(Reuters) – Allergan Plc said on Tuesday it will voluntarily recall and stop the sale of its Biocell textured breast implants in Canada after the country’s health agency suspended the company’s licenses for the implants, citing increased risk of cancer.
The Botox-maker in December took its textured breast implants off the market in Europe after a French regulatory body ordered a recall.
Textured breast implants, which have a rough surface and are more commonly used in Europe than in the United States, have been linked to a rare type of cancer known as breast-implant associated anaplastic large cell lymphoma (BIA-ALCL).
The potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada said here on Tuesday.
Health Canada’s decision is in contrast to public rulings and positions by other regulatory bodies around the world, including the U.S. Food and Drug Administration’s (FDA) recent position, Allergan said.
The FDA said in May it would not ban textured breast implants at this time as it investigates the implant and raises awareness related to safety of these devices.
The recall does not impact Natrelle smooth implants, Allergan said, adding it would explore options to appeal the Canadian health regulator’s decision.
Shares of the drugmaker closed down 3% at $131.4 on Tuesday.
MAY 28, 2019