FDA Safety Communication – Risks of Certain Textured Breast Implants

Published: 07/24/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued a safety communication to inform health care providers and the public that the agency has requested that the manufacturer 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 not

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