Woman who had breast implants removed urges Ottawa to mandate registry of medical devices

Update - May 19, 2021:Health Canada says it's reviewing the situation and plans to publish a report later this summer about findings around medical device safety. It says it is also "actively considering options to increase transparency" by making more information available to patients.

A British Columbia woman who learned second-hand that her breast implants had been linked to a rare form of cancer is demanding that the federal government mandate a system of personalized recallalerts for all items surgically implanted in people's bodies.

To prevent cancer, Carmen Smith opted to have both of her breasts surgically removed and five months later received implants as part of her reconstructive surgery. Seven years later, she paid $10,000 to haveher breast implants removed after they were recalled by the manufacturer.

The 48-year-old mother of two, areal estate agentwho lives in Port Coquitlam, said she was shocked to learn that there's no central registry kept or required to ensure people with breast implants are notified personally if something goes awry.

She wants Canada to requiremanufacturers to create a registry and co-operate with surgeons to ensure patients are notified, as fast as possible, if something is even potentially wrong.

While the federal government says the responsibility fornotifying patients rests with manufacturers, not Health Canada,when an issuearises with an implant, plastic surgeons in Canada saythere's a real need for a government-mandatedregistry, noting that thousands of people in the country were affected by the breast implant recall.

"It's simply not acceptable that we have better measures in place for motor-vehicle recall we are talking about a medical device that is in human beings," Smith said.

When Smith learned about Allergan's Biocell textured implant recall from a news story in 2019, she had to hunt down her own medical records to confirm which implants were inserted inside her. Smith said she fears some people never realize they have recalled devices in their bodies.

On April 4, 2019, Health Canada announced its intentto suspendlicences for the Biocell implant as a precautionary measure due to "the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)."

At the end of May 2019,Allergan voluntarily recalled the product that had been surgically implanted in thousands of Canadians.

Regulations in place, Health Canada says

In an email to CBC News, Health Canada said it's notresponsible for tracking breast implants, and there are regulations in place, which were recently strengthened, to ensure thatmanufacturers take responsibility to notify patients.

But Smith saidthat didn't happen in her case.

"After my surgery, I was given a card with the serial and reference numbers for the devices that were placed in my body by my plastic surgeon," she said.

"I have always thought that it was odd that Allergan didn't contact recipients that had their products placed in them, because the card that I was given was how they keep a record for warranty purposes. [It's] so odd that they don't use the same system to alert recipients to recalls or any important information with respect to the implants."

Allergan Aesthetics, an AbbVie Company based in Dublin, declined an interview about this case but said in a statement to CBC News that itdoes work to inform patients. The company said Health Canada does not recommend the removal of textured breast implants in asymptomatic patients, adding,"Patient safety is Allergan Aesthetics' highest priority."

In 2011, Smith had a double mastectomy after she learned she was at a high risk for cancer.

"The doctor said you have two ticking time bombs on your chest and it's not if, but when," she said.

Sowhen she learned that her implants were linked to a rare cancer, she said she wanted them gone.

Her former plastic surgeon told her that the provincial Medical Services Plan would not pay for the removal of the devices unless it was deemed medically necessary, a fact confirmed by the Ministry of Health.

So Smith paid $10,000 toremove the implants, which she then learned had ruptured. After she paid for the removal in 2019,the Medical Services Plan clarified that removal of all textured implants would be covered if recommended by a physician.

WATCH | More cases of cancer linked to textured breast implants:

More cases of cancer linked to textured breast implants

5 years ago

Duration 2:34

A type of cancer linked to textured breast implants may be more common than initially thought. CBC News looks at why the number of cases for this rare cancer keeps increasing.

The surgeon found that silicone from the gel capsules had migrated into her chest cavity and lymph nodes.

Smith said she was shaken by the news, despite the fact she was told itwas not life-threatening.

'It created a lot of anxiety in the patients'

Smithsaid she remainsconvinced that symptoms from hot flashes to itchy skin that she had before removal are an autoimmune response related to the leaked silicone.

So she opted not to replace her implants, and she wants more communicationin place to alert people of problems with implants.

"I found out we have no tracking system for medical devices, which is in my mind deplorable," Smith said.

Dr. Nancy Van Laeken, a Vancouver plastic surgeon who removed Smith's implants, saida registry of patients with implants is "absolutely critical."

Van Laeken said Allergan's Biocellswere"sought-after" tear-drop-shaped textured implants,about the consistency of gummy bears, that created a more natural shape. So the recall affected thousands of patients in Canada, she said.

The Canadian Society of Plastic Surgeons (CSPS) discussed the issue of a registry with Health Canada for years, urging the government to take over, but to no avail, said Dr. Peter Lennox, who served as president of the CSPSfor the 2016-17 term.

For now, the societyhas set up an unofficial database and does its best to alert individual patients, he said, adding it's the group's position that the data in that registry should be managed by the government.

"One of our big disappointments was wediscovered that there really wasn't a registry. It created a lot of anxiety in the patients. We had difficulty tracking [patients]all down," Van Laekensaid.

Health Canada said manufacturers of medical devices such as implants are required to keep records of who did the procedure on whom and where. In the case of a recall, themanufacturer is also responsible for "developing communications to inform affected parties."

But the federal government is not responsible for the tracking of breast implants nor does it require a registry.

Now that patients are complaining they were not notified by Allergan, CBC News asked Health Canada what action it will take,but it hasnot yet received an answer.