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.