BioZorb Recall Issued for All Breast Tissue Markers Following Implant Migration, Erosion Problems

Federal regulators are warning doctors not to use BioZorb Markers, due to serious adverse events reported among women who had implants placed in breast tissue for targeted cancer treatments.

The U.S. Food and Drug Administration (FDA) issued a BioZorb Marker safety communication on October 25, urging physicians to return all unused implants to the manufacturer, Hologic, Inc., and to continue monitoring for health complications among patients who had the device implanted in their breast tissue.

The BioZorb Marker is a small implant approved for use among breast cancer survivors and other individuals who require targeted radiation therapy, which consists of a biodegradable spacer made from polylactic acid, and six permanent titanium clips. The implant is designed to gradually break down and dissolve in the body, leaving only the clips in place to aid in the precise marking of previous surgical tumor removal sites.

Earlier this year, the FDA announced a smaller BioZorb recall, after the manufacturer sent a safety notification to medical providers indicating that the device may be prone to cause pain, infection, rash, device migration, erosion and other complications. While the manufacturer did not remove BioZorb from the market at that time, the FDA did classify the warning as a Class I medical device recall, suggesting that continued use of the product may cause serious injury or death.

In the wake of that earlier announcement, dozens of BioZorb Marker lawsuits have been filed by breast cancer survivors, alleging that the company failed to adequately disclose risks associated with the device to patients and the medical community. However, this week the company has expanded that prior BioZorb recall to remove all unused devices from circulation.

“This notification is different than the safety notification sent in February,” the manufacturer stated in a press release issued on October 24. “Hologic is now requesting all lots of unused BioZorb Markers to be returned.”

The manufacturer indicates that more than 90,000 BioZorb markers have been sold since 2015, and there have been nearly 300 complaints or adverse events reported. Typically only between 1% and 10% of all problems associated with a medical device ever get reported to the company.

As a result, Hologic is now instructing medical facilities to quarantine any remaining implants in their inventory, and the company is working closely with the FDA to remove the BioZorb Marker from the market.

FDA BioZorb Marker Recommendations

For those patients who already have a BioZorb Marker implanted, the FDA indicates they should report any adverse events to their healthcare provider. However, the agency indicates there is no need to have the device removed unless their doctor advises them to do so.

In addition, patients with BioZorb Markers are advised to discuss the possible risks if they are planning to receive any radiation treatments, as the FDA has never approved the implant for that purpose.

The FDA instructs health care providers and medical facilities to not implant BioZorb Markers, and return all unused products to Hologic. However, doctors should continue to be on the lookout for reports of problems with the implant, and to continue to monitor patients who are still waiting to see if the implant has absorbed successfully into their bodies.

The agency indicates that potential signs of problems with a BioZorb Marker may include:

• Pain
• Infection
• Rash
• Device migration
• Device erosion
• Fluid buildup (seroma)
• Discomfort
• The ability to feel the device in the breast

Patients and doctors who experience BioZorb Marker problems are encouraged to file a report through the FDA’s MedWatch adverse event reporting program.

2024 BioZorb Lawsuit Update

The recall comes as Hologic already faces dozens of BioZorb lawsuits being pursued by patients who experienced problems, and it is expected that the decision to remove the implant from the market will have a major impact on the litigation.

Nearly all complaints have been filed in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located. Given common questions of fact and law raised in the claims, the lawsuits over recalled BioZorb markers have been consolidated before U.S. District Judge Allison D. Burroughs, for coordinated discovery and pretrial proceedings.

Earlier this year, Judge Burroughs established a BioZorb lawsuit “bellwether” program, where the parties selected a small group of representative claims to go through pretrial motions and case-specific discovery in preparation for a series of early trial dates, which may begin by July 2025.

While the outcome of these first trials will not have any binding impact on other lawsuits, they will be closely watched to gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, and the average lawsuit payout may have a substantial impact on the amounts of BioZorb recall settlements Hologic may be forced to pay in the future.