Vaginal Mesh Implants: Experimental! NICE

Vaginal mesh operations should be banned, says NICE

By Anna Collinson

Reporter, Victoria Derbyshire programme

• 27 November 2017  FiDA highlight
  

Draft guidelines from NICE say the implants should only be used for research - and not routine operations.

Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.

One expert said it is highly likely the NHS will take up the recommendation.

However, the organisation is not compelled to act on findings it receives from NICE.

Both NHS England and NICE declined to comment.

'Life-changing consequences'

In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".

It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".

One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.

"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.

"These can last from two to six hours at a time and is like having a heart attack," she said.

Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.

She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.

The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through"

The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.

They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.

The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".

He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.

But he said it had come too late.

"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."

He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.

In April, the BBC learned more than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants.

The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.

About one in 11 women has experienced problems, the data suggests.

The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.

In Scotland, former Scottish Health Secretary Alex Neil requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed hundreds of operations have been performed since.

A number of Scottish health boards have stopped using mesh implants altogether.

The mesh is also used routinely in hernia repair despite concerns it is leaving many patients in chronic pain.

The Department of Health declined to comment.

Watch the Victoria Derbyshire programme on weekdays between 09:00 and 11:00 on BBC Two and the BBC News Channel.

http://www.bbc.com/news/health-42110076

Surgical Mesh Scandal: Worse Than Thalidomide. Truth.

Vaginal mesh 'disaster' could be 'worse than Thalidomide', experts warn

Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history.

16:40, UK,

Saturday 30 September 2017

The vaginal mesh that was fitted to tens of thousands of women, leading some to suffer pain

By Charlotte Lomas, Sky News Correspondent and Aubrey Allegretti, News Reporter

An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.

Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".

Speaking about the scale of the scandal, he said: "I think this is the worst one that we'll ever see in my lifetime because of the scale of the number of women affected."

More than 75,000 women in England had the procedure - known as TVT - between 2006 and 2016, according to NHS data.

One in 15 have had the implant removed.

The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.

While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.

The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.

Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.

She is now registered disabled, is in chronic pain and survives on benefits.

Image:

Lesley Elder has had 13 operations to repair damage caused by the fitting of the mesh

"I'm not the woman I used to be," she told Sky News. "I feel like a helpless no-hoper. I think I'd be better off dead; I don't want to live like this. I want my old life back."

Professor Heneghan, from the University of Oxford, said Lesley's case is not unique, and warned that the UK is heading for a "major disaster".

"Every young woman I have talked to has not been told about the adverse consequences," he told Sky News.

Professor Heneghan said the NHS was not offering the operation to patients based on "need" but on what manufacturers with a commercial interest wanted.

The mentality, he said, was: "Get people through the system - in and out."

Image:

Ms Elder says she has to take a cocktail of drugs after having the procedure

One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.

Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.

David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a "significant" medical case.

Total compensation, he claimed, could "run into the billions of pounds, which would make it the largest medical case in UK history".

A spokesperson for Johnson & Johnson told Sky News implantable mesh was "backed by years of clinical research" and that "Ethicon is confident in its products".

They said the use of pelvic mesh devices is "supported by medical experts around the world".

The spokesperson added: "Ethicon is defending lawsuits concerning the use of our pelvic mesh products.

"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."

http://news.sky.com/story/vaginal-mesh-legal-action-could-be-bigger-than-thalidomide-11060083

Criminal behavior, but no jail time. Lives lost, PREVENTABLE harm. Follow the money.

Los Angeles Lawyer Wins $119 Million Settlement Against Massachusetts-based Medical Company

Published : Friday, May 15, 2015 | 2:50 PM  (FiDA highlight)

Several hundred women that were represented by a Los Angeles-based attorney were a part of a $119 million settlement against a Massachusetts-based medical company over claims that its vaginal mesh product did not work and caused serious injuries.

“Most of the claims assert that the device manufacturer failed to properly test the pelvic mesh implant, ignored warnings, or that the device implanted into human tissue did not work and sometimes caused very serious problems,” said Los Angeles lawyer Dana Taschner, representing hundreds of women in the national medical device litigation involving several device

manufacturers.

Surgical mesh products were implanted in women in an effort to treat pelvic organ prolapse, stress urinary incontinence, and following hysterectomies.

Medical Device Company Boston Scientific agreed to settle thousands of lawsuits involving a vaginal mesh product, including the claims of an area woman claiming injury from the company’s transvaginal mesh medical device. Boston Scientific is paying $119 million to resolve almost 3,000 cases around the country, Taschner said.

“The trial that settled this week is one of thousands of transvaginal mesh lawsuits in federal and state courts across the country alleging product flaws” he said.

Boston Scientific claimed no admission of wrongdoing in the settlements, and insists their mesh medical device is not faulty or to blame for alleged problems.

Payments in the settlement are to be paid into a settlement escrow by the device manufacturer by October 1, 2015. Boston Scientific has reportedly set aside close to $1billion to cover costs, liabilities, legal expenses, and settlement associated with continuing transvaginal mesh and bladder sling claims.

Two other recent cases involving Boston Scientific resulted in significant and expensive defeats for the company.  In Miami, Florida, a federal jury returned a verdict of $26.7 million after plaintiffs argued that the company’s Pinnacle mesh device design was faulty and caused serious problems.

In another case in West Virginia, the jury returned a verdict of $18.5 million after the plaintiff sued Boston Scientific for injuries the plaintiff claims are a result of the medical device.

In addition to Boston Scientific, several other medical device companies are defending lawsuits for alleged transvaginal mesh problems.

“Boston Scientific is still exposed to claims from thousands of women claiming injury from the medical devices” said Taschner.

As of February, more than 25,000 product liability cases or claims regarding the mesh products had been made against the company, according to Boston Scientific filings.

Boston Scientific spokesperson Kelly Leadem said in an e-mail Tuesday that when it comes to those other cases and claims, the company will continue to look at all of its options.

“If there are opportunities to settle cases at reasonable terms in the future, then we will consider settling,” said Leadem in the e-mail. “Otherwise, we will continue to contest these claims

vigorously.”

FAIL: Vaginal Surgical Mesh - Women in Scotland report catastrophic adverse events

Women urge MSPs to act over mesh implants

by TOM PETERKIN  The Scotsman  June 4. 2014

Alex Neil has been pressed into action to help women whose lives have been ruined by the painful side-effects of plastic vaginal mesh implants.

The health secretary yesterday said he would seek an urgent meeting with the United Kingdom regulatory body for medical devices after a group of women told Holyrood of their suffering due to the controversial treatment.

Members of pressure group Scottish Mesh Survivors – Hear Our Voice have presented a petition to the Scottish Parliament urging treatment be suspended.

Polypropylene mesh medical devices are implanted in women who experience bladder and prolapse problems, typically after pregnancy.

Appearing in front of Holyrood’s petitions committee, sufferers told MSPs (Ministers of Scottish Parliament) their lives had been blighted after having the implant. Some were in tears as they spoke of severe mobility restrictions, immune system problems and damage to internal organs caused by the mesh or tape implanted in the pelvis.

There were reports of the mesh becoming infected and contracting – cutting through organs “like cheesewire” – and the extreme difficulty in removing the material safely.

Despite a campaign to have the procedures suspended until a full investigation is carried out, sufferers say government ministers are passing the buck.

Elaine Holmes, 49, from Newton Mearns, East Renfrewshire, had an implant to treat a leaky bladder in February 2011. Since then she has had four operations to remove the mesh.

“Too many women in Scotland are being hurt on a daily basis while we wait on the slow-moving wheels of Westminster to turn,” she said. “We already have the legal powers needed to make a difference in Scotland, today. The rest of the UK can follow suit, but let us lead the way.

“We have been told that regulation and safety is an issue for the European Commission. But we would contend that the current EU system is not working and if our First Minister shows political willingness to intercede over fishing quotas, he can surely show political willingness to intercede over something which is having such a detrimental effect on human life.”

MSPs requested that the health secretary and deputy Michael Matheson, the public health minister, appear before the petitions committee to give evidence on the Scottish Government’s position.

Yesterday, Mr Neil wrote to the Medicines and Healthcare Products Regulatory Agency (MHRA). He called on the MHRA to reach a swift conclusion to 
ensure that no further women suffered complications as a result of having the implant.

He said: “I met with some of the women affected and I am clear that no-one else should have to go through the suffering they have experienced.”

The Scottish Government has written to all GPs to ensure they make patients who may be considering this treatment aware of the potential side-effects.

Labour’s health spokesman, Neil Findlay, said: “The ball is firmly in the court of the government and I hope they finally take note of the evidence presented by the women.”

An MHRA spokesperson said the body would be happy to meet Mr Neil: “We listened to and understand the concerns many women have about vaginal tapes and meshes.

“The evidence currently available indicates that the benefits continue to outweigh the risks and can help in dealing with upsetting conditions such as urinary stress incontinence and pelvic organ prolapse.”

Harmed patient not healed by $3.35M verdict.

J&J Failed to Warn of VaginalMesh Risks, Jury Says

By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight

           

           

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.

Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor, the jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.

“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.

Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.

‘Doctors Knew’

J&J claims the Prolift is safe and effective and it warned of the risks.

“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments on Feb. 15.

Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.

Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.

Difficult Removal

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.

Slater claimed that Gross’s chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies and was difficult for surgeons to remove.

Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.

“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”

Little Risk

Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.

Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”

“I am fearful of dying because this pain is so bad,” she said.

On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”

Jurors saw the video deposition of Benson, who did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.

During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.

Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.

The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).

To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers