The Food and Drug Administration (FDA) has issued a warning against the use of Hologic’s Biozorb radiographic markers, following multiple reports of serious adverse effects in patients. These implantable devices, which were intended for radiographic marking of soft tissue sites such as breast tissue for future medical procedures, have been recalled but not removed from the market. Cumulatively, this recall impacts 91,531 units sold since 2015, with 188 of 399 complaints directly related to adverse patient outcomes.
These Biozorb markers, which have been available since 2015, comprise a plastic element designed to dissolve within the body over a period of a year or more, and a permanent titanium component. Their primary function is to facilitate the identification and treatment of tissue sites during subsequent medical interventions. However, issues with the devices have surfaced, including pain, infection, rash, undesirable movement or erosion of the device, and abnormal fluid buildup, leading in some cases to the necessity of removal and further medical intervention.
In March, following initial reports and a safety communication from the FDA in February highlighting the risks of serious complications, Hologic initiated a recall of the Biozorb markers. By May, the FDA elevated the status of this recall to Class I, indicating a situation where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Despite the severity of the recall, the product has not been completely withdrawn from the market.
Hologic has been proactive in addressing the issue, notifying customers and requesting the return of all unused Biozorb lots, although the company has advised that implanted devices do not need to be removed unless specified by a healthcare provider. As of the latest updates, there have been no reported fatalities associated with the device, though 71 injuries had been previously cited in the recall notice.
The company is in ongoing collaboration with the FDA to manage the voluntary recall effectively, aiming to mitigate any further patient risk associated with their product.
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