BioZorb Marker Lawsuit Overview

The FDA approved the BioZorb tissue marker in 2012 as an implantable medical device used in breast cancer treatment to mark soft tissue sites following tumor removal. The device was shaped like a spring or a sphere and featured a bioabsorbable framework with titanium clips, which were intended to help target radiation treatment and protect surrounding healthy tissue.

BioZorb markers were designed to dissolve and resorb into the body over time, leaving only the titanium clips in place for long-term monitoring.

Initially promoted as an advancement in breast conserving surgery, the device was marketed for patients undergoing targeted radiation after a lumpectomy or during treatment for DCIS. However, many breast cancer patients later reported that the device did not reabsorb as intended, resulting in increased scarring, encapsulation, and, in some cases, erosion or dislodgement into surrounding tissue.

Reported BioZorb side effects included pain, infection, rash, device erosion, seroma, discomfort, and other complications associated with migration of the implant, which sometimes required additional medical treatment or surgical removal.

Due to the severity and frequency of these complications, the U.S. Food and Drug Administration (FDA) issued a Class I recall of BioZorb implantable breast tissue markers in 2024, indicating that continued use of the recalled devices could result in serious injuries or death.

Following these reports, hundreds of women pursued BioZorb implant lawsuits against the manufacturer, alleging that the injuries were caused by design defects and inadequate warnings about the risks associated with the implantable markers. However, as of late 2025, new claims are no longer being reviewed by lawyers.

Who was Eligible for a BioZorb Lawsuit?

Financial compensation was sought through BioZorb lawsuits for individuals who received an implantable marker and suffered any of the following complications:

• Migration
• Erosion
• Severe Pain
• Swelling
• Infections
• Necrosis
• Fluid buildup (Seroma)
• Removal surgery
• Other complications

Attorneys handled all BioZorb implant lawsuits on a contingency fee basis, meaning there were no fees or expenses paid unless a settlement or lawsuit payout was received.

2026 BioZorb Marker Lawsuit Updates

• December 2, 2025 Update: The federal judge overseeing BioZorb breast marker lawsuits has paused all litigation deadlines, just weeks before the first bellwether trial was scheduled to begin in January. The stay comes after a recent hearing in Massachusetts, where Judge Allison Burroughs denied all pending motions but left the door open for them to be renewed later. The move suggests that settlement discussions may be underway, as the court and parties evaluate potential resolutions ahead of the scheduled 2026 trial dates. Lawyers are no longer reviewing new claims in this litigation.
• November 3, 2025 Update: The federal judge overseeing BioZorb breast marker lawsuits has scheduled four bellwether trials to take place between January and April 2026. These early cases will test key evidence and expert testimony in claims that Hologic’s defective breast marker implant caused migration, infections, and chronic pain after failing to dissolve as intended. The trial outcomes could heavily influence potential BioZorb settlement discussions and shape how the remaining 200 lawsuits move forward in the coming year.
• October 15, 2025 Update: Attorneys in the BioZorb implant litigation have filed a joint motion requesting new pretrial deadlines as the first bellwether trials approach. The court has now scheduled the second trial to begin on February 23, 2026, with additional trials set for March 30 and April 27. The revised schedule follows delays in the initial trial plan as parties prepare to test key evidence and expert testimony.
• September 15, 2025 Update: Five women have filed a joint BioZorb lawsuit alleging Hologic failed to warn about risks of pain, migration, infection, and other complications linked to the recalled breast implant. About 200 BioZorb lawsuits are now centralized before Judge Allison D. Burroughs in Massachusetts, with the first bellwether trial scheduled for January 20, 2026 to help guide potential settlement negotiations.
• September 2, 2025 Update: Judge Allison D. Burroughs has denied Hologic’s motion for summary judgment, finding that plaintiffs presented a triable question on whether BioZorb tissue markers caused their injuries. With nearly 200 lawsuits pending, the first bellwether trial has been delayed to January 20, 2026, where juries will begin weighing claims of migration, skin protrusion, and failed absorption linked to the recalled implant.
• August 1, 2025 Update: A newly filed BioZorb lawsuit highlights not only the implant’s failure to dissolve as promised but also previously undisclosed radiation risks. The complaint alleges that BioZorb may amplify skin radiation dose during treatment, potentially leading to scarring, skin reactions, and disfiguring effects like telangiectasias. The case will be consolidated with more than 100 others in the Massachusetts MDL, ahead of the first bellwether trial set for September 8.
• July 23, 2025 Update: The first BioZorb bellwether trial is scheduled to begin on September 8, 2025, involving claims that the breast tissue marker failed to absorb and caused severe complications. Parties have requested a case management conference next week to address pre-trial matters and finalize procedures for presenting evidence to the jury.
• July 3, 2025 Update: Women across the country are coming forward with stories of painful swelling, hard lumps, infections, and disfigurement after their BioZorb implants failed to dissolve as promised—often learning only after surgery that the device remained inside their body for years. As lawsuits continue to grow, many are now seeking answers about what the removal process involves and how to get justice. 👉 Read what women are experiencing and what to know about BioZorb removal surgery
• June 2, 2025 Update: A group of six breast cancer survivors has filed a new BioZorb lawsuit in Massachusetts federal court, each alleging painful complications after their recalled tissue marker implant failed to dissolve as expected. The case adds to more than 100 BioZorb lawsuits now centralized before Judge Allison Burroughs, who is preparing a series of early bellwether trials. The first BioZorb bellwether trial remains scheduled for September 8, 2025, and the outcomes are expected to heavily influence future settlement discussions. Lawyers continue to investigate claims nationwide for women who required surgical removal of the defective breast marker.

BioZorb Breast Tissue Marker Recalls

October 2024 BioZorb Marker Recall

The U.S. Food and Drug Administration (FDA) issued a BioZorb Marker safety communication on October 25, 2024, announcing that Hologic had begun removing all unused BioZorb markers from the market. The action followed reports of serious adverse events among patients who had the devices implanted in breast tissue, including:

• Pain
• Infection
• Rash
• Device migration (moving out of position)
• Device erosion (breaking through the skin)
• Seroma (fluid buildup)
• Discomfort
• Other complications from feeling the device in the breast

The FDA warned that physicians should no longer implant the BioZorb tissue markers in patients and should monitor patients who have already been implanted with a BioZorb Marker for signs of any adverse events.

May 2024 BioZorb Implant Recall

Hologic, Inc. issued a BioZorb Marker recall in the first half of 2024, following numerous reports of serious adverse events including infections, seromas (fluid buildup), device migration, breakage, pain, discomfort, rashes, extended resorption times, and other problems necessitating additional medical interventions to remove the device.

The manufacturer also indicated that it has become aware of reports describing similar adverse events including the device breaking through the skin of the nipple (erosion) and the device moving out of position from where it was implanted (migration).

At the time of the recall, there were at least 71 injuries related to these complications, leading the U.S. Food and Drug Administration (FDA) to assign the BioZorb recall a Class I status, suggesting that continued use of the recalled breast tissue markers may cause serious health consequences or death.

This recall impacts 53,492 BioZorb Markers that were distributed from April 29, 2019, to April 1, 2024, involving several model numbers, including;

• F0405 BioZorb Marker 4cm x 5cm
• F0404 BioZorb Marker 4cm x 4cm
• F0331 BioZorb Marker 1cm x 3cm x 3cm
• F0231 BioZorb Marker 1cm x 3cm x 2cm
• F0221 BioZorb Marker 1cm x 3cm x 2cm
• F0304 BioZorb Marker 3cm x 4cm
• F0303 BioZorb Marker 3cm x 3cm
• F0203 BioZorb Marker 2cm x 3cm
• F0202 BioZorb Marker 2cm x 2cm

Officials further instructed healthcare providers to monitor breast cancer patients who have an implanted BioZorb Marker or BioZorb LP Marker for signs of any adverse events.

What to do if you have a recalled BioZorb Marker?

The instructions provided by the manufacturer and federal health regulators indicate that individuals with a BioZorb implantable radiographic marker should consult with their healthcare providers if they experience any complications and report any adverse events to both Hologic and the FDA’s MedWatch Adverse Event Reporting program.

Problems with BioZorb Implants

The BioZorb Marker was advertised as a beneficial tool for breast cancer procedures intended to assist with future radiation treatment. However, problems with the device’s design were later associated with a range of injuries and complications that significantly affected patients’ health and quality of life.

BioZorb Material Composition and Integration Failure

The BioZorb was constructed from a bioabsorbable polylactic acid (PLA) that was supposed to dissolve within the body over a defined period. However, this dissolution process was reported to take longer than expected or not occur at all, resulting in prolonged exposure of the body to this foreign material.

Such prolonged presence can lead to inflammation, discomfort, and the formation of palpable masses that mimic tumor recurrence, causing undue stress and unnecessary surgical interventions.

Mechanical Structure and Migration

The bioabsorbable material surrounding the device contained titanium clips that were intended to remain in place after the PLA dissolved, marking the tissue site for future monitoring. When the PLA failed to dissolve as intended, the clips could become exposed and migrate within the tissue.

Migration disrupted the intended targeting of radiation therapy and, in some cases, damaged healthy tissue or required corrective surgery to reposition or remove the marker.

Erosion

Erosion of the BioZorb structure led to the breakdown of the device and the potential movement of fragments into surrounding tissues. These issues were associated with tissue damage, inflammation, infection, and other complications that sometimes required further medical intervention.

How long do BioZorb implants take to dissolve?

The BioZorb Marker was designed to dissolve within about 12 months after implantation. However, many patients later reported that the device did not resorb within this expected timeframe, or failed to dissolve at all, resulting in pain and other adverse side effects.

Side Effects of Recalled BioZorb Implants

BioZorb side effects were described in a number of lawsuits filed against the manufacturer, with plaintiffs alleging that defects in the device’s design and functionality led to complications that were not adequately disclosed.

Allegations Raised in BioZorb Complaints

Individuals throughout the United States previously pursued product liability lawsuits against Hologic Inc., raising similar allegations, including:

• Failure to provide adequate warnings or initiate a timely recall despite reports of device-related complications.
• Inadequate design and testing of the materials used in the construction of BioZorb implants, which were alleged to compromise the durability and strength of the device.
• False advertising and misrepresentation regarding the safety of BioZorb implants.
• Failure to disclose reported incidents of BioZorb implants migrating, fracturing, or malfunctioning.
• Lack of sufficient warnings to healthcare providers about the potential risks associated with the implants.

BioZorb Implant Lawsuit Examples

BioZorb Surgical Removal Lawsuit: In a joint complaint filed on March 29, 2024, in the U.S. District Court for the District of Massachusetts, multiple plaintiffs allege that the implantable BioZorb Marker is defectively designed and that the manufacturer failed to adequately warn about the device’s side effects.

The plaintiffs, Shellie Broeder, Amy Delgado, Marisa Sayers, Michelle Martinez, and Anita Mendiola, each contend that the defective BioZorb implant caused migration, failed to dissolve, or induced infections, necessitating surgical removal.

BioZorb Failure Lawsuit: A BioZorb implant lawsuit was filed by a group of breast cancer survivors in the U.S. District Court for the District of Massachusetts on December 28, 2023, claiming that defects related to the design of the BioZorb caused them injuries resulting in the need for removal surgery.

The plaintiff’s, Margaret Ciers, Julie Bauer, Selena Fisher, Karen Sellards, and Sarah Farley each claim the complications, adverse local tissue reaction, disfigurement, nonabsorption, palpable mass, and additional surgery are not warned of on the Instructions for Use but were risks Hologic Inc. knew or should have known, yet failed to disclose to physicians and patients.