Health Canada Plans to Suspend Allergan's Breast Implant License

By Reuters Staff

April 05, 2019

(Reuters) - Health Canada said on Thursday it was advising Allergan Plc of the regulator's plans to suspend the license for the Botox-maker's Biocell breast implants, after a review regarding the risk of a rare cancer linked to breast implants.

The health regulator said its move followed the completion of its assessment of textured breast implants as part of a larger ongoing safety review.

Allergan's Biocell implant is the only macro-textured device available in Canada.

Textured breast implants, which have a rough surface, have been linked to a rare type of cancer called anaplastic large cell lymphoma.

The company did not immediately respond to a request for comment.

Health Canada said it was monitoring all available scientific information regarding the safety of textured breast implants, including new evidence to be provided by Allergan in the next 15 days.

If the health regulator does not receive a satisfactory response by then, it would suspend the license to sell the Biocell implants in Canada, Health Canada said in a statement on Thursday.

Allergan stopped the sale of its textured breast implants in Europe in December, a day after they were recalled by France's National Agency for the Safety of Medicines & Health Products due to non-renewal of their safety certification by another agency.