July 24, 2019
Dear Valued Implant Customer,
Today, Allergan announced a voluntary worldwide recall of BIOCELL® textured breast implants and BIOCELL® textured tissue expanders. Allergan is taking this global action as a precaution after being notified 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).
Effective immediately, Allergan recommends that healthcare providers cease implanting BIOCELL® textured breast implants and BIOCELL® textured tissue expanders and requests that all unused product be returned to Allergan. Allergan will be providing guidance on how to return unused product.
It’s important to note that the FDA and other health authorities do not recommend the removal or replacement of textured breast implants or textured tissue expanders in asymptomatic patients.
FDA issued a press release today announcing the voluntary recall. In this press release, FDA included a section entitled “Recommendations for Health Care Providers”, as well as a section for patients entitled “Patients: Important Recommendations If You Have Allergan BIOCELL Breast Implants”. You should review FDA’s press release which can be found at
https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders. NATRELLE® smooth breast implants and smooth tissue expanders will continue to be available to physicians and for patients.
The recalled products include:
| Natrelle Saline Breast Implant Styles 168, 363, 468 |
| Natrelle 410 breast Implant Styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX |
| Natrelle INSPIRA Breast Implant Styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX |
| Natrelle Round Gel Implant Styles 110, 115, 120 |
| Natrelle 133 Tissue Expanders with and without Suture Tabs Styles 133FV, 133MV, 133LV, 133FX, 133MX, 133SX, 133SV, 133FV-T, 133MV-T, 133LV-T, 133FX-T, 133MX-T, 133SX-T, 133SV-T |
| Natrelle 133 Plus Tissue Expander Styles 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-FX-T, 133P-MX-T, 133P-SX-T, 133P-SV-T |
As you know, patient safety is of primary importance to Allergan. All breast implant patients should discuss benefits and risk of breast implants along with any specific concerns with their plastic surgeon.
Allergan will continue to partner with global health authorities on patient registry initiatives including Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) and National Breast Implant Registry (NBIR) as we believe these registries will promote better understanding of patients’ experiences with breast implants.
U.S. healthcare providers with questions regarding this announcement should 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.
Sincerely,
Richard Egan
VP Marketing, Plastic and Regenerative Medicine
Allergan, Inc.
