FDA Issues Warning on BioZorb Markers After Recall Due to Patient Complications

• The FDA has warned against using BioZorb Markers due to potential adverse effects (AEs), following Hologic’s recall of all unused devices.
• Patients report pain, infection, device migration, and other complications, sometimes requiring additional treatment or device removal.
• Patients with implants should contact providers if symptomatic; radiation therapy risks should be discussed with providers.

The FDA recently advised consumers, health care providers, and health care facilities to discontinue using BioZorb Markers and BioZorb LP Markers, implantable devices used in breast tissue radiographic marking.¹

This advisory follows Hologic’s October 25, 2024, announcement of a voluntary recall for all unused BioZorb Marker devices. The recall came in response to reports of significant AEs in patients who had the devices implanted, raising concerns about potential health risks.

The AEs reported by patients who received BioZorb Markers included pain, infection, rash, device migration, and device erosion. In some cases, the devices caused noticeable discomfort or seromas, prompting additional treatments and even device removal in certain instances.

Breast cancer cells: © LASZLO- stock.adobe.com

Hologic shared that, out of the 91,531 devices distributed since 2015, there have been 399 patient complaints, with 188 cases linked to AEs as of October 16, 2024. Hologic described the recall as a precautionary step to limit further incidents related to unused devices.²

BioZorb Markers are designed for radiographic marking in soft tissues, including breast tissue. They are composed of a dissolvable plastic component and a permanent titanium component. The plastic dissolves over approximately a year, while the titanium remains permanently.

Though BioZorb Markers are intended to mark areas for future treatment, they are not designed or approved for cosmetic purposes, filling tissue spaces, or serving as markers for radiation therapy.

The FDA issued specific guidance for patients with BioZorb Marker implants. Patients experiencing any AEs should contact their health care providers immediately. However, those without symptoms are not required to have the devices removed unless their doctor advises it. Patients planning to undergo radiation therapy should discuss the risks, as the FDA has not approved BioZorb Markers for radiation treatment marking. Additionally, patients are encouraged to report any device complications directly to the FDA.¹

For health care providers and facilities, the FDA recommended halting all BioZorb Marker implants and returning any unused units to Hologic. Providers should also review the FDA’s patient guidance with those who already have a BioZorb Marker implant, monitor these patients for potential adverse effects, and report any complications to the FDA.

The FDA also is encouraging the public to report any issues with these devices through the MedWatch Voluntary Reporting Form, ensuring that new or ongoing complications are properly documented.

“Our goal is first and always to provide high-quality products that enable our customers to provide safe, effective patient care to their patients. We are committed to providing you with the most accurate and up-to-date information and ensuring the ongoing safety and efficacy of our products,” Hologic wrote in the press release.²

REFERENCES:

1. Update: do not use BioZorb marker implantable radiographic marker devices: FDA safety communication. FDA. October 25, 2024. Accessed October 30, 2024. https://tinyurl.com/3x6k99yw

2. Urgent: medical device recall - BioZorb® 3D Bioabsorbable Marker. News release. Hologic. October 24, 2024. Accessed October 30, 2024. https://tinyurl.com/4jeeax9f