BioZorb Lawsuit Indicates Recalled Tissue Marker Migrated After It Failed To Absorb, Resulting in Severe Pain and Surgical Removal

Lawsuit comes days after FDA announced a BioZorb marker recall, indicating the implants are failing to properly be absorbed in women’s bodies.

An Arkansas woman has filed a product liability lawsuit against the manufacturers of the recently recalled BioZorb tissue marker, which is often implanted during breast cancer treatments, indicating that she was left with painful injuries after the device migrated out of position and failed to absorb inside her body, as advertised.

The complaint (PDF) was brought by Mindy Holcomb in the U.S. District Court for the District of Massachusetts on November 4, indicating that Hologic Inc. sold a defective and unreasonably dangerous breast tissue marker, without adequately warning about known risks associated with the device.

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. 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 previous surgical tumor removal sites.

However, 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, urging physicians to return all unused implants to the manufacturer and to continue monitoring patients who had the device implanted for health complications, like the ones experienced by Holcomb.

According to her lawsuit, Holcomb was diagnosed with breast cancer in June 2021, and underwent a lumpectomy and partial mastectomy on her left breast that August. At that point she was implanted with a BioZorb device to mark the site of her surgery.

However, instead of the tissue marker harmlessly absorbing in her body, the lawsuit indicates the BioZorb migrated out of position, causing her to experience pain and swelling at the implant site.

“As a result of the BioZorb implant, Plaintiff has been caused to have significant pain, disfigurement, and worry, leaving her permanently and physically scarred,” Holcomb states in the complaint. “Plaintiff’s complications, adverse local tissue reaction, disfigurement, non-absorption, device migration, and palpable mass 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.”

As a result of the BioZorb tissue marker failing to absorb, Holcomb indicates that she underwent a bilateral breast mastectomy in November 2021, at which point the implant was surgically removed.

She presents claims of strict liability, negligent failure to warn, negligent design defect, breach of implied warranty and negligence, seeking both compensatory and punitive damages.

November 2024 BioZorb Lawsuit Update

Given similar allegations and claims presented in complaints filed against Hologic Inc. in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located, all lawsuits over BioZorb tissue markers have been consolidated before U.S. District Judge Allison D. Burroughs for coordinated discovery and pretrial proceedings.

Earlier this year, Judge Burroughs established a “bellwether” program, where the parties selected a small group of representative claims to go through early motions and case-specific discovery.

In July 2024, Judge Burroughs directed the parties to select a group of BioZorb lawsuits for the bellwether process, with each side designating five cases for a Discovery Pool. Those BioZorb injury cases will go through depositions, exchange of medical records and other case-specific discovery, which must be completed by December 16, 2024.

After discovery is complete in the bellwether BioZorb side effects lawsuits, each side will be able to strike three cases from the pool, leaving a total of four claims that will be eligible to go before the first juries in or around July 2025.

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