Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent
FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it. The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore. For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.