If you or a loved one experienced pain, discomfort, or complications after receiving a BioZorb implant following breast cancer surgery, you are not alone. Across the United States, patients are taking legal action to hold the manufacturer, Hologic, accountable for the harm caused by this device.
The BioZorb implant, manufactured by Hologic, Inc., is a class II medical device first cleared by the FDA in 2012 under the 510(k) process. It is an implantable radiographic marker composed of a bioabsorbable material (polylactic acid) and six titanium radiopaque clips, which are designed to mark soft tissue sites during radiation therapy following breast cancer surgery. The device is intended to provide a three-dimensional marker for more precise radiation targeting while gradually dissolving in the body over time.
BioZorb works. But it has also been linked to several complications, including prolonged pain, discomfort, infection, device migration, and non-absorption. Many patients have reported the formation of hardened masses, scar tissue, and additional injuries at the implant site. The device has also been associated with increased radiation exposure and adverse reactions requiring further surgeries for removal.
FDA Safety Communication and Class I Recall
The FDA issued a Safety Communication regarding the BioZorb device on February 2, 2024, following reports of serious complications associated with its use. The FDA noted that these adverse events included pain, fluid buildup (seroma), device migration, device erosion through the skin, and non-absorption of the bioabsorbable component. As a result of these complications, the FDA classified Hologic’s communication to healthcare providers as a Class I recall on May 22, 2024—the most serious type of recall, indicating that the device poses a risk of serious injury or death.
The FDA’s recall does not require the removal of BioZorb from the market but emphasizes increased monitoring and transparency regarding its potential risks. The FDA’s Safety Communication and subsequent recall highlight the need for patients and healthcare providers to be aware of the risks associated with BioZorb and to report any adverse events to ensure proper follow-up care and safety.
Legal Issues and Allegations Against Hologic
Recent litigation has focused on allegations that Hologic failed to adequately warn patients and healthcare providers about the risks associated with BioZorb. Plaintiffs claim that the Instructions for Use (IFU) did not include warnings about the potential for non-absorption, prolonged pain, device migration, or increased radiation exposure. Additionally, there are concerns that Hologic marketed the BioZorb device for off-label uses, such as improving cosmetic outcomes and filling tissue space—claims that were not cleared by the FDA.
So Hologic BioZorb lawsuits alleged that the company marketed the BioZorb device with claims that it could fill space in breast tissue and improve cosmetic outcomes after surgery, despite the FDA not approving these specific indications. But the bigger problem is the allegations that the device’s Instructions for Use did not adequately warn doctors and patients about the risks of non-absorption, prolonged pain, device migration, or the need for higher radiation doses.
The core of every BioZorb lawsuit is that Hologic knew about these risks but failing to disclose them to patients and healthcare providers. The lawsuits claim that the company was aware of post-market adverse events, including infection, fluid buildup, device migration, device erosion, and the need for additional surgeries (and the Medical Device Reports submitted to the FDA prove it).
Summary of the Complaints and Injuries Reported
Patients who have experienced complications related to BioZorb have reported a range of injuries, including:
- Hardened masses or lumps at the implant site
- Formation of scar tissue and fat necrosis
- Chronic pain, swelling, and a burning sensation in the breast
- Complications requiring additional surgeries for device removal
- Emotional distress and fear of developing another tumor due to complications
These injuries have led to numerous lawsuits against Hologic, with claims focusing on defective design, failure to warn, and negligence. Plaintiffs are seeking compensation for medical expenses, pain and suffering, emotional distress, and other damages resulting from the complications caused by the BioZorb implant.
Implications for Patients and Healthcare Providers
The ongoing legal battles and FDA actions serve as a reminder of the potential risks associated with implantable medical devices, particularly those cleared under the 510(k) process. Patients and healthcare providers are encouraged to closely monitor for any adverse reactions and to seek further information about the risks associated with BioZorb before considering its use in surgical procedures. As more information becomes available, it is essential to stay informed and understand the potential impact of the device on patient health and safety.=