IRVINE, Calif., June
1, 2020 /PRNewswire/ -- Allergan Aesthetics, an AbbVie
company (NYSE: ABBV), is initiating a new digital campaign to
improve device tracking and further identify and reach breast
implant patients who have, or have had, BIOCELL®
breast implants and/or tissue expanders to inform them of the risk
of BIA-ALCL. Since July 2019
when the BIOCELL® recall was announced, robust
efforts were made to reach patients, however, the Company is still
seeking to directly contact all U.S. BIOCELL®
patients that have not yet been notified. This is due to incomplete
device tracking data for approximately 52,000
BIOCELL® breast implant units.
It is important to note the United States Food and Drug
Administration (FDA) has made the following recommendation,
"If you have no symptoms, we are not recommending the
removal of these or other types of breast implants due to the low
risk of developing BIA-ALCL. However, if you have any questions,
talk to your health care provider."1
Allergan Aesthetics will launch a multi-channel campaign which
will include digital and social media advertisements further
informing patients of the voluntary recall and directing them to
Allergan Aesthetics' www.BIOCELLinformation.com website for
education on how to identify their implant type and register their
implants.
"Allergan Aesthetics is committed to patient safety and we are
continuing to make every effort to make sure that each and every
patient is made aware of the BIOCELL® recall, and knows
their implant type and implant history," said John Maltman, Vice President of Medical Affairs
at Allergan Aesthetics.
If patients are not aware of the
BIOCELL® recall previously announced on
July 24, 2019 and do not know the
type of implant that they have in place or their implant history,
they should either:
- Go to www.BIOCELLinformation.com to reach out to Allergan
Aesthetics to determine if the company has their implant
information.
- Contact their surgeon or hospital where they received implants
to determine if the surgeon or hospital has records of their
implant information.
Patients who know that they have an Allergan implant, and may
not have participated in device tracking previously, or who need to
update their information on www.BIOCELLinformation.com. The website
will inform them how to register for device tracking, which is
strongly advised for all patients, and answer any questions they
may have.
Patients with BIOCELL® implants or tissue
expanders or a history of BIOCELL® implants or
tissue expanders should go to www.BIOCELLinformation.com to
learn about the BIOCELL® recall, symptoms of
Breast Implant Associated Anaplastic Large Cell Lymphoma
(BIA-ALCL), the importance of breast self-examination and the need
for regular breast implant monitoring.
"We are determined to make sure every woman has the information
they need related to the BIOCELL® voluntary
recall and we will continue to encourage women with breast implants
to determine their implant type and opt-in to our device tracking
system. Patient education is a priority. We have partnered with the
American Society of Plastic Surgeons (ASPS) and the American
Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives
to raise awareness regarding the importance of breast implant
tracking," said Carrie Strom, Senior
Vice President AbbVie and President Global Allergan Aesthetics.
About the GLOBAL
BIOCELL® Recall
On July 24, 2019 Allergan
initiated a voluntary global recall of its
BIOCELL® breast implants and tissue
expanders. Allergan has continued a global basis to ensure
that patients and health care professions are notified about the
BIOCELL® recall. The Company issued global press releases and
distributed letters directly to healthcare professionals regarding
the recall. To generate awareness and provide a resource for
patients, the Company launched a dedicated website,
www.BIOCELLinformation.com, to help patients identify their breast
implants and to provide information and resources related to the
risk of BIA-ALCL.
Allergan Aesthetics, an AbbVie company will continue to work
closely with global regulatory authorities and societies and
patient advocacy groups to provide important
BIOCELL® information to patients and health care
professionals regarding the voluntary recall.
For more information on the
BIOCELL® recall, please click here for the
press release.
More information on BIA-ALCL
BIA-ALCL is not breast cancer—it is a type of non-Hodgkin's
lymphoma (cancer of the immune system). At this time, the
likelihood of developing BIA-ALCL is thought to be low, occurring
in less than 0.03% of patients with
BIOCELL® textured breast implants. However,
BIA-ALCL is a serious condition and can lead to death, especially
if not diagnosed early or treated promptly.
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop,
manufacture, and market a portfolio of leading aesthetics brands
and products. Our aesthetics portfolio includes facial injectables,
body contouring, plastics, skin care, and more. Our goal is to
consistently provide our customers with innovation, education,
exceptional service, and a commitment to excellence, all with a
personal touch. For more information, visit
www.AllerganAesthetics.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
1 FDA.gov; 9/12/2019: Allergan Voluntarily Recalls
BIOCELL® Textured Breast Implants and Tissue Expanders
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SOURCE AbbVie