-- 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 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.
- 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 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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