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Ethicon Media Monitoring 7/24/2018
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5 Minutes With: Doncaster woman's surgery horror 'It's like barbed wire inside me'
Jul 23, 2018 | South Yorkshire Times
By Sally Burton
Eight years ago Clair Neal was fitted with vaginal mesh in a bid to stem issues with mild incontinence she had suffered since having children. -
Netflix’s “The Bleeding Edge” Exposes the Horrors the FDA Approves From Medical Device Makers
Jul 23, 2018 | The Village Voice
By April Wolfe
Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge.
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5 Minutes With: Doncaster woman's surgery horror 'It's like barbed wire inside me'
Jul 23, 2018 | South Yorkshire Times
By Sally Burton
Eight years ago Clair Neal was fitted with vaginal mesh in a bid to stem issues with mild incontinence she had suffered since having children. She had tried other methods of dealing with the problem, but nothing had helped.
As a married woman in her early thirties, in her own words, it was both a nuisance, and an embarrassing condition to live with.
The 20 minute mesh-fitting procedure in hospital would, she was told, change her life for the better.
But Clair, and many other women who have joined the Sling the Mesh facebook campaign for a full ban on the use of plastic mesh in surgery, claim to have suffered ongoing debilitating symptoms and trauma, after having had the gynaecological procedure done.
Clair said: “Chronic pain and fatigue takes its toll and apart from the campaign group and my best friend, no one understands exactly what we are going through on a daily basis.”
A recent Panorama programme highlighted the plight and suffering of women such as Clair.
It demonstrated the difficulty women have in getting troublesome mesh removed from the body, due to the lack of specialist centres equipped to do the operation.
The government has now inflicted strict conditions on its use, pending a full investigation which thousands hope will lead to a full ban of its use in surgery in the future.
Doncaster mum-of-two Clair, who is now 45, said: “In my case, the mesh eroded, which meant I had sharp fragments sticking out through my vaginal wall. “My husband actually suffered a cut during sex once. “I had the mesh trimmed back.
“In 2011 it was partially removed. In 2012 there was another partial removal but I was still having issues, and it has been a constant since. “The pain and discomfort has never gone away. “My marriage started to go downhill and eventually ended all together. “My health plummeted in general.It was making me depressed and work became difficult. “I have ended up going to Croydon for a specialist scan, and paid to see a top consultant, Dr Suzy Elneil, in London.
She referred me to her NHS list. It was confirmed last September that I had another erosion and I have had an open vaginal wound since last year. My condition is worsening all the time.
“I am on two waiting lists to have operations for full mesh removal, and have an appointment with Miss Elneil in January.
“I am classed as an urgent case - but there are thousands of us. Miss Elneil works all hours, six days a week, and hasn’t had a holiday for years. She is so dedicated to helping women like me. A wonderful lady!
“It’s a fact that once it is fitted, this mesh is not designed to come out.
“Women have been maimed by attempts to remove it surgically. “My GP at Dunsville Medical Centre has always been supportive. He referred me back to Doncaster again and again but in the end I lost trust and decided I was not going. “Internally, I can feel the mesh pressing on my lower back. It is now in four pieces and has been trimmed on two occasions. “One morning my discomfort was such I couldn’t walk and ended up on crutches for two weeks.
“I have been weeing blood for months and am on permanent antibiotics.
“As a single mum I need to work, but have had to give up my health and beauty salon, to try and work from home, and fit around my health as I feel poorly all the time.
“I feel my body is rejecting the mesh and pushing it out. It’s like being tortured...it feels like barbed wire. “Until they open me up properly it’s not known how bad it is.
“When I do get to London for my operation it will mean I can’t have visitors due to the distance.
“My mum is 87. When all this started I was helping to nurse my late dad who had cancer. He is sadly no longer with us.”
“The government’s suspension of use of the mesh is a massive breakthrough, but I feel it must be banned all together. There are so many horror stories.”
The Sling the Mesh campaign was set up by Kath Sansom and over 6,000 women have joined so far, explained Clair. The mesh is also used for prolapses, hernia repairs and other surgical procedures.
“We are banning plastic from the oceans because of the effect it was having on wildlife but we are still putting it in to our bodies,” said Clair. “ I want to highlight this as much as I can. “I have told my story so that more people know about the dangers and hopefully will support our campaign.”
https://www.southyorkshiretimes.co.uk/news/5-minutes-with-doncaster-woman-s-surgery-horror-it-s-like-barbed-wire-inside-me-1-9264724
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Netflix’s “The Bleeding Edge” Exposes the Horrors the FDA Approves From Medical Device Makers
Jul 23, 2018 | The Village Voice
By April Wolfe
Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. Prepare to be scared shitless of vaginal mesh or high-tech surgery robots. Through a series of personal stories from both qualified medical professionals and laypeople, the film explores just what exactly the word complications means on a device’s warnings. In the cases Dick investigates, those complications become a ripple effect of lives ruined by untested but FDA-approved devices.
The film, which premieres on Netflix on July 27, traverses the spectrum of medical devices but opens and closes on one particular item, Essure, a metal coil that’s inserted into the fallopian tubes for sterilization purposes. We meet a mail carrier from upstate New York whose doctor sold her on Essure years ago. As the documentary jumps around to different people, devices and experts, we return again and again to the horrifying story of this mail carrier, who came to find that her body was rejecting the coil, which led her to nearly bleed to death. Another woman, a Latina account executive with four children, relays a frighteningly similar story, only with the added layer of racism; her doctor told her he assumed Latinas just bled more than white women did. Neither woman’s story takes a turn for the better, but it’s the Latina woman whose entire life — and the lives of her daughters — get smashed all because of one doctor not taking her concerns seriously.
Dick seems to anticipate that viewers — just like doctors — may be conditioned to think women overexaggerate their pain, so at the fifteen-minute mark of the film he jumps into the story of a respected older white male doctor who got a cobalt hip joint and began suffering from neurological issues. These were so severe that he had a complete mental breakdown in a hotel room, smashing things and scrawling cryptic messages on the walls. He begins questioning established medicine’s embrace of cobalt implants; upon the removal of his, every neurological issue he had developed disappeared. If a completely healthy man with medical training can go so quickly from zero to delusional, what of the millions of other Americans with cobalt in their bodies? What of the injured vets already fighting PTSD who live with an implant that could be poisoning them? What are the metal plates and screws in my own ankle made of, and why didn’t I know to ask?
The director backs up all these anecdotes with some hard facts about the FDA approval process for medical devices, which — even according to a former head of the department — is a broken system. The medical device industry is the least understood and regulated in the FDA umbrella. Dick exposes so much that I yelled, “Oh, my God!” multiple times while watching. There is nothing more upsetting than listening to a charming Southern woman say the words, “My colon’s falling out!” Worse yet are the profit-hungry companies that have been able to slide by unnoticed for so long. Here’s hoping The Bleeding Edge gets the right attention on a decidedly unsexy topic.
https://www.villagevoice.com/2018/07/23/netflixs-the-bleeding-edge-exposes-the-horrors-the-fda-approves-from-medical-device-makers/
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