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Ethicon Media Monitoring 09/19/16
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Mesh scandal lawyer claims material used in controversial medical supplies was counterfeit
Sep 18, 2016 | Daily Record
By Marion Scott
A top US lawyer claims that counterfeit materials were used to manufacture controversial mesh implants. Attorney Steve Mostyn is taking thousands of mesh cases to court in America. -
Mesh survivor: 'I’m living in a waking nightmare'
Sep 18, 2016 | Evening Times
By Catriona Stewart
IT was supposed to give Marian Kenny back her freedom - but instead it has robbed her of a decade of her life.
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Mesh scandal lawyer claims material used in controversial medical supplies was counterfeit
Sep 18, 2016 | Daily Record
By Marion Scott
STEVE Mostyn is taking thousands of cases to court and says he has documents that show mesh makers sourcing polypropylene resin from China.
A top US lawyer claims that counterfeit materials were used to manufacture controversial mesh implants.
Attorney Steve Mostyn is taking thousands of mesh cases to court in America.
He has documents that appear to show mesh makers Boston Scientific (BSc) sourced the polypropylene resin used in implants from an area of China notorious for counterfeit materials.
The US firm supplied NHS hospitals across Scotland with Obtryx, Advantage and Pinnacle products to treat bladder problems and pelvic organ prolapse in women.
Documents from Boston Scientific’s officials appear to show their women’s health division believed
Chinese supplier EMAI were offering the counterfeit goods.The firm denied the Boston Scientific claims and said they had carried out rigorous testing and found the resin safe.
They said documents and emails had been “taken out of context”.
Texas-based Mostyn claims the documents show BSc, who make £100million a year from mesh implants, turned to China when the original maker of the resin material withdrew it from the market five years ago.
In one, mesh makers Phillips Sumika had warned medical buyers not to use the product in any implant operations.
They said: “Do not use Phillips Sumika material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissue.”
According to emails requested by Mostyn, BSc’s women’s health division used the website alibaba.com, which appeared on US government warning lists because half the products sold are fake.
EMAI claim they bought the resin material, Marlex, from Texas and import it to China.
They had no documents to prove it was genuine, or how it had made its way into China.
After Phillips Sumika withdrew supplies, senior BSc executives allegedly warned colleagues that trying to source the resin from places like China was risky.
A memo in August 2011, warned the lot number on a batch of resin supplied by EMAI was fake.
In June 2012, a memo titled “counterfeit material from a supplier you use – ACTION REQUIRED”, from BSc executive John Kummailil, raised concerns about EMAI over a different plastic resin with suspect lot numbers.
BSc women’s health division executive Charles Smith replied: “Thanks, we will review. Our material was in sealed bags and we tested as we had no certification trail to Marlex.”
BSc, who sold more than 1000 implants a week, bought enough resin from EMAI to last 25 years.
Mostyn flew to Scotland last week to hand MSPs and mesh victims the documents he has gathered.
He said: “Internal emails show that BSc were offered genuine Marlex resin from another supplier at £55 per lb. The price in China was 85p per lb. That alone should’ve caused alarm. Photographs and sworn statements from Phillips Sumika executives claim counterfeit Marlex bags were made up using fake logos the wrong colour.”
Boston Scientific rejected the allegations. A spokesman said: “BSc tested this resin extensively both in accordance with our quality system at the time of purchase and again following Mr Mostyn’s allegations.”
The firm said internal emails warning of counterfeit by EMAI were “taken out of context”.
Elaine Holmes, of Scottish Mesh Survivors, said: “I sit on the Expert Group and counterfeit mesh has never been included in our remit when it should have been.”
Mesh lawyer Cameron Fyfe said: “Anyone injured by a counterfeit product would have a strong claim.”
http://www.dailyrecord.co.uk/news/scottish-news/mesh-8859881
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Mesh survivor: 'I’m living in a waking nightmare'
Sep 18, 2016 | Evening Times
By Catriona Stewart
IT was supposed to give Marian Kenny back her freedom - but instead it has robbed her of a decade of her life.
Marian was in her early 40s and had completed training as a mature student for her dream job - nursing.
She was looking forward to starting an exciting new chapter in her life as a community psychiatric nurse.
But first she had to get one small thing out of the way: a minor operation, so she was told, to deal with bladder issues.
Marian said: "I have three children and, while they weren't big babies, three labours had left me with stress urinary incontinence.
"It came to a head one day when I went to play badminton with friends and I had an accident - I had to tie my cardigan around my waist to cover myself up.
"And I thought, 'No, that's enough now, I am 42. Something has to be done about this.'
"I had thought I was going to have a procedure called a Burch colposuspension. I was told it was a tried and tested way of lifting the pelvic floor using stitches.
"My 86-year-old mum had it when she was in her 40s and has had no problems in the intervening years.
"Then it was suggested to me that there was a much better operation, well, they predicted that would be much better for me - a mesh implant.
“I thought it was all going to be wonderful.”
Marion had asked for the operation to be delayed while she finished her lifelong ambition of training to be a nurse.
Once she qualified and had secured a job as a community psychiatric nurse, Marion asked to be put back on the waiting list for surgery, which went ahead a few months later.
But Marian knew immediately after the procedure that something was wrong.
She said: “I woke up from surgery and couldn’t close my legs - they were hanging out of the bed.
“A nurse came in and said, ‘Look at the state of you.’ She had to physically lift up my legs and close them, which was very, very painful.
“I was supposed to be off for three days and then back to work but ended up being off for three weeks. It wasn't anything like what I was expecting."
Transvaginal mesh implants are inserted in the body to support muscles and are supposed to repair damaged or weakened tissue to help stop incontinence.
The procedure is used across the UK, Europe, Australia and America where class action suits have been filed at court by women who say they have been crippled by side effects.
But Marian was not aware of this and says her consultant at no point explained the procedure was permanent - or had caused terrible problems for other women.
The 57-year-old said: "For the next few years I had recurrent urinary tract infections (UTI).
"I must have had around 70 UTIs with the accompanying symptoms, which was really hard.
"For so long I put up with infection, after infection, after infection. I had to wonder, what was this doing to my body?
"One of my patients one day noticed how unwell I was - and it's supposed to be the other way round.
“There was always this pain in my leg and in my pelvis, so I would go to my doctor.
“They would send me for an x-ray, which didn’t show anything wrong.
“I then started to notice an area outside my knee that was completely numb, just like when you’ve had an anaesthetic at the dentist.
“The doctor thought it was very unusual but that there was nothing that could be done about it - ‘Hey ho, that’s the way it is’.
“I also had pain in my hip, which became worse and worse, and pain down below."
Slowly, Marian's world became smaller as she couldn't walk too far without help, she was having to take time off work sick and she was struggling with constant pain.
One evening she was out for dinner and picked up a newspaper to read. Inside was a story about Scottish Mesh Survivors, a support group for other women who had been through the procedure.
She had believed her problems were being caused by her mesh implant - and now she knew she wasn't alone.
Marian contacted the group, founded by campaigners and mesh survivors Elaine Holmes and Olive McIlroy, where she says she has made some incredible friends.
Thanks to their work, three out of four types of mesh implants are now suspended in Scotland pending a Scottish Government inquiry - although they are still available in England.
She said: “I have got a bunch of friends and make friends easily - I’ve always had friends. But things become hard when you're in a situation like this.
“The friendships I have made - I don’t know what I would do without these girls.
“We laugh and love each other’s company. The only, only good thing to come out of this is these girls.
"I couldn't do anything without my best friend Gill. She's my rock."
While their support is invaluable and makes all the difference to Marion, her condition is increasingly unbearable.
She added: “It is ruining my life. I feel as though I’m living in a waking nightmare.
“I walk with crutches now. I tried so hard over the past year to stay in work and do my job.
“I’m hoping to recover from the surgery and go back to work, I’m hanging everything on that."
Marian, whose sons are 35, 29 and 27, takes a drug called pregabalin, which is an anti-seizure drug for epilepsy but can also be used as pain relief.
She has stabbing pains to her legs and her lower abdomen that mean she uses crutches and finds walking very difficult.
Five years ago she managed to walk the 5k Race for Life but says that would not be possible now, adding: "Everything I do is determined by how many steps I can take."
http://www.eveningtimes.co.uk/news/14749266.Mesh_survivor___I___m_living_in_a_waking_nightmare_/
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