Canada’s health regulators suspended Allergan’s licenses for textured breast implants after a safety review found a “significantly higher” risk of ALCL when textured implants were compared to smooth implants.

The cancer is rare, but it can develop within a few months or several years after a woman gets breast implants.

Health Canada identified 26 women with breast implants who developed ALCL and all of them had textured implants. Twenty-two of the women had Allergan’s Biocell macro-textured implants.

The agency concluded that “the potential risks associated with the implants outweigh their benefits.”

The researchers estimate that women with Allergan’s macro-textured breast implants have a 1 in 3,565 chance of developing lymphoma.

Allergan has already pulled all of their textured breast implants off the market in 38 countries, but they remain available in the United States, where the FDA continues to investigate the safety risks.

In Europe, Allergan withdrew all textured breast implants in December 2018 after French regulators demanded a recall.

Earlier this year, the FDA identified 457 women who had developed ALCL due to their breast implants since 2010, including 9 women who died. There have been at least 246 new cases since 2017, the majority of which occurred in women with textured breast implants.

Source: Canada bans Allergan Biocell breast implants

Posted by Elizabeth Bradley

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