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FDAJuly 24, 2019device

McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

What to do

FDA enforcement status: Ongoing

Brands named

allergan plcallergan

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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