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Ethicon Media Monitoring 4/30/2018
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‘Don’t suffer in silence’ Cambridgeshire doctor tells women in pain from vaginal mesh implants
Apr 29, 2018 | Cambridge Independent
By Gemma Gardner
A Cambridgeshire doctor is encouraging women to not “suffer in silence” after an NHS review found hundreds are undergoing surgery each year to have vaginal mesh implants removed. -
97,000 People Have This Operation Each Year – Here’s What Happens When It Goes Wrong
Apr 29, 2018 | HuffPost UK
By Rachel Moss
“I feel like I’m a burden to my family. The whole thing’s absolutely disgusting. It’s horrible. I wouldn’t wish this upon anybody, I really wouldn’t.” -
Netflix’s ‘The Bleeding Edge’ Exposes Dark Side of Medical-Device Industry
Apr 27, 2018 | Drug Watch
By Michelle Llamas
From birth-control devices to hip implants, the majority of medical devices hit the market without proper testing. -
Stevenage woman’s surgical mesh implant agony
Apr 30, 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.
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‘Don’t suffer in silence’ Cambridgeshire doctor tells women in pain from vaginal mesh implants
Apr 29, 2018 | Cambridge Independent
By Gemma Gardner
A Cambridgeshire doctor is encouraging women to not “suffer in silence” after an NHS review found hundreds are undergoing surgery each year to have vaginal mesh implants removed.
The report by NHS Digital shows that in each year since 2008, surgeons have performed at least 500 removal operations in England.
The implants are used to treat pelvic organ prolapse and incontinence after childbirth, but some can cut into the vagina and cause severe discomfort.
But Dr Helen Johnson, consultant urogynecologist at Hinchingbrooke Health Care NHS Trust, is encouraging women to speak to a healthcare professional about their problem as a priority as alternatives to mesh are available.
Campaigners say that the report does not show the extent of the problem as it does not include private patients or women going to GPs for pain relief medication or antibiotics to treat urinary infections.
In a Parliamentary debate on the use of the implants, Jackie Doyle-Price, junior minister at the Department of Health, said it was a tragedy that women who had put their trust in the medical establishment had “come out with the most debilitating injuries”.
Labour’s Emma Hardy, who secured the Parliamentary debate on the issue, led calls to suspend the use of surgical mesh and for the government to consider launching a full public inquiry.
Dr Johnson said patients are now too scared by the mesh complications to seek treatment.
“As a healthcare professional, committed to helping women regain their confidence and quality of life following a diagnosis of stress urinary incontinence, it worries me that so many women are apparently avoiding expert help and the opportunity to explore a successful treatment plan,” Dr Johnson said.
“As such, I encourage women to take those first steps towards discussing their condition with a GP. There is really nothing to be frightened or embarrassed about and I feel some of the less invasive non-surgical treatments available should now be at the forefront of any discussions.”
Dr Johnson concluded: “While it’s always important that women are encouraged to report symptoms and that complaints are addressed, it’s vital that recent reports do not erode the opportunity for women to understand their choices for treatment and see them resigned to living with uncomfortable and often embarrassing conditions such as stress urinary incontinence.
“There are now increasingly popular and minimally invasive treatments widely available as an alternative to mesh implants and the more traditional surgical procedures, and I urge women to speak to their doctor or nurse about these options and remember that it is all about their decision, their choice.”
http://www.cambridgeindependent.co.uk/news/health/don-t-suffer-in-silence-cambridgeshire-doctor-tells-women-in-pain-from-vaginal-mesh-implants-1-5497245
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97,000 People Have This Operation Each Year – Here’s What Happens When It Goes Wrong
Apr 29, 2018 | HuffPost UK
By Rachel Moss
“I feel like I’m a burden to my family. The whole thing’s absolutely disgusting. It’s horrible. I wouldn’t wish this upon anybody, I really wouldn’t.”
In August 2017, Sarah Bookham was rushed into the intensive care unit at Great Western Hospital in Swindon. Bookham, 48, had recently undergone a hernia mesh operation and was recovering at home when her stomach ruptured - even now, she is trying to understand what led to that incident. She spent the next 11 days in intensive care where she had six further life-changing operations.
The mum-of-four now has a large stoma – an opening on her abdomen which allows food waste to pass out of her body. Part of Sarah’s bowel hangs outside of her body in a bag, meaning she is unable to leave her home in Oxfordshire, without the help of family and a wheelchair. The ordeal has had an impact on her mental health, to the extent that she’s felt suicidal and has been prescribed anti-depressants. “I didn’t deserve this. It has impacted my life drastically,” she said.
Bookham’s situation may sound extreme, but she is not alone. Campaigners have told HuffPost UK they know of “at least 300 people” who have experienced hernia mesh problems. After we wrote about this topic earlier this year, HuffPost UK also heard from 12 people who’ve experienced complications relating to hernia mesh - two of whom required treatment in intensive care.
But unlike the issues around vaginal mesh that have hit headlines, there are no plans for a Government audit into hernia mesh.
Bookham’s health problems began when she developed a hernia above her belly button in 2012. In December of that year, she had her first of two hernia mesh operations.
Hernias occur when an internal part of the body pushes through a weakness in the tissues that hold muscles together. Hernia mesh is a synthetic material similar to nylon that’s inserted into the body to “patch” up the weakened area. According to data from NHS digital, more than 97,000 hernia mesh operations are completed in England each year.
More than nine months after her first operation, Bookham was still leaking pus from her bellybutton and having to pack the wound with material to blot the liquid. The leaking did eventually stop in October 2013, but almost four years later, Bookham developed a second hernia in the same area, requiring another operation.
In summer 2017, when she was booked in to have the hernia removed and mesh re-fixed, Bookham claims she specifically asked the surgeon whether there was any risk she would end up with a stoma before going into theatre. “It was one of my worst fears, to be left with a stoma bag,” she said.
Bookham claims the surgeon explicitly said she would not end up with a stoma, adding if she had been warned it was a possibility, she would “never have gone through” with the operation. “I would have suffered through the hernia pain,” she said.
At first her recovery seemed to be going well, but 10 days after the op, she and her husband noticed a strong smell in their house. “He thought the drains were blocked outside or something, that’s how bad it was,” she said.
When her husband realised the smell was coming from her, and spotted a black line appearing around her stomach, the pair rushed back to hospital. Bookham’s stomach ruptured as she arrived in A&E, and she was taken into intensive care, where she received six operations over the course of 11 days.
“When I came around, I didn’t realise [I had a stoma],” she said. “When I did see it, it was just horrifying, absolutely horrifying. I’ve looked at stomas online and they are diddy, usually on one side, but mine is in the middle and I’ve got this massive long bit of bowel hanging as well.”
Bookham’s life has since changed beyond recognition and months later, she is still being visited by district nurses. She has written to the NHS’s Patient Advice and Liaison Service (PALS) to complain about the treatment she received and ask “what went wrong” with her two hernia mesh operations.
“The reason why I am not satisfied is because I’ve been told nothing,” she said in the letter, seen by HuffPost UK. Bookham claims the hospital has yet to provide her with a clear explanation addressing what happened to her.
Her MP, Ed Vaizey, confirmed she is one of “a number of constituents who have contacted [him] over problems with mesh following an operation”.
“These stories are horrific, and have no place in a modern medical system. Sarah’s case is particularly frustrating as she has yet to receive any clear answers from the hospital, despite my office trying several times to contact them since January,” he told HuffPost UK.
In a statement given to HuffPost UK, Great Western Hospitals NHS Foundation Trust said: “We take all complaints very seriously and we are sorry that Mrs Bookham is unhappy with the treatment she received. We will be working closely with her as we continue to investigate her concerns.”
Like Bookham, Gayle Devlin, was admitted to intensive care following a hernia mesh operation. The 43-year-old, from Falkirk Scotland, underwent mesh surgery in 2009 after developing an umbilical hernia when she was pregnant with her second child. She claims doctors were not clear about the size of the incision and she was “absolutely horrified” when she woke up with 34 clips in her body, which would leave her with a scar from her breast to her pubic bone. ”It just didn’t feel right from the very beginning,” she said.
Over the next three years, Devlin, who works as a practice nurse at a GP surgery, was forced to cut down her hours because she continued to experience abdominal pain, sweats, and was struggling to control her type 1 diabetes with her usual insulin. She claims she visited multiple doctors, but no one linked her symptoms to the hernia mesh. Instead, she was told she may be suffering from post traumatic stress disorder (PTSD) as a result of the surgery, or may have developed irritable bowel syndrome (IBS).
But in 2012, after experiencing a burst of intense pain, Devlin’s husband rushed her to hospital, where a CT scan revealed the mesh had slipped and cut into her small bowel. “Even when they gave me morphine, I was still screaming in pain,” she said.
She was taken into intensive care, where doctors discovered parts of loose bowel in her body had become gangrenous. The mum-of-two developed sepsis and spent the next seven days being treated in the ICU. “My family were sent for because they thought I was going to die. Basically, I’m very lucky to be alive,” she said.
Although Devlin is now back at work, the experience has had a long-lasting impact on her mental health. “I feel very angry and distressed and I get anxiety now,” she said. “When I get a sore stomach at all now, I feel very anxious that something else is going to happen. It has left me a different person.”
While the vaginal mesh scandal has been reported on a global scale - prompting the Department of Health and Social Care to complete a wide-scale audit into complications, revealing a third of patients had sought “urgent” help for pain - the same cannot be said for hernia mesh.
The National Institute for Health and Care Excellence (NICE) also issued guidelines recommending the suspension of mesh for vaginal wall prolapse until more research has been completed. In an email to HuffPost UK, NICE confirmed it has not issued any guidelines relating to hernia mesh and did not comment further.
Despite this, Kath Sansom, founder of Sling the Mesh, which was originally set up to raise awareness of vaginal mesh complications, told HuffPost UK a “growing number of men and women” have been visiting the site looking for advice on hernia mesh. She says “at least 300” of the campaign group’s members have experienced hernia mesh problems.
“The number [nationally] will be way higher though, as the campaign has focused on pelvic mesh for women so the penny won’t have dropped for a lot of people that hernia mesh is the same plastic causing the same problems,” she said.
The Medicines and Healthcare products Regulatory Agency (MHRA), which is sponsored by Department of Health and is responsible for the regulation of medical devices, claimed it has not had any evidence which would lead it to alter its current stance on surgical mesh for hernia repairs.
“Patient safety is our highest priority and we recognise some patients do develop complications after surgery,” a spokesperson said in a statement given to HuffPost UK. “We encourage anyone who suspects they have had a complication after having a medical device implanted, to discuss this with their clinician and report to us via the Yellow Card Scheme regardless of how long ago the implant was inserted.”
https://www.huffingtonpost.co.uk/entry/97000-people-have-this-operation-each-year-heres-what-happens-when-it-goes-wrong_uk_5acc9258e4b0337ad1eb928a
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Netflix’s ‘The Bleeding Edge’ Exposes Dark Side of Medical-Device Industry
Apr 27, 2018 | Drug Watch
By Michelle Llamas
From birth-control devices to hip implants, the majority of medical devices hit the market without proper testing. Sometimes, these untested devices, meant to improve lives, ruin them instead. Device companies make billions. Patients pay with their health.
Those are the main messages in the Netflix documentary “The Bleeding Edge,” which recently premiered at the 2018 Tribeca film festival.
“We want the public to be aware. We want the public to protect themselves. We want these medical device companies to do right by the public,” director Kirby Dick told Drugwatch at the New York City premiere. “They claim to be operating in the public’s interest. We see examples — millions of examples — when they are not, so hopefully this film will cause them to change their approach.”
Academy Award-nominated filmmakers Dick and Amy Ziering take on the multibillion-dollar medical-device industry in “The Bleeding Edge.” The documentary asserts that this industry is more powerful than Big Pharma.
The filmmakers are no strangers to controversial topics.
Their previous films, “The Hunting Ground” and “Invisible War,” tackled the problems of sexual assault on college campuses and in the military. In these films, powerful organizations ignored victims and covered up wrongdoing.
The medical-device industry also marginalizes its victims and covers up its negligence with “glossy” marketing campaigns, the documentary said.
Through the personal stories of women and men permanently injured by medical devices, the film questions the price of innovation without proper testing.
The film presents some hard-hitting, well-researched facts from top experts in the field, legal documents and medical studies.
For example, device manufacturers use a 1976 FDA loophole called the 510(k) to sell their devices without testing. If devices are “substantially equivalent” to devices already on the market, the U.S. Food and Drug Administration clears them for sale.
Some manufacturers sold their devices by comparing them to recalled products that were unsafe.
“When it comes to medical devices, we created a system that doesn’t work,” former FDA commissioner Dr. David Kessler said in the documentary.
The film presents several examples of innovation gone wrong.
Devices in the film include Essure birth control, transvaginal mesh implants, metal-on-metal hips and the DaVinci surgical robot.Netflix Film Called ‘Powerful Tool’
Angie Firmalino is one of the patients who appeared in the film. She has had several surgeries to correct Essure complications. She founded the Essure Problems group, which now has more than 35,000 members. Several members were at the premiere.
“Everyone should care about seeing this film in order to empower people with the tools needed to advocate for themselves and their loved one’s own health care decisions,” Amanda Dykeman said on behalf of Essure Problems.
Tammy Jackson appeared in the film and attended the premiere on behalf of women injured by a net-like plastic implant called transvaginal mesh.
“Living with mesh the last 11 years has been hard on me and my family. Big Pharma and the FDA need to step up their game in protecting humans,” Jackson told Drugwatch. “I’m so thankful to be able to share my story. The documentary is a powerful tool to spread awareness.”
A day before the film premiered, a New Jersey jury awarded $68 million to mesh sufferer Mary McGinnis.
McGinnis filed a lawsuit against manufacturer C.R. Bard. She said mesh led to more surgeries and left her with debilitating pain.Women Suffered Horrific Complications
Teresa Hershey, founder of Unplug the Robot, a DaVinci robot surgery support group, also attended the premiere. Hershey and group members Astarre Gudino and Lori Shanyfelt told Drugwatch they wanted others to be aware of the risks of DaVinci surgery.
“I think ‘The Bleeding Edge’ pretty much covers what I know to be true,” Hershey said. “Our complications were horrific, and I hope our stories will help save lives.”
Ziering said that patient awareness is one of the main goals of the film.
“If the corporations can’t grow a conscience and put patient safety above profits, which is a heavy lift, then at least on the macro level we are spreading awareness with consumers,” Ziering said. “Like buyer beware, pay attention, do your research, ask questions.”
Dick and Ziering are hopeful the film will get doctors and government officials to put patients before profits and spur regulatory reform. They also thanked Netflix for producing the film and taking up the fight with them.
“In the past, we have had good luck,” Dick said. “Our films have changed the way the military has approached sexual assault. They have changed the way higher education has approached sexual assault.”
“The Bleeding Edge” will stream this summer on Netflix.
https://www.drugwatch.com/news/2018/04/27/netflixs-the-bleeding-edge-exposes-dark-side-of-medical-device-industry/
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Stevenage woman’s surgical mesh implant agony
Apr 30, 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.
A House of Commons debate on the procedure on April 19 resulted in the House calling on the Government to suspend prolapse and incontinence mesh operations while a retrospective audit is carried out.
Carole Davies, who lives in Stevenage, says her life has been hell since she had a tension-free vaginal tape operation due to a prolapsed bladder in 2007.
During a TVT operation, which takes about half-an-hour to perform, a piece of mesh made of prolene – a synthetic material – is inserted to replace tissue that has weakened and caused the pelvic organs to prolapse.
Carole, who is now 72, said: “My problems started almost imediately after the operation. I bled a lot and was in terrible pain.
“I’m still in a lot of pain and it has limiting effects on my life. I can’t stand for long, I can’t walk far and I can’t play with my grandchildren.
“It has caused me to wonder if life is worth living, and I want to get this poison out of me.”
Carole says she has paid to go privately to London’s Harley Street Clinic, where a doctor told her the mesh tape was eroding around her urethra.
Carole is due to undergo a series of tests and scans in the hope she will be given the green light for an operation to remove the TVT, but she says the removal could leave her paralysed.
Carole explained: “The tissue and nerve endings grow through the mesh, so if I have it removed I could end up losing the use of my legs, but I’m prepared to risk being paralysed to have it taken out of me.”
Carole is determined to raise awareness of her plight in a bid to prevent others from suffering. She said: “It’s too late for those of us who have already had it done. There is very little that can be done to reverse the damage that has been done to us and it’s basically ruined our lives, but it should be made much more public to save others going through the same pain and life-altering experiences.”
http://www.thecomet.net/news/stevenage-woman-on-surgical-mesh-implant-agony-as-house-of-commons-debate-suspension-of-procedure-1-5495862
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