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Canada may soon get a breast implant registry. Why experts, patients say it’s crucial

Judith Coates, a cancer survivor from Orillia, Ont., had her breast implant for six months before feelings of chest pain, blurry vision and breathing difficulty started to take hold of her health. She even started dropping things as she said she had numbness in her hands.

In 2015, Coates had a textured silicone implant after undergoing a mastectomy on her right breast. After years of pain, she decided to remove the implant in 2018, believing the silicone was making her sick.

She was right.

“I woke up from the operating table and I immediately felt like that elephant was gone from my chest,” she said. “I could take a deep breath and gradually (most of) the other symptoms went away as well.”

After the removal, she had her implant tested and got a report back that stated the silicone was leaking out of it.

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“The silicone did not stay in the implant … I know it was the silicone affecting my body that was giving me all those symptoms,” she said.

Coates believes more regulation is needed when it comes to breast implants. Not only should women be made aware of the danger involved, but setting up a database would help track patients when an implant recall is issued.

She is happy that Canada is starting to take a step forward toward the latter.

In a meeting on Tuesday, the House of Commons Health Committee launched a study into whether Canada should implement a national breast implant registry.

“A breast implant registry could be proposed for two different broad purposes,” said David Boudreau, the director general at Health Canada. “It could serve to support patient safety notifications, also referred to as ‘track and trace,’ or have a research purpose, or both.”

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He added that the cost of a registry would “be quite expensive,” but did not detail a price tag.

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The study was first proposed in February 2022 by Quebec MP Luc Theriault, who is also vice-chair of the health committee. A central breast implant registry would make it mandatory for practitioners who implant, remove or replace breast implants to enter certain data into the registry.

“The trouble we’ve had in this … stems from the fact that the problems, in many instances, emerge 10, 15 or 20 years later,” Theriault stated at the time.

“The practitioners in question are often retired or no longer in the picture. Since there’s no registry, the women who are dealing with the problems or who are unaware of any potential problems can’t verify what was implanted in them.”

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Other countries, such as the United States, Australia and the Netherlands, have national breast implant registries as ways to collect data on the safety and effectiveness of the procedure.

In the Netherlands, the cost of the registry falls on the patient, who pays the equivalent of about C$40 when they have surgery (it is covered by insurance if it is a medical procedure and not cosmetic).

Juliana Wu, the director of Acute and Ambulatory Care Information Services at CIHI, spoke at the meeting earlier this week, saying in order to establish a registry for breast implants, it’s important to get the data from the surgeon to the patient.

The problem with that, she said, is many breast implant surgeries are done at private clinics, so there will have to be a “willingness of providers and patients to participate.”

In an email to Global News on Wednesday, Health Canada said the registry is a “complex endeavour and important challenges and considerations would need to be addressed.”

“Aspects would be related to health-care services and the regulation of health-care professionals which is a provincial and territorial responsibility. In addition, a high degree of participation and coordination across multiple levels of government would be required for a registry to be useful and leveraged by the different parties,” a spokesperson stated.

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Coates said for women like her, who have personally experienced a health problem relating to breast implants, even the government’s willingness to hold a meeting about the topic is a step in the right direction.

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“I’m just really pleased to hear that the House of Commons has stepped up and some members of Parliament are taking this on, and they’re putting it on the agenda,” she said.

Coates is part of a breast implant illness Facebook group and said it plans on putting together a submission requesting to be heard in person for the next meeting on the registry.

‘I see so many patients who suffer’

There are many safety issues connected with breast implants, including recalls, cancers and autoimmune illnesses.

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In April 2019, Health Canada moved to ban textured silicone breast implants made by Allergan under the name Biocell. This was due to a link between these implants and a rare form of cancer called breast implant-associated large-cell lymphoma.

There are other risks too.

Aside from the general risks of any surgery, as the tissue around the implant heals, it creates a “capsule” of scar tissue surrounding the implant. If that grows improperly, it can distort the implant or make the breast feel harder to the touch – a condition known as “capsular contracture.”

And then there is breast implant illness, which is not an official medical term, but a term used — often by patients or doctors — to describe a constellation of symptoms believed to be caused by breast implants.

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Dr. Jan Willem Cohen Tervaert, director of rheumatology at the University of Alberta’s medical school, has spent decades studying and detailing connections between breast implants and autoimmune illnesses, or Breast Implant Illness (BII).

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“The complaints are mainly fatigue, widespread pain in joints and muscles, very dry eyes, very dry mouth, feverish feelings, cognitive impairments and sometimes strokes and multiple sclerosis by cortex at a very young age,” he explained. “So these can be quite severe, these complaints, and it is coming more and more out in the literature.”

In fact, the FDA has issued BII as a risk associated with breast implant surgery. Health Canada does not mention BII on its website.

Because of the safety issues, Cohen Tervaert believes it’s important that a national breast implant registry is on the agenda, even if it’s in the early stages.

“I see so many patients who suffer a lot from these implants and who are very happy that they are finally removed,” he said.

He’s hoping the Canadian government will form the registry as an “opt-out” option, as is done in the Netherlands. This means all plastic surgeons are required to register the implants in the system except when the patient refuses to be included on the registry.

— with files from Leslie Young, Laura Hensley