Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders

Summary

Company Announcement Date:: July 24, 2019
FDA Publish Date:: July 25, 2019
Product Type:: Medical Devices
General & Plastic Surgery
Reason for Announcement:: Recall Reason Description

Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
Company Name:: Allergan plc
Brand Name:: Brand Name(s)
Product Description:: Product Description

BIOCELL® textured breast implants and tissue expanders

Company Announcement

— 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:

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 [email protected]. For all other countries, please use the contact details at the following link on Allergan’s website: Allergan Global Medical Information Contacts.

Adverse reactions 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
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

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 Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan’s Quarterly Report on Form 10-Q for the period ended March 31, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:
Allergan:
Investors:
Manisha Narasimhan, PhD
(862) 261-7162
Christine Chiou
(862) 261-7396
Media:
Fran DeSena
(862) 261 8820
Mark Marmur
+44 7725 758677
Lisa Brown
(862) 261-7320

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Link to FDA Announcement