Breast Cancer Survivors File BioZorb Tissue Marker Lawsuit After Implant Fails

Lawsuits continue to be filed as the first cases are being prepared for early “bellwether” test trials.

A group of six breast cancer survivors have jointly filed a BioZorb tissue marker lawsuit, indicating they all experienced complications involving the recalled implant, which they say was defectively designed.

The complaint (PDF) was brought by Tammie Lowry, Catherine James, Susan Quidley, Melinda Bianconi, Ann Berry and Trisha Johnson in the U.S. District Court of Massachusetts on May 14, naming Hologic, Inc., BioZorb’s manufacturer, as the defendant.

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.

In October 2024, the U.S. Food and Drug Administration (FDA) announced a BioZorb recall, removing all of the breast tissue markers from the market due to a higher-than-expected rate of failures and complications, often resulting in the need for the implant to be surgically removed.

This latest lawsuit joins more than 100 similar BioZorb lawsuits brought by women nationwide, each raising similar allegations that the marker failed to dissolve properly once implanted, often causing infections, severe pain, migrating out of position, and eroding through the skin.

The women all report having suffered various BioZorb marker complications, causing pain, suffering, physical scarring, and concerns about the potential return of their cancer.

All six say neither they, nor their doctors, were warned about the potential risks of failure, and say Hologic knew, or should have known, about the potential complications linked to the BioZorb tissue marker.

“The IFU (information for use) for BioZorb contains no warnings or contraindications of any substance to effectively warn patients, physicians, or hospitals of the relevant risks associated with the use of the device,” the lawsuit states. “The BioZorb IFU and Defendant’s marketing of the BioZorb indicate the device is intended to completely resorb in up to one or more years. However, there is evidence that the device can take significantly longer than one year to absorb, or it may fail to absorb at all. These risks are not mentioned in BioZorb’s IFU.”

The women note that Hologic received numerous Medical Device Reports of patient complications but failed to update the label warning.

They present claims of design defect, failure to warn, manufacturing defect, negligence, and breach of implied warranty of merchantability. The women seek both compensatory and punitive damages.

BioZorb Tissue Marker Lawsuits

All BioZorb lawsuits have been filed in the U.S. District Court for the District of Massachusetts, where Hologic’s headquarters are located. Due to 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.

Last year, the Court ordered plaintiffs and defendants 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.

Last December the parties cut 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.