a whole, the study actually undermines the central premise of the film's representation of Essure. The independently funded research compared women with Essure to those who had tubal ligation surgery, the only other method of permanent birth control, and found that many of the concerns described in the film with regard to Essure -- pain (analgesic use) and hysterectomy -- were lower in Essure patients than in tubal ligation patients at both one and three years post procedure. The authors of the study concluded: "These findings do not support increased medical risks associated with hysteroscopic sterilization (e.g., Essure)." The decision by the filmmakers to exclude highly relevant conclusions from a study they cited, apparently because they conflict with their desired narrative, do raise serious concerns about the objectivity and accuracy of the movie.
The totality of scientific evidence, which was not discussed in the film, includes 40 published studies involving approximately 200,000 women over two decades, and demonstrates the safety and efficacy of Essure, which has remained consistent over time. The FDA also has not changed its conclusion that Essure's benefits outweigh any potential risks. Most of the movie's focus on Essure is told not through science, but rather through the stories of women who reported concerns about the device. Bayer takes any concerns regarding its medicines and devices seriously. Still, it is notable that not a single woman who is satisfied with Essure is included in the film. This omission is important because in the Phase II and Pivotal trials at follow up time points of three, six, 12, 18, 24, 36, 48, and 60 months, at least 99% of women were reported to have rated comfort of wearing the Essure inserts as "good" or "excellent." In the Pivotal trial, at least 97% of women were reported to be "somewhat" to "very satisfied" at all visits through five years. This is summarized in FDA's executive summary prepared in advance of the 2015 Advisory Committee.
No discussion of the movie and Essure should ignore the issue of removal, which most women featured in the film discuss. The film provides no balance on this important topic. Providing women with inaccurate or misleading information about the safety of Essure, or encouraging removal via hysterectomy, is potentially a serious public health issue as it may lead women with Essure to unnecessarily seek removal, and can result in new or additional health problems. Moreover, the singular focus on hysterectomy is inconsistent with Essure's FDA-approved Instructions for Use (IFU), which state that "hysterectomy generally is not required to remove the Essure inserts" as there are other methods identified in the IFU. The IFU is based on scientific/clinical data and opinions from medical experts worldwide. Bayer strongly encourages women with Essure who have questions or concerns to consult with their physicians.
The Bleeding Edge also relies on a number of sources to explain and validate its story regarding Essure, but the movie does not disclose conflicts that are essential for viewers to fully evaluate the credibility of these individuals and the film. ... The film also omits any mention of the FDA-approved Instructions For Use (IFU), which provide doctors with important information about the product and include detailed references to the potential risks for Essure. For example, the IFU mentions the potential risk of perforation more than 20 times, contains multiple references to pain and allergic or hypersensitivity reactions – all based on Essure data.
Other content in the film is completely misrepresented in order to make Essure appear unsafe, ineffective or both. One example is the inclusion of a misleading and selectively edited portion of the Essure 2002 FDA Advisory Committee meeting, which recommended the approval of the device. The movie suggests that members of the committee joked about the possibility of serious adverse events. They did no such thing. The Advisory Committee was not even discussing adverse events or the safety of Essure in that portion of the meeting. The full body of scientific evidence, clinical trials and more than two decades of science and real world clinical experience continues to support the positive benefit/risk profile of Essure and its strong efficacy of 99.3% in patients who chose to rely on Essure for birth control.
****
Essure is an innovative Class III medical device that was approved under FDA's Premarket Approval (PMA) review, the agency's most rigorous pathway for medical devices. Since the initial application for Essure was approved in 2002, the agency has continued to review and approve Essure's safety and efficacy through 48 supplements to the original application.
On July 20, 2018, Bayer announced that it had made a business decision to voluntarily discontinue sales and distribution of the Essure System for Permanent Birth Control in the United States after December 31, 2018. This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable. Several factors have contributed to declining interest in Essure among women in the U.S., including decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives (LARCs), and inaccurate or misleading publicity about the device, such as The Bleeding Edge. Notably, the benefit-risk profile of Essure has not changed, and Bayer continues to stand behind the product's safety and efficacy.WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.
About EssureEssure is indicated for women who desire permanent birth control (female sterilization) by blocking the fallopian tubes.
Important Safety InformationEssure is not right for you if you are uncertain about ending your fertility, suspect you are pregnant, can have only one insert placed, have had your tubes tied, have a known allergy to contrast dye, are unwilling to undergo the Essure Confirmation Test, have unexplained vaginal bleeding, or have suspected or known cancer of the female reproductive organs.
You should delay having the Essure procedure if you are or have been pregnant within the past 6 weeks, have an active gynecological infection, or are in the second half of your menstrual cycle.
Tell your doctor if you are taking immunosuppressants, have, or think that you may have, a history of metal allergies, or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system, are currently using an IUD for contraception, or have had or are considering a procedure to reduce bleeding from the uterus such as endometrial ablation.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.
WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. For some women, it may take longer than 3 months for Essure to be effective, requiring a repeat confirmation test at 6 months. Talk to your doctor about which method of birth control you should use during this period. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.
During the Procedure: In the premarketing study, some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure inserts correctly. In rare cases, part of an Essure insert may break off during placement. If breakage occurs, your doctor will remove the piece, if appropriate. There is a risk of perforation of the uterus or fallopian tube by the hysteroscope, Essure system or other instruments used during the procedure. In the original premarket studies, perforation due to the Essure insert occurred in 1.8% of women. A perforation may lead to bleeding or injury to bowel or bladder, which may require surgery. Your doctor may recommend a local anesthesia. Ask your doctor about the risks associated with this type of anesthesia.
Immediately Following the Procedure: In the premarketing study, some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experience headaches, nausea and/or vomiting (10.8%), or dizziness and/or fainting. You should arrange to have someone take you home after the procedure. In rare instances, an Essure insert may be expelled from the body.
During the Essure Confirmation Test: As one of the Essure Confirmation Tests (a modified HSG) requires an x-ray, you may be exposed to very low levels of radiation, as with most x-rays, if this test is used. Some women may experience nausea and/or vomiting, dizziness and/or fainting, cramping, pain or discomfort. In rare instances, women may experience spotting and/or infection.
Long-term Risks: Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. This is also more likely to occur in women with a history of pain. There are reports of an Essure insert being located in the lower abdomen and pelvis. If this occurs, you cannot rely on Essure for birth control. Patients with known hypersensitivity to any of the components of the Essure system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts. No birth control method is 100% effective. Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening. If insert removal is indicated, surgery will be necessary. The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old. Essure does not protect against HIV or other sexually transmitted diseases.Prescription Only
IMPORTANT
· Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases.
· The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.
Talk to your doctor about Essure and whether it is right for you. Review the Patient-Doctor Discussion Checklist in the Patient Information Booklet with your doctor before deciding to have the Essure procedure.https://www.cbsnews.com/news/the-bleeding-edge-filmmakers-on-risks-of-medical-devices/
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Jul 27, 2018 | TIME
By Alexandra Sifferlin
A new Netflix Original documentary sheds light on a topic that’s opaque to many: the medical device industry in America.
The film, called The Bleeding Edge, claims that the way medical devices make it to the U.S. market is lax and potentially dangerous. The filmmakers interview doctors and patients who say they’ve been personally harmed by an array of devices—including cobalt-based hip replacements, vaginal mesh and robotic surgery devices—and who feel that the guardian group of the medical device industry, the U.S. Food and Drug Administration (FDA), is not doing enough to protect them.
It’s normal for medical devices to come with risks for adverse reactions, and it’s a physician’s responsibility to discuss those risks with their patients. However, medical devices often escape scrutiny on their path to the American market, the filmmakers say, and demand more research and testing than they currently have.
The FDA began regulating approvals for medical devices in 1976. Little has changed about the process since then, but the devices have: critics in The Bleeding Edge argue that medical devices today have become much more complex, and testing requirements haven’t evolved along with them.
Their main concern is a loophole which allows many devices to reach the market without much clinical testing. New devices are supposed to go through a pre-market approval process similar to a new drug, which requires that the device be tested in humans to show it’s both effective and safe. Yet because so many new devices are brought to market, including new iterations of already approved devices, some medical companies argue that it’s too expensive to send each device through massive amounts of clinical testing.
To address that, a provision called the 510(k) pathway was created, whereby a manufacturer can also obtain approval if they can prove that their device is “substantially equivalent” to another device already on the market. The problem, the film argues, is that while that pathway was supposed to be an exception, it’s become a common way devices are approved for sale, and sometimes, it creates an approval chain of devices that are on the market without recent testing.
“That provision, which was meant as an exception, in essence [is] a loophole,” says Dr. David Kessler, a former FDA commissioner, in The Bleeding Edge. “[It] became the rule, so that the vast majority of devices today regrettably are regulated under this framework.”
The topic is a timely one, and there are signs that oversight is weakening even further. In June, the Trump administration released its proposed plans for an FDA reorganization, which would limit the agency’s purview, rather than expand it.
One of the devices targeted in the film for not undergoing enough pre-market testing or oversight has also recently come under fire. Just a week before Netflix released The Bleeding Edge, Bayer, the pharmaceutical company behind Essure—a controversial, permanent form of birth control that, when placed inside the fallopian tubes, creates scar tissue that prevents pregnancy—announced it was dropping the product.
More than 16,000 lawsuits have been filed against Bayer over Essure, with women citing complications like migraines, hair loss, organ perforation and even unintended or dangerous pregnancies, according to ConsumerSafety.org. Many of these women have banded together online in Facebook groups, and the documentary follows several of the women who have been affected. Some women said the coils came loose, causing severe bleeding and the need for surgeries, including hysterectomies.
On July 20, Bayer announced that Essure will no longer be available in the U.S. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” Bayer said in a statement. The company also says that the device is safe, writing in a statement on Thursday that, “Bayer is reminding women with Essure that the safety profile of Essure, the only Food and Drug Administration (FDA)-approved non-incisional form of permanent birth control, remains positive and unchanged.”
“This is exactly why we do this work,” said Kirby Dick, one of the filmmakers of The Bleeding Edge, in a statement about the announcement. “This film has already changed policies and changed history.”
http://time.com/5346330/what-the-netflix-documentary-bleeding-edge-gets-right-about-the-dangers-of-medical-devices-in-america/
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The dangerous reality of medical devices exposed in new film
Jul 27, 2018 | Think Progress
By Amanda Gomez
The pharmaceutical industry has recently come under intense scrutiny for driving the opioid epidemic, insurance companies and hospitals are faulted for rising health care costs, and even the insurance “middlemen” (pharmacy benefit managers) recently got called out by President Donald Trump for their role in high drug prices. But a new documentary premiering Friday on Netflix asks audiences to pay attention to a health sector they otherwise wouldn’t: the medical device industry.
The Bleeding Edge is a story in the vein of the big risks with Big Tech — except the risk isn’t being trolled by Russian bots, it’s having your colon literally fall out of your body days after a robot named da Vinci performs your hysterectomy.
Academy Award-nominated documentary filmmakers Kirby Dick and Amy Ziering reveal, compellingly and thoroughly, how easy it is for medical devices — be they artificial joints or pacemakers — to enter the market without rigorous testing, thanks to government loopholes and powerful lobbying groups. And patients are ultimately the ones who stand to lose.
“We all have to be really aware of not only the products we’re consuming pharmaceutically, but also the products we’re implanting and going to be solicited to implant in the very near future with great frequency,” Ziering told ThinkProgress. She added that this goes for younger patients — invisibles, as they’re called — too.
By the end of the film, audiences learn not to assume that manufacturers test medical devices on humans, compile data, and then present it to the Food and Drug Administration (FDA). In fact, these days, most devices get the FDA okay through a loophole used by manufacturers, who point to similar devices already on the market — even though those devices also may not have been tested on humans and, in some cases, may even have been recalled.
A 510(k) exception, as it’s called, is how doctors are able to implant vaginal mesh into patients who need pelvic floor treatments, without any prior testing on humans, according to the documentary. Some doctors were told the mesh was superior to the traditional stitches, but many patients treated with mesh would dispute this, including Tammy Jackson, who’s featured in the film. The mesh was scarred into Jackson’s pelvic tissue around delicate organs, including the urethra. Thus began her cascade of medical troubles, as it is impossible to fully remove vaginal mesh once it takes hold in the body. When it was partially removed, she thought she could go on with her life, but she discovered her mistake while having intercourse with her husband. The mesh had cut him.
Jackson is one of several patients featured throughout the film — most of them women — who cite initial discomfort with their medical device. Early in their stories, it’s almost easy to dismiss the pain they feel (one woman even convinced herself that her pain was in her head) — and given everything we know about how women’s pain is minimized in the doctor’s office, many likely were not believed at first. But what starts as pain inevitably turns into serious medical problems that debilitate every aspect of their lives. Perhaps most heart-wrenching is Ana Fuentes’ experience with the birth control Essure, a four centimeter coil that caused her so many health problems, she ultimately lost her job. In one of the documentary’s final scenes, Fuentes, a single mother, is forced to leave her four daughters with a church foster family, as she can no longer afford to support them. It appears that medical debt drove her to it.
A week before The Bleeding Edge official release, the manufacturer of Essure, Bayer AG, announced that it would take the birth control implant off the market after this year, citing declining sales.
“In my opinion, it is for business reasons,” Dick told ThinkProgress. “The real reason is not declining sales. The real reason is that they knew that the truth will finally come out and really make them look bad and they tried to somewhat dodge the bullet … I think people will be enraged at Bayer and rightfully so.”
The filmmakers said the patient advocates who fought to get Essure off the market were “absolutely elated” by last week’s news.
“I hope that everybody sees this as not the end of the story, but the beginning,” said Ziering. “Now, let’s look at all the ones that are still on the market. What do we do about those and what needs to change in order to make this whole health care system and the device system a much safer one for everyone.”
Indeed, the fight has just begun, as the medical device industry still has a tight grip on FDA leadership and Congress, both Republicans and Democrats alike. The industry has an ally in FDA commissioner Scott Gottlieb, who has worked with a range of medical device companies before being appointed as commissioner. The Medical Device Manufacturers Association has spent millions lobbying Congress and building allies as it tries to repeal an Obamacare tax on medical devices. This week, the House successfully passed legislation to that effect.
“What we show within medical devices is that these companies are putting profits over patient safety,” said Dick. “You’re coming into that system where that’s the motivator. So, yes, you have to step up — and you and your advocates have to step up and protect yourself.”
For this, patients and doctors need to stay vigilant. This is film is for them. For us.
https://thinkprogress.org/tech-health-sector-medical-devices-bleeding-edge-290ced64e9a9/
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Jul 27, 2018 | Romper
By Mishal Ali Zafar
High healthcare costs are a point of contention in practically every political debate in today's era. Netflix’s new documentary, The Bleeding Edge, investigates one major healthcare expense — medical devices. The doc covers the medical device industry, which has benefited from weak regulations and by selling their products at extremely high prices. So why are medical devices so expensive? It’s all about the profit.
The Bleeding Edge documents the complications and high costs of a variety of medical devices, including metal hip replacements, the Essure birth control coil, and transvaginal mesh. In one segment, a woman who received a vaginal mesh revealed that the device had actually melded with her organs, causing intense pain and bleeding. Her physician said the mesh was akin to “bubblegum stuck in hair” and she would need extensive surgery to get it out. Not only did the patient pay for this mesh with her health, but it also came with a huge price tag. In the film, an obstetrician talks about the price of controversial device, stating, "It costs about $25 to bring to market, and they sell for about $2,000 bucks a pop.”
In a 2012 report, the U.S. Government Accountability Office (GAO) found that another big reason for the high costs of certain medical devices is the lack of transparency. The report, titled Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices, looked into the purchase history of 60 hospitals, and found that some hospitals were paying far more for the same device than others. But because hospitals’ confidentiality clauses prevent them from price sharing, the report found many manufacturers can charge much higher prices, which ultimately land on the shoulders of the patients.
The GAO also found that your doctor’s preference in medical device, like the brand or model, could also impact the costs. “Although physicians are not involved in price negotiations, they often express strong preferences for certain manufacturers and models of implantable medical devices (IMD),” the GAO noted, “To the extent that physicians in the same hospital have different preferences for IMDs, it may be difficult for the hospital to obtain volume discounts from particular manufacturers.”
Unlike many other countries, the healthcare system in the United States involves many middlemen and monopolies. A report by the New York Timesrevealed that there can be up to 13 levels of vendors between a device manufacturer and patient, including brokers, billing companies, and purchasing consultants. So when everyone in the middle is looking for a profit, the cost of medical devices can skyrocket.
The same NYT report highlighted the story of Michael Shopenn, a man who traveled to Belgium to save $65,000 on his hip replacement, which ultimately only cost him $13,660, including his artificial hip joint, surgery, the hospital stay, rehab, and his round-trip airfare from the United States. The cost of manufacturing a hip joint in the U.S. is approximately $350, the outlet noted, but patients can be asked to pay almost $40,000 for the same device.
As a patient, it’s a good idea to stay informed about the medical devices you may have or need. If your doctor is suggesting a device, go ahead and ask about the costs, the risks, and the alternatives. You could also refer to the Federal Drug Administration’s (FDA) Division of Industry and Consumer Education (DICE) to learn about specific FDA approved medical devices. Not everyone can travel to Belgium for a procedure, but you can make yourself an informed consumer, so that you know exactly what you and your pocket are getting into.
https://www.romper.com/p/why-are-medical-devices-so-expensive-the-bleeding-edge-reveals-the-outrageous-costs-of-some-dangerous-devices-9910662
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