FDA Warns Against BioZorb Markers Following Recall Due to Adverse Events
Key Insights
The FDA has issued a warning against the use of BioZorb and BioZorb LP Markers due to reports of adverse events, subsequent to a voluntary recall by Hologic.
Patients with BioZorb implants have reported complications such as pain, infection, device migration, and rash, sometimes necessitating further treatment or device removal.
The FDA advises patients with implants experiencing adverse effects to contact their healthcare providers and encourages reporting any device-related complications to the agency.
The FDA has cautioned healthcare providers and patients against the use of BioZorb and BioZorb LP Markers, implantable devices used for radiographic marking in breast tissue, following a voluntary recall by Hologic on October 25, 2024. The recall was initiated due to increasing reports of significant adverse events (AEs) in patients who had received the implants, raising concerns about potential health risks.
Adverse Events and Recall Details
Patients with implanted BioZorb Markers (search) have reported a range of AEs, including pain, infection, rash, device migration, and erosion. In some instances, these complications led to noticeable discomfort or seromas, requiring additional treatments and, in certain cases, device removal. Hologic reported that, as of October 16, 2024, out of 91,531 devices distributed since 2015, there had been 399 patient complaints, with 188 cases linked to AEs. The company described the recall as a precautionary measure to prevent further incidents related to unused devices.
Device Information and Intended Use
BioZorb Markers (search) are designed for radiographic marking in soft tissues, particularly breast tissue. The device comprises a dissolvable plastic component and a permanent titanium component. The plastic is intended to dissolve over approximately one year, while the titanium remains permanently in the tissue. It is crucial to note that BioZorb Markers are intended for marking areas for future treatment and are not designed or approved for cosmetic purposes, filling tissue spaces, or serving as markers for radiation therapy.
FDA Guidance for Patients and Providers
The FDA has issued specific guidance for patients with BioZorb Marker implants. Patients experiencing any AEs should promptly contact their healthcare providers. However, asymptomatic patients are not required to have the devices removed unless advised by their doctor. Patients planning to undergo radiation therapy should discuss the risks with their providers, as BioZorb Markers (search) have not been approved for radiation treatment marking. The FDA also encourages patients to report any device-related complications directly to the agency.
For healthcare providers and facilities, the FDA recommends discontinuing 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.
Reporting Complications
The FDA encourages the public to report any issues with these devices through the MedWatch Voluntary Reporting Form to ensure that new or ongoing complications are properly documented.
According to a press release from Hologic, “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.”