Failed BioZorb Tissue Marker to Require Surgical Removal, Lawsuit Claims

Pain, swelling, rashes and scar tissue occurred after breast cancer procedure, which included the insertion of a BioZorb tissue marker at the radiation treatment site.

A breast cancer survivor says she had to endure additional surgeries after her BioZorb tissue marker implant failed due to a flawed design that ultimately led to the device being pulled from the market.

In a complaint (PDF) filed in the District of Massachusetts on July 29, Christine Portele accuses Hologic, Inc. of knowingly selling a defective or dangerous product without adequately warning patients or the medical community of the risks.

BioZorb is a surgical implant marketed over the past decade for patients undergoing targeted radiation therapy. It was designed to mark the site of treatment in case future procedures were needed. The device consists of a biodegradable polylactic acid coil and six permanent titanium clips, which were intended to remain in the body as reference points after the implant dissolved.

However, following numerous reports that the implants failed to properly dissolve and absorb into patients’ bodies, the U.S. Food and Drug Administration announced a BioZorb recall in May 2024. The agency cited incidents where the tissue marker migrated out of position, protruded through the skin, or failed to dissolve properly, requiring surgical removal.

Portele’s claim is one of more than 100 similar BioZorb lawsuits filed by breast cancer survivors throughout the federal court system, each raising similar allegations that Hologic put profits ahead of patient safety through its inadequate design and testing of the implants.

The lawsuit indicates Portele, of Illinois, was diagnosed with breast cancer in July 2023, and underwent a lumpectomy of her left breast in August 2023. During the procedure, she was implanted with a BioZorb tissue marker.

According to the complaint, Portele suffered injuries at and around the BioZorb implant after surgery, including pain, swelling, rashes and scar tissue. Portele expects to have to undergo further treatment and future surgeries to remove the failed BioZorb tissue marker and address the resulting complications.

“Hologic was aware of Medical Device Reports that reported patient complications including, but not limited to, infection, fluid buildup, device migration, device erosion, pain, discomfort, rash, extended resorption time of the device, and additional surgeries… Hologic also knew, or should have known, of clinical evidence that BioZorb can cause a hard, palpable lump causing patient pain and discomfort.”

–Christine Portele v. Hologic, Inc.

Despite having knowledge of these problems, the lawsuit indicates BioZorb failed to put proper warnings into its Instructions for Use.

Portele presents claims of design defect, failure to warn, breach of implied warranty of merchantability, manufacturing defect, and negligence. She seeks both compensatory and punitive damages.

BioZorb Failure Lawsuits

The BioZorb lawsuit filed by Portele will join more than 100 other similar claims currently consolidated before U.S. District Judge Allison Burroughs in the District of Massachusetts, where Hologic is headquartered.

Judge Burroughs has the parties preparing a group of BioZorb lawsuits to serve as representative cases in early “bellwether” test trials. These trials will help the parties see how juries are likely to respond to evidence and testimony likely to be repeated throughout the litigation. The first BioZorb bellwether trial is scheduled to begin on September 8.

While the outcome of these early trial dates will not have any impact on other claims being pursued against the manufacturer, the average BioZorb lawsuit payouts awarded by juries are likely to have a substantial impact on settlement negotiations needed to avoid each claim ultimately being set for trial in the future.

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