National breast implant registry much needed but long overdue, patients and doctors say

A House of Commons health committee is studying the feasibility of a national breast implant registry, something advocates have been calling for since the 1990s. (Benoit Tessier/Reuters - image credit)
A House of Commons health committee is studying the feasibility of a national breast implant registry, something advocates have been calling for since the 1990s. (Benoit Tessier/Reuters - image credit)

Patients and doctors are applauding the news that Canada might eventually have a national registry for breast implants, describing it as a big step for public safety, but say it should have happened long ago.

During a meeting on Tuesday, the House of Commons Standing Committee on Health heard submissions for a study examining the feasibility of creating a nationwide registry. The news follows years of advocacy by women who've been harmed and joint investigations from CBC, Radio-Canada and the Toronto Star into the potential dangers of the implants, which can include cancer and autoimmune disorders.

Julie Elliott, the Canadian representative for the Breast Implant Safety Alliance and spokesperson for the Breast Implant Failure and Illness Society of Canada, said a registry that includes data on all implants in this country is long overdue.

"To me, it's something that should have happened the moment breast implants started to be manufactured in 1964," she told CBC.

She argues that it's strange for foreign objects to be placed in the human body with no way for patients and their doctors to track any problems with those devices.

"If you have a car and … something happened with this car, there's a recall, you're going to automatically receive an email or card stating that you have to go to your dealership to deal with that problem," Elliott said.

The federal feasibility study will look at what information might be included in a national registry and how it might function once it's in place.

Health Canada spokesperson Mark Johnson said the federal agency will consider the committee's study and provide a formal response at that time.

"Any next steps with respect to a breast implant registry would heavily depend on its purpose, structure, and design," Johnson wrote in an email.

He described a breast implant registry as a "complex endeavour" that would require participation and coordination from multiple levels of government.

'Nobody has been willing to take responsibility'

Some advocates argue that a national registry with details of every implant performed in Canada is necessary to make sure researchers and patients can track illnesses, injuries and other information.

Nancy Pratt says there have been calls for something like this dating back to the 1990s.

Pratt, the B.C.-based president of the Breast Implant Failure and Illness Society, suffered permanent harm after the breast implants she received in the 1990s ruptured. She later learned that her implants had been recalled, but no one had informed her.

"Everybody is making money off breast implants and nobody has been willing to take responsibility for tracking them," Pratt said.

As recently as January or February of this year, she's heard from women who've made similar discoveries to her own.

"Women are still finding out that their implants were recalled in 2018, 2019 — and they had no idea," Pratt said.

She added that any registry shouldn't just be limited to implants, but should also include other materials like mesh and clips that may also be placed inside the body during implant surgery.

"Nobody should have a device that has been recalled or carries a safety warning and they're not aware of it," Pratt said.

Lennox Cosmetic Surgery
Lennox Cosmetic Surgery

News of a potential registry came as a bit of a surprise to Dr. Peter Lennox, a clinical professor of plastic surgery at the University of B.C.

He recalled reaching out to Health Canada in 2017 to recommend creating a registry, in his role as a member of the executive for both the Canadian Society of Plastic Surgeons and the Canadian Society for Aesthetic Plastic Surgery.

"Nothing progressed. We had multiple conference calls and meetings with them, and there was no resolution," Lennox said.

Other countries already do it

Lennox said he's glad to hear a registry might finally happen, although there are many questions that will need to be answered first, including whether reporting is mandatory, who controls the database, who has access to it and how it's funded.

"There's multiple other countries which have very robust breast implant registries and there's been lots of research done on what makes up a good registry," he said.

"They don't have to reinvent the wheel."

One of those registries is in the Netherlands, where Dr. Jan Willem Cohen Tervaert began studying complications caused by breast implants in the 1990s.

Now a professor of medicine at the University of Alberta, Cohen Tervaert said a series of scandals involving the manufacturers of implants have made registries necessary.

"It's clear that the medical device industry and especially the breast implant medical device industry need more supervising, and authorities are failing to do so," he said.

Craig Chivers/CBC
Craig Chivers/CBC

He pointed to the example of Poly Implant Prothèse, a French company that was revealed in 2010 to be selling implants made from industrial-grade silicone rather than the mandatory medical-grade product. The company's founder ended up in prison for fraud as a result.

"The problem there was that nobody had a registry of implants. So while it was said that the implant should be removed, nobody knew which patients did have these implants," Cohen Tervaert said.

He noted that in the Netherlands, the cost of the registry is now covered by patients, who pay the equivalent of about $40 when they have surgery. The registry operates on an opt-out basis, which it's mandatory unless patients choose for their information not to be included in the database.