Allergan Voluntarily Recalls BIOCELLĀ® Textured Breast Implants and Tissue Expanders
-- Global Action Follows Notification of Updated Safety Information from the
-- FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients --
-- Smooth and MICROCELL® Breast Implants and Tissue Expanders Not Impacted --
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 and unused products should be returned to
Patient safety is a priority for
Importantly, the
This global recall does not affect
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, |
Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, |
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. For all other countries, please use the contact details at the following link on
Adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- 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 1-800-
FDA -1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA -0178.
About
With colleagues and commercial operations located in approximately 100 countries,
For more information, visit
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect
CONTACTS:
Investors:
(862) 261-7162
(862) 261-7396
Media:
(862) 261 8820
+44 7725 758677
(862) 261-7320
View original content to download multimedia:http://www.prnewswire.com/news-releases/allergan-voluntarily-recalls-biocell-textured-breast-implants-and-tissue-expanders-300890213.html
SOURCE