medical Class I Updated 2019-09-18

Allergan PLC recalls Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breas

Recalled Product

Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF 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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