Hologic BioZorb Marker Lawsuit Claims, Recall FDA Class 1 Warning

Hologic’s BioZorb device has been the subject of concern and legal scrutiny due to reports of serious side effects, including pain, discomfort, scarring, and other complications, raising questions about its safety and efficacy.

Some patients are calling and reporting serious side effects and complications after having the BioZorb device implanted during lumpectomy procedures. The Schmidt National Law Group is investigating potential lawsuit actions against Hologic, the manufacturer of BioZorb, we expect large cash settlements to commence from the possible class action lawsuit.

If you or someone you know has experienced any adverse reactions including discomfort, pain, scarring, swelling, or other serious complications due to the BioZorb implant, contact the Schmidt National Law Group attorneys as soon as possible to explore our legal options and seek justice for your injuries. 1-800-631-5656. Use the secure intake form below to start the claims process.

Hologic BioZorb Marker: Device Overview

The BioZorb Marker, previously manufactured by Focal Therapeutics and now owned by Hologic, is an implantable radiographic marker used to mark soft tissue, such as breast tissue, for future medical procedures like radiation therapy. The device consists of two components: a permanent titanium component and a resorbable plastic component.

FDA Identifies Hologic BioZorb Recall as Class I

In a recent development, the FDA has classified the actions taken by Hologic to notify customers about the risks associated with the BioZorb Marker and BioZorb LP Marker devices as a Class I recall, the most serious type of recall. This recall is a correction, not a product removal, as Hologic aims to address the potential risks and ensure patient safety. The FDA states that 71 injuries were reported as being related to BioZorb Markers. 

Potential Risks of Device Migration

The FDA has highlighted the potential consequences of the device moving out of its implanted position (migration) and breaking through the chest cavity and/or blood vessels, which can be severe and potentially life-threatening. Additionally, device migration may impact the targeting of radiation to the intended site, potentially compromising the effectiveness of future medical procedures.

FDA’s Safety Communication and Recommendations

In response to the reported issues, the FDA has issued a safety communication to inform patients and healthcare providers about the potential risks associated with the use of BioZorb Marker and BioZorb LP Marker devices. The communication provides recommendations for both patients and healthcare providers, emphasizing the importance of discussing the benefits and risks of all available implantable breast tissue markers and reporting any problems or complications to the FDA.

BioZorb Device Description and Intended Use

The BioZorb Marker and BioZorb LP Marker are designed to mark soft tissue sites, including breast tissue, for future medical procedures, such as radiation therapy. However, the FDA has not cleared or approved these devices for the purpose of filling space in the tissue or improving cosmetic outcomes after procedures.

Ongoing Collaboration between FDA and Hologic

The FDA is working closely with Hologic to evaluate all available information about the safety of the BioZorb Marker and BioZorb LP Marker devices and to address the potential risks associated with their use in breast tissue. The agency will continue to monitor reports of adverse events and keep the public informed of any significant new developments.

Key Points on the BioZorb Class I Recall

• The FDA has classified the Hologic BioZorb Marker recall as a Class I recall, the most serious type, due to reported complications and adverse events.
• Potential risks include device migration, erosion, and the ability to impact future radiation targeting, which can be severe and life-threatening.
• The FDA has issued recommendations for patients and healthcare providers, emphasizing the importance of discussing available options and reporting any issues.
• The Unique Device Identifier (UDI) system plays a crucial role in improving the traceability and reporting of adverse events related to the BioZorb Marker and BioZorb LP Marker devices.
• Ongoing collaboration between the FDA and Hologic, as well as the reporting of problems by patients and healthcare providers, are essential for addressing the identified risks and ensuring patient safety.

Hologic BioZorb Marker Lawsuit Claims, Recall FDA Class 1 Warning page updated on April 8, 2025.