Health Canada has released a detailed blueprint for beefing up policing of medical devices — from defibrillators to breast implants — including a new online database of device-related health incidents.

The regulator announced Thursday that it will also form an advisory committee on women’s health that will focus on breast implants, vaginal meshes and contraceptive devices. Tougher requirements will force device makers to notify Health Canada within 72 hours if foreign regulators issue a warning about serious risks related to their products.

“Additional efforts are needed to further strengthen our work,” said Dr. Supriya Sharma, chief medical adviser for Health Canada. “This plan will help ensure that medical devices used in Canada continue to meet the highest possible standards for safety, effectiveness and quality."

The moves follow a groundbreaking Toronto Star/CBC/Radio-Canada investigation, in partnership with the International Consortium of Investigative Journalists, that revealed previously unreleased federal data showing at least 1,400 Canadians have died since 2008 in incidents involving various medical devices, while another 14,000 reported injuries.

Devices placed inside Canadians without testing in humans were tied to serious health issues, the investigation found. And recurring problems remained secret to both Canadians and their doctors due to a lack of public reporting. Unlike the U.S., where medical device “adverse events” are published online, no such data has been available to Canadian patients or their physicians.

“I’m really encouraged to see that Health Canada is moving forward ... on these initiatives to ensure that medical device safety remains top priority,” says Judith Coates, an Orillia woman who had breast implants in 2015 as part of a mastectomy surgery.

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Ten months later, the 62-year-old began suffering debilitating symptoms she believes were tied to her implants. Coates, who had her implants removed in October, has collected 1,300 signatures on a petition seeking stronger federal oversight of medical devices.

“This is an issue that concerns many Canadians and needs to remain in the forefront of Health Canada’s mandate to ensure the well-being and health of all Canadians.”

Medical devices have transformed innumerable lives around the world. Pacemakers have restored normal heart beats. Orthopedic implants, among the most popular of devices, have helped people walk again. Millions of Canadians are helped by sophisticated and complex devices every day. The numbers will continue to rise, and as they do, Health Canada is trying to keep up.

Set to roll out in 2019, the reforms also include:

Health Canada will be more rigorous in its approval of new medical devices for implantation into Canadians. As it stands, the agency routinely approves devices based on design similarities to earlier versions of devices without new testing in humans. Beginning next month, the regulator will review its approval process, “with a view to strengthening the evidence requirements” for devices approved based on previous versions.

Canada’s 776 hospitals will be required to report medical device incidents for the first time. Until now, only manufacturers and importers were required to submit medical device incident reports.

Health Canada will have the power to force device manufacturers to conduct safety assessments, tests and studies on their products.

Health Canada will add eight inspectors and two “investigational analysts” to respond to “higher-risk incidents.” The regulator will also increase foreign inspections of device plants outside Canada to 95, up from 80, beginning in April, the action plan reads.

Health Canada plans to make more of the evidence supporting medical devices available to the public. New regulations will make it easier for doctors and patients to obtain clinical information held by the regulator, which “will enable independent analysis and can offer new insights and perspectives that can benefit patients in Canada,” Health Canada’s action plan said. Going forward, the regulator plans to also post more summaries of its decisions to approve certain devices so Canadians “can have confidence in the regulatory system and the medical devices they use.”

Gloria McSherry, who suffered debilitating pain after receiving an artificial hip in 2007, said the new measures are a victory for patients’ access to information.

Her hip implant had been pulled from the U.S. market following concerns about its high failure rate, but it continued being implanted in Canadians for several more years. Like many patients, McSherry said she felt the Canadian health care system left her in the dark about the risks and effectiveness of the medical device put inside of her.

“I shouldn’t have to be digging all of this information out myself. The doctors and the medical system should be telling me,” she said.

If the government is going to make that stuff available, I think that’s an amazing thing. At the end of day, what’s most important is that the device is safe.”

The Star’s investigation found that faulty devices continued to be implanted into Canadians months or years after they were pulled from the market in other countries — in part because ongoing device safety monitoring is heavily reliant on the device manufacturers reporting problems.

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Health Canada acknowledged under-reporting as a “known and chronic issue” in a response to questions last month. In one case, the Star found a major breast implant maker — Mentor — failed to report incidents involving its own devices until the regulator caught the issue last year during an inspection.

The steps announced Thursday did not specifically address one of the key findings in the Star’s investigation: a connection between textured breast implants and a cancer called anaplastic large cell lymphoma (BIA-ALCL).

Plastic surgeons across the country told the Star they have serious concerns about the devices and have stopped using them. Several are calling for the devices to be removed from the market.

On Tuesday, France suspended sales of textured implants made by industry giant Allergan. The company issued a statement saying it “disagrees” with the decision but is co-operating with French health regulators.

On its website, Health Canada lists five Canadians confirmed with BIA-ALCL in the last 10 years — of which four are tied to textured implants. Two leading Canadian plastic surgeons have documented 25 cases — 23 of which they traced to textured implants. Globally, 615 cases of BIA-ALCL have been confirmed, overwhelmingly in patients with implants that have textured surfaces, according to data collected by our investigation.

“We should do the same (as France),” says Dr. Elizabeth Hall-Findlay, a Banff plastic surgeon who was one of the first to raise concerns about textured implants in a 2010 study that found elevated health issues in her own patients who had the devices.

On Thursday, Health Canada’s Sharma said the agency is aware of the French decision and is reviewing safety issues around textured implants.

“We’re having discussions internationally with our colleagues ... and based on that assessment we’ll decide if we need to take additional action here in Canada,” she said. “We received additional cases of cancer in Canadian patients over the summer. And so we’re re-looking at the assessment and also looking at additional information from published studies and from other international sources as well.”

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

“Women are sick. They are sick because they trusted the medical system when it said that the devices were safe. Health Canada needs to step up to the plate to help these women that they let down.”

Terri McGregor, another BIA-ALCL survivor who lives in North Bay, says that after two years of receiving a “dismissive” response from Health Canada in her attempts to raise breast implant health issues, Thursday’s announcement is striking.

“It sounds like the backrooms at Health Canada have been very busy,” says McGregor, 54. “Without (investigative reporting), … that response wouldn’t exist.

“It’s sad that that’s the way it has to go. However, I’m so grateful and so glad that this issue was finally given the priority that it needs.”

Sue Ross, a professor in the University of Alberta’s department of obstetrics and gynecology, called the government’s action plan impressive and comprehensive — but also years overdue.

Ross has done extensive research into pelvic meshes, inserted through a woman’s vagina to treat urinary incontinence or prolapsed pelvic organs. While the common procedure has dramatically improved the lives of many Canadian women, Ross said, there are patients who have suffered debilitating health problems.

By making public the reports Health Canada receives concerning adverse health events involving devices, researchers and doctors will be better able to capture problems “early on,” she said.

“I wish we had this 10 or 15 years ago and we could have prevented so much tragedy happening in women’s lives.”