Allergan Aesthetics contacting 52,000 U.S. BIOCELL® patients not already notified who have BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL.
Per FDA, “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."
Allergan Aesthetics launching multi-channel campaign of digital and social media advertisements informing patients of the voluntary recall and directing them to Allergan Aesthetics' 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 External Link Disclaimer to reach out to Allergan Aesthetics to determine if the company has their implant information. Or 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. External Link Disclaimer 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 External Link Disclaimerto 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, OCELLinformation.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.
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.