BioZorb Implant Lawsuit Alleges Tissue Marker Caused Swelling, Fluid Buildup and Chronic Pain

The complaint will be consolidated with dozens of similar claims involving complications with BioZorb implants, which are consolidated in Massachusetts federal court.

A breast cancer survivor says a BioZorb tissue marker failed to properly absorb into her body, resulting in severe injuries and the eventual need to have the implant surgically removed from her breast, where it was placed to mark the precise location for radiation treatments.

The complaint (PDF) was filed by Janet Wallenmeyer in the U.S. District Court for the District of Massachusetts on May 2, alleging that Hologic, Inc. designed a defective implant that caused additional harm to patients who had already endured the physical and emotional toll of breast cancer treatment.

The BioZorb implant is a small tissue marker approved for use among breast cancer survivors and other individuals who require targeted radiation therapy. It consists of a biodegradable spacer made from polylactic acid, and six permanent clips. 

While the BioZorb Marker is marketed to gradually dissolve into the body, leaving only the titanium clips behind to aid in the precise marking of previously removed tumor sites, breast cancer survivors report experiencing severe pain, discomfort and other BioZorb implant injuries after the device failed to absorb, or fractured inside the body.

Due to these complications, the U.S. Food and Drug Administration (FDA) announced a BioZorb recall in October 2024, removing all of the breast tissue markers from the market after Hologic acknowledged that there was a higher-than-expected rate of problems. These included incidents where the marker failed to absorb into the body, migrated, protruded through the skin, or required surgical removal.

According to the lawsuit, Wallenmeyer was diagnosed with breast cancer in January 2021. She underwent a segmentectomy on her left breast in April 2021, at which time she was implanted with a BioZorb tissue marker.

After receiving the BioZorb implant, Wallenmeyer began suffering from chronic pain, soreness, swelling and fluid buildup near the implantation site.

“Plaintiff underwent physical therapy as a result of the swelling and fluid building near the site of the BioZorb device,” her lawsuit states. “Plaintiff is actively seeking further treatment and anticipates the need for future surgery to remove the BioZorb device.”

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

BioZorb Implant Lawsuits

All BioZorb implant lawsuits are currently centralized in the District of Massachusetts under District Judge Allison D. Burroughs, who is presiding over coordinated discovery and preparing a small group of cases for early trial dates

In July 2024, the Court ordered 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.

In December 2024, the parties whittled that list down to four bellwether trial candidates, and in January 2025, Judge Burroughs announced that the first BioZorb lawsuit bellwether trial will begin on September 8, 2025.

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.