FDA Issues Warning Letter Over Recalled BioZorb Tissue Marker Manufacturing Problems

Investigators found deficiencies in the manufacturer’s design process, the implantation procedure, and a failure to properly respond to complaints about BioZorb Marker problems in a timely manner.

In the wake of last year’s BioZorb tissue marker recall, federal investigators have sent a warning letter to Hologic, highlighting problems found at the manufacturer’s facility in Massachusetts, as well as a number of failures to follow good manufacturing practices.

The BioZorb marker is a small implant used during certain breast cancer treatments and other procedures, involving a biodegradable spacer made from polylactic acid and six permanent titanium clips, which are designed to stay in place to pinpoint areas for targeted radiation therapy.

Although the implant was supposed to gradually break down and dissolve in the body, a large number of patients reported experiencing painful BioZorb complications, when the device failed to absorb into the body, migrated out of position, poked through the skin, or caused other painful injuries, often requiring surgical removal.

Due to the problems, Hologic first recalled BioZorb Markers in May 2024, urging doctors to carefully monitor patients who still have the device in their body, and subsequently requested that any un-implanted devices be returned by medical facilities late last year.

More than 100 patients are now pursuing BioZorb lawsuits, seeking financial compensation for painful and devastating injuries they have experienced, and federal regulators are beginning to scrutinize the manufacturing practices employed by Hologic.

On January 14, the U.S. Food and Drug Administration (FDA) released a warning letter it sent to Hologic in December 2024, which listed a number of problems discovered during inspections between July 30, 2024 and September 24, 2024, which they say made the BioZorb marker an adulterated product.

According to the FDA, those problems likely emerged due to a lack of a proper device design process, failure to put in place a program for implementing corrective and preventative actions, and failure to submit required reports to the FDA on corrections and removals in a timely manner.

The letter indicates that the company failed to make key design considerations, including failure to identify the intended patient population, or addressing intended anatomy types. In addition, the FDA indicates Hologic did not consider the surgical requirements, appropriate placement or fixation of the device, and did not determine how deeply the BioZorb marker should be implanted into the patient’s tissue.

The company also did not “include a requirement related to how in-vivo radiation treatments can impact the performance of the device and the ability of the device to resorb into patient’s body,” the warning letter states.

“Your firm does not have any verification testing to demonstrate that the bioabsorbable spacer material (poly lactic acid) is absorbed by the body,” agency investigators determined. “Your firm received complaints and filed Medical Device Reports regarding devices requiring explant and a lack of resorption, including Hologic Complaint Report CPT-01345922 which stated that the device failed to dissolve for almost five (5) years.”

BioZorb Problems Continue to Pose Risks for Patients

While the agency acknowledges the implants are no longer being sold, the letter expresses concern for the safety of patients still implanted with the device, noting that Hologic will not be performing specific design studies to address the problems, and has not made efforts to ensure that the risks of the device are mitigated for the remaining patients.

In fact, the agency determined that the company failed to implement proper corrective actions once reports of problems were received. The FDA letter notes that in September 2023 Hologic saw a spike of adverse event complaints. They included reports of breast pain, erythema, itching and burning sensations, infections, scar tissue, sleep dysfunction, seroma, necrosis and additional surgeries and device explantations.

However, the company did not initiate a corrective action investigation until May 2024. The company also failed to determine an occurrence rate after receiving the complaints. It also failed to report many of the incidents to the FDA within the required 10 days, inspectors determined.

Despite the BioZorb recall, the FDA still wants the manufacturer to explain to the FDA how it intends to resolve the deficiencies in its design and incident reporting process.

2025 BioZorb Tissue Marker Lawsuit Update

There are now a rapidly growing number of BioZorb tissue marker lawsuits being pursued against Hologic by breast cancer survivors, each raising similar allegations that design defects caused the device to migrate, fracture, poke through the skin, or cause other injuries.

Given common questions of fact and law raised in each of the complaints brought in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located, the litigation has been consolidated before Judge Allison D. Burroughs for coordinated pretrial proceedings and a series of early test trials.

In July 2024, Judge Burroughs directed 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.

Last month, the parties whittled that list down to four bellwether trial candidates, and Judge Burroughs announced that the first BioZorb lawsuit will go before a jury on September 8, 2025, with a second trial set to begin on January 20, 2026. The order indicates that both trials are expected to last three weeks, and that the next two trial dates will be set later.

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.