Sunday , January 29 2023

Health Canada introduces new safeguards against defective medical devices



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Health Canada has published a detailed plan to improve the performance of police medical devices – from defibrillators to breast implants – including a new online database of device health related incidents.

The regulator announced on Thursday that it will set up an advisory committee on women's health, focusing on breast implants, vaginal nodes and contraceptive devices. Stricter requirements will compel device manufacturers to notify Health Canada within 72 hours if foreign regulators issue warnings about serious risks related to their products.

Judith Coates is among the growing numbers of women who come with health problems that they believe are related to breast implants.
Judith Coates is among the growing numbers of women who come with health problems that they believe are related to breast implants. (Andrev Francis Vallace / Toronto Star)

"Further efforts are needed to further strengthen our work," said Dr Supriia Sharma, Canada's Chief Health Advisor. "This plan will help to ensure that medical devices used in Canada continue to meet the highest possible standards of safety, efficacy and quality."

The movements are accompanied by a revolutionary investigation by Toronto Star / CBC / Radio-Canada in association with the International Consortium of Investigative Journalists, who uncovered previously unpublished federal data showing that at least 1,400 Canadian people have died since 2008 in incidents involving various medical devices, while another 14,000 reported injuries.

Devices placed inside Canadians without human testing were tied to serious health issues, an investigation found. And recurring problems remained secrets both to Canadians and their doctors because of lack of public reporting. Unlike the US, where the "unwanted event" medical device is published online, such data is not available to Canadian patients or their doctors.

Ten months later, the 62-year-old began to experience symptoms that are symptoms that he believes are related to her implants. Coates, who removed the implants in October, collected 1,300 signatures on a petition seeking stronger federal control of medical devices.

"This is a question that concerns many Canadians and must remain at the head of Health Canada's mandate to ensure the well-being and health of all Canadians."

Medical devices have transformed countless lives around the world. Pacemakers have restored normal heartbeats. Orthopedic implants, among the most popular devices, helped people walk again. Every day millions of Canadians contribute sophisticated and complex devices. The numbers will continue to grow, and like that, Health Canada is trying to keep up.

In 2019, reforms include:

  • Health Canada will be stricter in granting new medical devices for implantation to Canadians. As it stands, the agency routinely approves devices based on similarity of design with earlier versions of the device without new tests in humans. Starting next month, the regulator will review the approval process "in order to strengthen evidence" for devices approved on the basis of previous versions.
  • Of the 776 hospitals in Canada, they will need to report for the first time the incidents of medical devices. So far, only manufacturers and importers have been required to submit reports on medical device incidents.
  • Health Canada will be able to force manufacturers of devices to conduct safety assessments, tests and studies of their products.
  • Health Canada will add eight inspectors and two "research analysts" to respond to "high risk incidents". The regulator will also increase overseas inspections of devices for devices outside of Canada to 95, and from 80, starting from April, the action plan reads.
  • Health Canada plans to increase the number of evidence supporting medical devices available to the public. New regulations make it easy for doctors and patients to get clinical information held by the regulator, which will "enable independent analysis and can offer new insights and perspectives that can benefit patients in Canada," said Health Canada Action Plan. By advancing, the regulator plans to publish more summaries of its decisions in order to approve certain devices, so that Canadians "can trust the regulatory system and the medical devices they use."
Medical devices withdrawn from markets in other countries due to health risks continue to implant in unimportant Canadians? Sometimes with tragic results, recent research by Toronto Star-CBC has been found.
Medical devices withdrawn from markets in other countries due to health risks continue to implant in unimportant Canadians? Sometimes with tragic results, recent research by Toronto Star-CBC has been found. (Jesse Winter / StarMetro)

Gloria McSherri, who suffered from pain after her artificial hip in 2007, said that the new measures to win patients' access to information.

Her hip implant was withdrawn from the US market after caring for a high rate of failure, but continued to implant with Canadian for several more years. Like many patients, McSherry said she felt that the Canadian health care system had left him in the dark because of the risk and effectiveness of the medical device he put in her.

"I should not copy all this information myself. Doctors and the medical system should tell me," she said.

If the government makes this available, I think that's it an incredible thing. At the end of the day, the most important thing is that the device is safe. "

Investigation Star found that defective devices continued to be implanted in Canadians for months or years after being withdrawn from markets in other countries – partly because monitoring of device safety is largely dependent on problems with device vendors.

Healthy Canada has acknowledged the undermining as a "known and chronic issue" in response to questions last month. In one case, Star found the largest breast implant manufacturer Mentor did not report incidents involving their devices until the regulator caught the problem last year during the inspection.

Steps published on Thursday did not specifically address one of the key findings of the Star research: a link between textured breast implants and cancer called anaplastic large cell lymphoma (BIA-ALCL).

Plastic surgeons all over the country told Star that they had a serious concern over the device and stopped using them. Several calls for removing devices from the market.

On Tuesday, France suspended the sale of textured implants made by the industrial giant Allergan. The company issued a statement stating that it "does not agree" with the decision, but cooperates with the French health regulators.

On its Health Canada website, five Canadians have confirmed BIA-ALCL in the past 10 years – four of which are related to textured implants. Two leading Canadian plastic surgeons documented 25 cases – of which 23 were textured implants. On a global level, 615 BIA-ALCL cases have been confirmed, predominantly in patients with implants having textured surfaces, according to data collected by our research.

"We should do the same (as France)," says Dr. Elizabeth Hall-Findlai, a plastic surgeon Banff who was one of the first to take care of textured implants in a 2010 study that revealed high health problems in her patients. They had devices.

On Thursday, Health Canada Sharma said the agency was aware of French decisions and looked at the security issues surrounding textured implants.

"We have international talks with our colleagues … and based on that assessment, we will decide whether we need to take further action here in Canada," she said. "We have received additional cancer cases in Canada's patients during the summer, so we review the assessment, and we also look at additional information from published studies and from other international sources."

Dawn Criss tested positive for cancer called anaplastic large cell lymphoma (BIA-ALCL) in January. Star research has found a link between textured breast implants and BIA-ALCL.
Dawn Criss tested positive for cancer called anaplastic large cell lymphoma (BIA-ALCL) in January. Star research has found a link between textured breast implants and BIA-ALCL. (Codie McLachlan / Toronto Star)

Dawn Criss, a 48-year-old mother of three from Stony Plain, Alta, who tested positive for BIA-ALCL in January, says that while new reforms are positive, "we still have many women in agonizing limb with a breast implant. "

"Women are sick. They are sick because they believed the medical system when they said the devices were safe." Canada's health care should be advancing on a plate to help these women fall. "

Terri McGregor, another survivor of BIA-ALCL living in North Bai, says that after two years of receiving a "dismissed" response from Health Canada in attempting to raise health problems with the implant, Thursday's statement is crucial.

"Sounds like closed rooms in healthcare Canada are very busy," says McGregor, 54. "Without (research reporting) … that answer would not exist.

"It's sad that this should be done, however, I am so grateful and glad to see that this issue is finally given the priority it needs."

Sue Ross, a professor at the Department of Obstetrics and Gynecology at the University of Alberta, called the government's action plan impressive and comprehensive – but for many years.

Ross has conducted extensive research on the pelvic nets inserted through the female vagina to treat urinary incontinence or prolapsed pelvic organs. While the joint procedure drastically improved the lives of many Canadian women, Ross said that there are patients who have suffered ill health problems.

By publishing reports that Health Canada receives about unwanted health events involving devices, researchers and doctors will be able to catch up early, she said.

"I wish we had 10 or 15 years ago and we could prevent so many tragedies that happen in the life of women."

Robert Cribb is a research journalist from Toronto. Follow him on Twitter: @ thecribbi

Jesse McLean is a Toronto reporter. Follow him on Twitter: @ jesse_mclean

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