FDA Warns Against Use of BioZorb Markers

The Food and Drug Administration (FDA) is alerting patients, health care providers and health care facilities against the use of BioZorb Markers and BioZorb LP markers from Hologic, Inc., according to an advisory warning released by the agency.

The company has also issued a voluntary recall for the removal of all lots of unused BioZorb Markers due to reports of serious side effects that occurred among patients with the devices implanted in breast tissue.

BioZorb Markers, according to the agency, are implantable devices used in soft tissue such as breast tissue, and are made of a plastic component designed to dissolve in a patient’s body after at least a year and a permanent titanium metal component. The device is indicated for the radiographic marking of sites in soft tissue and for when a soft tissue site needs to be marked for future medical procedures, according to the FDA.

The BioZorb Marker, according to Hologic Inc.’s website, is a 3D marker consisting of “a spiral, bioabsorbable framework embedded with six permanent titanium clips designed to precisely mark your surgical excision site.”

The FDA in its alert advised that the device is not indicated to improve cosmetic outcomes, fill space in tissue or be a marker for radiation treatment.

Regarding the risks associated with the use of BioZorb Markers in breast tissue, the FDA reported that complications and side effects that include serious injuries are pain, infection, rash, the device moving out of position, the device breaking through the skin, fluid buildup, discomfort and other complications from feeling the device in the breast, with the agency noting that in some instances additional treatment, such as having the device removed, was required.

If patients with a BioZorb Marker experience any side effects, they are advised to contact their health care provider, although the agency stated that there is no need to have the marker removed unless a health care provider advises a patient to do so. However, if a provider is planning radiation therapy treatments, patients are advised to discuss possible risks, and patients are urged to report any problems or complications related to the marker to the agency.

Hologic Inc., according to an Oct. 24 post on its website, previously alerted health care providers in February 2024 about possible health risks that had been reported in relation to the device. According to the February 27, 2024, advisory from the FDA, other side effects that were reported included complications potentially associated with the component not being resorbed in the body for several years and the need for more treatment to remove the device. This was then updated to a Class I recall, the most serious type of recall, by the FDA on May 22, 2024.

The company stated that it has sold 91,531 devices since 2015, with there having been 399 complaints — out of which 188 had been associated with side effects as of Oct. 16. According to the FDA, there have been 71 reported injuries, and no reports of death.

The FDA, according to its advisory, will continue to work with Hologic to monitor reports of problems with the devices, and will continue to update the public if significant new information later becomes available.

Reference:

“Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication,” posted by the FDA.

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