Criminal?: Scottish Surgical Mesh Scandal

Revealed: Two doctors on mesh safetyreview team linked to makers of controversial devices

         Oct 05, 2014 13:53

         By Marion Scott  Daily Record (UK)  FiDA highlight

HEALTH Secretary Alex Neil under fire after victims claim the government probe into mesh implants is being rigged to give operations the all-clear.

Health Secretary Alex Neil

TWO doctors on the government team reviewing the safety of mesh implants have links to the makers of devices used in the controversial surgery.

The appointments have fuelled concern of campaigners that the review has been weighted to support the continued use of the procedures, which have left women around the world crippled and led to multi-million-pound compensation payments.

Ash Monga and Karen Guerrero have been paid by Ethicon, the makers of a mesh product called Gynecare.

Dr Monga described himself as a “consultant for Gynecare” in a 2009 medical research paper.

Dr Guerrero, a surgeon at Glasgow’s Victoria Infirmary, received “educational sponsorships” – including payments and travel costs – from Ethicon and another major mesh manufacturer called Bard.

Dr Karen Guerrero

Both were appointed to a 22-strong safety review commission investigating mesh products launched by Health Secretary Alex Neil.

He won plaudits in June after apparently suspending mesh procedures when Hear Our Voice campaigners, supported by the Sunday Mail, gave evidence to reveal how they have been left in crippling agony by mesh, used to treat prolapse and bladder problems.

At the time, Neil said: “I’m proud Scotland has taken this stance and I believe we are leading the way on what is a significant global problem.”

But we revealed the anger of campaigners last week after discovering government medical advisers wrote to hospitals within weeks of Neil’s announcement to say the suspension was voluntary and encouraged them to use mesh on patients as part of clinical trials.

Yesterday, politicians and campaigners raised new concerns about the appointments to the review body to establish if there are any conflicts of interest.

Scottish Labour’s shadow health secretary Neil Findlay said: “It is outrageous that, after taking over a year to reach a decision on mesh implants, the Health Secretary has appointed doctors to the review who might appear to have a vested interest.

“Those affected have been through far too much in the past few years and this latest development is simply inexcusable.”

Mesh product

Olive McIlroy, of Scottish Mesh Survivors, said: “We are dismayed that people appointed to carry out this vital review have such links to the manufacturers who profit from the use of these devices.

“Alex Neil promised victims would be at the very heart of the independent review but it feels very much like we are lone voices pitted against the country’s most powerful mesh supporters.”

Ethicon, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared as “defective” by a US court.

It has also emerged that Gibraltar-born Guerrero was among 23 signatories backing an objection to Neil’s suspension of mesh use in the NHS in June.

Dr Guerrero backed the call made by Aberdeen-based urology consultant Mohamed Abdel-Fattah asking for mesh trials to be exempted.

Abdel-Fattah, who has also received “travel sponsorship” from Ethicon, was supported by two other members of the review group, Professor Charis Glazener and consultant urologist Voula Granitsiotis.

Read about US mesh victim Martha Salazar who won a £60m payout.

Ethicon’s Lucinda Macari said: “Ethicon, in conjunction with the Association of British Healthcare Industries, are supporting efforts by the Scottish Independent Review to gather full and accurate information about pelvic mesh products.”

The Scottish Government said: “This must be an entirely independent review and will be completed as such.”

          

Mesh scandal: Another boost forScottish campaigners as US victim wins £60m payout

         Sep 14, 2014 14:11

         By Marion Scott  Daily Record (UK)

MARTHA Salazar's case in Dallas, Texas – the second major victory for mesh victims in America within days – prompts new calls for criminal inquiry in Scotland.

Campaigner Elaine Holmes in the Scottish Parliament.

AN American mesh patient has been awarded £60million compensation by a US court.

Martha Salazar won the huge payout after the court in Dallas, Texas, heard that the Obtryx implant made by Boston Scientific was defective.

They jury was also told that the manufacturers had failed to properly test the device on humans.

It was the second major victory for mesh victims in the States within days.

Earlier this month, Jo Huskey was awarded damages totalling £3million by a West Virginia court for pain and suffering caused by a TVT-O mesh 
implant made by Johnson & Johnson firm Ethicon.

Both these mesh devices were given to Scottish women on the NHS before the procedures were suspended pending safety reviews after an outcry by mesh victims.

The US payouts have led to politicians and victims calling for the Scottish Government to sue manufacturers and launch a criminal probe.

Labour’s shadow health secretary Neil Findlay said: “These cases are proof, if any further evidence is needed given the hundreds of women injured here, that the mesh scandal is shaping up to be a very big issue for Scotland’s NHS.

“It’s high time the Scottish Government challenged the manufacturers over the catastrophic health problems these devices have inflicted on so many women.

“If there’s evidence of clinic data and trial evidence being deliberately withheld, criminal action should be considered.”

Elaine Holmes, of Scottish Mesh Survivors, added: “A car manufacturer who did this would face a criminal investigation and lengthy jail sentences. It should be the same for mesh manufacturers.”

Lawyer Cameron Fyfe, who is acting for over 400 women involved in the biggest-ever medical legal action in Scotland, said: “Potential damages in 
Scotland would be a fraction of those in the US but we expect to have similar success.”

Gareth Easton

Scottish Health Secretary Alex Neil

Health Secretary Alex Neil suspended mesh operations in March pending an independent safety review.

It followed a Sunday Mail campaign which exposed the hidden agony of hundreds of women given mesh implants to treat incontinence and bladder problems.

Surgical Mesh: Scandal Deepens in Scotland

Mesh surgeryscandal: Doctor hired to lead mesh probe used to work for manufacturers

         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 

SCANDAL: Surgical mesh in Scotland

            News

            Scottish News

            Mesh surgery scandal

Labourhealth spokesman Andy Burnham accuses the Government of failing women living inagony because of mesh implants

         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.

www.scottish.parliament.uk/gettinginvolved/petitions/scottishmeshsurvivors

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

           

Health Secretary Alex Neil'smedical advisers held secrettalks with controversial multinational mesh implant firm

9 Feb 2014 09:26  By Marion Scott

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.”

Shocking: Transvaginal surgical mesh scandal!

Revealed: Shocking figures reveal that hundreds of women have been affected by mesh implant 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.”