medical Class I Updated 2019-09-18

Allergan PLC recalls Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Hei

Recalled Product

Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE 133LV-T: 133LV-11-T, 133LV-12-T, 133LV-13-T, 133LV-14-T, 133LV-15-T, 133LV-16-T; STYLE 133SV-T: 133SV-11-T, 133SV-12-T, 133SV-13-T, 133SV-14-T, 133SV-15-T, 133SV-16-T STYLE 133FX-T: 133FX-11-T, 133FX-12-T, 133FX-13-T, 133FX-14-T, 133FX-15-T, 133FX-16-T; STYLE 133MX-T: 133MX-11-T, 133MX-12-T, 133MX-13-T, 133MX-14-T, 133MX-15-T, 133MX-16-T; STYLE 133SX-T: 133SX-11-T, 133SX-12-T, 133SX-13-T, 133SX-14-T, 133SX-15-T, 133SX-16-T; 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.

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; Product Code/UDI STYLE 133FV-T: 133FV-11-T 10888628004221, 133FV-12-T 10888628004238, 133FV-13-T 10888628004245, 133FV-14-T 10888628004252, 133FV-15-T 10888628004269, 133FV-16-T 10888628004276; STYLE 133MV-T: 133MV-11-T 10888628004405, 133MV-12-T 10888628004412, 133MV-13-T 10888628004429, 133MV-14-T 10888628004436, 133MV-15-T 10888628004443, 133MV-16-T 10888628004450; STYLE 133LV-T: 133LV-11-T 10888628004344, 133LV-12-T 10888628004351, 133LV-13-T 10888628004368, 133LV-14-T 10888628004375, 133LV-15-T 10888628004382, 133LV-16-T 10888628004399; STYLE 133FX-T: 133FX-11-T 10888628004283, 133FX-12-T 10888628004290, 133FX-13-T 10888628004306, 133FX-14-T 10888628004313, 133FX-15-T 10888628004320, 133FX-16-T 10888628004337; STYLE 133MX-T: 133MX-11-T 10888628004467, 133MX-12-T 10888628004474, 133MX-13-T 10888628004481, 133MX-14-T 10888628004498, 133MX-15-T 10888628004504, 133MX-16-T 10888628004511; STYLE 133SX-T: 133SX-11-T 10888628004580, 133SX-12-T 10888628004597, 133SX-13-T 10888628004603, 133SX-14-T 10888628004610, 133SX-15-T 10888628004627, 133SX-16-T 10888628004634; STYLE 133SV-T: 133SV-11-T 10888628004528, 133SV-12-T 10888628004535, 133SV-13-T 10888628004542, 133SV-14-T 10888628004559, 133SV-15-T 10888628004566 133SV-16-T 10888628004573

View official government recall

Were you affected by this recall?

If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Get the next US recall alert before it hits the news.

Free. Weekly digest or instant alerts. Unsubscribe anytime.

CAN-SPAM compliant · No spam · Unsubscribe anytime