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Ethicon Monitoring 10/16/2018
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The damning vaginal mesh dossier: Shocking failures behind the scandal - and the man who made millions from inventing them
Oct 15, 2018 | The Daily Mail
By Jonathan Gornal
For the thousands of women caught up in the vaginal mesh scandal, the question must be: how did a product that’s caused them such agony ever come to be approved? -
Mesh Injured Speak Their Truth to Urogynecologists
Oct 15, 2018 | Mesh Medical Device News Desk
By yane Akre|
They traveled from across the country. Mesh injured women spoke directly to urogynecologists at their annual meeting.
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Oct 15, 2018 | The Daily Mail
By Jonathan Gornal
It's the medical scandal, exposed by the Mail, that's left countless women in pain
Now, a six-month investigation has laid bare the shock failings of mesh implants
Here, as part of our on-going justice campaign, we detail all the complete details
For the thousands of women caught up in the vaginal mesh scandal, the question must be: how did a product that’s caused them such agony ever come to be approved?
And it was a seemingly innocuous email response last week from Johnson & Johnson that provided the final, damning piece in the jigsaw puzzle. ‘According to our records,’ it read: ‘TVT devices were launched in Europe in late 1997.’
It was an astonishing admission, because at that time a major trial in the UK to check whether TVT — tension-free vaginal tape — was a safe, or even effective, treatment for women with stress incontinence had not even begun recruiting patients. And yet this email showed that UK regulators had already approved the use of these mesh devices.
This was purely on the basis of evidence provided by Ethicon, the subsidiary of U.S. drugs and medical devices manufacturer Johnson & Johnson that made them.
That utter failure of regulatory oversight was bad enough. But we can also reveal that this evidence was tainted by a multi-million- dollar deal between that company and the Swedish doctor who invented TVT.
Furthermore, the professional organisations representing surgeons who do these procedures have accepted funding from implant manufacturers, while surgeons themselves have received fees for speaking and consultancy work.
TVT has been a public health disaster. Good Health has campaigned for eight years to raise awareness about problems with the surgery which, while it has helped many, has also left thousands of women with complications including chronic infections, agonising pain and bleeding.
For years, the medical profession — apart from a few, lone voices — failed to take the suffering of these patients seriously, refusing to accept that it was the mesh causing them so much distress. But now, across the world, mesh manufacturers are facing multiple claims for compensation.
Last week, as the National Institute for Health and Care Excellence (NICE) finally ruled that the mesh should be used to treat stress incontinence only as a last resort, and only by specialists, the BMJ published my investigation into how it was fast-tracked into widespread use.
The word ‘scandal’ is overused. But in the case of an unproven procedure, foisted upon tens of thousands of women in the UK alone, often with crippling consequences, no other word will do.
Stress incontinence, caused by a weakening of the ligaments or muscles that support the urethra and bladder, affects up to a third of women over the age of 40. It means that coughing, sneezing or other sudden exertion causes them to pass urine involuntarily.
Until 1998, the standard surgical treatment, in use since 1959, was colposuspension, a specialist operation where tissue around the urethra is raised and held in place by stitches attached to ligaments at the back of the pubic bone.
Still performed in a very small number of cases, colposuspension is a major operation. In the Nineties, it meant seven days in hospital and a long recovery — a daunting prospect for patients and a costly one for NHS trusts. Unsurprisingly, not many women were offered it.
Then, in 1996, a Swedish obstetrician and gynaecologist called Ulf Ulmsten published a paper reporting the results of a revolutionary new operation. He was about to become a very rich man.
Ulmsten and colleagues at Uppsala University Hospital had developed a procedure in which a narrow length of plastic mesh tape was inserted to act as a kind of hammock for the urethra.
As the name suggests, tension-free vaginal tape allows the bladder to work normally, until it is tightened by a sudden muscle contraction, such as that caused by coughing or sneezing, which closes the opening of the urethra.
The operation could be performed under local anaesthetic as an outpatient procedure in less than half an hour. The financial implications were immediately obvious — especially to Ethicon.
Ulmsten’s team had operated on 75 women and reported the results in a paper published in the International Urogynecology Journal in March 1996: 63 patients (84 per cent) were ‘completely cured’ throughout a two-year follow-up, and six (8 per cent) ‘significantly improved’.
Ethicon made Ulmsten an offer he couldn’t refuse. If the results of a larger trial due to be carried out across several hospitals matched those of the first, they would pay him $1 million to secure the rights to TVT — for starters. On February 25, 1997, Ulmsten filed a U.S. patent application naming himself and a colleague as the inventors.
He formed a company, Medscand, to which he assigned the patent, and the following month signed a licensing agreement with Johnson & Johnson. The results of his larger trial, involving 131 women in six hospitals in Sweden and Finland, appeared in the International Urogynecology Journal in July 1998. TVT performed even better than before: 119 patients (91 per cent) were declared ‘cured’, and a further nine (7 per cent) ‘significantly improved’.
Ulmsten’s million dollars would soon look like small change. A Johnson & Johnson spokesman confirmed that in 1999 it paid Medscand £18.6 million, at today’s exchange rate, for ‘all assets associated with the TVT business’.
Was the outcome of Ulmsten’s second trial influenced by that prospect? Ulmsten can’t answer that — he died in 2004.
But a systematic review of 75 studies (covering all kinds of medical treatments) by the authoritative Cochrane Library in 2017 concluded that industry-sponsored studies were more favourable to the sponsor’s products than non-industry- backed studies.
In the UK, mesh was adopted with indecent haste. In 1998-99, only 214 women in England had the treatment. The following year there was an explosion in its use, and by 2009 the number of annual operations using polypropylene mesh tape (not just Ethicon’s) had climbed to an all-time high of 11,365 in England alone. The use of colposuspension fell from 3,719 cases in 2000-01 to just 276 by 2008-09.
TVT wasn’t cheap — in 2003, each kit cost £425 plus VAT — but the major saving was in hospital time.
The advent of mesh meant that more women were being offered surgery for stress incontinence. Between 2000 and 2008 the overall number of surgical procedures a year in England and Wales more than doubled, to 13,201.
In the U.S., TVT had been approved thanks to a principle known as ‘substantial equivalence’ — approval is fast-tracked if a device works in a similar way to one already approved.
That was a woven polyester sling made by a rival company and approved by the U.S. Food and Drug Administration in 1996.
That product was recalled early in 1999 after it was found to cause erosion of the urethra and bladder, leading to infection and pain — all side-effects that have since been suffered by TVT patients. But by then, Ethicon had been able to use the original approval to piggyback Ulmsten’s product to market.
In the UK, TVT was nodded into use with no scrutiny by the Safety and Efficacy Register of New Interventional Procedures (SERNIP), the forerunner of NICE.
Evidence of this shocking regulatory failure came to light in the pages of a forgotten medical textbook, sent to me by an anonymous, concerned gynaecologist.
‘Incontinence in Women’, a collection of reports from a study group convened by the Royal College of Obstetricians and Gynaecologists in 2001, includes a verbatim record of a revealing exchange between members of the UK and Ireland TVT Trial Group, which was still in the throes of assessing the safety of mesh.
One gynaecologist said it was ‘astonishing’ that SERNIP had approved the use of TVT without evidence from any random controlled trials — where a new drug or product is tested on one group of patients and the results compared with those in another group having the standard treatment.
The lead investigator of the trial group said it was ‘highly regrettable’ that TVT had been approved ‘on the basis of no evidence at all’, other than ‘documentation submitted by the manufacturers of the device’. And as Johnson & Johnson confirmed, it was marketing TVT in Europe by late 1997.
Surgeons and hospitals in the UK were quick to jump on the cost-effective TVT bandwagon.
But in the process the medical profession, from individual surgeons and their trusts to the royal colleges responsible for the specialities involved, failed to ensure surgeons were properly trained to carry out the procedure which, although quick to perform, demanded a high degree of skill.
Insufficient care was also taken to ensure that only appropriate patients were selected to undergo the operation — some would have benefited better from non-invasive treatments such as pelvic floor and bladder training exercises.
Perhaps worst of all, in the scramble to adopt the new, cheap operation, no one bothered to set up a registry of procedures — a record of results and other outcomes that is a standard method of determining whether a procedure is safe.
At the same time, however, as my six-month investigation revealed, individual surgeons were — and still are — happy to accept money from mesh manufacturers in the form of fees for speaking and consultancy work, while many industry bodies are heavily subsidised by industry sponsorship.
In 2016-17 the Royal College of Surgeons had ‘funding partnerships’ with 68 companies, including Ethicon, while recently published accounts for the Royal College of Obstetricians and Gynaecologists show a contribution of £133,402 from Ethicon. The UK Pelvic Floor Society, whose members use synthetic meshes for prolapse and incontinence surgery, is supported by several mesh manufacturers.
Had a registry of procedures been in existence from the earliest days, many of the longer-term problems with mesh would have been spotted sooner, sparing countless thousands of women unnecessary suffering.
Yet time after time, calls for such a registry to be set up were ignored — NICE first suggested it in 2003.
Patient campaigners and concerned medics have also repeatedly called for it. It wasn’t until February 21, 2018 — 20 years after mesh was introduced — that Jeremy Hunt, then Health Secretary, announced his department would be investing £1.1 million ‘to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues’.
It was, as campaigners pointed out, much too little, far too late.
It took the scandal of a faulty hip replacement in 1998 to persuade the government to set up the National Joint Registry, which since 2002 has monitored all hip, knee, ankle, elbow and shoulder joint replacements.
Since then, the registry has been used to identify and remove unsafe devices from the market and shine a light on poor surgical practice.
Similarly, a registry of breast implants was launched in 2016 in the wake of the PIP scandal, in which thousands of women were found to have been fitted with implants made from non-medical grade silicone.
The only correct response is for the Government to introduce mandatory registries for all devices that companies would have doctors insert in our bodies. This should be an obligatory pre-condition of approval.
That way the suffering of the thousands of victims of mesh will not have been completely in vain.
https://www.dailymail.co.uk/health/article-6278979/The-damning-vaginal-mesh-dossier-shocking-failures-scandal.html
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Mesh Injured Speak Their Truth to Urogynecologists
Oct 15, 2018 | Mesh Medical Device News Desk
By yane Akre|
They traveled from across the country. Mesh injured women spoke directly to urogynecologists at their annual meeting. (2 Min. Read)
They came from as far away as Portland, Oregon and Tyler, Texas.
The Chicago weather dropped to the 40’s as a group of about ten women braced themselves against the cold Chicago morning.
They were there to counter protest the messages of AUGS. The American Urogynecologic Society’s annual meeting (October 9-13,2018) is a gathering for those doctors practicing Female Pelvic Medicine and Reconstructive Surgery.
Here is the program.
AUGS members, about 1,900 urogynecologists, largely promote the use of polypropylene (PP) mesh as a treatment for stress urinary incontinence (SUI) and pelvic floor prolapse (POP).
The women had another message – Mesh Destroys Lives – accompanied by a mesh voodoo doll, banner and shouting from the street to those driving or walking by to the conference inside the Hyatt.
They should know. All nine protesters claim they are sick from their PP mesh implants promoted by AUGS members as a treatment for incontinence and pelvic floor problems.
That didn’t stop Barbara Lynn Melling, who came from Portland, Oregon. The pain from the grueling plane ride had her lying down in the coach seat as much as possible.
“Even if I die, I’m fighting for all these people who aren’t getting help,” said the small, frail woman.
The women were braced for the bitter reaction from the medical society and its 1,900 urogynecologists.
One doctor came by to talk. He was a supporter of the mesh rally message. Another doctor told Dawn Rasmus-Brown she looked too good to be injured.
You are only a small group that is affected, one doctor said. He insisted mesh does not move.
“You look fine. You’re out here standing,” the doctor told Dawn.
“Looks can be deceiving,” she told him. “I’ll be in bed rest for the next three days after this rally,” she told him.
He insisted she was wrong.
Exasperated, she walked away.
Mesh News Desk joined AUGS in 2016 and attended its annual meeting, Pelvic Floor Disorders (PFD) Week in Denver. It offered a full day of scientific presentations along with one day of surgical and clinical workshops.
Then president Douglass Hale, M.D. called out the “anti-mesh” movement blaming the injured and trial lawyers for eliminating “tools” in a physicians’ toolbox, used to treat incontinence and pelvic floor collapse.
In reality, the medical device industry, facing heat from huge jury verdicts, saw the writing on the wall and quietly removed a few of the more problematic products from the market.
Not an official recall, a quiet removal gives industry the option to reintroduce a similar device after a few tweaks.
There is generally no patient presence at AUGS, but there is always a great trade show on the floor with the latest “innovative” medical devices promoted such as those from Boston Scientific, Coloplast, Allergan, Ethicon, Bard, Cook Medical, Medtronic, Caldera, among others. This year 166 sponsors provided about half of the budget for the gathering.
In 2017 industry sponsored 44% of the underwriting the annual meeting, according of the organizations 2017 annual report.
It pays to advertise.
AUGS says (here) says “More than 60% of meeting attendees said that they rely on the products and services displayed in the exhibit hall to incorporate into their practice. Nearly 75% of attendees approve or influence purchases in their work environments.”
There was no patient presence at AUGS 2016. Even a scheduled mock trial, that would have informed doctors about the issues being raised in defective product litigation, was cancelled at the last minute.
This year would be a bit different.
Four women had arranged to meet with four members of AUGS – President Charles R. Rardin, M.D. was there, so was Geoffrey Cundiff, M.D., a urogynecologist from Canada, along with Elisa Trowbridge, MD and another female doctor.
They were escorted by the AUGS nonprofit CEO, Michelle Zinnert, shortly after 6 pm into a back room at the Hyatt Regency.
Each of the four women present, Regina, Katrina, Nancy, and Robin took about two minutes to tell her story, truncating years of mesh complications, removals, pain, and what the new normal their life had become.
Regina Holcomb used to be a private investigator. She knows how to size up people.
Of one doctor, she says, “He seemed compassionate to the cause, like it was eye opening to him, she says. The head of AUGS appeared disinterested.
“He kept a smug grin the entire time, there was no visual sign of compassion at all.”
Their message was simple.
Mindful not to be combative to the very doctors who still call incontinence mesh the Gold Standard, instead they asked for help.
Regina Holcomb told MND, “I would say two things – We are living with mesh and we are all looking for help. We brought up the fact that you train people to put this in, but have you started training to take it out?”
“I said if this had been a car, it would be recalled and they would fix the issue. These are our bodies what are you doing to help us!”
They said they are doing research but never would say what kind of research. They just kept saying working on research, she says.
Katrina Spradley drove in from Wisconsin.
“They said we have doctors, but never gave us names.”
Her new nonprofit is about to launch its website, www.meshvictimsunited.org. As part of its talking points, Katrina asked the doctors if there was a procedural code for mesh injuries.
”How can any of the reports out there be accurate when you don’t know how many revisions are made?” she asked. “When it’s eroding you put another mesh on top of it.”
AUGS members talked about a device registry to get an accurate handle on injuries but at the current time it does not exist.
The FDA’s medical device registry (MAUDE) is full of regulatory jargon making it nearly impossible for the layman to access or file a complication report. Add to that, reporting is not mandatory and any complication report must first pass through the manufacturer. More often than not, they reject the complication as a result of the device.
The General Accounting Office (GAO) in 1986 (here) found 99 percent of the problems associated with medical devices surveyed in hospitals had not been reported to the FDA.
Have things improved since then? Not really. It is easier to find a car to recall via its #VIN number than a faulty medical device, according to Madris Tomes of Device Events, who used to work at the FDA.
After the meeting, Regina says, the woman at the gathering came back and apologized for what she was going through.
Nancy Gretzinger had hoped to share her book, with AUGS membership but was told not to hand it out in the Hyatt lobby.
Meanwhile out in the street, Barbara asked one doctor, why industry is spending money on lawyers instead of using those dollars to help women.
For most, the powerful feeling came from the gathering of mesh sisters.
“Being able to talk, understanding what’s going on, emphasizing. You see their names on Facebook and you don’t know who they are,” said Nancy. “Now you do”
They ate spaghetti and salad made by Katrina’s husband, Terry, and shared a condo to keep costs down.
THE NONPROFIT
The rally had some media attentions- a WBBM radio reporter was there. So was a journalism student from Northwestern University who vowed to do more stories.
They handed out pamphlets with mesh information and talking points from a newly formed 501 (c) (3) charitable organization started by Katrina.
She is learning WordPress, and doing the work herself creating www.meshvictimsunited.org. The nonprofit will have a board of about 13 women, all mesh injured and hopes to push for registries, coding, and more awareness so future generations don’t meet the fate of these women.
The money for tee-shirts and pamphlets was donated.
Almost as if on cue, Boston Scientific has just launched its new website to promote treatments, mesh among them, for incontinence and pelvic organ prolapse. See Choose You here.
The small group of women vow this will not be their last visit to AUGS.
Next year it will be held in Nashville, TN September 24-28, 2019, and in Vancouver, Canada PFD Week 2020 will be October 6-10.
Whether negative or positive feedback, “at least we were visible,” Holcomb concluded. ##
This is Part One, Part Two, The Doctors: AUGS Today is in production.
https://www.meshmedicaldevicenewsdesk.com/mesh-injured-speak-their-truth-to-urogynecologists/
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