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‼️📢‼️FDA MEDWATCH - FDA SAFETY COMMUNICATION on BioZorb Markers and Potential Risks with Use in Breast Tissue‼️📢‼️ The FDA issued a safety communication to inform patients and health care providers about the potential risk of serious complications with the use of Hologic BioZorb Marker and BioZorb LP Marker devices in breast tissue. The BioZorb Marker and BioZorb LP Marker are devices implanted in soft tissue, including breast tissue, to mark the site for future medical procedures, such as radiation for breast cancer treatment. The FDA has received reports and is aware of published literature describing serious adverse events in patients who were implanted with the BioZorb Marker or BioZorb LP Marker devices in the breast tissue. The FDA has cleared BioZorb Marker and BioZorb LP Marker for radiographic marking of sites in soft tissue (including breast). Also, the markers are indicated in situations where the soft tissue site (including breast) needs to be marked for future medical procedures. The FDA has not cleared or approved these devices to fill space in the tissue or to improve cosmetic outcomes after procedures. To read more and find out about what the safety communication provides, follow the link below. #fda #safety #breastimaging #biomarkers #softtissue #radiography #hologic #cosmeticsindustry #cosmeticscience #radiation #radiationtherapy #radiationoncology #breastcancerawareness #breastcancer #breastcancercare #healthcareindustry #risks #serious #complications #medicaldeviceregulation

BioZorb Markers and Potential Risks with Use in Breast Tissue

BioZorb Markers and Potential Risks with Use in Breast Tissue

fda.gov

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