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.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label Daily Record. Show all posts
Showing posts with label Daily Record. Show all posts

Sunday, January 4, 2015

Surgical Mesh Ban Scandal in Scotland

Former SNP Health Secretary Alex Neil accused of lying over suspension of mesh implant
FORMER Health Secretary Alex Neil has been accused of lying over the suspension of mesh implants blamed for crippling thousands of women.
Neil banned the controversial surgeries in June and promised they would not resume until a major investigation into the procedures and their side-effects.
But, months after the announcement, he wrote in secret to a surgeon who supports mesh, promising to reinstate the use of implants before the results of a European Commission safety inquiry.
Campaigners yesterday voiced anger and said Neil was claiming credit for launching the investigation while secretly prejudicing the outcome.
He wrote to Aberdeen-based Dr Mohamed Abdel-fattah and pledged to ask the Independent Review – a probe he launched claiming to be proud that Scotland was leading the way in investigating concerns about mesh safety – to reintroduce the use of standard mid-urethral slings (SMUS).
Consultant gynaecologist Abdel-fattah is at the centre of a probe into a trip to Brazil and laptops being offered to the medical team who sign up the most mesh patients.
The surgeon, who has accepted “travel sponsorships” from mesh manufacturer Ethicon, a subsidiary of medical giant Johnson & Johnson, had written to Neil demanding he lift the suspension, claiming it would affect a research programme worth £4million.
In his response, Neil wrote: “I acknowledge the difficulties you highlight as a result of boards’ decisions to suspend the use of SMUS and the impact this is having on patients and on research.
“It is clear from the summary that there is significant evidence to support the use of SMUS in the treatment of stress urinary incontinence.
“What I intend to do is ask the Independent Review for their view about how quickly they can update the evidence base you have summarised in relation to the use of SMUS to consider if they are content to recommend that the use of SMUS can be reinstated ahead of the expert opinion being published from the European Commission.”
Neil was forced to take action against mesh implants last June after a Sunday Mail campaign led to him being called before the Public Petitions Committee.
He was ordered to explain what he was doing in light of mounting evidence of injuries to women being treated for bladder problems and pelvic organ prolapse.
Mesh manufacturers have already pledged payouts of more than £1.5billion in the US and the NHS are braced for an avalanche of negligence claims, with more than 400 cases in Scotland alone. As a result, Neil announced he was suspending mesh procedures across Scotland pending an independent safety review and introducing new patient consent forms spelling out all the possible dangers, including permanent nerve damage and life-changing injuries.
Neil told the Public Petitions Committee: “We should all be very concerned to hear how these implants have affected the lives of some women in Scotland and elsewhere.
“I’ve personally met with women who’ve been adversely affected and I was deeply troubled to hear how they have suffered.”
Campaigners say they feel badly let down by Neil, now Secretary for Social Justice, Communities and Pensioners’ Rights.
Elaine Holmes, of the Scottish Mesh Survivors’ Hear Our Voice campaign, said: “To say we feel betrayed is an understatement. We trusted Alex Neil to do the right thing. To find he was saying one thing in public and something else in private is awful.”
Neil’s successor Shona Robison has assured campaigners she has no plans to reinstate mesh procedures before the report is published.

She said: “All efforts are being made to ensure as much evidence is collected as swiftly as possible. This includes work to gather evidence regarding use of SMUS.
“The Independent Review will be asked for an update prior to the next meeting in January.
“There are no plans for any pronouncements prior to the final report.”

A spokesman for Neil said that he did not wish to comment.

Monday, June 16, 2014

Surgical Mesh: Scandal Deepens in Scotland



         Jun 15, 2014 12:33
         By Marion Scott  Daily Record  FiDA highlight
        
MESH victims have become concerned over the news that Dr Fred Milani, who worked for one of the mesh manufacturers will be investigating safety issues.

A doctor who was once a consultant to one of the world’s biggest mesh manufacturers has been appointed by the European Commission to investigate safety issues.
The appointment of Dutch urogynaecologist Dr Fred Milani has sparked concern among mesh victims, who say they would have preferred someone with no ties to the industry that they blame for their injuries.
We can reveal that, less than two years ago, Dr Milani stated in medical papers that he had a “consultancy agreement” with Ethicon, the Johnson & Johnson company who produce mesh implants to treat pelvic organ prolapse and bladder problems.
The firm also manufactured the TVT-O mesh implant device which was ruled as defective in a US court of law two months ago.
Milani co-authored a number of medical studies and papers with some of Ethicon’s high-profile management team including Dr Piet Hinoul, former medical director of Ethicon’s Gynecare women’s health and urology.
He has also written medical papers with Ethicon’s clinical director in Scotland, Judi Gauld, and Vanja Sikirica, another ex-associate director at Ethicon.
And in his report to Holland’s Health Care Inspectorate into mesh complications last year, it was noted Milani’s research was partially financed by Ethicon.
Campaigner Olive McIlroy, 57, of Scottish Mesh Survivors, said: “This investigation will have a huge influence across European countries in how they deal with the emerging mesh injury crisis.
“We already feel let down by doctors because so very few of them bothered reporting adverse incidents, allowing the mesh industry and medical watchdogs to continue saying the benefits outweigh the risks. It is vital that the victims have complete confidence in what happens from now on.”
Despite 328 women having repeat surgeries to correct damage, just 12 cases were reported by Scottish doctors.
Dutch health experts have delivered new guidelines on mesh surgery but said a ban on products was not in the best interests of patients.
However, mesh will only be used in patients where traditional methods fail.
A spokeswoman for European Commissioner for Health Tonio Borg said: “Strict rules are in place to assure an independent, excellent and transparent 

Sunday, April 27, 2014

SCANDAL: Surgical mesh in Scotland



            News
            Scottish News
            Mesh surgery scandal
         Apr 27, 2014 14:18
         By Marion Scott
THE health spokesman says the Government must act now to end the devastating injuries and enduring agony suffered by hundreds of Scots women.


Mesh victim Caroline Tait outside Scottish Parliament
LABOUR'S health spokesman Andy Burnham has accused the Government of failing women living in agony because of mesh implants.
He criticised SNP health secretary Alex Neil over his refusal to suspend the use of the controversial treatments.
It follows a Sunday Mail campaign which has highlighted devastating injuries and enduring agony suffered by hundreds of Scots women.
Burnham said: “The evidence from health boards is shocking and clearly shows thousands of women have been affected by these products which can have life-altering consequences.
“Some of the cases revealed by the Sunday Mail are heart-breaking when what should be a simple procedure has left women disabled.
“I’m surprised by the lack of action or leadership being shown by the Scottish Government.”
Burnham backs Scotland’s shadow health secretary Neil Findlay who has called on Alex Neil to suspend the use of mesh until an inquiry can properly assess the scale of the scandal.
Pressure on Neil is growing after a US court decision found one of the most widely used vaginal mesh implants, produced by Johnson & Johnson subsidiary Ethicon, was defective.  (Batiste v. McNabb/J&J Ethicon in Dallas, TX)
Findlay said: “After the US ruling, Alex Neil should have suspended the use of mesh in Scotland and instructed health boards to 
contact every woman given this implant to check whether they are experiencing any problems.”
Hundreds of thousands of women around the world have reported injuries inflicted by mesh eroding in their bodies.
Many have faced a series of ops as surgeons struggle in vain to remove the mesh used to treat prolapse and bowel conditions.
American courts have already awarded damages of millions of pounds to the victims.
More than 400 cases are lodged in Scotland. The Scottish Government said: “We continue to work with professional organisations to improve 
reporting and monitoring of procedures using mesh.”
Johnson & Johnson are considering appealing last month’s judgment that their TVT-O device was defective.
Spokeswoman Lucinda Macari said: “The verdict is disappointing and we believe we have strong grounds for an appeal.”
Leslie McGlinchey, 33, of Drumchapel, Glasgow, who was forced to use a wheelchair after a mesh implant three years ago, said: “Politicians continue to ignore this scandal at their peril.
“When things go wrong, the damage is so devastating, it affects whole families.
“We’re calling on everyone to sign our petition and get this stuff out of our hospitals.”
The Hear Our Voice petition closes on Wednesday.

Sunday, February 9, 2014

Johnson & Johnson surgical mesh and secret talks with health officials in Scotland . . .

           
HEALTH secretary Alex Neil’s medical advisers held secret talks with a multinational firm making controversial mesh implants.
The Scottish Government’s deputy chief medical officer Dr Frances Elliot and public health consultant Dr Sarah Davies met Johnson & Johnson in July.
Weeks after the meeting, Neil told victims he feared being sued by manufacturers if he suspended mesh surgery.
A Sunday Mail campaign has revealed the agony of thousands of women who underwent mesh ops for stress incontinence and pelvic prolapse.
Labour’s shadow health secretary Neil Findlay said: “Directly after this secret meeting, Alex Neil publicly admitted there were serious flaws in reporting adverse side-effects, which was more than enough to take action. But he refused to suspend the use of mesh, telling victims he feared he’d be sued by manufacturers.
“I’ll be making it my business to find out what was discussed at that meeting and why the health secretary seems more scared about offending manufacturers than protecting the health of hundreds of women.”
The Scottish Government claimed 2915 women have had mesh surgery since 2007 but figures from individual health boards show more than 10,500 had the implants.
Mesh campaigner Elaine Holmes, from Newton Mearns, near Glasgow, said: “So many lives have been destroyed by mesh implants, the pressure on NHS resources is going to be enormous thanks to the same manufacturers that officials are having secret meetings with.”
Findlay said: “We’re potentially facing the biggest legal action in Scotland. If mesh manufacturers are found liable, we should be pursuing them to pick up the cost of trying to repair the damage done to so many women as well as picking up our legal costs.”
Victims’ lawyer Cameron Fyfe said: “We’ve lodged around 100 of the planned 400 court actions for damages in the Court of Session and NHS Scotland are named with manufacturers.”
The Scottish Government said: “Officials held an informal meeting with Johnson & Johnson and the Association of British Healthcare Industries.
“An update was provided on the requests made by the women affected by mesh complications.”
Lucinda Macari, of Johnson & Johnson, said: “At the meeting, we affirmed our commitment to working with UK regulatory authorities and professional societies to ensure the safety of our products.”



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.”