Lawsuit Indicates Biozorb Side Effects Left Woman With Chronic Pain, Disfiguring Injuries

Complications occurred after the breast tissue marker failed to absorb inside her body, which may result in need to have the BioZorb surgically removed.

A Louisiana breast cancer survivor has filed a product liability lawsuit against Hologic, Inc., indicating that side effects from a BioZorb tissue marker left her with serious and disfiguring injuries, after the small implant failed to absorb back into her body like it was supposed to.

The complaint (PDF) was brought by Delane Bailey in the U.S. District Court for the District of Massachusetts on July 1, indicating that Hologic designed and sold a defective medical implant, which was recalled last year amid a number of similar reports involving BioZorb side effects experienced by patients.

BioZorb is a small tissue marker approved for use in breast cancer survivors and other individuals who have undergone targeted radiation therapy. It is implanted into the breast, consisting of a biodegradable spacer made from polylactic acid and six permanent titanium clips, which the manufacturer indicated would remain behind to mark the location of previously removed tissues after the device gradually dissolves into the body.

Following growing reports of complications experienced by patients, the U.S. Food and Drug Administration (FDA) announced a BioZorb tissue marker recall last year, citing incidents where the marker migrated out of position, protruded through the skin, or failed to absorb, often resulting in the need for surgical removal.

More than 100 BioZorb side effects lawsuits have now been filed by breast cancer survivors, each raising similar allegations that the manufacturer prioritized profits over patient safety and failed to adequately warn about design defects that may cause the device to fail to dissolve, shift or break through the skin.

According to Bailey’s lawsuit, she was implanted with a BioZorb tissue marker in May 2021, following a breast cancer diagnosis.

However, since the procedure, Bailey has suffered from various issues around the site of the BioZorb device, including chronic pain, soreness and swelling. She is now undergoing further treatment for the BioZorb side effects and expects to have the implant surgically removed.

“As a result of the BioZorb implant, Plaintiff has been caused to have significant pain, disfigurement, and worry, leaving her permanently and physically scarred. Plaintiff’s complications, disfigurement, and non-absorption 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.”

–Delane Bailey v. Hologic, Inc.

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

July 2025 BioZorb Lawsuit Update

The BioZorb lawsuit filed by Bailey will be consolidated with hundreds of similar claims currently pending before U.S. District Judge Allison Burroughs, who is presiding over coordinated discovery and pretrial proceedings in the District of Massachusetts, where Hologic’s headquarters are located.

A year ago, 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. 

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.

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