Allergan has finally issued a worldwide recall of the breast implants it has been putting into human bodies for years after they were linked to a rare form of cancer.
The move comes after France and Canada banned textured breast implants, including Allergan’s Biocell version, back in April after a review found links to a type of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Australia followed suit earlier this month after its own review, and at least 35 other countries have banned the breast implants.
While the U.S. Food and Drug Administration had ruled earlier this year that the implants could stay on the market, the agency appears to have succumbed to pressure and asked Allergan to remove them from the U.S. market. Allergan will just have to rely on sales of Botox to make up the difference to its bottom line.
The textured breast implants, which have a rough surface to prevent slippage and minimize scar tissue, are reportedly more common in Europe. While they account for just 5% of the breast implants in the U.S., an analysis from the FDA found that the risk of lymphoma was approximately six times greater with Allergan’s model than for other manufacturers’ textured implants.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” FDA commissioner Amy Abernethy said in a statement announcing the recall.
The FDA also updated the number of cases of BIA-ALCL to 573 total worldwide, 481 of which are attributed to Allergan implants. Thirty-three women have died.
Currently, the FDA is not recommending that women with the implants have them removed, unless they are experiencing problems.