Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, April 13, 2016

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



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


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