Problems With Recalled BioZorb Markers Could Cause Severe Injury or Death, FDA Warns

Federal medical regulators are warning doctors and patients to take a recent BioZorb recall seriously, indicating that problems with the tissue markers can lead to severe injury or death.

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 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.

However, in late October, the U.S. Food and Drug Administration (FDA) reported that Hologic, Inc. was removing all BioZorb implants, placed in breast tissue for targeted cancer treatments, from the market due to the increased risks of pain, infection, rash, device migration, erosion and other complications.

On December 18, the agency announced it was giving the BioZorb recall a Class I designation, the most serious classification of recall, removing all remaining models from the market.

Following the first recall, dozens of BioZorb marker lawsuits have been filed in courts nationwide by breast cancer survivors who say Hologic failed to adequately warn consumers or the medical community about the risks of the BioZorb design.

The FDA now says that doctors and patients should take this recall as seriously as possible.

“The use of affected product may cause serious adverse health consequences, including pain, infection, rash, device moving from where it was placed (migration), device breaking through the skin (erosion), fluid buildup under the skin (seroma), other complications and/or additional medical treatments, and death,” the agency warns. “There have been 252 reported injuries. There have been no reports of death.”

The FDA instructs healthcare professionals not to implant the BioZorb Marker or BioZorb LP Marker in any future patients. In addition, the agency indicates doctors should monitor those who have already received the implant.

BioZorb Marker Recall Instructions

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 to 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.

December 2024 BioZorb Marker Lawsuit Update

Hologic already faces dozens of BioZorb recall lawsuits filed by patients, and it is expected that the class I recall designation will lead to more complaints in the coming weeks and months.

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.