FDA Requests Voluntary Recall of Certain Breast Implants & Tissue Expanders
The Food & Drug Administration (FDA) recently announced that it was recommending the voluntary recall of certain textured implants manufactured by Allergan due to the risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Allergan responded by moving forward with a world-wide recall of their BIOCELL textured breast implant products, (including tissue expanders) so that these will no longer be placed in patients moving forward. The FDA also issued a safety communication for patients with breast implants, patients considering implants and health care professionals. It is important to note that for asymptomatic patients, the FDA is not recommending the removal of these or other types of breast implants.
The following additional resources have been made available by the FDA.
Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)