Due to a link between Allergan’s Biocell textured breast implants and tissue expanders and cancer, Allergan has officially issued a worldwide recall. This recall comes after the U.S. Food and Drug Administration made the request recently.
“Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA),” according to a press release by Allergan.
According to Dr. Binita Ashar, director of the office of surgical and infection control devices at the FDA during a press conference today, the FDA estimates hundreds of thousands of women have these implants.
The recalled products include:
|Natrelle Saline breast implant styles 168, 363, 468|
|Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX|
|Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX|
|Natrelle 510 Dual-Gel styles LX, MX, FX|
|Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX|
|Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch|
|Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM|
|Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM|
|Natrelle 150 Full Height and Short Height double lumen implants|
|Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T|
|Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T|
U.S. healthcare providers with questions regarding this announcement can contact Medical Information at 1-800-678-1605 option #2 or IR-Medcom@allergan.com.