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

Regulatory Capture and Patient Safety Failures

Failing medical implants are causing hundreds of thousands of people misery

September 20, 2017 7.09am EDT

Author

• Thomas J Joyce Professor, Newcastle University 

Disclosure statement

Thomas Joyce has received funding from EPSRC, the FDA and the BOA for his work on metal-on-metal hips. Thomas Joyce does medico-legal consultancy regarding metal-on-hip implants. All income goes to Newcastle University.

Partners

Newcastle University provides funding as a member of The Conversation UK.

Thousands of women across the world have been left in terrible pain after being implanted with transvaginal mesh – a device to treat urinary incontinence or prolapse. How did a medical implant that has caused so much damage to these women’s bodies and lives come to be sold?

Most people probably have a good idea of how drugs are tested and approved – through clinical trials and placebos – but they probably don’t know how medical implants make it onto the market. If a headache pill that works for four hours has undergone clinical trials, what about an artificial hip that has to last for 40 years inside you?

The truth is, that for most medical implants, no clinical trials are undertaken. Instead, most medical implants are approved on the basis of “substantial equivalence”. In other words, if your new implant is substantially equivalent to an implant already on the market, then it likely gets approved.

Clearly someone has to decide how close one implant is to another. And in my experience, they can be quite different from each other and still get approved. Indeed, when independently reviewed in the US, the substantial equivalence process was said to give no evidence that “the cleared device was safe or effective”.

Three recent scandals

Many implant makers highlight the regulatory “burden” required to bring a new implant to market. However, despite these regulations, there have been three recent scandals involving medical implants: metal-on-metal hips, breast implants and mesh implants. Arguably, this shows that medical implant regulation isn’t working. At the very least, these scandals have left hundreds of thousands of people worrying about the long-term effects of defective implants in their bodies.

Many thousands of people have been left in pain, perhaps unable to work. Others have seen relationships break down and feel that their lives have been ruined.

There are many heartbreaking stories from patients who were told their lives would be changed for the better, not worse, and it seems reasonable to ask how this situation came about so that it can be prevented in future.

Why do we have these scandals?

I think there are three main factors. First, despite some companies’ claims of a primary responsibility to their patients, most companies exist to make a profit, which means bringing implants to market quickly and selling as many as possible. Why spend money on a long, expensive clinical trial when regulations say you don’t have to?

The second factor is the regulators themselves. These organisations are often guided by their government to work with industry to bring innovative medical implants to market, both to benefit manufacturers (who provide jobs and pay taxes) and patients. If the pull is too much towards industry, this is known as “regulatory capture”. This is where a regulator that has been set up to act in the public interest, instead advances the concerns of the sector it is charged with regulating.

It is also interesting to consider the word “innovative”; why do medical implants need to be innovative rather than safer or longer lasting or less expensive? Innovative means that a patent can be obtained, which can then be used to generate income. A safer implant doesn’t appear to carry the same potential financial reward as an innovative implant.

The third factor is a lack of transparency over the approval process. If the implant was approved in the EU, the information is confidential. This makes it very difficult to assess how an implant was tested and what the test results were. So the main judgement on an implant’s performance will come only after implantation – maybe two, five, even ten years down the line. To me, if the implant is deficient, that’s too late. By that time, thousands of people will have been implanted with a substandard device.

How to fix it

Of course, there are ways to make the system work better. For example, there could be phased introduction of new medical implants undertaken at specialist centres where all details of the implants and the procedures are fully tracked. Once the efficacy is shown after a certain amount of time, then the implant could be introduced more widely.

It is also important that regulatory capture is acknowledged. The priority for regulators should be stated as patient safety. If that means regulators stopping medical devices being implanted while patient concerns are investigated, then so be it.

Finally, transparency needs to be improved. We need to know what tests were done on implants and what the results were. With these changes in place, we might make implant scandals a thing of the past, not ongoing news.

Surgical Mesh Lawsuits Proliferate as Industry Suppresses Patient Outcome Harm

The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics.

Souders CP1, Eilber KS, McClelland L, Wood LN, Souders AR, Steiner V, Anger JT.

Female Pelvic Med Reconstr Surg. 2017 Jun 27. doi: 10.1097/SPV.0000000000000433. [Epub ahead of print]

Abstract

OBJECTIVES:

Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making.

METHODS:

We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents. Outcomes and measures used included annual rate of claim, mesh type, time interval between surgery and claim, defendants, and surgeon training.

RESULTS:

The search returned 76,865 results, and 2979 were excluded, leaving 73,915 claims. Of 739 claims (1%), 63.3% involved slings for SUI, 13.3% mesh for POP, and 165 (23.2%) involved both. The mesh named most often in claims was retropubic slings at 30.3% and transobturator slings at 27.1%. The number of cases filed increased significantly from 730 in 2011 to 11,798 in 2012, which then almost tripled in 2013 to 34,017. The interval from surgery to claim filing ranged from 4.8 to 5.3 years. Only 12% of implanting surgeons were or became board certified in Female Pelvic Medicine and Reconstructive Surgery. Only 4 cases named providers as codefendants.

CONCLUSIONS:

Most legal claims involved slings for SUI and began after the 2011 Food and Drug Administration communication about mesh for POP. The rise in lawsuits does not reflect the acceptably low complication rates for slings for SUI reported in the literature.

PMID: 28657986 DOI: 10.1097/SPV.0000000000000433

J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.

“I would not want my wife to undergo this procedure”: pelvic mesh inventor

Joanne McCarthy

4 Jul 2017, 12:04 p.m

LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.

Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.

The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.

Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".

Mr Bannon told the court the comments' message was "those of us who were in the know".

"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.

The landmark case, which has attracted international media attention, is expected to take six months.

Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.

"Their enjoyment of life has been seriously compromised,” he said.

"Their lives have been dramatically altered for the worse.”

Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.

The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.

The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.

They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.

Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.

They were more likely "mid-career doctors" who saw their practices as businesses.

The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.

The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".

Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.

He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.

The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.

One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.

Ms Manion was visibly upset through some of the evidence.

The hearing continues.

http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

Jury Verdict: Johnson and Johnson to pay for 'malice' toward patient.

UPDATE 2-Johnson & Johnson ordered to pay $5.7M in California mesh trial

Thu Mar 5, 2015 4:04pm EST

By Jessica Dye

(Reuters) - A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.

The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.

The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.

Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.

Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.

Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."

Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.

Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.

Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.

The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123. (Reporting by Jessica Dye in New York; editing by Chris Reese, Alexia Garamfalvi and Lisa Von Ahn)

http://www.reuters.com/article/2015/03/05/johnson-johnson-mesh-verdict-idUSL1N0W728U20150305

Scotland takes action: patient harm from surgical mesh.

Transvaginal Mesh Warnings to beStrengthened in Scotland at the Urging of Mesh-Injured

Oct 1st, 2013 | By Jane Akre | Category: Media Reports FiDA highlight and comment below

The Sunday Mail

Scotland is making changes in the way the public is warned about transvaginal mesh.

The Scottish Parliament set up a transvaginal mesh working group in May 2013. Last week the TVM working group met with the Minister for Health and Well Being.

Scotland’s Health Minister Alex Neil has ordered the National Health Service to warn women about transvaginal mesh surgery after a series of reports in the Sunday Mail about the “horrific complications” suffered by hundreds of patients.

“Officials will produce revised consent forms and information leaflets within two weeks. The move follows our campaign revealing how women have been crippled and maimed by polypropylene mesh implanted during surgery meant to help bladder and prolapse problems.”

Mr. Neil made the announcement with five mesh victims and vowed that all health boards will be asked to use these new forms. A leaflet will be given to all women considering surgery with mesh. The Sunday Mail reports it has received contacts from more than 300 people who tell “how their lives were destroyed by the implants.”

Ironically there have been only six reports of complications by doctors in Scotland to United Kingdom’s version of the FDA, the Medicines and Healthcare Regulatory Agency.

Neil says “clearly the system isn’t working. Doctors aren’t compelled to report adverse incidents to the MHRA.”

Anti-mesh campaigners are calling for an implant register to record procedures involving implantable medical devices such as mesh, breast implants and hip replacements. The European Union was recently rocked by the PIP breast implant scandal where a French manufacturer was using industrial grade silicone to fill breast implants. The government has had to step in and pay for implant removal surgeries.

Drs. Raz, Margolis Help

Dr. Michael Thomas Margolis of Bay Area Pelvic Surgery and Dr. Shlomo Raz, a urologist from UCLA added their comments to the proceedings. Dr. Margolis wrote a letter to Minister Alex Neil and DR. Raz commented by email.   Here is the letter.

Dr. Margolis is a surgeon in the area of female pelvic reconstruction. He’s been removing mesh implants since the mid 1990’s and now removes two a week. He reports complications include injuries to the bladder, bowel, blood vessels and vagina.

He told the parliament he’s treated “patients with vaginal mesh erosion, chronic complications of mesh including chronic infection, chronic scarring, chronic pain, morbid disfigurement and loss of function of the vagina.”  Many marriages are ended by the mesh issue, he says.

Dr. Raz reported that partial mesh removals do not work for pain “It must be removed completely. Ultrasound is the only test that shows mesh. No other imaging will show it.”

“In the last 6 years we have removed more than 500 mesh complications. 70% of the patients are improved or cured while 30% are permanent disabled from the mesh including vaginal pain, leg pain, pain during intercourse. We remove all the mesh. This is the only hope for patients with complications from mesh,” Dr. Raz wrote in an email.

The working group in Scotland is making positive progress, say advocates, as are colleagues in England that recently met with Lord Howe at Westminster in London. #

Learn More:

Scottish Parliament News Release,   September 27, 2013
http://www.theparliament.com/latest-news/article/newsarticle/meps-vote-for-tougher-controls-on-medical-devices/#.UkgJb4akoZ6

Facebook Scottish Mesh Survivors
https://www.facebook.com/karen.neil.16503

http://meshmedicaldevicenewsdesk.com/media-reports/transvaginal-mesh-warnings-to-be-strengthened-in-scotland-at-the-urging-of-mesh-injured/

Tags: chromic complications, chronic pain, chronic scarring, disabled comoplications, Dr. Michael Margolis, Dr. Shlomo Raz, infection erosion, leg pain, mesh removal, morbid disfigurement, National Health Service, pain during intercourse, PIP breast implants, Scottish Parliament, the Sunday Mail, transvaginal mesh injuries, ultrasound, vagina, vaginal pain

Joleen Chambers says:

October 1, 2013 at 8:57 pm

Bravo Scotland! Valuing harmed patients and validating their stories by direct corrective action will save lives and the healthcare budget of your nation. In the U.S. the overly entitled medical device cartel is now holding our country hostage in a budget funding shut down to force changes in the Affordable Care Act to eliminate the paltry 2.3% tax. The U.S. FDA was the gold standard of regulation until it was infiltrated by industry influences, defunded to a level of irrelevance and ignored by legislators that could have progressively adapted laws to reflect the advancement of profiteering by this industry and updating the FDA/CDRH charter.