medical Class I Updated 2019-09-18

Allergan PLC recalls Natrelle and McGhan Silicone-Filled Breast Implants, TruForm

Recalled Product

Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots: Note:This product was not distributed within the US
View official government recall

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