BioZorb Marker Recall Issued After Dozens of Injuries Linked to the Radiographic Implants

FDA warns that problems with BioZorb Marker can cause users to suffer severe and potentially life-threatening complications from the bioabsorbable radiographic markers used for breast care and other exams

Federal safety officials have announced a recall of BioZorb Markers due to the potential for the devices to migrate and require surgical removal, among other injuries.

The BioZorb Marker is an implantable marker used in medical imaging to identify soft tissues, like breast tissue, for future treatments such as radiation therapy. The device consists of a permanent titanium component and a temporary plastic component that gradually dissolves over time. The marker is sterile and intended for single use.

The markers are commonly implanted at the site of the tumor in breast cancer patients receiving radiation therapy to eliminate any remaining cancer cells.  By marking the exact location, the implant helps focus the radiation on the tumor bed while minimizing exposure to the surrounding healthy tissue.

After identifying at least 71 reports of injuries caused by the device, ranging from pain and infection to more complex complications like device movement and erosion, the U.S Food and Drug Administration (FDA) announced a BioZorb Markers recall on May 22, indicating that the problems with the device often result in the need for medical interventions to address or remove the implant.

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Recalled BioZorb Markers May Cause Serious Injury or Death

The device manufacturer, Hologic, sent an Important Medical Device Safety Notification to all customers on March 13, alerting radiologists, surgeons, oncologists and other health care providers that the devices may be prone to causing pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, which may require surgical removal.

While the manufacturer is not withdrawing the devices from the market, the FDA has categorized the BioZorb Marker as a Class I recall, the most serious recall classification, warning that the use of the device may result in serious injuries or death.

The recall affects 53,492 BioZorb Markers, including model numbers F0405 , F0404, F0331, F0231, F0221, F0304, F0303, F0203, and F0202. They were distributed between April 29, 2019 to April 1, 2024.

Hologic is requesting patients who experience any issues after the placement of a BioZorb Marker to contact their healthcare provider and to discuss the benefits and risks of the marker, and report any problems to Hologic at breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.

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