As a follow-up to a device correction issued several months prior, Hologic, Inc. is now announcing a full product removal of all models of their BioZorb Markers after numerous reports of injury. The FDA is calling this a Class 1 recall.
Health care professionals typically use devices such as BioZorb Markers to mark certain areas of soft tissue for radiographic imaging and monitoring. Such markers are frequently used to mark breast tissue in patients who are at risk for developing cancer or who are undergoing treatment for breast cancer. The markers are designed to be implanted into the soft tissue. The body naturally absorbs the plastic part of the marker, while the titanium element remains in the body.
In total, Hologic has received 71 reports of injury connected to implantation of the their BioZorb Markers. Customers and health care providers have reported numerous complications with use of the markers, including “pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast.” Some patients have required surgery to remove the markers from their body.
The recall applies to 53,492 devices distributed between April 29, 2019 and April 1, 2024. The following BioZorb Marker model numbers are included in the recall: F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, and F0202. The UDIs included in the recall are: 15420045514065, 15420045514058, 15420045514041, 15420045514034, 15420045514027, 15420045514010, 15420045514003, 15420045513990, and 15420045513983.
Along with the company’s announcement, the FDA released its own safety communication to health care professionals and patients. According to the FDA, patients who have existing BioZorb Markers do no need to have them removed unless their doctor determines that such a removal is medically appropriate. Patients should know that BioZorb Markers are not FDA-approved for use in conjunction with radiation therapy. Finally, patients should report any adverse symptoms related to an implanted BioZorb Marker to their health care provider.
Additionally, the FDA advises health care providers and facilities to cease use of the recalled product, to quarantine all unused BioZorb Markers, and to return the devices to Hologic, Inc. Doctors should closely monitor patients with existing BioZorb Markers and should refrain from using the markers in conjunction with cosmetic procedures or radiation therapy.
Anyone with questions or concerns regarding the recall can contact the company at breasthealth.support@hologic.com.
Patients and health care providers can report any new adverse health events related to Hologic’s BioZorb Markers through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to the implantation of a BioZorb Marker, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medication to health care facilities in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.