Mandate Compulsory Reporting of Surgical Implant Device Complications
- par: Noreen Wideman, on behalf of Canadian Victims of Transvaginal and Hernia Mesh Implants
- destinataire: PM Steven Harper, and the Honourable Minister of Health Leona Aglukkaq,The Honourable Robert Douglas Nicholson Minister of Justice and Attorney General of Canada 284 Wellington Street Ottawa, Ontario K1A 0H8 Email: mcu@justice.gc.ca
People need to sign this petition because synthetic medical mesh implants among other permanent surgically implanted devices can be fast tracked through the FDA 510 process which allows clearance of medical devices without significant or any testing on humans because they are substantially the same as a predicate device.
The identified problem is that the FDA has no recourse to recall subsequent devices when the predicate device is recalled because of defects and higher complications and death rates than predicted.
Devices that subsequently escaped long term and in depth testing by an agency with no affiliation with manufacturers are now in the bodies of men and women.
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