Hologic’s recall of the radiographic marker implant is a serious concern

The FDA issued a recall for Hologic

(NYSE: HOLX)
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BioZorb Class I radiographic marker, the most serious type.

BioZorb — previously manufactured by Focal Therapeutics, which Hologic acquired in 2018 — is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures such as radiation therapy. It contains two elements. One permanent element is made of titanium. The second is an absorbable element made of plastic, which becomes absorbable over time. The company designed it as a sterile device for single use.

Hologic has recalled the marker due to complications and adverse events reported with the implanted devices. Complaints included reports of pain, infection, rash, device migration, device erosion, seroma formation, discomfort, or other complications related to the sensation of the device in the breast. The company also received reports that additional treatment was required to remove the device.

To date, Hologic has received 71 reports of injuries and zero reports of deaths, according to the FDA notice.

Hologic’s recall covers nine BioZorb device models distributed between April 29, 2019 and April 1, 2024. The company initiated the recall, which affected a total of 53,492 devices, on March 14, 2023.

In a letter to affected customers, the company requested that patients contact their providers if they experience side effects after being placed with BioZorb. They should also discuss the benefits and possible risks of the devices with their doctor.