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If you had a lumpectomy for breast cancer, there is a reasonable chance something was placed at the surgical site to mark it for future imaging, and it could have been a recalled BioZorb marker.
Most women were never told which device it was, and there is no reason they would remember. You were being treated for cancer. The marker was a footnote.
But after the BioZorb recalls in 2024, it definitely matters which marker you have. Here is exactly how to find out, step by step. And if you suspect you have a BioZorb lawsuit, talk to a lawyer.
The Real Deal: Do You Have a BioZorb Marker?
To find out if you have a BioZorb marker, request the operative report and implant log from your lumpectomy. These records may identify the device by name, part number, or unique device identifier (UDI).
BioZorb and BioZorb LP are implantable markers made by Hologic, Inc. Each has a plastic framework designed to dissolve over time and six permanent titanium clips that remain visible on medical imaging.
BioZorb Marker FAQs
The operative report from your lumpectomy and the implant log or device sticker sheet from that procedure. Both are part of your medical record, and the facility must generally produce them within 30 days of receiving your request, although one additional 30-day extension may be allowed with written notice.
Recalled BioZorb part numbers begin with F followed by four digits, such as F0202 or F0405. Each also carries a UDI beginning with 154200455.
Often, yes. Radiologists routinely describe implanted markers, sometimes by brand name, sometimes by shape, such as a “spiral” or “coil” marker, or as a three-dimensional surgical marker with multiple titanium clips at the lumpectomy site. If the report isn’t clear, ask your radiologist whether the images can help identify the device.
If the hospital has closed, its records may have been transferred to another facility or a medical records custodian. Contact your state’s health department or medical board for help identifying where your records may be stored.
Potentially, yes. You can ask your surgeon or radiologist whether you have a BioZorb marker. The device’s titanium clips can often be identified on mammograms, X-rays, or other imaging scans. Your doctor may be able to confirm whether you have BioZorb without you having to track down your medical records yourself.
Step 1: Request Two Documents
Contact the medical records department at the hospital or surgical center where your lumpectomy was performed. Ask for two things by name.
The Operative Report
This is the surgeon’s written account of the procedure. It describes what was done and what was placed. If a BioZorb marker was implanted, it should appear here.
The Implant Log or Device Sticker Sheet
Hospitals keep a record of every implanted device used in a procedure, usually built from the peel-off labels on the device packaging. This is the document that has the part number and the UDI. Both are part of your medical record.
Under HIPAA, the facility generally has 30 days to respond, although it may take one additional 30-day extension if it provides written notice. You may be charged a reasonable copying fee.
If you had a revision or removal surgery later, request that operative report too. It is often the most important document of all because it describes what the surgeon found.
Step 2: Read What Comes Back
You are looking for the words “BioZorb” or “BioZorb LP,” or a part number.
The recalled BioZorb part numbers all begin with F followed by four digits. Examples include F0202, F0203, F0303, F0304, F0221, F0231, F0331, F0404, and F0405. Each also has a UDI, a unique device identifier, which is a long numeric string beginning with 154200455.
The complete list of recalled part numbers and their UDI codes is published on our BioZorb lawsuit page.
If the operative report mentions a marker but does not name the brand, the implant log usually will. If neither does, move to step three.
Step 3: Check Your Imaging Reports
Radiologists often note implanted markers like BioZorb in imaging reports so they can distinguish them from surrounding tissue or other findings. Pull your mammogram, ultrasound, and MRI reports from the years after your surgery.
Look for references to BioZorb, BioZorb LP, a three-dimensional or bioabsorbable surgical marker, or a group of titanium clips at the lumpectomy site. If the report doesn’t identify the device by name, ask your radiologist whether the imaging can help confirm what was implanted.
If your imaging reports identify a possible complication, such as the device moving from its original position, save those records. They may help establish when you first learned about a potential problem, which could be relevant to your filing deadline.
If the Records Are Hard To Get
This happens more than it should. Facilities close, records get transferred to a third-party custodian, or requests sit unanswered.
A few things that can help:
- Put the request in writing rather than calling.
- Give the exact date of surgery and the surgeon’s name.
- Ask specifically for the implant log rather than just “my records,” because a general request often returns a discharge summary and nothing else.
- If the facility has closed, the state health department or the medical board can usually tell you who holds the records now.
If you are still stuck, an attorney can request them for you at no cost. This is routine work, and it does not commit you to anything.
If It Turns Out You Have a BioZorb Marker…
Having the device is not the same as having a claim. The October 2024 recall required unused devices to be removed from the market; it didn’t direct patients to have previously implanted devices surgically removed. If the BioZorb marker is in place and causing you no problems, the FDA doesn’t recommend removal, and there is generally nothing to pursue.
However, you may have a claim if you had a complication. For instance:
- Chronic pain
- Infection
- Plastic framework that hasn’t dissolved as expected
- Migration
- Erosion through the skin
- Seroma
- Scarring
- A second surgery to take it out
If any of those describe your experience, the next thing to consider is your state’s filing deadline, and that is worth checking sooner rather than later.
Get Real Answers About Your BioZorb Implant
Bernheim Kelley is actively investigating and filing BioZorb cases. If you need help getting your records, or if you already have them and want to know what your deadline is, we can help. We offer a FREE case review, and we don’t get paid unless we win for you.
You deserve Real Justice for what you’ve gone through. Contact our experienced team at 617-420-1111 or reach out online today.