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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Tuesday, April 18, 2017

Hernia Mesh Harm: Canada Health

















Published Monday, April 17, 2017 10:00PM EDT CTV News.ca Staff  FiDA highlight
Warning: Some of the content may be disturbing to some viewers
There is growing concern over the number of recalls of hernia mesh in Canada, as patients speak out about complications they believe are linked to the surgical device.
Patients across the country contacted CTV News after a story on health problems linked to hernia mesh aired last month.
Patient Ivan Richardson said his hernia mesh has caused him ongoing, unexplained pain.
"You couldn't even touch me, I would cry, I mean literally cry and I went to the doctor and they kept saying they couldn't find nothing," Richardson said in an interview with CTV News.

That is until one doctor cut open his abdomen. There, what was supposed to be flat plastic mesh was rolled up inside Richardson's torso.
Even with part of it removed, Richardson said he still suffers.
"It will feel like a bunch of little needles," he said. "I assume that is the edge of the plastic mesh. I'm scared to do anything anymore, really."
Figures from Health Canada show that some 12 brands of hernia mesh have been recalled or removed from the Canadian market since 2000.
Some were linked to infections and perforations. There were 185 reports of serious injury and other complications, including three deaths.
Still, studies indicate the majority of hernia mesh patients have no problems, and its use is on the rise.
Data shows mesh helps improve recovery and lowers hernia recurrence.
But Dr. John Morrison, president of the Canadian Hernia Society, warns it may be used too often given the growing questions of the harm being done to some patients. In some cases, he said, mesh may not be required.
As part of his practice, Dr. Morrison often removes mesh that's shifted and punctured organs.
"I've seen pictures of it in the bladder, I've seen mesh in the stomach," Morrison told CTV News. "The mesh can erode into other organs over a period of time."
Morrison said studies show 10-20 per cent of people are left with chronic pain.
"It is a very serious phenomenon that's happened," Morrison said.
The physician said if the pain persists longer than three months, a hernia patient should find another physician or a hernia surgeon.
Morrison called the complications an "epidemic, and unfortunately, there's no end in sight, it's going to get worse because almost all hernias are now repaired with mesh."
Dr. Morrison advises patients who are scheduled for hernia surgery to "ask their surgeon if they're going to be using mesh, ask them exactly what type of hernia they have, why the mesh is being used.
He said prior to the operation, a patient should read on the internet the effects of the mesh being used on the hernia they're having repaired.
"An educated patient is the number one thing that will solve this problem," Morrison said.
There is research underway to try to better understand these emerging complications. The research will be of vital importance to the thousands of Canadians who have hernia surgery every year.

With a report by CTV medical specialist Avis Favaro and producer Elizabeth St. Philip

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