BioZorb Lawsuit

BioZorb Marker Lawsuit Overview

The FDA approved the BioZorb tissue marker in 2012, as an implantable medical device used primarily in breast cancer treatment to mark soft tissue sites following tumor removal. The device is shaped either like a spring or a sphere and has a bioabsorbable structure with titanium clips, which are intended to accurately mark the area for targeted radiation treatment and protect surrounding healthy cells.

Over time, the BioZorb markers are supposed to dissolve and resorb into the body, leaving only the clips to assist in long-term monitoring and future medical procedures.

Initially advertised as the next wave in breast conserving surgery, BioZorb has been marketed for patients undergoing targeted radiation treatment after a lumpectomy or in the treatment regimen for DCIS patients. However, many breast cancer patients’ bodies have not reabsorbed the tissue marker as advertised, leading to increased scarification and encapsulation of the implant. In severe cases, the product has been found to erode or dislodge into tissue.

These BioZorb Marker side effects have led to individuals experiencing pain, infection, rash, device erosion, seroma, discomfort, or other complications from the device migrating, requiring the need for additional medical treatment and 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.

A growing number of individuals who experienced complications are now pursuing BioZorb implant lawsuits against the manufacturer, alleging that the problems are the result of dangerous design defects with the implantable markers, which were not adequately disclosed to patients or the medical community.

Who is Eligible for a BioZorb Lawsuit?

Financial compensation may be available through a BioZorb lawsuit for individuals who received a Biozorb marking device and suffered any of the following complications:

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

To determine if you or a loved one may have a case, submit information for review by a BioZorb Marker lawyer, who will help evaluate the circumstances and determine whether you may be eligible for a settlement.

Attorneys handle all BioZorb implant lawsuits on a contingency fee basis, which means that there are no fees or expenses paid unless a settlement or lawsuit payout is received.

2025 BioZorb Marker Lawsuit Updates

• January 1, 2025 Update: With additional BioZorb implant lawsuits anticipated in 2025, four cases have been selected for early bellwether trials to help assess how juries may respond to key evidence and testimony common across the growing litigation over the recalled tissue markers. These bellwether trials, designed to guide the direction of the broader litigation, are scheduled to begin in early September 2025.
• December 19, 2024 Update: 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.
• November 1, 2024 Update: As news of the BioZorb recall spreads nationwide, removing all unused breast tissue markers from the market, many women are just now discovering they might be eligible for compensation due to injuries caused by these recalled devices. Lawyers are actively offering free consultations to those affected by the BioZorb marker and experiencing side effects, anticipating that thousands could be impacted.
• October 25, 2024 Update: Hologic announced a voluntary BioZorb recall to remove all lots of unused BioZorb Markers on October 24, urging physicians not to implant the devices in any more patients, and to continue to monitor those who have the implants for device migration, erosion and other potential injuries or side effects.
• October 4, 2024 Update: In a newly filed BioZorb lawsuit by Laura Nudel in the U.S. District Court for the District of Massachusetts, Nudel claims she was diagnosed with breast cancer in August 2021 and underwent a lumpectomy the following month, during which a BioZorb marker was implanted in her left breast. Post-surgery, she has experienced significant complications including a hardened mass, scar tissue, and severe pain around the implant site, symptoms that have persisted for over a year. The lawsuit claims these issues are due to the non-absorption of the BioZorb device, necessitating potential further treatment and possibly even the removal of the device or the entire breast.
• September 3, 2024 Update: Six plaintiffs who were not part of the bellwether process filed a motion to amend their BioZorb complaint, adding new facts about the recent BioZorb recall in May, and how defects in the BioZorb implant caused their injuries. The new complaint details the painful and sometimes disfiguring complications experienced by plaintiffs Shellie Broeder, Amy Delgado, Marisa Sayers, Michelle Martinez, and Anita Mendiola due to their BioZorb implant failures.
• August 21, 2024 Update: The BioZorb injury litigation is progressing as parties have recently exchanged lists of potential BioZorb bellwether cases, selecting a total of 10 cases for the Discovery Pool. These cases, involving similar allegations as others in the larger pool, are set for detailed case-specific discovery including depositions and medical record exchanges, with a completion deadline of December 16, 2024. After this discovery phase, each side will have the opportunity to strike three cases, leaving four that may proceed to trial, with the first trial scheduled for around July 2025.
• May 22, 2024 Update: The U.S. Food and Drug Administration (FDA) has issued a recall for BioZorb Markers, following the identification of at least 71 injury reports associated with the device. These injuries include pain, infection, and more severe complications such as device movement and erosion. The issues with the implant frequently necessitate medical interventions, including surgical removal or other corrective procedures.
• May 7, 2024 Update: As parties focus on preparing bellwether cases in the BioZorb litigation, Judge Allison D. Burroughs has issued a new case management order (PDF), which addresses steps that will be taken in BioZorb lawsuits that were not selected for the initial bellwether discovery pool. The order outlines initial discovery steps that can be taken in these cases, including specific instructions for written interrogatories, document requests, and the authorization for medical records.
• February 26, 2024 Update: With a number of BioZorb injury lawsuits pending in the U.S. District Court for the District of Massachusetts, U.S. District Judge Allison D. Burroughs has established a bellwether plan (PDF), where lawyers will select a small group of representative claims to go through case-specific discovery in preparation for early trial dates that may impact the average value of BioZorb lawsuit settlements in the future.

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, indicating that Hologic is removing all unused BioZorb markers from the market due to reports of serious adverse events in 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 stated for 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 has been advertised as a beneficial tool for breast cancer procedures, to assist in future radiation treatment. However, problems with the BioZorb design have been associated with a number of different injuries and complications, which can significantly affect a patient’s health and quality of life.

BioZorb Material Composition and Integration Failure

The BioZorb is constructed from a bioabsorbable polylactic acid (PLA) that is supposed to dissolve within the body over a defined period. However, this dissolution process has been 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

Embedded within the bioabsorbable material are titanium clips meant to remain after the PLA dissolves, marking the tissue site. If the PLA fails to dissolve, these clips can become exposed and migrate within the tissue.

Migration disrupts the intended location of radiation therapy, potentially damaging healthy tissues and necessitating corrective surgeries to reposition or remove the marker.

Erosion

The erosion of the BioZorb’s structure leads to the breakdown and potential migration of fragments into surrounding tissues. This can provoke further tissue damage, inflammation, and infection, necessitating additional medical interventions to manage these complications.

How long do BioZorb implants take to dissolve?

The BioZorb Marker used in breast cancer treatments for radiographic marking is designed to dissolve within about 12 months after implantation.

However, many who have received a BioZorb marker have reported that the device failed to resolve within this time frame, or at all, leading to severe pain and side effects.

Side Effects of BioZorb Implant Failure

BioZorb side effects have been reported in a number of lawsuits filed against the manufacturer, each raising allegations that the device’s design and functionality have resulted in unknown potential side effects.

Allegations Raised in BioZorb Complaints

Individuals throughout the United States are currently pursuing product liability lawsuits against Hologic Inc. raising similar allegations, including;

• Inadequate design and testing of the materials used in the construction of BioZorb implants, compromising their durability and strength.
• False advertising and misrepresentation of the safety of BioZorb implants.
• Failure to disclose incidents of BioZorb implants migrating, fracturing, and malfunctioning.
• Lack of sufficient warnings to healthcare providers about the hazardous and defective nature of BioZorb implants.
• Failure to provide adequate warnings or initiate a timely recall of BioZorb implants despite known issues.

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.

Contact a BioZorb Injury Lawyer

If you or a loved one were injured by an implantable BioZorb Marker, submit information about your potential claim for review by a BioZorb lawyer to determine whether a settlement or lawsuit payout may be available.

BioZorb lawyers provide free claim evaluations and consultations. There are no fees or expenses unless a recovery is obtained in your case.