BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication
Date Issued: February 27, 2024
The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential risk of serious complications with the use of BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc. The BioZorb Marker and BioZorb LP Marker are devices implanted in soft tissue, including breast tissue, where the site needs to be marked for future medical… read more
I have emailed the radiologist who did my biopsy and placed my marker to ask if I have one of this brand marker. I'm having no problems but would like to know so I can watch for possible future issues.
You need to ask the person who did your initial biopsy to find out if they used this device. I emailed my doctor and asked her and she answered immediately. She does not use this brand of marker and anyway, she said it would have been removed when I had my lumpectomy unless the surgeon chose to leave it for radiation. Instead of worrying and trying to figure things out for yourself just ASK.
Good question.
Someone in this feed mentioned that the BioZorb is supposed to dissolve and the markers are left.
Wonder how much testing was done on this.
All you have to do is email or call the person who did your biopsy. I did that this morning and asked and got an email back saying that she did NOT use the BioZorb markers. It's no mystery, nothing you need to figure out for yourself, just ASK. Now I have peace of mind. Your doctor will tell you.
These are the listed complications: The FDA has received reports describing complications (adverse events) with the use of BioZorb Marker and BioZorb LP Marker in breast tissue, including infection, fluid buildup (seroma), device moving out of position (migration), device breaking through the skin (erosion), pain, discomfort from feeling the device in the breast, rash, other complications possibly associated with extended resorption time (resorbable component of the device not resorbing in the patient's body for several years), and the need for additional medical treatment to remove the device. The FDA is also aware of literature reports describing similar adverse events including the device breaking through the skin of the nipple (erosion) and the device moving out of position from where it was implanted (migration).