Hologic’s BioZorb Marker FDA Woes ContinueHologic’s BioZorb Marker FDA Woes Continue

Now subject to a Class I device removal, this is just the latest product safety notification from the company this year.

Katie Hobbins, Managing Editor

October 29, 2024

3 Min Read
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Hologic recently announced the voluntary recall of all unused lots of BioZorb markers and BioZorb LP markers due to reports of serious adverse events (AEs) occurring in patients who had the product implanted in breast tissue.

BioZorb markers are implantable devices used in soft tissue sites. The device is indicated for radiographic marking of sites in soft tissue and marking soft tissue for future medical procedures. Coming in two parts, the markers have a plastic component that is intended to be dissolved completely in the patients’ body in one year or longer and a permanent titanium metal component.

Reported complications and AEs associated with using the marker in breast tissue include pain, infection, rash, device migration, device erosion, seroma, discomfort, and complications from feeling the device in the breast. Additionally, in some instances, additional medical treatment like having to have the device removed was needed, according to the company.

On Oct. 25, Hologic distributed the recall notice telling healthcare providers and facilities to not implant BioZorb markers, quarantine unused product, and return all unused lots to the company. The notice also recommended providers be aware of reports of AEs following the placement of BioZorb in breast tissue and that the device is not indicated to improve cosmetic outcomes after procedures, fill space in the tissue, or be a marker for radiation treatment.

FDA said it is working with the company to monitor reports of product problems, “including issues that may develop over time,” according to the recall notice. “The FDA will continue to keep the public informed if significant new information becomes available.”

BioZorb’s tough year

The BioZorb initially hit choppy waters in early 2024 when FDA advised patients and healthcare providers to be aware of potential risks of serious complications when using the devices. At the time, the safety communication highlighted reports and published literature describing AEs in patients who were implanted with BioZorb in breast tissue.

“FDA wrote it has received reports of serious AEs in patients implanted with the devices in the breast tissue, including during breast conservation procedures like lumpectomy,” MD+DI previously reported. “Described complications include infection, fluid buildup, the device moving out of position, the device breaking through the skin, pain, discomfort from feeling the device in the breast, rash, complications possibly related with an extended resorption time — not resorbing in the patient’s body for several years, and the need for additional medical treatment to remove the device. Additionally, literature reports have shown similar AEs including the device breaking through the skin of the nipple and moving out of position from when it was initially implanted.”

The February safety communication then evolved into a Class I device correction in May after Hologic reported 71 injuries related to issues when implanted in breast tissue.

"Hologic and the FDA issued a safety notification in February to help ensure patients and healthcare providers had the most up-to-date information regarding BioZorb," a Hologic spokesperson told MD+DI in May. "The recent administrative classification of the Safety Notification posted on the FDA’s website was an expected step in the regulatory process. BioZorb continues to be offered and used safely and successfully with patients undergoing radiation treatment following breast conserving surgery. Patient safety is, and has always been, our top priority."

About the Author

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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