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.
Please share what you have learned!
Twitter: @JjrkCh

Wednesday, May 18, 2016

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

Newcastle man demands hospital records


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.

No comments:

Post a Comment