Australia withdraws J&J pelvic mesh

Johnson & Johnson withdraws pelvic mesh device from Australian market

Regulator says the mid-urethral vaginal sling, subject of a class action, is no longer being imported

Melissa Davey @MelissaLDavey

Mon 22 Jan 2018 23.14 EST

• Pharmaceutical giant Johnson & Johnson has withdrawn from the Australian market its supply of the vaginal mesh device that is the subject of a class action before the federal court.

On Tuesday a spokeswoman for Australia’s medical devices regulator, the Therapeutic Goods Administration, confirmed to Guardian Australia that the mid-urethral vaginal sling devices, used to treat stress urinary incontinence in women, were no longer being imported.

The devices are produced by the Johnson & Johnson company Ethicon and no longer appear on the Australian Therapeutic Goods Register, which is a list of products that can be lawfully supplied in Australia. The TGA has not responded to questions about whether the removal of the products from the register also means that products already on hospital shelves cannot be used by surgeons.

The TGA asked all manufacturers of transvaginal sling and mesh devices to update the “instructions for use” on transvaginal mesh and tape products before 17 January to include information about possible adverse events such as severe chronic pain, groin pain and bladder perforation.

According to the TGA, Johnson & Johnson did not meet this deadline and withdrew the supply of their mid-urethral sling devices to enable them to consider their options. A list of pharmaceutical companies that have met the new requirements has been made public.

The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson, told Guardian Australia he had written to all members to alert them to the development. It was his understanding that Johnson & Johnson slings already on hospital shelves could still be used but new supplies could not be imported.

Robson said he did not have “exact figures”, but the Johnson & Johnson devices were probably the most widely used by surgeons to treat incontinence.

“What I have heard is once the stock on the shelf is gone that’s it, and many hospitals, if not most, are looking at other options including other brands of urethral tape, which are still available,” Robson said.

“The feedback is some places are exploring transition arrangements so women can be offered other similar products. What I also wrote to our members yesterday was that it is clear mid-urethral tapes are the most appropriate response to incontinence which has not responded to other clinical treatment. We recirculated a Cochrane review that shows that mid-urethral tapes are the most appropriate treatment when used appropriately, and are very safe.

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“In fact, I think it’s regrettable it won’t be available for a while, but there are other similar products.”

The Johnson & Johnson/Ethicon implant became the subject of a class action run by Shine Lawyers in 2017, with 700 Australian women alleging that faulty pelvic mesh implants caused them debilitating pain.

Similar class actions involving thousands of women are also under way in the UK and US. More than 100,000 transvaginal mesh lawsuits have been filed in the US, the largest number against Johnson & Johnson, the manufacturer of the most commonly used meshes. Shine Lawyers alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients.

A Senate inquiry has examined whether any financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants; the lack of data available on how many procedures were performed; and the type and incidence of health problems woman have experienced.

The class action is due to return to the federal court in Sydney on Monday.

Johnson & Johnson has been contacted for comment.

https://www.theguardian.com/society/2018/jan/23/johnson-johnson-withdraws-pelvic-vaginal-mesh-device-from-australian-market

International #MeshAwarenessDay #LiveLifeMeshFree May 1, 2017

Caz Chisholm recognised for campaign supporting women pelvic mesh victims

Joanne McCarthy

1 May 2017, 10:23 a.m.

A WOMAN who launched a campaign to support women victims of pelvic mesh and hold Australian health regulators to account has won two awards for consumer health advocacy.

Australian Pelvic Mesh Support Group founder Caz Chisholm received the Western Australian Health Consumers Council health consumers award and the Rosemary Caithness Award for outstanding service to health consumers after a campaign, supported by the Newcastle Herald, for a Senate inquiry into pelvic mesh.

Winner: Australian Pelvic Mesh Support Group founder Caz Chisholm with two health consumer awards received for her work since 2014 campaigning for victims of pelvic mesh.

Ms Chisholm’s group jumped from 39 members in early 2015 to more than 600 by Thursday when she received the awards, only days before International Mesh Awareness Day on Monday, May 1. The day was initiated by mesh support groups in countries including Australia, America, New Zealand, Great Britain and European countries including the Netherlands. In America alone more than 125,000 women have initiated legal action against mesh manufacturers after they were implanted with transvaginal mesh (surgery through the vagina rather than the abdomen) after post-childbirth complications.

An American woman on Friday was awarded $20 million compensation for complications after mesh surgery in 2007 using a Johnson & Johnson transvaginal mesh. In Australia 450 women have joined a class action against Johnson & Johnson, another 350 women have joined a class action against a second American device manufacturer, and more than 1000 women in total have complained of serious injuries after mesh surgery.

Ms Chisholm said she was “thrilled and honored to receive these awards as this represents the acknowledgement of all women suffering from the devastating effects of mesh”.

“What we seek first and foremost is recognition of our pain and suffering because most of us have been ignored by doctors, and when we do present with complications we are told they are caused by anything other than mesh,” Ms Chisholm said.

“Yet when women join the support group and they read about the same complications as others, they breathe a sign of relief and often cry because finally they have the recognition that they are not imagining their pain and they are not going crazy.

“They realise their pain is real and their pain is from mesh.”

Western Australian Health Consumers Council executive director Pip Brennan said Ms Chisholm’s double win of the two most prestigious consumer health awards recognised her tireless advocacy for mesh victims and outstanding work on giving them a voice.

“The use of mesh is now the subject of a federal Senate inquiry, which is taking submissions until May 31, and the inquiry’s title is ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. This highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications,” Ms Brennan said.

“Caz Chisholm has spent significant time and energy raising awareness for women about the issue and providing essential peer support. She was also directly responsible for ensuring that the Senate inquiry was successfully advocated by Senator Derryn Hinch.”

In 2016 Australia’s peak health regulator for medical devices, the Therapeutic Goods Administration, quietly placed on its website a list of at least 30 known complications following pelvic mesh surgery, after TGA executives met with Ms Chisholm and other support group members.

The complications include punctures of vessels, nerves, structures or organs including the bladder, urethra or bowel; foreign body response including erosion of mesh into the vagina, bladder or bowel; chronic infections; acute or chronic pain; pain during intercourse; temporary or permanent inability to void via the lower urinary tract; bleeding; chronic pain in the groin, thigh, leg or abdomen; atypical vaginal discharge; exposed mesh may cause pain to the patient’s partner during intercourse and abscess.   

Who is Crazy Now? Pelvic Mesh Device Failures in Australia.

Newcastle man demands hospital records

JOANNE McCARTHY

April 14, 2016, 8:33 a.m.

THEY’RE the women told they’re going crazy – that the excruciating, extraordinary pain in their groins, backs and legs is actually all in their heads.

They’re women who received pelvic mesh implants over more than a decade from 2005 when regulators failed them, and medical devices hit the market without clinical evidence of safety or efficacy.

They’re women like Jane, 66, of Newcastle, who had mesh implanted in November, 2013, to treat prolapse. Twenty months later the pain started.

“First I was getting severe pain in my left side, then it went into my right side, then it was severe back pain. I didn’t know where the pain was coming from,” she said.

She saw doctors. They prescribed painkillers, laxatives and antibiotics for the infections she kept getting, and ran tests which came back negative. By February she was in hospital and her frantic son, Paul, was pulling no punches with doctors.

“They actually told her the pain was all in her head but she’s a different person since this started. This has absolutely broken my mother. They’ve basically experimented on women by putting these things in them, and when the women come looking for help they’re put in the too-hard basket, but no-one’s got the balls to say it,” Paul said.

Jane insists she was not told what kind of mesh device would be used during her surgery.

“I was told it was a mesh but not what brand. I was told nothing else about it and I never questioned anything,” she said.

Paul is close to tears when he describes how his once vibrant mother spends her days. She struggles to leave the house.

“She’s lucky to have one good day in three months,” he said.

He is fighting to get her medical and hospital records to determine what mesh device she received and how her surgery was conducted, as a first step to having the mesh removed.

“I spend most of my time here laying on the lounge, or in bed,” said Jane.

“You’re not living.”

She gave a date in April when another test is scheduled, then gave the kind of statement that horrifies her son: “The way I feel I could be dead by then.”

Toni Shannon is 49.

Three months after she received a mesh device in April, 2014, the inexplicable excruciating pain started. It eventually stopped her from working and left her barely able to walk 50 metres at a time. It also left her devastated by the mental consequences of shockingly severe chronic pain and debilitating fatigue.  “I felt an incredible hopelessness because I could not understand why my once strong body and mind had let me down,” she said.

Before mesh surgery: Toni Shannon and husband Eric four months before pelvic mesh surgery left Mrs Shannon with devastating complications.

The pain came in waves and stabbing bursts – deep burning pain into the bones, muscles and nerves, and jolts of nerve pain “that would stop me in my tracks”.

“It was excruciating groin pain. It was like you had a knife in your vagina with super sharp burning pains that would come with a shock. Absolutely shooting pain. Completely unexpected. Terrifying. I was really thinking, am I going crazy?”

Then there was the shutdown of once normal activities. She needed help showering and dressing. The surfing she had loved for many years was out of the question. Relationships with her husband, family and friends suffered while her life was focused on managing pain and fatigue.

“I felt my life was spiralling out of control and I often thought that dying would be a better option for myself and my family,” she said.

Hospital: Toni Shannon in an American hospital after surgery to have mesh completely removed. She cannot work and has permanent complications.

There were trips to doctors, a trip to America for surgery to completely remove the mesh, and a dawning understanding of controversies about mesh devices which she was unaware of until recently.

She is outraged that her transvaginal mesh surgery – surgery through the vagina – occurred more than two years after the American Food and Drug Administration issued its first serious warnings that complications from transvaginal mesh devices were not rare, and were potentially “life-altering” for women.

She is also outraged that the Australian Therapeutic Goods Administration allowed mesh devices on the market without the clinical evidence required to make drugs available, and that as late as 2012 it reported the likelihood that unskilled doctors, rather than the mesh devices, were responsible for any complications.

Mrs Shannon cried when she spoke about her life today. She is not working, she has lost the fitness and confidence that she was once known for, and she still experiences pain after surgery to remove the mesh that had eroded into her vagina, requiring removal from muscle, nerves, tissue and bone.

She does not know when, or if, she will work again.

Overwhelmed: Caz Chisholm has more than 100 women registered on her Australian Pelvic Mesh Support Group Facebook page launched after her mesh surgery in 2014.

“It’s an unknown future. I was right at the top in my work with a lot of responsibility, but it’s like I’m stuck in a holding pattern. It’s really like a death sentence.”

Carolyn Chisholm is founder of the Australian Pelvic Mesh Support Group.

In January 2014 she was implanted with a mesh device, at almost exactly the same time an American woman was being awarded $US3.27 million in a civil suit over the same device.

The American woman’s court case was told mesh became entangled in her internal organs, eroded through her vagina, caused infections and was unable to be completely removed from her body.

Within three months of surgery Ms Chisholm was experiencing extraordinary, excruciating pain in her groin and legs, debilitating fatigue and a skin disease.

“When I complained of this unbelievable pain I was told it was ‘just healing pain’, but I was freaking out. I was told it was probably not the mesh but I knew it was,” she said.

By November 2014 she started up a Facebook page for women with mesh problems, which became the Australian Pelvic Mesh Support Group. In the past few months Ms Chisholm and 10 other women have paid more than $30,000 each to travel to America and have their mesh completely removed.

In May the women will travel to Canberra to rally against the Therapeutic Goods Administration, which registered the first transvaginal mesh devices for prolapse surgery in Australia in 2004 and 2005, with no evidence of their safety and efficacy for prolapse surgery, and with clear warnings of the need for controlled clinical trials for related mesh devices.

http://www.standard.net.au/story/3848272/sons-fears-for-mother-broken-by-mesh-surgery/?cs=2452

AU "living nightmare" with J&J Prolift pelvic mesh!

'We've lost so much': Senate urged to act on failures over mesh device implants

April 13, 2016 - 8:15PM

Joanne McCarthy (FiDA highlights)

EXCLUSIVE

Five years ago Gai Thompson warned Australia's peak health bodies of a looming disaster involving women receiving mesh device implants to treat common problems after pregnancy, birth and hysterectomies.

This week Mrs Thompson and others are speaking publicly for the first time as they plan a rally in Canberra and call for a formal inquiry into the health regulators and medical bodies they say have failed them.

They are the women who, in many cases, can no longer have sex, have lost their jobs, have had to mortgage or sell their homes, have travelled overseas for surgery to remove the mesh, have suffered excruciating chronic pain, are resistant to some antibiotics because of chronic infections, and have suffered in isolation and silence – often for years.

"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson said.

In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of up to $12.5 million. In Australia the response from women has been slower because of fewer numbers and isolation, but it is growing, says Australian Pelvic Mesh Support Group founder Caz Chisholm.

A planned rally by her group in Canberra in late May will target one of Australia's peak health regulators, the Therapeutic Goods Administration (TGA), which approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. Prolapse is where pelvic muscles and ligaments are weakened after pregnancy, birth or hysterectomy.

The TGA approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.

Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been "mature" and lacked "rigour". The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.

Mrs Thompson's life after mesh surgery in February, 2008, is reduced to a one-page incident report on the TGA website.

She is the woman whose adverse event report to the TGA in October, 2011 about the Johnson & Johnson Prolift mesh device, noted she could no longer have sex and her life after February, 2008 had become "a living nightmare".

The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.

She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.

It took almost exactly three years for the TGA to complete its investigation of Mrs Thompson's October, 2011 complaint, until it placed her adverse event report on its website in October, 2014.

This week she said she first contacted the TGA by phone in 2010, after two years of seeing different medical specialists to deal with the consequences of the surgery.

"You don't know where to complain when something like this happens. When I first phoned the TGA they said they'd had no other complaints. I kept ringing them. I kept saying to them 'What else have I got to do to get you to do something'?" she said.

"They just kept saying sorry, but I was the only complaint they had."

A Senate inquiry into Australia's health care complaints processes will consider a submission by a patient advocate arguing the complaints process has spectacularly failed women given transvaginal mesh devices to treat prolapse surgery.

While it is mandatory for manufacturers to report adverse events to the TGA, they have to be made aware of any adverse events experienced by women. The TGA has confirmed it is not mandatory for doctors to report adverse events experienced by patients.

Ms Chisholm and Mrs Thompson say the majority of women were completely unaware they could complain to the TGA, or even that mesh was classed as a "device" that came under the TGA.

When Mrs Thompson was told three or four years ago that she had irreversible nerve damage in her pelvis because of the mesh, she was advised she could try morphine patches to cope with the pain.

She rejected the idea. Her life is about managing pain and the stress that flows from it.

"I can't get up and down steps. I can't go out for a walk. I feel like I have barbed wire in my pelvis and every time I move it causes me pain," she said.

"To have one day pain free, when you've had years and years of chronic pain, is something I can't even imagine now."

The Therapeutic Goods Administration said it started monitoring urogynaecological meshes in 2008, with a review in 2010 that found complications were closely linked to the skill and training of surgeons.

By August 2014 after a clinical review it reassessed the clinical evidence for devices and took action against some manufacturers, including the cancellation of devices.

In a statement to the Newcastle Herald the TGA said it had strengthened its oversight of new applications for mesh approvals, including conducting its own clinical assessment of the evidence rather than relying solely on European approvals as the basis for approval in Australia.

Johnson & Johnson was contacted for comment.

Newcastle Herald

http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html

Read more: http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html#ixzz45hzjwkUb 

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What is torture? What is criminal? Australian women sue J&J.

ABC News 7.30 Australia
Click on the link and watch this short news video. It is essential to understanding the story below.

Johnson & Johnson facing massive class action

10/15/2012 By Matt Wordsworth   ABC News 7.30 Australia (FiDA highlight added.)

Medical giant Johnson & Johnson is facing its third class action in Australia in as many years.

The case filed in the Federal Court yesterday relates to a product called transvaginal mesh.

It has helped many women who have suffered prolapsed organs by assisting their muscles with support, but for a significant number it has caused life-changing harm.

Lawyers believe it could be the largest product class action in Australian legal history.

It has also cast fresh light on the system of approvals because the mesh was introduced without any pre-market testing, with surgeons leading the call for change.

When Julie Davis was younger she had a plan to travel the world, meet the man of her dreams and settle down to have a family.

She succeeded, but along the way she endured a traumatic birth and some terrible consequences.

"I'd had a very bad forceps delivery with my first child who's now 10 and I had to wait until all my children were born to fix a very significant bladder prolapse," Ms Davis said.

"From my understanding it was the worst kind of prolapse because the bladder was actually outside my body."

It is a common problem, but there was a relatively new product to Australia - transvaginal mesh - that could be stitched in near the top of the vagina to help the pelvic floor muscles support the internal organs, much like a sling.

"The surgery itself was way more traumatic and devastating than I had imagined," Ms Davis said.

"I just felt unwell all the time, I was in pain, a lot pain, discomfort down below. I also had this feeling - lack of energy, like my body was fighting something all the time."

While her husband shouldered the load of earning an income and running the household, Julie, who was only in her 40s, was forced to use a mobility scooter.

For her, walking was painful, so too was sex, and the emotional toll was almost too much.

"It did get to the point where I just actually was chronically depressed and I had to go to see a GP and go on antidepressants," she said.

"There was one point [when] I was driving my car and I was just thinking, 'jeez, it would be easy just to turn the wheel at Curl Curl headland and just go off' because I felt that desperate."

'Adverse events'

It was after this that Ms Davis sought out a new surgeon, urogynaecologist Richard Reid.

He says the mesh was acting like a cheese grater in her body and had literally rubbed a hole in the wall of her vagina.

"When the mesh is put underneath the bladder, the bladder moves back and forth as it fills and it moves back and forth during intercourse," Dr Reid said.

"Because mesh scar is fundamentally quite fibrous and the bladder is very soft, we call this compliance mismatch, which means the same as rubbing a piece of cheese over a metal grater; the metal grater is obviously harder than the cheese."

Research published last May in the New England Journal of Medicine found mesh kits had "higher short-term rates of successful treatment" but also "higher rates of surgical complications and post-operative adverse events".

Two months later, in July 2011, the Food and Drug Administration (FDA) in the United States issued a formal warning saying they were a "greater risk" with "no evidence of greater clinical benefit".

Johnson & Johnson removed its product from sale earlier this year and class actions are already underway in America and Canada, and now Australia.

Rebecca Jancauskas, who is representing Ms Davis as the lead plaintiff in the class action, estimates as many as 20,000 Australian women may have had transvaginal mesh implanted, and that is despite the product having undergone no clinical trials.

"This prolapse mesh class action that we've commenced in the Federal Court today has the potential to be the biggest product class action that Australia has ever seen," Ms Jancauskas said.

Certain classes of medical devices may be sold without adequate testing if they are going to be used in a similar way to existing products.

Mesh kits had already been very successful in treating urinary incontinence, an area where there is not the same friction from internal organs.

"So the system was set up and the device companies have used the system," Dr Reid said.

"I think that with the wisdom of hindsight, it would have been more prudent for them to have done more testing before it was released, but in many I see the primary fault is the system didn't think out what was going to happen."

Previous class action

It is not the first legal trouble for Johnson & Johnson in Australia.

Last year a class action was launched over its DePuy hip replacement device which left hundreds of patients poisoned and seriously disabled.

In 2010 the company faced similar legal proceedings over its knee replacement products.

Just like the mesh kits, neither product had undergone pre-market clinical trials.

"Given that this is now the third product class action that Johnson & Johnson has faced in three years, it should raise some serious concerns about their product safety standards," Ms Jancauskas said.

The company has issued a statement saying:

Johnson & Johnson Medical continues to have confidence in the safety and efficacy of these products.

The decision to discontinue these products was based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.

This is not a product recall, and based on this notification it is not necessary for women who have received one of these products to take any action.

For more than a decade, our organisation has invested in the research, development and clinical study of products to treat a wide range of pelvic disorders.

We remain committed to advancing the standard of care for women's health and will continue to offer safe and effective treatment options for women.

Some are angry at the Australian regulator, the Therapeutic Goods Administration (TGA).

Senator Nick Xenophon, who was part of a parliamentary inquiry into the hip devices, says he is concerned that similar problems are still happening.

"Well this is another instance of regulatory failure. The TGA is meant to be a watchdog of these devices but it's failed time and time again," Senator Xenophon said.

"This is the third serious instance in the last 12 months. After the problems with hip replacements, breast implants and now this, [it] indicates there are some serious systemic problems with the TGA."

And while America's FDA issued its warning to consumers last year, there has been no such move from the TGA.

In a statement, it explained that it held a detailed review in 2010 and found the complication rate was low and depended on the skill of the surgeon, but that it would continue to monitor the situation.

Ms Davis says "it's been a tough road" and she has now had her mesh surgically removed.

She and husband Tim are desperately hoping that after four years and five surgeries, there is something to look forward to.

"I hope that we're over the hill now and start rebuilding our lives again in the way that we planned to begin with," Mr Davis said.

"We had great plans and great ideas of how we wanted to build our life, with the children et cetera, and I feel that life has been running away from us and we haven't been able to sit back and enjoy some of it."

Statement from the TGA in response to  ABC News 7.30 (Australia) - go to link above, please.