Saturday, June 22, 2024

Radiographic Marker Recall: Hologic Pulls Over 53,000 Units Due to 71 Reported Injuries

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Radiographic marker manufacturer Hologic has issued a recall for more than 53,000 units, specifically the Biozorb devices, following reports of 71 injuries. Despite the recall, these radiographic marker devices will remain available on the market. However, Hologic has urged users to report any adverse events, such as pain, and has advised physicians to discuss the potential benefits and risks with their patients.

Biozorb devices are designed to help physicians mark sites in soft tissue where a patient requires radiation treatment for cancer. These radiographic marker devices consist of a plastic component intended to be resorbed by the body over a year or more and a permanent titanium metal part. Despite their intended use, there have been complications associated with these radiographic marker devices. The Food and Drug Administration (FDA) alerted healthcare providers in February after receiving reports that the plastic component of the Biozorb devices can persist in the body for several years, leading to complications.

FDA Issues Class I Recall for Biozorb Radiographic Markers Due to 71 Reported Injuries

The FDA issued a Class I recall notice, the most serious type of recall, indicating a high risk of adverse health consequences. Complaints about Biozorb devices have included reports of pain, infection, rash, device migration, and other adverse events, such as the sensation of the device within the breast. Some patients required additional treatments to remove the device. The FDA’s recall notice confirmed 71 reported injuries related to the Biozorb devices, although no deaths have been reported.

In response to these issues, Hologic has reiterated the recommendations made in its March letter to customers. The company has advised patients to contact their healthcare providers if they experience any adverse events after receiving a Biozorb radiographic marker. Physicians are encouraged to discuss the benefits and risks of the radiographic marker devices with their patients and monitor them closely for any complications.

Radiographic Marker

Hologic’s $125 Million Acquisition of Biozorb Radiographic Markers Leads to Reports of Severe Complications and Lawsuits

Hologic acquired the Biozorb devices in its $125 million acquisition of Focal Therapeutics in 2018. Since then, there have been several reports of complications. In 2021, doctors published case reports highlighting severe issues, including an implant that “eroded through” the skin at the border of the nipple and another that created “an open wound.” These complications have led to lawsuits from plaintiffs claiming injuries related to the implants.

The recall of over 53,000 Biozorb radiographic markers by Hologic is a critical step in addressing the reported injuries associated with these devices. While the devices will remain on the market, Hologic and the FDA are urging patients and physicians to be vigilant about potential adverse events. This situation underscores the importance of continuous monitoring and transparent communication between healthcare providers and patients to ensure the safe and effective use of medical devices.

In summary, the Biozorb recall highlights significant concerns regarding the long-term safety of these devices. With the FDA’s involvement and Hologic’s proactive measures, there is hope that future complications can be minimized, and patient safety can be prioritized. The ongoing legal challenges and reported cases will likely continue to shape the landscape of medical device regulations and patient care practices, emphasizing the need for rigorous testing and monitoring of new medical technologies.

 

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Resource: Food and Drug Administration, May 22, 2024

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