Allergan Voluntarily Recalls BIOCELL Textured Breast Implants and Tissue Expanders
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
-- Global Action Follows Notification of Updated Safety Information from the?U.S. Food and Drug Administration?(FDA) --?
-- FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients --
--?Smooth and MICROCELL??Breast Implants and Tissue Expanders Not Impacted --
DUBLIN,?July 24, 2019?/PRNewswire/ --?Allergan plc?(NYSE: AGN) today announced a voluntary worldwide recall of BIOCELL??textured breast implants and tissue expanders.?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).
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?Allergan.?Allergan?will provide additional information to customers about how to return unused products.
Patient safety is a priority for?Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.
Importantly, the?FDA?and other health authorities have not recommended removal or replacement of textured breast implants?or tissue expanders?in asymptomatic patients.
This global recall does not affect?Allergan's?NATRELLE??smooth or MICROCELL??breast implants and tissue expanders.
The recalled products include:
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?Allergan's?website:?Allergan Global Medical Information Contacts.
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.
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 |
- 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.