Seven breast cancer survivors have united to file a product liability lawsuit against Hologic, Inc., alleging they experienced painful complications from the BioZorb implant, a tissue marker commonly used in breast cancer treatment to help guide radiation therapy after a tumor is surgically removed.

The lawsuit was filed on July 24 in U.S. District Court for the District of Massachusetts. The plaintiffs claim that the BioZorb implant is dangerously defective and unsuitable for its intended use in breast cancer treatment.

Lawsuits Claim Hologic Failed to Warn of BioZorb Risks

BioZorb lawsuits, many of which have been filed in various state and federal courts, allege that BioZorb maker Hologic (formerly Focal Therapeutics) failed to adequately warn both healthcare providers and patients of the risks associated with the BioZorb marker. The lawsuits claim that the company either knew or should have known about the potential complications, yet continued to market and sell the device without sufficient warnings or instructions on potential risks.

The growing number of adverse events and the FDA’s Class I recall of BioZorb implants have triggered a wave of lawsuits against medical device manufacturer Hologic Inc.

Patients and their legal representatives argue that Hologic’s negligence led to preventable harm, including additional surgeries, infections, and irreversible tissue damage. The litigation focuses on claims of defective design, manufacturing flaws, and failure to properly communicate the risks. As of September 2024, numerous lawsuits have been filed, and more are expected to follow as awareness of the recall grows and more patients come forward.

The legal landscape surrounding the issue is also rapidly evolving, with many patients seeking compensation for injuries allegedly caused by the device. In addition to financial compensation for medical bills, plaintiffs are seeking damages for pain and suffering, lost wages, and, in some cases, punitive damages aimed at discouraging similar corporate behavior in the future.

Reports of Injuries That Prompted the BioZorb Recall

A wave of injury reports led to a broad and growing recall effort of BioZorb tissue marker. Hologic, Inc., has recalled affected batches of the BioZorb marker from hospitals, clinics, and breast cancer treatment centers across the U.S., although it’s unclear how many devices were implanted before the recall took full effect.

The BioZorb recall, which began in 2024, has sparked significant concern as patients report complications associated with the device. As of now, there have been numerous adverse event reports submitted to the U.S. Food and Drug Administration (FDA), some of which detail severe health consequences.

The FDA has classified the recall as a Class I recall, which is the most serious designation from the federal agency. It means that use of the recalled BioZorb devices can potentially cause “serious injuries or death.”

The recall affects:

• Patients who have had the BioZorb marker implanted.
• Patients receiving radiation treatment guided by a BioZorb marker that may have shifted.
• Patients undergoing cancer treatments that may be delayed due to complications with the BioZorb marker.
• Radiologists, surgeons, oncologists, and other healthcare providers who use the BioZorb marker for their patients’ treatments.

The BioZorb Marker: What Went Wrong

The BioZorb marker, designed to help guide radiation therapy by marking the tumor removal site, is typically implanted in breast tissue following a lumpectomy. The device is made up of bioabsorbable material, which was intended to dissolve over time while leaving small metal clips behind to assist in imaging and future treatments. However, the device has been linked to numerous complications that have led to its recall.

According to the FDA, the recall was initiated because of “serious health consequences,” including reports of the BioZorb marker migrating from its initial implant site, causing pain, inflammation, and tissue damage.

The most alarming reports suggest that the marker can erode into adjacent tissue and cause infections, requiring additional surgeries to remove the device. Some patients have reported significant pain and prolonged recovery periods due to these complications.

By May 2024, the FDA had officially classified the recall of BioZorb markers as a Class I recall, which is its most serious designation. This classification is used when there is a reasonable probability that the use of a device could cause serious health problems or death .

Reports of Adverse Health Effects

The FDA’s recall notice reveals that, as of May 22, 2024, at least 71 cases of injuries have been linked to the BioZorb marker. These injuries include a wide range of complications, from localized pain and inflammation to severe infections that required surgical intervention. Many of these adverse events were reported by both patients and healthcare providers who noticed unusual reactions following the implantation of the device.

Patients have reported that the migration of the BioZorb marker from the implant site caused discomfort and, in some cases, necessitated the removal of the marker. Some patients even experienced damage to surrounding soft tissue, which posed additional risks during recovery .

Health Consequences for Patients

For many patients who underwent surgery for breast cancer, the BioZorb marker recall has added unnecessary hardship to an already challenging process. In addition to the physical toll, patients are facing emotional and psychological distress from the complications caused by the device. Many patients have required additional surgeries to remove the marker, leading to prolonged hospital stays, increased medical expenses, and more time away from work or normal life.

For cancer survivors, who often already suffer from ongoing health concerns, the added burden of BioZorb-related complications has left them reeling. The migration of the marker, in particular, has resulted in serious infections that require aggressive treatment. For some, the presence of the marker in unintended areas of the body has caused long-term pain and scarring, leading to further physical and emotional trauma.

Looking Ahead: Implications for Patients and Healthcare Providers

The recall of the BioZorb marker has significant implications not just for Hologic Inc., but for the entire medical device industry. The growing litigation signals a need for greater oversight of medical devices, particularly those used in cancer treatment, where patients are already vulnerable. The FDA’s decision to classify the recall as a Class I recall—the most severe—highlights the gravity of the situation and the need for prompt action.

Healthcare providers are now tasked with informing their patients about the recall and addressing the health concerns caused by the device. Hospitals and clinics must assess which patients may have received the BioZorb marker and determine the best course of action for those affected. For many patients, this may involve additional surgery or a change in treatment plans.

As the litigation continues to unfold, it remains to be seen how Hologic will respond to the growing number of lawsuits and whether any broader regulatory changes will be enacted to prevent future incidents of this nature. In the meantime, affected patients are encouraged to consult with their healthcare providers and seek legal counsel if they believe they have been harmed by the BioZorb marker.

What Should Patients Do?

The FDA sent an Important Medical Device Safety Notification to patients in March 2024, advising them to:

• Reach out to their healthcare provider if they notice any problems after having a BioZorb marker implanted.
• Talk with their healthcare provider about the benefits and potential risks of using implantable breast tissue markers during breast cancer treatments.
• Report any issues or complications after getting a BioZorb marker to Hologic at breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.
• Have a conversation with their healthcare provider to understand the risks and benefits of implantable breast tissue markers for cancer procedures.