FDA Advisory on BIOCELL Textured Breast Implants

September 4, 2019—On August 7, 2019, the FDA requested a voluntary recall of the Natrelle BIOCELL textured breast implants and tissue expanders in response to an increasing risk of developing breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).

At this time, the overall incidence of developing BIA-ALCL is low; however, the diagnosis is serious and can lead to death if not diagnosed early or promptly treated.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

J12119 09/19

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