Certain Textured Breast Implants by Allergan: Safety Communication - Due to an Increased Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma AUDIENCE: Patient, Consumer, Health Professional, Surgery, Risk Manager ISSUE: The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market. Based on the currently available information, including newly submitted data, FDA analysis demonstrates that the risk of BIA-ALCL  with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s Biocell BIOCELL textured breast productsimplants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL. BACKGROUND: BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy. RECOMMENDATION: For a complete list of recommendations for patients and health care providers, see the FDA Safety Communication. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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