Women who remove breast implants urge Ottawa to authorize medical device registration

A woman in British Columbia learned from second-hand information about her breast implants and a rare type of cancer. She asked the federal government to develop a personalized recall alert system for all items implanted in the human body through surgery. .

To prevent cancer, Carmen Smith chose surgery to remove both breasts and underwent implantation surgery five months later as part of her reconstructive surgery. Seven years later, she paid $10,000 to remove the breast implant after the manufacturer withdrew it.

The 48-year-old mother is a two-year-old mother who lives in Port Coquitlam and works as a real estate agent. She was shocked to learn that there is no central registry or request that the central registry ensure that the breast implant can be notified in person if there is a problem.

She hopes that Canada will require manufacturers to create registration forms and work with surgeons to ensure that patients are notified as soon as possible even if there is a possible problem.

The federal government stated that the responsibility for notifying patients lies with the manufacturer, not Health Canada, and when there is a problem with the implant, Canadian plastic surgeons stated that a government-authorized registration agency is indeed required and pointed out that the country has thousands Of people are affected by the recall of breast implants.

Smith said: “We cannot take better measures to recall cars. This is simply unacceptable. We are talking about medical equipment in humans.”

When Smith learned from the 2019 news that Allergan’s Biocell textured implants were recalled, she had to look for her medical records to confirm which implants had been inserted into her body. Smith said she is worried that some people will never realize that they have recalled the device in their body.

On April 4, 2019, Health Canada announced its intention to suspend licenses Due to the “rare but serious risk of anaplastic large cell lymphoma (BIA-ALCL) associated with breast implants”, Biocell implants are used as a preventive measure.

At the end of May 2019, Allergan voluntarily recalls the product Thousands of Canadians have been surgically implanted.

Health Canada says regulations are in place

In an e-mail to CBC News, Health Canada stated that it is not responsible for tracking breast implants and has enacted regulations that have recently been strengthened to ensure that manufacturers have a responsibility to notify patients.

But Smith said that it did not happen in her case.

She said: “After the operation, I got a card with the serial number and reference number of the device my plastic surgeon placed in my body.”

After the product was associated with anaplastic large cell lymphoma (a rare cancer) associated with breast implants, the company recalled a Biocell-textured breast implant from Allergan Aesthetics in May 2019. (CBC)

“I always thought it was strange that Allergan didn’t contact the recipient with the product, because the card I received was the way they recorded it for warranty purposes. [It’s] It’s so strange that they didn’t use the same system to remind recipients about implant recalls or any important information. “

Allergan Aesthetics, a Dublin-based AbbVie company, declined to be interviewed on the case, but said in a statement to CBC News that it can indeed inform patients. The company stated that Health Canada does not recommend the removal of textured breast implants in asymptomatic patients, adding: “Patient safety is the top priority of Allergan Aesthetics.”

Smith underwent two mastectomy procedures in 2011 after learning that he was at a high risk of cancer.

She said: “The doctor said you have two time bombs on your chest, not when, but when.”

Therefore, when she learned that her implants were related to a rare cancer, she said she hoped they would disappear.

Her former plastic surgeon told her that the provincial medical service plan would not pay for the removal of these equipment unless deemed medically necessary, and the Ministry of Health confirmed this fact.

So Smith spent $10,000 to remove the implant, and then she learned that the implant was broken.

Watch | More cancer cases related to textured breast implants:

A type of cancer associated with textured breast implants may be more common than originally thought. CBC News explored why the number of cases of this rare cancer continues to increase. 2:34

The surgeon discovered that the silicone in the gel capsule had migrated to her chest cavity and lymph nodes.

Smith said that although she was told that it was not life-threatening, she was shocked by the news.

“It caused a lot of anxiety among patients”

Smith said she still firmly believes that her symptoms (from hot flashes to itchy skin) before the removal were autoimmune reactions related to silicone leaks.

Therefore, she chose not to replace the implant. She hoped that there would be more communication to remind people of the implant problem.

Smith said: “I found that we don’t have a tracking system for medical equipment, which is regrettable in my opinion.”

Dr. Nancy Van Laeken, a plastic surgeon in Vancouver who removed Smith’s implant, said that the registration of implant patients is very important.

Van Laeken said that Allergan’s Biocells are “buy” teardrop-like texture implants, which are related to the consistency of the gummy bear and can create a more natural shape. She said the recall has affected thousands of patients in Canada.

Dr. Peter Lennox, who served as the chairman of CSPS, said that the Canadian Society of Plastic Surgeons (CSPS) has discussed the issue of registry with Health Canada for many years and urged the government to take over, but to no avail. 17 semesters.

He said that at present, the association has established an unofficial database and tried its best to remind individual patients, adding that the group’s position is that the data in the registry should be managed by the government.

Vancouver plastic surgeon Dr. Nancy Van Laeken said that the Canadian Association of Plastic Surgeons and Health Canada have discussed registration issues for many years, but to no avail. She said that the registration of implant patients is very important. (Maggie MacPherson/CBC)

“One of our biggest disappointments is that we found that there is indeed no registration system. It caused great anxiety for patients. It is difficult for us to track [patients] It’s all down. “Van Lyken said.

Health Canada says that manufacturers of medical devices (such as implants) must keep records of who and where the operation was performed. In the case of a recall, the manufacturer is also responsible for “developing communications to notify the affected party.”

But the federal government is not responsible for tracking breast implants, nor does it require a registration agency.

Since the patients complained that Allergan had not notified them, CBC News asked Health Canada what measures would be taken, but has not yet received an answer.

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