Joint BioZorb Marker Lawsuit Claims Implant Caused Seroma, Infections and Other Complications

The women were left with intense pain and fears of the development of new tumors caused by BioZorb after undergoing breast cancer surgery.

Six women have joined together to file a BioZorb lawsuit, claiming that they had a defectively designed tissue marker implanted in their bodies, which caused them to experience a wide range of complications and side effects, often requiring removal surgery of the device after it failed to dissolve inside their body.

The complaint (PDF) was filed by Nessa Wetterman, Natricia Heagy, Stacey Bartis, Pamela Garrett, Rebecca Morrow and Linda Blake on January 31, in the U.S. District Court for the District of Massachusetts, where a number of similar complaints have already been brought against Hologic, Inc., BioZorb’s manufacturer.

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.

Although 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, women have been complaining for years about continuing pain, discomfort and other complications that persisted long after receiving the implant.

Following dozens of BioZorb tissue marker lawsuits and adverse event reports that described a wide variety of painful and disfiguring complications linked to the device, the U.S. Food and Drug Administration (FDA) announced a BioZorb recall on October 25, 2024.

The recall urged physicians to stop implanting the devices, and to return all unused BioZorb devices to the manufacturer. In addition, doctors are now being advised to carefully monitor patients with the implant for health complications, including infections, seromas, device migration, pain and cases of the device protruding through the flesh. As a result, a rapidly growing number of women are now joining the litigation.

According to this recent lawsuit, Wettermann, a resident of California, was diagnosed with ductal carcinoma in her left breast in July 2022. In September of the same year, she underwent a lumpectomy on her left breast, during which a BioZorb tissue marker was implanted to aid future surgeons in identifying the surgical site.

Wetterman was diagnosed with a seroma, which is a build-up of fluid, at the site of the marker in December 2022, and again in March 2023, leading to the need for multiple drainage treatments. In addition, she also had to undergo physical therapy in efforts to reduce the painful side effects of the implant.

Her surgeon has advised against removing the implant at this time.

“As a result of the pain and complications of the BioZorb Marker, Plaintiff Wettermann fears the possibility of another tumor every day, causing significant emotional distress,” the lawsuit indicates. “As a result of the BioZorb, Ms. Wetterman has been caused to have additional procedures, significant pain, and worry, leaving her permanently and physically scarred. The complications, including, but not limited to, pain, nonabsorption, palpable mass, and additional surgery, are not warned of on the BioZorb Instructions for Use (IFU) but were risks Defendant knew or should have known yet failed to disclose to patients, physicians, and hospitals.”

Another plaintiff, Natricia Heagy, of Idaho, was implanted with a BioZorb tissue marker in July 2023, which also led to a seroma, a chronic infection and swelling. She had the BioZorb removed on February 20, 2024, and has had to undergo multiple right breast drainage treatments.

The other women in the lawsuit tell similar stories of pain, infections, seromas and fears of returning cancer, with most having the implant surgically removed if possible, and complaining that the BioZorb failed to simply dissolve and be absorbed into their bodies as advertised.

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

February 2025 BioZorb Tissue Marker Lawsuit Update

The joint complaint will be consolidated with other BioZorb tissue marker lawsuits being pursued against Hologic by breast cancer survivors nationwide, each raising similar allegations that design defects caused the device to migrate, fracture, poke through the skin, or cause other injuries.

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

In July 2024, Judge Burroughs directed the parties to select a group of 10 BioZorb lawsuits for a “bellwether” process, with each side designating five cases for a Discovery Pool. Those BioZorb injury cases have been going through depositions, exchange of medical records and other case-specific discovery, to help the parties gather information to select a smaller group of cases to present to juries as early test cases.

Late last year, the parties whittled that list down to four bellwether trial candidates, and Judge Burroughs announced that the first BioZorb lawsuit will go before a jury 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 settlement negotiations needed to avoid each claim ultimately being set for trial in the future.