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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Sunday, April 27, 2014

SCANDAL: Surgical mesh in Scotland

            Scottish News
            Mesh surgery scandal
         Apr 27, 2014 14:18
         By Marion Scott
THE health spokesman says the Government must act now to end the devastating injuries and enduring agony suffered by hundreds of Scots women.

Mesh victim Caroline Tait outside Scottish Parliament
LABOUR'S health spokesman Andy Burnham has accused the Government of failing women living in agony because of mesh implants.
He criticised SNP health secretary Alex Neil over his refusal to suspend the use of the controversial treatments.
It follows a Sunday Mail campaign which has highlighted devastating injuries and enduring agony suffered by hundreds of Scots women.
Burnham said: “The evidence from health boards is shocking and clearly shows thousands of women have been affected by these products which can have life-altering consequences.
“Some of the cases revealed by the Sunday Mail are heart-breaking when what should be a simple procedure has left women disabled.
“I’m surprised by the lack of action or leadership being shown by the Scottish Government.”
Burnham backs Scotland’s shadow health secretary Neil Findlay who has called on Alex Neil to suspend the use of mesh until an inquiry can properly assess the scale of the scandal.
Pressure on Neil is growing after a US court decision found one of the most widely used vaginal mesh implants, produced by Johnson & Johnson subsidiary Ethicon, was defective.  (Batiste v. McNabb/J&J Ethicon in Dallas, TX)
Findlay said: “After the US ruling, Alex Neil should have suspended the use of mesh in Scotland and instructed health boards to 
contact every woman given this implant to check whether they are experiencing any problems.”
Hundreds of thousands of women around the world have reported injuries inflicted by mesh eroding in their bodies.
Many have faced a series of ops as surgeons struggle in vain to remove the mesh used to treat prolapse and bowel conditions.
American courts have already awarded damages of millions of pounds to the victims.
More than 400 cases are lodged in Scotland. The Scottish Government said: “We continue to work with professional organisations to improve 
reporting and monitoring of procedures using mesh.”
Johnson & Johnson are considering appealing last month’s judgment that their TVT-O device was defective.
Spokeswoman Lucinda Macari said: “The verdict is disappointing and we believe we have strong grounds for an appeal.”
Leslie McGlinchey, 33, of Drumchapel, Glasgow, who was forced to use a wheelchair after a mesh implant three years ago, said: “Politicians continue to ignore this scandal at their peril.
“When things go wrong, the damage is so devastating, it affects whole families.
“We’re calling on everyone to sign our petition and get this stuff out of our hospitals.”
The Hear Our Voice petition closes on Wednesday.

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