Inadequate regulation for synthetic surgical mesh products has exposed thousands of Canadians to unnecessary harms;
All implantable medical device materials and devices can be more readily tracked, patterns of use monitored, and patients later judged to be at risk more easily identified;
International Standars Organization (ISO) agreements between countries allows substantially similar products to be cleared for sale instead of approved for sale, which means that biocompatibility testing may not be required for 510k cleared implant products to be licensed;
Implant mesh materials substantially the same as previously cleared mesh materials in the USA are considered to have met biocompatibility requirements, even though the approved predicate mesh may have been recalled; and
No mechanism is in place to recall 510k cleared products.
We, the undersigned, citizens of Canada, call upon the House of Commons to:
1. Restrict the use of urogynecological surgical mesh materials to use within clinical studies with a duration follow up of no less than 5 years;
2. Temporarily suspend the licensing use of polypropylene surgical meshes as used in vaginal mesh implants until an oversight committee assures benefit over risk ratios are assessed for patient quality of life, versus durability of quick mesh fixes;
3. Implement a mandatory registry system for all implant materials and devices;
4. Close the ISO loophole in the approval process for fast tracked class 2 and 3 permanent implant devices and materials;
5. Establish a patient registry for all implantable devices to enable long term patient follow-up notification, and surveillance.
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