Mesh Medical Device News Desk, January 10, 2018 ~ She has been a very active member of the Canadian group of anti-mesh campaigners since 2011, now Noni Wideman is bringing demands directly to the Canadian government.
Image: Noni Wideman on CTV, Jan 2018
On Monday, January 8, CTV reporter Avis Favaro writes on the CTV National News blog about Noni Wideman.
As anti-mesh campaigners have done in Scotland and in England, Wideman has filed a petition to the House of Commons in Ottawa to stop the use of polypropylene plastic mesh implants until more study has been done to assure safety.
From Rose Prarie, British Columbia, Wideman has always been outspoken, contributing to a Patient Profile on Mesh News Desk in May 2012. Read it here.
Wideman was implanted with a TVT-Secur (Johnson & Johnson) mesh in 2011 to treat incontinence but soon she developed complications including fatigue and pain.
Blue plastic mesh particles were in her urine and poking out of her vagina. The more she researched, she learned she was not alone.
There were thousands of women in Canada and the U.S. also claiming adverse reactions to the polypropylene mesh.
Wideman’s research led to Links on Mesh, a chronicle of the lack of biocompatibility of polypropylene (PP) plastic mesh used to make medical devices of “mesh” used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
The recent death of the mesh-injured Ontario woman, Chrissy Brajcic, encouraged Wideman to do more.
The e-Petition has more than 350 signatures (here) but will need up to 500 to be filed with the House of Commons. The Petition is open for signatures until April 20, 2018.
Wideman tells MND she is hoping to get a response from Health Canada and Parliamentary support.
“Our new government seems ready to address issues the past one ignored and swept under the table.”
In Canada, about 25,000 women have had surgery to treat stress urinary incontinence (SUI) where weakened pelvic muscles allow for the release of urine. CTV reports another 5,000 procedures are done for pelvic organ prolapse (POP) where the organs in the pelvic region literally fall sometimes outside of the body.
Canada followed the U.S. in allowing the mesh products, also called “tape” onto the market with little oversight and no clinical trials.
CALLS FOR SAFETY ASSURANCES
A recent British Medical Journal study (here) finds the regulatory bodies allowed untested implantable medical devices on the market with no assurances of safety and efficacy.
Wideman wants the government to oversee research where women with mesh implants are followed for at least five years. Typically testing cited by the manufacturers lasts one year or less. She wants to see the implant use suspended until those studies are done.
Wideman also calls for a registry of all implanted medical devices to watch for emerging complications. Canada does not currently have any way to track trends in complications. The U.S.’s MAUDE database within the Food and Drug Administration is not an active registry and captures a small percentage of events.
The medical establishment in Canada and the U.S. refuses to stop the use of mesh products because some surgeons say they are still useful in some patients.
Here is the Petition to the House of Commons in Parliament Assembled:
PETITION TO THE HOUSE OF COMMONS
IN PARLIAMENT ASSEMBLED
Inadequate regulation for permanently implanted devices and materials has exposed Canadians to unnecessary harms;
There is no mandatory registry of and for patients with implantable medical device materials so that devices can be more readily tracked, patterns of use monitored, and patients later judged to be at risk more easily identified;
International Standards 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 materials and devices substantially the same as previously cleared predicate materials are considered to have met bio-compatibility requirements, even though the approved predicate product may have been recalled; and
No mechanism is in place to recall 510k cleared products substantially the equivalent of a recalled predicate product.
We the undersigned citizens of Canada call upon the House of Commons to;
Identify and restrict the use of surgical implant materials and devices that have not undergone bio-compatibility testing required by the pre-market approval (PMA) application process to use within clinical studies with a duration follow up of no less than 5 years to remedy the lack of clinical evidence and experimental nature of using untested, vaguely studied, materials and devices in surgical procedures.
Make it mandatory to report all implant initiated complications observed by physicians, and to include complications reported to physicians by patients;
Temporarily suspend the licensing use of all subsequent medical implant materials and devices that gained clearance via a recalled predicate product. For example, suspension of controversial polypropylene surgical mesh implants materials, until an oversight committee, taking into account new Canadian research regarding the degradation of polypropylene in the human body, taking into account the under reporting of complications, taking into account the recent study that identifies an inadequate regulatory process for medical devices, assures Canadians that benefit over risk ratios are assessed for patient quality of life, versus durability of quicker mesh fixes;
Implement a mandatory registry system for all implant materials and devices.
Close the ISO assisted 510k loophole that does not recall products that have a recalled predicate. A recall should make it necessary for manufacturers who avoided costly clinical studies via the 510k process to bear the burden of PMA costs for subsequent substantially same products that escaped biocompatibilty testing that put Canadians at risk of life altering and threatening complications.
Establish a patient registry for all implantable devices, enabling long term patient follow-up notification, and patient surveillance to remedy lack of reporting by medical practitioners, and alert medical practitioners of emerging complications.