FDA

The FDA requested the recall of all BIOCELL textured implants and tissue expanders marketed in the United States based on newly submitted Medical Device Reports detailing worldwide cases of BIA-ALCL and BIA-ALCL related deaths associated with the devices... The recalled implants and tissue expanders share the same BIOCELL textured surface, used exclusively by Allergan. An FDA analysis indicates a new worldwide reported total of 573 cases of BIA-ALCL and 33 deaths. Of the 573 cases, 481 patients are reported to have had BIOCELL implants at the time of diagnosis... On July 24, 2019, Allergan announced a global recall of its BIOCELL textured breast implants and tissue expanders following a US Food and Drug Administration (FDA) requested recall. 1

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