Problems With BioZorb Tissue Markers Not Adequately Disclosed by Manufacturer: Lawsuit

Lawsuit over BioZorb’s failure to dissolve and potential radiation exposure risks will be consolidated with more than 100 other claims in Massachusetts.

A New York woman who received BioZorb tissue markers during breast cancer treatment says the manufacturer falsely claimed the device would safely dissolve or absorb back into her body after it was implanted, while failing to investigate or disclose numerous reports of painful and debilitating complications being experienced by patients.

Dinamaria Maggiore filed a complaint (PDF) against Hologic Inc. in the U.S. District Court for the District of Massachusetts on July 24, claiming that the BioZorb device was unreasonably dangerous and sold with inadequate safety warnings.

BioZorb tissue markers were sold over the past decade as safe and effective treatment options for breast cancer survivors and other individuals, who require targeted radiation therapy. The device consists of a biodegradable spacer made from polylactic acid and six permanent titanium clips, which were supposed to mark the location of previous radiation therapy with the titanium clips, as the implant gradually dissolves into the body.

Last year, the U.S. Food and Drug Administration (FDA) announced a BioZorb tissue marker recall following numerous reports that the implant failed to properly dissolve into patients’ bodies, migrated out of position or protruded through the skin, often resulting in the need for surgical removal.

Maggiore’s claim joins more than 100 similar BioZorb lawsuits now being pursued by breast cancer survivors nationwide, each raising similar allegations that Hologic failed to properly design the implants or disclose the potential BioZorb side effect risks to women or medical providers.

In the lawsuit, Maggiore highlights a series of risks that she says were known to Hologic but never disclosed in the BioZorb implant’s Instructions for Use, which are provided to physicians. 

Maggiore claims the device was sold without any warnings or contraindications, and marketed with the promise that it would fully dissolve within a year. However, internal evidence cited in the complaint suggests the implant can take significantly longer to absorb, or may not resorb at all, leaving patients with lingering complications.

The complaint points to numerous adverse event reports submitted to the company involving infection, device migration, necrosis, fluid buildup, and the need for additional surgeries, yet none of these risks were included in the product’s labeling. She also alleges the company knew the implant could form a hard, palpable lump in the breast that causes pain and discomfort, but failed to include this information in patient or physician guidance.

In addition, the complaint introduces concerns about radiation exposure, citing clinical data that suggests BioZorb may increase the skin’s radiation dose during treatment. This amplification can lead to early and late-stage skin reactions, including scarring and visible damage such as telangiectasias, or red spider veins. 

These risks, Maggiore argues, were omitted from the warnings even though the manufacturer had evidence linking the implant to these complications well before she received hers in 2022.

“As you increase in energy electrons, it increases the skin dose and you run the risk of seeing more early and late skin reactions. The most disfiguring side effect [of using the BioZorb device] is the appearance of telangiectasias, which look like red spider veins. These risks are not mentioned in BioZorb’s IFU.”

–Dinamaria Maggiore v. Hologic, Inc.

Maggiore presents claims of design defect, failure to warn, breach of warranty of merchantability, negligence and manufacturing defect.

BioZorb Tissue Marker Lawsuits

Maggiore’s complaint will be consolidated in the District of Massachusetts with similar BioZorb lawsuits filed by women nationwide, which are currently centralized before U.S. District Judge Allison Burroughs for coordinated discovery and pretrial proceedings.

In July 2024 Judge Burroughs 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. 

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.

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