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Health Canada bans certain Allergan breast implants due to cancer risk

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Health Canada bans certain Allergan breast implants due to cancer risk

Canada's public health regulator has banned Allergan PLC's Biocell breast implants after a safety review found that there was an increased risk of cancer in patients who have the implants.

Health Canada said in a May 28 recall alert that the rate of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, is higher with Allergan's devices. This type of lymphoma can occur in patients many months or years after a breast implant procedure. So far, 26 cases of BIA-ALCL have been reported, and 22 of those patients had Allergan's Biocell implants.

Allergan's license to sell the implants in Canada was suspended on April 4 pending a more in-depth safety review. The company supplied the regulator with more information during the review period, but ultimately, Health Canada determined that the risk associated with the breast implants outweighs the benefits, and the license has been suspended permanently.

The Dublin-based company is voluntarily recalling all unused Biocell devices from the Canadian market. Other breast implants manufactured by the company are not affected by the decision.

Allergan pulled the breast implants from the European market in December 2018 after a regulatory approval expired amid a number of investigations into the safety of the devices. The U.S. Food and Drug Administration identified a possible link between lymphoma and breast implants in 2011 and strengthened that assessment in August 2017.

The Biocell implants are textured to stick to the body's tissue and stay in position over time. This type of breast implant has been linked with lymphoma. Allergan's Biocell products, specifically, have a more aggressive form of texturing and a higher level of lymphoma cases have been linked to the products.

As a result of the safety review, Health Canada plans to work with breast implant manufacturers to strengthen the instructions for use on devices that have a risk of BIA-ALCL, among other regulatory steps. Patients who have the Biocell implants should discuss the risks with their doctors, but the removal of the devices is not recommended in cases without signs of BIA-ALCL.

Shares of Allergan fell just over 3% to $131.41 as the market closed May 28.