Biocell breast implants pulled from sale in Canada

A brand of breast implant that has been linked to a rare form of cancer has been barred from Canada, following a joint investigation by CBC News, Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists.

Health Canada said Tuesday it has suspended the licences of Ireland-based Allergan for its Biocell implants, after finding “significantly higher” rates of a type of non-Hodgkin lymphoma among patients with macro-textured breast implants.

Biocell implants are the only macro-textured implants available in Canada, the agency said in a statement.

They have been linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma that attacks the immune system. It is not a cancer of breast tissue.

The suspension prohibits the sale or import of five Biocell products in Canada.

The joint investigation found deaths and serious injuries potentially tied to breast implants and other medical devices are underreported in many countries, including Canada.

Health Canada asked the company for more evidence on the benefits of the devices, but said the response was “insufficient.”

Allergan said it has recalled its implants from Canada but stands behind their safety.

“The company plans to explore options to appeal this decision with Health Canada,” the company said in a statement.

Removal not recommended

Health Canada said it has been notified of 26 confirmed cases of BIA-ALCL in Canada, of which 22 (85 per cent) involve Biocell implants.

The agency estimates the risk of BIA-ALCL are one in 3,565 with Biocell macro-textured breast implants, compared to one in 16,703 for a brand of micro-textured breast implants from another manufacturer.

“No cases of BIA-ALCL have been reported in Canada with any smooth surface implants,” Health Canada said.

Removing Biocell or other implants is not recommended if the person doesn’t have any signs or symptoms suggesting BIA-ALCL, the agency said. People are encouraged to speak to the health-care professional about the risks and benefits of removal.

Rough surface

Textured breast implants have a rough surface that is sometimes compared to sandpaper, the International Consortium of Investigative Journalists said. Unlike smooth-surfaced implants, they adhere to the tissue around them, preventing sliding, surgeons say.

France has also pulled macro-textured implants from its market.

Other regulators including the U.S. Food and Drug Administration and health ministries in Italy and Spain, have reviewed textured implants and their BIA-ALCL risk without pulling them, Allergan said.

Last September, Vancouver-based plastic surgeon Dr. Nick Carr and his team published a study in the journal Plastic and Reconstructive Surgery suggesting, of all the implant types examined, Biocell textured implants had the shortest lifespan.

After a “honeymoon period” of about five to 10 years, Canadian women with Biocell implants started to experience tearing, bleeding and inflammation that could also be part of the genesis of BIA-ALCL, Carr told CBC News.

“The interesting thing is that the experience with these implants in the U.S. is about five years or so behind Canada because we had approval to use them earlier,” he said.

He says setting up a system for reporting potential problems in Canada would serve the public better.

“There’s never really been a co-ordinated collection of adverse event reporting that’s been of any use of patients or physicians in this regard.”

‘Sending a message’

By barring the implants from Canada, health authorities are “sending a message to Canadian women,” according to Terri McGregor of North Bay, Ont., who had eight rounds of chemotherapy after she was diagnosed with BIA-ALCL. A routine mammogram at age 50 had ruptured her Biocell textured implants, which surgeons had to remove along with scar tissue.

Health Canada is “stepping away from the FDA legacy of being in their shadow,” McGregor said.

As part of the recall, any unused Biocell saline-filled and silicone-filled textured breast implants (medical device licences 3112, 72262, 72263, 87277 and 87279) will be removed from the Canadian market.

Health Canada’s information on breast implants, including what you should ask the surgeon, is provided on the breast implant section on Canada.ca.

Canadian patients or health-care professionals who have questions about Biocell breast implants can contact the company’s medical information team: [email protected] or 1-800-668-6424.