FDA announces class 1 recall for radiographic breast tissue marker
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Hologic Inc.’s BioZorb Marker a class 1, indicating a risk of serious injury or death. BioZorb is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Provided sterile…
FDA updates reports of squamous cell carcinoma in capsule around breast implants
Editor's Note The Food and Drug Administration (FDA), on March 8, issued an update on reports of squamous cell carcinoma in the scar tissue (capsule) that forms around breast implants—both saline and silicone as well as textured and smooth. Previously, on September 8, 2022, the FDA informed the public of…
FDA: Reports of squamous cell carcinomas, lymphomas in breast implant scar tissue
Editor's Note The Food and Drug Administration (FDA) on September 8 issued a Safety Communication informing the public about reports of cancers, including squamous cell carcinomas and various lymphomas in the scar tissue that forms around breast implants. The various lymphomas are not the same as the lymphomas reported in…
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