Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, January 10, 2014

Shocking: Transvaginal surgical mesh scandal!


By Marion Scott  22 Dec 2013 07:31

POLITICIANS joined victims and experts yesterday to demand the immediate suspension of mesh implants as figures reveal hundreds of women suffered horrific side effects – not just six as ministers claimed.
The call comes as lawyers prepare to lodge the biggest medical claim in Scottish legal history, with 400 victims set to sue the implant manufacturers and the NHS.
Pressure was mounting on Health Secretary Alex Neil over the scandal – first exposed by the Sunday Mail in March – after his officials 
were accused of understating the number of women who endured terrible pain caused by the transvaginal mesh.
Yesterday, Labour’s health spokesman Neil Findlay said: “The Scottish Government do not appear to have a clue what is going on.
Heath officials told us just six women had been reported as suffering adverse effects, therefore mesh was safe to use to treat stress incontinence and pelvic prolapse.
“But figures from individual health boards across Scotland confirm almost 300 victims are showing such severe complications that 
surgeons are trying to remove the mesh.
“Two health boards are still to release figures so the final toll is likely to be many more.
“We must suspend mesh procedures until we know the true picture.
“The burden the NHS now face legally, as well as trying to treat those with life changing complications, is catastrophic.”
Government figures state just 2915 women have been given implants since 2007 but figures from health boards suggest at least 8077 women have had the surgery.
While the procedure was successful in many cases, some women were left with a legacy of crippling pain and have been forced to endure years of worry and further surgery.
Medical experts warn it can take years for the complications to emerge.
Lawyer Cameron Fyfe intends to use laws designed to allow asbestos victims to claim compensation without showing immediate physical damage.
He said: “We are so confident, we are proceeding on a no-win, no-fee basis so victims need not worry about the difficulties of trying to claim legal aid.
“The claim against manufacturers will state mesh was deficient and not fit for purpose.
“Claims against the NHS will be that they did not properly inform patients of all the risks or offer alternative treatment in many cases.
“Many were unaware mesh implants are supposed to be permanent. Others fear they have a timebomb inside them.”
Victims have had to undergo up to a dozen operations as doctors battle to remove mesh designed to merge with a patient’s tissue.
Complications range from pain during intercourse to bowel and bladder perforations, crippling nerve damage, lifelong pain and mobility problems.
Manufacturers claimed mesh was soft but evidence shows that it can harden inside the body and damage tissue and organs.
In one test sample of a mesh product, almost one in four showed bladder perforations.
In another test of almost 700 women, a third developed complications.
One of the world’s top specialists in the field wrote to Neil, imploring him to stop the use of the controversial products.
US professor Tom Margolis said: “The use of transvaginal polypropylene mesh for the treatment of prolapse and incontinence must stop immediately.
“There are a host of traditional surgical procedures available which have a zero mesh complication rate.”
The Health Secretary claims banning mesh ops may leave the Scottish Government open to legal action from manufacturers.
But Lothians MSP Findlay said: “Despite being alerted to the crisis nine months ago, Alex Neil has done nothing more than pay victims lip service while the numbers and seriousness of the situation have been obscured.
“As it is quite clear the government have no idea how many women are affected, they must issue a suspension notice on use of transvaginal mesh products until a public inquiry can establish the facts.
“Victims asked Neil to create a Scottish register and legally compel doctors to report adverse reactions to these products so we can get a true picture of the depth of this scandal.
“But although UK medical watchdog the MHRA have said Scotland has the power to do both things, he has refused to do so.
“When victims asked him to suspend the use of mesh products until an inquiry takes place, Alex Neil told them he feared legal action by manufacturers.
“Is he really prepared to put the quality of women’s lives at risk for the sake of offending manufacturers? Surely not.”
Last month, we revealed NHS officials knew four years ago that patients were not being fully informed of all the risks involved with mesh implant surgery. When Neil met victims in May, he promised that GPs would be contacted to inform them of all the possible side effects and every patient would be told which implant they have received.
But yesterday campaigner Elaine Holmes, 49, said: “We’re still waiting.
“GPs are still unaware of all the side effects to look out for and women are still not being told the truth about a device that can change their lives forever.
“If people were told the truth, nobody would consent to having these implants.”
The Scottish Government have denied that they have deliberately played down the number of women affected by the mesh scandal.
A spokesman said: “It is not possible to compare numbers without examining what questions health boards were asked or which procedures they were reporting on.”
Leslie McGlinchey was just 29 when she had the operation which doctors promised would change her life.
Yesterday, the mum-of-two said: “It did change my life. Because of what they did to me, I’m in a wheelchair until I die.”
She said: “When I think about it now, I could weep. I’d had a couple of ‘accidents’ when I was running about daft with the kids. When I told my doctor, she said, ‘Why not get treatment?’
The specialist said it was a routine operation, and I’d be back on my feet in a couple of days. It 
all sounded so simple.
“I didn’t realise they were going to implant a permanent mesh tape device which would cause so much pain and nerve damage, I’d end up crippled and in a wheelchair.
“If I’d known any one of the things I now know about mesh, I would never have agreed to surgery.
“When I woke up after the op, I was in agony but the nurses told me not to worry as some pain was normal.
“I was discharged from hospital the next day still in agony and I’ve now lost count of how many times I’ve had to go back.
“Eventually, the specialists finally agreed that the pain and numbness I was feeling in my back and lower body was down to the implant.
“In October, they tried to remove as much as they could but I’m convinced there’s still mesh inside me because of the pain.
“Now I can’t stand for more than a couple of minutes without falling on my face.
“My body feels as if it isn’t my own any longer. I can’t control it. I don’t feel like a woman any more – I’m broken and in constant pain.
“The doctors have told me all they can do now is try to manage my pain, which means I’ve got to spend the rest of my life taking the most powerful drugs my body can handle.
“I was about to start a new life and become a hairdresser. Now I’ll be on disability benefits for the rest of my life.”
The hardest thing for Leslie, of Drumchapel, Glasgow, is how to tell her daughters Morgan, 10, and Elle, eight, that she won’t ever be able to run with them in the park or take them out shopping.
She said: “They’re really frightened because they’ve seen me screaming in pain and trying to stand and falling over. I can’t find the words to tell them I’ll never be the mummy I used to be.
“Last time I tried to stand and fell over, the girls lay down beside me and stroked my hair and told me they had fallen down too.
“It’s gut-churning to see them trying to cope with what has happened.
“I can’t even dress myself. I rely on them, my parents or my friends to help me get washed and dressed in the mornings.
“I can’t do all the things I used to do for my girls, take them to the park or just a trip to the shops. I feel like someone has stolen my life and I’ve been left in this broken shell – and all because I believed what the doctors told me.
“I feel very angry. There are so many things I wasn’t told about this operation. I feel I have been betrayed and lied to.
“I yearned to be a mum and have my own family. Now my family are having to help me look after my girls. If it wasn’t for them all and my best friend, I don’t know how I would get through each day.”
Leslie never dreamed there were other women suffering the same life-changing complications until she read the Sunday Mail reports revealing the full extent of the mesh scandal.
She said: “When I read the paper, there were tears running down my face. These stories could have been written about me.
“The helplessness, the despair, the feeling of hopelessness and the lies we’ve all been told.
“Reading the Sunday Mail saved my life. I was in such despair, I’d been planning to end it all.
“But reading about the others has given me a new strength and resolve to get justice for what’s been done to us all.
“My friends and family have been able to sympathise but nobody really knows how this feels until it happens to them.
“If my story helps change anything and stops this happening to any other women, I will feel vindicated.
“Experts have known for years the damage these implants have been causing but they couldn’t even be bothered filling out a few forms to warn others about what’s been happening.
“Those who keep silent and do nothing now shouldn’t be allowed to be doctors because they know full well the harm this stuff is doing.
“It’s down to politicians to stop other women’s lives being destroyed. I dare them to look into my eyes and tell me this is all in my head.
“I want them to imagine having their whole life ahead of them and it all being taken away in an instant. Only then will they know how I really feel.
“Those who sit on their hands and do nothing to protect us are not fit to be in public office.
“They have to get this stuff banned before even more women are butchered.”
Mum-of-three Karen Neil was about to kill herself in despair after doctors told her she was imagining the horrific 
complications of her mesh op.
Only the fear that it would be her young daughter who found her body stopped her.
She kept a diary of her day-to-day battle with pain and the Sunday Mail initially told her story anonymously. Now she has the courage to go public after realising she is not alone.
She said: “From the moment that mesh implant was placed in my body two years ago, there was an immediate reaction and I awoke screaming in pain.
“But specialists told me the pain was just in my head – there was no way it was related to the mesh implant.
“They had me believing I was going crazy when all along they knew mesh was to blame. When I read the Sunday Mail, I couldn’t believe my eyes.
“I wasn’t alone after all but ours is the saddest sisterhood in the world.
“Our lives and health have been broken but together our determination to stop this happening to other women is keeping us strong.”
Teaching assistant Linda McLaughlin, 57, from Greenock, said: “I’ve had 10 operations to try to repair mesh damage and I’m waiting to go into hospital again.
“I get angry when I think about the legions of doctors who have seen for years the damage these mesh implants cause but they’ve all kept their heads down and their mouths shut instead of speaking out for their patients.

“Until recently, only two doctors in Scotland had reported an adverse complication and that is a shameful dereliction of duty.”

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