The US Food and Drug Administration (FDA) has categorised Hologic’s recall of BioZorb Marker as Class 1, the most serious kind of recall.
BioZorb Marker is an implantable radiographic marker. It is supplied sterile and intended for single use only.
Used for marking soft tissue, particularly in regions like breast, it facilitates future medical interventions such as radiation therapy.
Hologic is issuing a recall for the Biozorb Marker following reported complications and adverse events associated with implanted devices.
Complaints included various issues such as pain, infection, rash, device migration, erosion, seroma, discomfort, or other complications stemming from the presence of the device within the breast.
The patients also complained about the need for further medical treatment for device removal.
BioZorb Marker features a permanent element crafted from titanium metal and a resorbable counterpart made from a plastic material designed to naturally resorb over time.
The device was designed by Focal Therapeutics, which was acquired by Hologic in 2018 for $125m.
The FDA said that the people implanted with the BioZorb marker can be affected. It can also affect those who receive radiation guided by the marker which may have migrated.
Patients undergoing systemic cancer treatments may also experience delays due to complications arising from the marker.
Additionally, it can affect a range of healthcare professionals, including radiologists, surgeons, oncologists, and other providers.
As of now, the health agency has reported 71 injuries with no reports of death.
Hologic has recalled 53,492 devices in the US, which were distributed between 29 April 2019 and 01 April 2024.
The recall was initiated on 13 March 2024 and includes F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, and F0202 model numbers.
In March 2024, Hologic issued all affected customers an important medical device safety notification.
The American medical technology company requested patients to contact their healthcare provider if they feel any adverse events after device placement.
The patients should report the complications to Hologic and the FDA’s MedWatch Adverse Event Reporting programe.
Additionally, the letter urged healthcare providers to spot serious adverse events and inform all patients about the BioZorb marker use.
