Four Women File BioZorb Lawsuit Over Breast Tissue Marker Failures and Injuries

Lawsuit indicates the BioZorb markers failed to properly absorb into the women’s bodies, leading to infections and other serious complications.

Hologic, Inc. faces a multi-plaintiff lawsuit brought by a group of four women who received the company’s BioZorb tissue marker during breast cancer treatments, and each experienced complications that later required surgical removal of the implant, and reignited fears about a possible cancer recurrence.

The complaint (PDF) was filed by Diane Wheatley, Penny Armstrong, Donna Bolden and Tiffany Haines in the U.S. District Court for the District of Massachusetts on April 30, alleging the the BioZorb breast tissue marker was defective and unreasonably dangerous as originally designed and sold in recent years. 

Their lawsuit joins more than 100 other federal BioZorb lawsuits brought by women throughout the U.S., each raising similar allegations that the marker failed to dissolve once it was implanted, resulting in severe pain, infections, rashes, migration, erosion and other complications.

BioZorb Complications Experienced by Women Nationwide

The BioZorb Marker is a small implant 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 supposed 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 marker injuries after the device failed to absorb.

As a result of 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 the manufacturer acknowledged that there was a higher-than-expected rate of problems, including incidents where the marker failed, resulting in the need for surgical removal of the device.

This recent multi-plaintiff complaint outlines complications experienced by four unrelated women, each indicating that they received a BioZorb tissue marker implant and subsequently experienced serious side effects.

Wheatley, from Pennsylvania, was implanted with a BioZorb during a right breast lumpectomy in May 2023. The lawsuit indicates the BioZorb failed to absorb, resulting in deformity, pain, scarring, swelling, infection, seroma and rash. She had the implant removed in January, but fears it may lead to the return of her cancer.

Armstrong, a Michigan resident, says she received a BioZorb implant during breast cancer surgery in October 2017 and later suffered sharp stabbing pain, deformity, scarring and infection. The device was surgically removed in September 2018 after it failed to absorb as intended, according to the complaint.

During a June 2021 lumpectomy, Bolden, of Oregon, received a BioZorb implant that later caused infection, pain and other complications. The device remains in place and has not yet been removed.

Haines, a Tennessee resident, was implanted with a BioZorb in October 2021, just months after Bolden, and experienced similar issues. She continues to fear the possible return of her tumor and associated cancer.

The women say Hologic knew or should have known about the risks and the device’s frequent failure to absorb, but failed to pass on those concerns to patients or the medical community.

“Hologic was aware of Medical Device Reports (“MDRs”) that reported patient complications including, but not limited to, infection, fluid buildup, device migration, device erosion, pain, discomfort, rash, extended resorption time of the device, and additional surgeries,” the lawsuit states. “Hologic also knew or should have known of clinical evidence that shows that BioZorb can cause a hard, palpable lump, causing patient pain and discomfort.”

Instead, the lawsuit claims the company willfully endangered cancer patients’ health in order to maximize profits. The women present claims of design defect, failure to warn, manufacturing defect, negligence, and breach of implied warranty of merchantability.

May 2025 BioZorb lawsuits Update

Currently, all BioZorb lawsuits have been filed in the U.S. District Court for the District of Massachusetts, where Hologic’s headquarters are located. Given similar allegations and claims raised in the complaints, the litigation has been consolidated before U.S. 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.