KBA is Litigating BioZORB Cases
With an attorney licensed in Massachusetts, a partner with vast medical device experience, and a legal team skilled at caring for clients and getting cases worked-up, KBA is well-positioned to help people BioZORB injured.
Michael Appel is an attorney in the state where the company is located. He has litigated medical device cases, complex medical malpractice cases, and more for decades. A true trial lawyer, Michael has led complex litigations and mentors KBA’s attorneys.
Partner Robert Price has litigated many medical device cases. He recently tried one in NJ. He hails from a preeminent firm and has taken the reigns of the medical device team here at KBA. Our firm is passionate about fighting this matter.
BIOZORB Medical Device Recall: Impact and Risks
The U.S. Food and Drug Administration (FDA) has classified the recall of Hologic’s BioZorb Marker as a Class I recall, the most serious type, indicating a high risk of serious injury or death. This recall, initiated on March 13, 2024, affects 53,492 devices distributed between April 29, 2019, and April 1, 2024.
Reported Issues and Complications
The recall was prompted by numerous reports of complications and adverse events associated with the BioZorb Marker, including:
- Pain
- Infection
- Rash
- Device migration and erosion
- Seroma (fluid buildup)
- Discomfort
- Necessity for additional medical treatment to remove the device
As of now, 71 injuries have been reported, although no deaths have been associated with the device (FDA) (FDA) (MPO Magazine).
Usage and Distribution
The BioZorb Marker is an implantable radiographic marker used to mark soft tissue, such as breast tissue, for future medical procedures, including radiation therapy. The device has a permanent titanium component and a resorbable plastic component designed to dissolve over time (Medical Device Developments) (Health Imaging).
Potential Harm and Affected Population
Given the number of units sold, the potential impact is significant. The recall affects a wide range of healthcare professionals, including radiologists, surgeons, and oncologists, who use these markers in breast cancer procedures. Patients with implanted BioZorb markers are at risk, and those undergoing systemic cancer treatments may experience delays due to complications from the marker.
Lack of Warnings
Many patients with the implanted BioZorb Markers are not aware that they are at risk or know the possible side effects to expect. The device lacks important warnings that consumers and their healthcare professionals should be aware of before the implanting the device.
Risk Mitigation and Recommendations
Hologic has issued safety notifications to all affected customers, urging patients to contact their healthcare providers if they experience any adverse events. Healthcare providers are advised to continue monitoring patients with the implanted device and report any complications to Hologic and the FDA’s MedWatch Adverse Event Reporting program (FDA Access Data) (Medical Device Network).
In summary, the recall of the BioZorb Marker highlights the need for vigilant monitoring and reporting of medical device complications to ensure patient safety and mitigate potential harm.
Stay Informed about BioZORB
KBA continues informing patients about the latest developments. Here are some recent blog posts:
Understanding BioZORB: Benefits, Complications, and Concerns
CONTACT KBA TODAY – What Can KBA Do For You?
We litigate medical device cases at our law firm. We support to individuals who have suffered injuries. Our skilled attorneys are committed to helping you navigate the complexities of personal injury law. If you or a loved one has suffered harm from this medical device BioZORB – contact us immediately, strict deadlines apply.