Lawsuit Claims BioZorb Marker Caused Chronic Pain, Multiple Surgeries After Lumpectomy

North Carolina woman alleges the recalled tissue marker did not dissolve into her body after breast surgery, resulting in painful complications.

A breast cancer survivor has filed a BioZorb marker lawsuit after having to undergo a foreign body removal procedure when the implant failed to properly absorb into her body as advertised.

The complaint (PDF) was brought by Priscilla McBrayer in the U.S. District Court for the District of Massachusetts on April 4, naming BioZorb’s manufacturer, Hologic, Inc., as the sole defendant.

BioZorbs are small implants used during breast cancer treatment. They consist of a biodegradable spacer made from polylactic acid and six permanent titanium clips.

Although the BioZorb marker is advertised to gradually break down and dissolve in the body, leaving only the clips in place to mark the location for targeted radiation therapy, women have been complaining for years that they have suffered continuing pain, discomfort and other complications when the device failed to absorb back into the body. Women have also reported issues with BioZorb markers migrated out of position or even protruded painfully through the skin, often resulting in the need for the breast tissue marker to be surgically removed.

The number of adverse event reports steadily grew in the years after it was introduced, until the Hologic announced a BioZorb recall in October 2024, recommending that doctors carefully monitor women who still have the marker implanted in their body.

Currently, at least 122 plaintiffs are involved in roughly 30 different BioZorb tissue marker lawsuits, raising allegations that are nearly identical to those presented by McBrayer. However, the size of the litigation is expected to grow in the coming months as more women discover that their implants may have failed to dissolve in prior years due to design defects.

According to the lawsuit brought by McBrayer, a BioZorb marker was implanted following her diagnosis with breast cancer in 2023. In August of that year she underwent a partial lumpectomy and mastectomy of her right breast, and a BioZorb marker was placed to mark the location for radiation treatment.

Despite the implant being properly placed, McBrayer indicates she experienced severe pain, scarring, hardening and dimpling at the implant site. As a result of the complications, she underwent a surgical procedure to remove the BioZorb marker in February 2025.

“As a result of the BioZorb implant, Plaintiff has been caused to have significant pain, disfigurement, and worry, leaving her permanently and physically scarred,” the lawsuit states. “Plaintiff’s complications, foreign body reaction, disfigurement, and non-absorption are not warned of on the Instructions for Use but were risks Defendant knew, or should have known, and failed to disclose to physicians and patients.”

McBrayer presents claims of design defect, failure to warn, breach of implied warranty, manufacturing defect and negligence. She is seeking both compensatory and punitive damages.

April 2025 BioZorb Marker Lawsuits Update

McBrayer’s claim will be combined with dozens of others currently consolidated in the District of Massachusetts, where the manufacturer’s headquarters are located and U.S. District Judge Allison D. Burroughs is presiding over coordinated pretrial proceedings and preparing a group of claims for early test trials, which are expected to begin in September 2025.

Last month, the court appointed seven plaintiffs’ attorneys to leadership roles in the litigation. This includes two co-lead counsel and a five-member Plaintiffs’ Executive Committee (PEC), who will be responsible for coordinating discovery on common issues, arguing motions before the court, and leading settlement discussions on behalf of all plaintiffs. Each individual plaintiff will still retain their own lawyer to pursue case-specific injury claims and damages.

Just days later, Judge Burroughs also rejected a motion to dismiss filed by Hologic, allowing plaintiffs’ design defect claims to proceed. The court found that the complaints sufficiently alleged that the BioZorb marker’s materials, shape and surface texture may prevent proper absorption in the body, leading to migration, infections or painful protrusions.

The ruling is expected to apply broadly across the litigation and significantly strengthens the claims moving forward.