Allergan, Inc. has announced a voluntary recall of its Biocell textured breast implants in Canada, following reports linking the devices to a rare form of cancer called anaplastic large cell lymphoma.
Health Canada suspended Allergan’s license to sell Biocell breast implants in April. The move came after a review found that 24 of 28 Canadian women with BIA-ALCL had received the textured breast implants prior to their diagnosis.
In a May 28th statement, Allergan said it “stands firmly behind the benefit / risk profile of its breast implant products,” and would explore options to appeal this decision with Health Canada.
For the time being, however, the company is removing Biocell textured implants from the Canadian market. Allegan’s Nattrelle smooth implants and tissue expanders are not impacted by the Canadian license suspension or voluntary recall.
ALCL is slow-growing form of non-Hodgkin’s lymphoma that develops in the scar capsule that eventually develops around breast implants. Signs and symptoms of the disease include:
Breast implant associated (BIA) ALCL is highly treatable when detected early. Women who have the disease undergo surgery to remove their breast implants and any masses, but may also require chemotherapy and radiation if the cancer has spread beyond the scar capsule.
Roughly 93% of patients who undergo treatment remain disease free three years later. When patients have died, diagnosis and treatment were delayed an average of two years after symptoms first appeared.
Allergan recalled Biocell breast implants in Europe last December, after ALCL concerns also prompted French regulators to suspend their marketing certification.
At least 457 women in the United States have developed BIA-ALCL, including 9 who died. Six hundred cases, including 17 deaths, have been reported worldwide. Most victims received textured breast implants.
Yet the FDA recently decided not to ban textured breast implant, and indicated it would instead take steps to raise awareness about their risks.