TORONTO — Allergan PLC says it’s voluntarily recalling Biocell textured breast implants and tissue expanders worldwide, a move that follows Canada’s suspension of the product’s licences due to potential risks from cancer.
The international pharmaceutical company says in a press release from Dublin, Ireland that it’s issuing the recall as a precaution following recently updated safety information from the U.S. Food and Drug Administration.
However, Health Canada announced in May that it had suspended the licences for Biocell macro-textured breast implants after completing a safety review that was launched two years ago.
The Canadian agency said at the time that it had been notified of 22 confirmed Canadian cases of breast-implant-associated lymphoma involving Allergan’s Biocell breast textured implants, but no cases with smooth implants.
Allergan told Health Canada at the time it would voluntarily recall unused Biocell devices from the Canadian market.
The company now says healthcare providers worldwide should immediately stop using Biocell saline-filled and silicone-filled textured breast implants and tissue expanders, and unused devices are being recalled from all markets.