May 31, 2019 — Allergan has recalled all textured breast implants in Canada due to the risk of cancer.
Textured implants, which have a rough surface, are linked to a rare cancer called Anaplastic Large Cell Lymphoma (ALCL). The cancer can develop within months or years after breast implant surgery.
Health Canada suspended Allergan’s licenses for textured breast implants based on the results of a 2017 safety review, which found a “significantly higher” risk of cancer from textured breast implants:
As a result, because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).”
Health Canada found 26 reports of women in Canada with breast implants who developed ALCL, with 85% of those women implanted with Allergan’s Biocell textured implants. No cases of ALCL have been linked to smooth breast implants in Canada.
Researchers estimate that the risk of ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants.
Allergan pulled all textured breast implants off the market in Europe in December 2018 after French regulators demanded a recall.
In the United States, the FDA is still investigating the safety of textured breast implants.
In February, the FDA said that it has received reports of 457 women who developed cancer due to breast implants since 2010, including 246 new cases since 2017 and 9 women who died.
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