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Health Canada advises Allergan of its intent to suspend its licences… — public safety notice 59319

Government of Canada recall portal · Canada · 2019-04-04

As described by Government of Canada recall portal: Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure

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Agency
Government of Canada recall portal
Recall identifier
59319
Date of alert
2019-04-04
Country / jurisdiction
Canada
Notice type
recall
Product category
Medical devices
Product type
Communications and Public Affairs Branch
Reported risk: On April 17, Health Canada received a response from Allergan. Departmental experts are currently reviewing this information. Canadians and healthcare professionals will be informed of any further decisions related to the licensing of Biocell breast implants once this review is complete. Original Information Update – April 4, 2019 This follows the completion of Health Canada's scientific assessment of macro-textured implants, as part of its larger ongoing safety review of breast implants and BIA-ALCL, which was launched in November 2018. Health Canada initiated the review because of an increase in Canadian and international cases of BIA-ALCL. As of today, Health Canada has been notified of 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86%) involve Allergan's Biocell breast implant.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/health-canada-advises-allergan

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