There have been more than 500 cases of anaplastic large cell lymphoma (BIA-ALCL) linked to textured breast implants worldwide.
“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 to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Dr. Amy Abernethy said in a statement.
On Wednesday, the FDA also updated the number of cases of BIA-ALCL to 573 total worldwide. Of those cases, 481 are attributed to Allergan implants. Thirty-three women have died.
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