Lawsuit Claims Biozorb Implant Penetrated Skin, Causing Massive Infection

Hologic, the manufacturer of Biozorb tissue markers, chose profits over the safety of breast cancer survivors, lawsuit says.

A Kentucky couple has filed a BioZorb lawsuit, indicating that the implantable tissue marker, which was placed in the wife’s breast during cancer treatments, is defectively designed and caused her to suffer severe and permanent injuries.

Patricia Shemwell and her husband, John, brought the complaint (PDF) in the U.S. District Court for the Western District of Kentucky on May 28, naming BioZorb’s manufacturer, Hologic, Inc., as the sole defendant.

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

However, breast cancer survivors like Shemwell have reported experiencing severe pain, discomfort and other BioZorb implant injuries after the device failed to absorb, or fractured inside the body.

After the number of complications and reports began to build up, 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 due to 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.

The couple’s lawsuit indicates Shemwell was diagnosed with breast cancer in 2022 and underwent a left partial mastectomy, lumpectomy and removal of several lymph nodes in May of that year. The procedures also included the implantation of a BioZorb tissue marker.

“In October of 2022, Plaintiff Patricia Shemwell began to have problems in her left breast including but not limited to, a hard painful knot, infection, fluid build-up, and much pain. Plaintiff sought emergency medical treatment and was diagnosed with a massive infection at the site of her prior surgery,” the lawsuit states. “While receiving treatment the BioZorb Marker penetrated through Plaintiff’s skin.”

After the recall was announced two years later, Shemwell discovered that the incident was not a one-off and became aware of the serious problems with the BioZorb tissue marker’s design.

The lawsuit alleges Hologic knew, or should have known, about the problems with the BioZorb implants long before the recall, and indicates the company was aware that the implant was not performing in patients’ bodies the way it had been marketed.

The couple claims Hologic failed to provide adequate warnings about the problems in order to maximize profits at the expense of women with breast cancer. They present claims of strict liability and negligent design defect, breach of implied warranty of merchantability and negligence. They seek both compensatory and punitive damages.

June 2025 BioZorb Lawsuit Update

The Shemwells’ complaint is one of the first cases brought outside of the District of Massachusetts, where Hologic’s U.S. headquarters are located and hundreds of similar BioZorb lawsuits have been centralized 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, 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.