The U.S. Food and Drug Administration (FDA) requested the voluntary recall from Allergan in reference to the company’s Biocell textured implants linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to the Agency, Allergan agreed and is removing these products from the global market.
The decision for the requested recall is based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. To read more about the FDA’s analysis, visit the FDA website.
“Patients and their caregivers will understandably have questions with regard to the recall of these implants,” said Izumi Nakano, Associate Director of Support Services at the Lymphoma Research Foundation. “It is important to provide up-to-date and evidence-based information to patients who may be affected, so they can be empowered and participate in shared treatment decision making with their physicians. We encourage patients with questions to contact our Lymphoma Helpline for additional information.”
For more information about BIA-ALCL, visit the Anaplastic Large Cell Lymphoma Learning Center or contact the LRF Helpline at 800-500-9976 or firstname.lastname@example.org.
Resources and Support:
Trained LRF Helpline staff members are available to answer your questions about a lymphoma diagnosis and treatment information, as well as provide individual support and referrals to you and your loved ones. Callers may request the services of a language interpreter. To contact the LRF Helpline, email email@example.com or call 800-500-9976, Monday through Friday, from 9:30am – 7:30pm Eastern Standard Time (EST).