BioZorb Implant Complications Result in Lawsuit Brought by 7 Breast Cancer Survivors

Each of the women experienced severe complications from the BioZorb implant, after the radiographic marker failed to dissolve, migrated or fractured

A group of seven breast cancer survivors have joined together to file a product liability lawsuit against Hologic, Inc., each claiming that they suffered painful complications from a BioZorb implant, which is a radiographic tissue marker used to mark the location for targeted radiation therapy.

The complaint (PDF) was filed in the U.S. District Court for the District of Massachusetts on July 24, by Lisa Galaini, Laura Mahony, Jacqueline Demontigny Rauh, Lauren Sims, Ginger Iconos-Watkins, Joan Hayden and Jaima Aldrich, claiming that the BioZorb implant is unreasonably dangerous and unfit for its intended use during breast cancer treatments.

BioZorb is a small device that is implanted into soft tissue, most commonly during treatments for breast cancer, consisting 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 areas where a tumor has been surgically removed.

Hologic Inc. has marketed the Biozorb markers as a safe and effective treatment option for breast cancer survivors, providing a critical guide for targeted radiation therapy to eliminate of any remaining cancer cells, while protecting the surrounding healthy tissue. However, a growing number of reports have been submitted to the manufacturer and FDA, involving painful Biozorb complications where the device moved, fractured or failed to absorb back into the body, often resulting in the need for surgical interventions.

As a result of these problems, a BioZorb recall was issued earlier this year, and a rapidly growing number of BioZorb implant lawsuits are now being pursued against the manufacturer.

BioZorb Side Effects Lawsuit

Each of the seven plaintiffs named in the latest lawsuit are women who survived breast cancer, but now face additional complications from the BioZorb implant, after it failed to dissolve, moved out of position or fractured inside the body.

Lead plaintiff Lisa Galiani, of Kentucky, indicates she was diagnosed with breast cancer in 2023, undergoing a left breast lumpectomy in February of that year. Although her doctor properly implanting the BioZorb tissue markers, the lawsuit indicates that she experienced a severe infection, adverse tissue reactions, and unrelenting pain and itchiness where the BioZorb was implanted.

These complications led to the device being surgically removed in April 2024, and doctors discovered that the BioZorb implant had shattered into shards, according to the lawsuit.

Laura Mahony, of Florida, was implanted with a BioZorb tissue marker in January 2020, after she was diagnosed with cancer in her left breast. Following implantation, she developed a hard lump at the implant site, constant pain, discomfort, inflammation, fat necrosis, excessive scar tissue and other BioZorb complications that affected her daily life and made it difficult to sleep. She also underwent revision surgery to have the device removed.

Jacqueline DeMontigny-Rauh, of South Carolina, received her BioZorb in 2016 after being diagnosed with invasive ductal carcinoma in her left breast. She had her device removed in May 2024.

“Ms. Rauh suffered from intense and unrelenting pain, tenderness, and pressure at the site of the BioZorb Marker,” the lawsuit states. “Ms. Rauh’s pain worsened upon contact or movement, disrupting her daily life, making it difficult to sleep, and causing excruciating pain during mammograms.”

Allegations outlined in the lawsuit describe similar problems experienced by Laura Sims, of Florida, who was implanted with a Biozorb tissue marker in 2019, but had it removed due to complications that included necrosis, excessive scar tissue, tissue damage, inflammation, infections, disfigurement and a hard lump where it was implanted.

Texas resident Ginger Iconos-Walkins not only had a BioZorb implant removed in October 2023, less than two years after it was placed in her body, but her doctor determined that the device had migrated to a different area of her breast, which made it visible underneath the skin.

Joan Hayden, of Indiana, had her BioZorb implanted in November 2019 after she was diagnosed with breast cancer in her right breast. BioZorb complications have led to her suffering a hard painful lump, pain, tenderness and discomfort. The device has yet to be explanted.

Both Hayden and the last plaintiff, Jaima Aldritch, who received her BioZorb in 2020, say their complications arose when the device failed to dissolve correctly. Aldritch indicates the implant is still palpable in her left breast four years later.

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

August 2024 BioZorb Implant Lawsuit Update

The case will be centralized with a number of other BioZorb complication lawsuits currently pending against Hologic, Inc. in the District of Massachusetts, where the manufacturer’s headquarters are located. Since each of those claims involve nearly identical questions of fact and law, the litigation in that federal district has been assigned to U.S. District Judge Allison D. Burroughs for coordinated discovery and pretrial proceedings.

As part of the management of the growing BioZorb marker litigation, Judge Burroughs has established a bellwether plan, where a small group of cases are being prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that could be repeated in numerous claims.

The Court has established detailed guidelines for how discovery disputes will be handled, and procedures for the exchange of medical records and other documentation, ensuring that the litigation proceeds in an orderly and fair manner.

Although the outcome of these early trial dates will not have any binding impact on other breast cancer survivors pursuing lawsuits against BioZorb manufacturers, the average amounts any lawsuit payouts may influence how much Hologic pays as part of any BioZorb settlement agreement to avoid each individual claim going before a jury in the future.

As the early discovery proceeds in those bellwether claims, BioZorb injury lawyers are continuing to investigate and review lawsuits for individuals that have suffered injuries from the device failing to dissolve, fracturing or migrating.