Allergan has announced a voluntary worldwide recall of its BIOCELL textured breast implants and tissue expanders. The company said it is taking this action as a precaution following notification of recently updated global safety information concerning breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).
BIOCELL saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new BIOCELL textured breast implants and tissue expanders. Unused products should be returned to Allergan.
The company notes that the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.
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
The global recall does not affect Allergan’s NATRELLE smooth or MICROCELL breast implants and tissue expanders.
U.S. healthcare providers with questions regarding the recall can contact Allergan Medical Information at 800.678.1605, option #2 or [email protected]. For all other countries, visit allergan.com>Allergan Global Medical Information Contacts.
Adverse events or problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 800.FDA.1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 800.FDA.0178.
