Hologic Faces Lawsuit Over BioZorb Complications Experienced by Five Breast Cancer Patients

Women experienced infections, scarring, device migration and other complications after a BioZorb marker failed to absorb properly, lawsuit claims.

Five women have joined together to file a lawsuit against Hologic, Inc., indicating that they experienced complications after a BioZorb implant intended to mark previous breast cancer tumor sites failed to properly absorb in their bodies, leading to severe infections, device migrations, disfiguring injuries and fears of new tumors developing.

The BioZorb Marker is a small implant approved for use among breast cancer survivors and other individuals who require targeted radiation therapy, which consists of a biodegradable spacer made from polylactic acid, and six permanent titanium clips. The implant is designed to gradually break down and dissolve in the body, leaving only the clips in place to aid in the precise marking of previous surgical tumor removal sites.

Following at least 71 reports of injuries caused by the device, ranging from pain and infection to more complex BioZorb complications like device movement and erosion, the U.S Food and Drug Administration (FDA) announced a BioZorb Marker recall in May 2024, indicating that problems with the device often result in the need for medical interventions to address or remove the implant.

In a joint complaint (PDF) filed late last month in the U.S. District Court for the District of Massachusetts, the breast cancer survivors outline strikingly similar experiences each of them had after their BioZorb failed to reabsorb, indicating that Hologic, Inc. knew or should have known about these risks, yet failed to disclose the potential BioZorb complications to patients, doctors or hospitals.

In an order (PDF) issued on October 21, the case brought by Joanne Bates, Patricia Markway, Shawn Allen, Denise Bibro and Sheryl Portez was consolidated with a growing number of other BioZorb lawsuits that are already pending in the District of Massachusetts, where the manufacturer’s U.S. headquarters are based.

The women all experienced failures of the BioZorb device after being treated for breast cancer. The complications resulted in pain, scarring, fears of the return of tumors, device migration and infections, after the implant failed to absorb harmlessly into the body as advertised.

For example, Markway indicates that she had a BioZorb marker implanted during a right breast lumpectomy, after she was diagnosed with right breast invasive ductal carcinoma in 2022. However, the BioZorb failed to dissolve as intended.

“Ms. Markway suffered from pain, redness, and swelling, along with burning and stabbing sensations at the site of the BioZorb Marker,” the lawsuit states. “The BioZorb migrated, and Ms. Markway developed an infection at the site of the device.”

As a result of the complications, she had the BioZorb implant surgically removed later that same year.

The complaint alleges the manufacturer knew about the device’s risks through Medical Device Reports, which indicated that patients were experiencing a high rate of complications from BioZorb. However, rather than warning consumers and the medical community, Hologic continued to sell the device in a defective and unreasonably dangerous condition.

The women present claims of failure to warn, design defect, breach of implied warranty and negligence. They are seeking both compensatory and punitive damages.