Breast Cancer Survivors File Lawsuit Over Recalled BioZorb Tissue Marker

Women suffered BioZorb complications like migration, fluid buildup and severe pain after the tissue marker was implanted for breast cancer treatments.

Five breast cancer survivors have joined together to bring a BioZorb lawsuit against Hologic, Inc., alleging that they all experienced severe and painful complications after the now-recalled tissue marker was implanted to mark the location for targeted radiation treatments.

The complaint (PDF) was filed by Debra Sigmund, Megan Clapper, Joanne Downing-Malik, Cindy Corder and Lilia Rathburn in the U.S. District Court in Massachusetts on March 7, joining more than 100 other breast cancer survivors now claiming the BioZorb tissue marker was defectively designed.

The BioZorb Marker is commonly for use among breast cancer survivors and other individuals undergoing radiation therapy, which consists of a biodegradable spacer made from polylactic acid, and six permanent titanium clips.

While it 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, women have complained for years about continuing pain, discomfort and other complications that persisted long after receiving the implant.

In October 2024, a BioZorb recall was announced, removing the device from the market entirely, following dozens of reports that describe a wide variety of painful and disfiguring complications, and the manufacturer now faces a growing number of product liability lawsuits being filed by women who had one of the devices placed in their breast.

This recently filed lawsuit includes claims from five women from different states, who each indicate they are breast cancer survivors who had a BioZorb implanted before the recall to mark previous surgical sites.

Sigmund, of New Jersey, indicates she received hers in October 2020, after a right breast lumpectomy. The lawsuit notes that the BioZorb failed to absorb, resulting in pain, discomfort and permanent physical scarring.

Clapper, of Alaska, received her BioZorb tissue marker after a partial mastectomy in December 2016, and she experienced complications that closely mirrored those of Sigmund.

“Ms. Clapper suffered from a hard painful lump, deformity, scarring, sensitivity, itching, swelling and redness at the site of the BioZorb Marker,” the lawsuit states. “In addition, the BioZorb marker failed to absorb.”

Downing-Malik, of Florida, experienced her BioZorb migrating to under her armpit, while Cindy Corder, of Kentucky, experienced painful fluid buildup at the BioZorb implant site, and had to have the area aspirated eight times since May 2023. Rathburn, of California, required physical therapy for lymphedema after her BioZorb failed to absorb properly and had to be removed, and continues to experience swelling and discoloration, according to the complaint.

The women present claims of design defect, failure to warn, manufacturing defect, negligence, and breach of implied warranty of merchantability.

March 2025 BioZorb Lawsuit Status Update

Given common questions of fact and law raised in each of the complaints, all BioZorb lawsuits have been centralized before Judge Allison D. Burroughs in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located, for coordinated pretrial proceedings and a series of early test trials.

As part of the coordinated management of the litigation, Judge Burroughs has directed the parties to prepare a small group of early BioZorb lawsuits for a “bellwether” process, which will present a series of cases to juries later this year, to help gauge the response to certain evidence and testimony that will be repeated throughout the litigation.

In July 2024, Judge Burroughs directed each side to designate five cases for a Discovery Pool, which have been going through depositions and other case-specific discovery over the past nine months.

Late last year, the parties whittled that list down to four bellwether trial candidates, and Judge Burroughs announced that the first BioZorb lawsuit bellwether trial will begin on September 8, 2025, with a second trial set to begin on January 20, 2026.

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 negotiations needed to avoid each claim ultimately being set for trial in the future.