Product Liability Lawsuit for BioZorb Complications & Injuries
If you’re looking for answers regarding a BioZorb lawsuit, you’re not alone. Across the country, patients with BioZorb® 3D Bioabsorbable surgical markers are coming forward after suffering painful complications. For many, what was supposed to help has turned into another heartache. But there is hope.
When what has been promised to us as a “trusted” medical device turns out to be anything but that, there needs to be accountability and compensation, at the very least. The mass tort trial attorneys here at Bernheim Kelley are ready for that fight.
BioZorb lawsuits are being filed against Hologic, Inc. due to severe injuries from the device, including device migration, infection, seroma, and erosion. BioZorb markers have been recalled, and victims may be able to seek compensation for their medical bills and hold the manufacturer accountable.
Our team brings decades of Real Experience and a reputation for fearlessness and Real Advocacy to the table. We’ve gone up against Big Tobacco, Big Pharma, and major medical device companies and secured hundreds of millions of dollars for our clients. Let’s hear your story, discuss your legal options, and create a plan that meets your needs, goals, and hopes for the future.
If you have experienced complications from a BioZorb marker, you may be entitled to compensation through a BioZorb lawsuit. At this time, the attorneys at Bernheim Kelley are actively investigating these claims and accepting new clients nationwide. We offer FREE case evaluations to determine your best path forward.
Call 617-420-1111 or contact us online today. We only collect our fee if we win you the compensation you deserve, so there’s no reason to wait. Get Real Justice with a team that brings unparalleled compassion and legal representation.
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What Is the BioZorb Lawsuit About?
A BioZorb product liability lawsuit is about holding Hologic® Inc., the manufacturer of BioZorb® Markers, accountable for a medical device that was supposed to aid in healing but has instead left too many women in pain or back in surgery.
The BioZorb device is a 3D bioabsorbable marker implanted in the breast after a cancer-related surgery. Its purpose is to mark the area for future medical procedures and follow-up imaging. On paper, this sounds like an amazing innovation. In practice, however, many of the markers have ended up causing terrible complications. Patients have reported the device migrating, causing chronic pain and infections, and even eroding through tissue. Some women have had to endure additional surgeries to remove the device.
BioZorb lawsuits allege that Hologic®, Inc. failed to adequately warn doctors and patients about risks and misled surgeons about resorption rates. Even more troubling, the company is alleged to have delayed reporting known adverse events to the FDA. Eventually, a Class I FDA recall was issued. But by that time, 71 reported injuries had already been linked to BioZorb markers.
At its heart, this lawsuit is about truth, safety, and accountability. Patients trusted the device, and it left many with pain, uncertainty, and more to recover from.
We’ve pursued many high-stakes mass tort and product liability cases and secured Real Results for our clients. That includes $74.4M for defective hip implants, $200M against Big Tobacco, and $250M in GranuFlo dialysis litigation. We don’t just show up, we show up ready to fight for you.
Bernheim Kelley is currently investigating claims related to BioZorb complications. We believe every injured patient has the right to pursue Real Justice that addresses your health, your peace of mind, and your future. Contact our dedicated mass tort trial attorneys to set up a FREE case evaluation if you’ve experienced pain, scarring, unexpected surgeries, or any other complications after receiving a BioZorb marker.
What Is BioZorb?
BioZorb® is a surgical marker used in breast cancer surgeries (e.g., lumpectomies, partial mastectomies). The device is designed to be implanted at the surgical site to help identify the exact location where tissue was removed.
Made by Hologic®, Inc., BioZorb is composed of two parts:
- A three-dimensional spiral structure made of polylactic acid (PLA), a bioabsorbable material intended to dissolve naturally over time.
- Six titanium clips embedded within the structure remain in the body permanently to serve as long-term radiographic markers.
BioZorb was cleared by the FDA through the 510(k) process in 2012 for use in radiographically marking soft tissue sites. In layman’s terms, the device helps medical professionals locate and monitor the area for follow-up imaging or future procedures.
Though BioZorb has been used for additional purposes in clinical practice, those uses were not part of the FDA-approved indications for the device. The FDA has stated that it “has not cleared or approved the use of BioZorb Markers to fill space in the tissue or to improve cosmetic outcomes after procedures, or as a marker for radiation treatment.”
What Are the Problems with BioZorb?
The BioZorb® 3D Bioabsorbable Marker was introduced as “an implantable radiographic marker used to mark soft tissues (such as breast tissue) for future medical procedures” (FDA). It was designed to be absorbed by the body over time. However, for many patients, the device failed to absorb, leading to unforeseen complications.
Women already struggling with a breast cancer diagnosis and treatment were forced to endure a second wave of fear and heartache.
BioZorb Injuries & Complications
Some of the reported problems with BioZorb® Markers include:
- Device Migration: The implant can shift from its original position, causing localized pain or tissue damage.
- Device Erosion: In severe cases, the device has pushed through tissue and broken the surface of the skin.
- Non-Absorption: The PLA component has, in some cases, failed to dissolve as expected, resulting in hardened masses or long-term inflammation.
- Infection: Some patients developed infections at the implant site, requiring antibiotics and/or surgical removal.
- Seroma Formation: Fluid buildup around the device can cause swelling, pressure, and discomfort.
- Chronic Pain: Ongoing, unexplained pain at or near the implant site is one of the most frequently reported symptoms.
- Scar Tissue & Deformities: The body’s response to the implant can create thick scar tissue or visible lumps and affect both comfort and appearance.
For some women, these complications triggered additional medical treatments to investigate the problem or to remove the BioZorb device entirely.
BioZorb Recalls
Concerns about the BioZorb® Marker became public in early 2024. In March, after receiving hundreds of reports of complications, Hologic initiated a voluntary recall of all unused BioZorb Markers.
On October 24 of that year, Hologic expanded the BioZorb recall to include all lots of unused markers. The FDA issued a safety communication the following day, advising healthcare providers and patients not to use the device due to the risk of serious complications.
Finally, BioZorb implants were officially recalled by the FDA on December 18, 2024, following hundreds of patient complaints and 71 reported injuries. The FDA classified the recall as Class I, the most serious category reserved for products that “may cause serious injury or death” with continued use.
Despite the recall, the FDA does not recommend removing BioZorb implants from patients who aren’t currently experiencing symptoms. Instead, they advise close monitoring between patients and their healthcare providers.
What BioZorb Markers Have Been Recalled?
| Part Number | Part Description | UDI(DI) |
|---|---|---|
| F0405 | BioZorb Marker 4cm x 5cm | 15420045514065 |
| F0404 | BioZorb Marker 4cm x 4cm | 15420045514058 |
| F0331 | BioZorb Marker 1cm x 3cm x 3cm | 15420045514041 |
| F0231 | BioZorb Marker 1cm x 3cm x 2cm | 15420045514034 |
| F0221 | BioZorb Marker 1cm x 3cm x 2cm | 15420045514027 |
| F0304 | BioZorb Marker 3cm x 4cm | 15420045514010 |
| F0303 | BioZorb Marker 3cm x 3cm | 15420045514003 |
| F0203 | BioZorb Marker 2cm x 3cm | 15420045513990 |
| F0202 | BioZorb Marker 2cm x 2cm | 15420045513983 |
Potential Compensation for BioZorb Complications
If you’ve had pain, infections, scarring, or an additional surgery because of a BioZorb® implant, you’ve been to hell and back at least twice. The team at Bernheim Kelley wants to help give you a voice and seek the support and compensation you deserve for what you’ve been through.
Depending on the specifics of your situation, filing a BioZorb legal claim may help you recover compensation for the following:
- Medical bills
- Pain & suffering
- Disfigurement
- Lost wages
- Future care needs
- Other out-of-pocket costs
In some cases, punitive damages may be appropriate. These are meant to punish a company for reckless or irresponsible behavior.
If Hologic knew the risks and failed to take action, endangering the health of thousands of women, they need to be held responsible. Punitive damages would send a message to them and other corporations that this behavior is unacceptable, perhaps saving other patients from the same fate.
At Bernheim Kelley, we want to make things right as best we can. We champion your rights with commitment and compassion, fighting for the full, fair compensation you need to move forward with confidence.
Let’s talk through what happened, what it cost you, and how we can make it right. We’ll handle the legal side while you focus on healing, and don’t worry, you won’t pay us a dime unless we win.
Can I File a BioZorb Lawsuit?
If you received a BioZorb® implant after breast surgery and later experienced complications (e.g., pain, infection, scarring, migration, erosion, additional surgery), you may be eligible to file a lawsuit. This would typically fall under a defective medical device or product liability claim.
Pursuing a claim can help hold Hologic accountable for the harm caused by the device. Moreover, it could provide the financial security and closure you need to go forward with hope after so much pain and frustration.
Don’t let doubt or fear stand in the way of getting the help you need. If you’re unsure whether you have a case, give us a call. We offer a FREE case evaluation where we’ll listen to your story, determine whether you have a viable claim, and explain your legal options.
Evidence Needed for a BioZorb Complications Lawsuit
Our mass tort trial attorneys have extensive experience with these types of claims. After speaking with our team, you’ll have a better understanding of what will be involved in building your case.
If we decide to move forward, we’ll help gather the documentation and evidence needed. This may include:
- Proof that a BioZorb marker was implanted (surgical notes, implant logs, operative reports, etc.)
- Medical records documenting your complications (e.g., infection, seroma, device migration, erosion, etc.)
- Imaging scans that show the device didn’t dissolve as expected or has shifted position
- Records of follow-up treatment or revision surgery to address BioZorb-related issues
- Doctor’s notes or testimony linking the device to your symptoms or injuries
- Photos or documentation of visible scarring or physical changes
Frequently Asked Questions About BioZorb Lawsuits
The FDA has issued a Class I recall of BioZorb® devices. This is the most serious type of recall for products that carry the risk of serious injury or death. While BioZorb was initially cleared to mark soft tissue after surgery, the reality for many patients has been far from safe. Reports include pain, infection, device migration, and even erosion through the skin. Although the FDA does not recommend removal of the device for patients without symptoms, they advise close monitoring.
If your BioZorb implant is causing you pain, inform your medical provider as soon as possible. Then, contact our mass tort attorneys. We are actively investigating these cases and offering FREE case evaluations across the country.
BioZorb Markers are manufactured by Hologic®, Inc. The device was developed by Focal Therapeutics, which Hologic later acquired. Hologic, Inc. is a global medical technology company known for developing and marketing diagnostic products, medical imaging systems, and surgical devices, particularly in women’s health.
Yes. Some patients have reported complications long after surgery. The BioZorb device sometimes failed to absorb as expected, remaining intact and causing physical pain and issues years later.
You may have a valid claim if you’re experiencing symptoms and previously received a BioZorb implant. The mass tort trial attorneys at Bernheim Kelley have extensive experience with these claims and are taking new clients nationwide. Contact us today for a FREE consultation.
Absolutely. Needing revision surgery due to a BioZorb implant is one of the strongest indicators that you may be eligible to file a product liability lawsuit. Whether it was due to infection, device failure, or pain, a second procedure could signal that something went seriously wrong. Contact our mass tort trial attorneys today for a FREE review of your case.
You may be eligible to sue over BioZorb complications if:
- You received a BioZorb implant during breast cancer-related surgery
- You later experienced serious complications, including:
- Chronic pain or discomfort
- Infections
- Seroma (fluid buildup)
- Device migration or erosion through the skin
- Unnatural hardening or lumps
- The need for a second surgery to remove the implant
Bernheim Kelley is actively investigating BioZorb cases, taking on new clients, and offering FREE consultations nationwide.
A BioZorb claim falls under product liability law. A product liability case holds companies accountable when a defective or dangerous product causes harm. These cases typically fall under three categories: design defects, manufacturing defects, or failure to warn.
Product liability claims are often grouped together as part of a larger mass tort. A mass tort lets people with similar experiences and injuries share evidence and resources but still maintain their own case and outcome.
Not at this time. A formal class action has not been filed, but cases are expected to be consolidated into multidistrict litigation (MDL). This process allows individual claims with similar injuries to move forward together for efficiency while preserving each client’s right to pursue compensation based on their unique situation.
There is no set average since every case is so different. Compensation depends on your injuries, medical costs, emotional impact, and other factors. Of course, cases involving second surgeries or long-term complications may result in higher damages and, therefore, higher recoveries.
As of now, there have been no settlements, as these lawsuits are still in the early stages. Our legal team can help determine if you have a viable BioZorb recall claim and discuss what your claim may be worth during a FREE case evaluation.
At Bernheim Kelley, you don’t pay us unless we win. We work on a contingency basis, which means there are no upfront costs or hourly fees.
Legal help needs to be accessible because no one should have to suffer financially to seek the justice they deserve. Despite these big corporations having deep pockets, they must be held responsible for their negligence and wrongdoing.
You have us! We have the law on our side and the trial experience necessary to help you recover the compensation you may be entitled to.
The time frame to file a BioZorb recall lawsuit (known as the statute of limitations) varies by state. Typically, a state’s statute of limitations ranges from 1 to 4 years from the date of injury or when the injury should have reasonably been discovered.
These deadlines matter. When you fail to file a claim within the statute of limitations, you forfeit your right to pursue compensation. Though there are some exceptions, they are rare.
If you think BioZorb caused your injury, don’t wait. Call us today for a FREE case review.
If you think your BioZorb implant is causing complications, it’s important to act quickly.
Here’s what you need to do:
- Talk to your doctor immediately about your symptoms and whether the device should continue to be monitored or removed
- Keep detailed records of your symptoms and medical visits
- Reach out to our trusted product liability attorneys to understand your legal options
We’ll listen to your story, explain your rights, and help you figure out your next steps.
How Do I File a BioZorb Lawsuit?
Thinking about filing a BioZorb lawsuit is bound to feel overwhelming, especially when you’re struggling to heal and deal with the secondary trauma you’ve experienced. But that’s exactly why we’re here.
At Bernheim Kelley, we don’t expect you to show up with all the paperwork in hand or every detail figured out. That’s not your job, it’s ours. All you have to do is reach out to us.
Once you do, here’s what the process will typically look like:
- FREE Case Evaluation: We’ll start with a conversation. You tell us your story, and together, we’ll determine whether you have a valid claim and build an approach suited to your best interests.
- Gathering Your Medical Records: Our team will work to collect and review your surgical records, imaging, follow-up documentation, etc.
- Building the Case: We’ll investigate how the BioZorb implant impacted your recovery, what complications you’ve experienced, and how it’s affected your life.
- Filing the Claim: This is where the fight officially begins, and we take that responsibility seriously. You’ve trusted us, and now we will show you why you made the right choice.
- Staying the Course: Real Advocacy is evident in our commitment to your cause from the moment you come through the door, through negotiations, all the way to the courtroom if that’s what it takes to get you the outcome you deserve. And we’re ready for it.
You don’t have to take this on alone. In fact, you shouldn’t. Our experienced team of mass tort trial attorneys is investigating BioZorb cases and taking on new clients. Schedule your FREE case evaluation today.
How Can Bernheim Kelley Help You Get Real Justice?
You’ve already dealt with enough. Pain, doubt, the feeling that something wasn’t right and no one was listening, it’s more than anyone should have to deal with. We see that, and we want to do something about it.
At Bernheim Kelley, we help people who’ve been wronged get back on their feet. You need a compassionate team that shows up for you, helps you make sense of what’s happened, builds a strategy that protects your future, and demands the accountability you deserve.
Unwavering support and unrivaled representation—that’s what you get with a Real Advocate. It doesn’t matter how big these corporations are, our team is by your side, Keeping It Real the whole way there.
– you are in good hands!
Real Advocacy, Real Experience & Real Results
If you’re here, something didn’t go as it should have. The BioZorb® Marker is supposed to support your recovery, not cause pain, infection, or the need for more surgery. If that was your experience, that’s not okay.
At Bernheim Kelley, we’ve seen how defective medical devices can impact lives. We’ve met clients in severe pain from faulty hip implants or grieving after dialysis chemicals caused an unimaginable loss in their family. We were there to help them get the compensation they deserved. Now, we’re here to help you.
Our Mass Tort Trial Attorneys Are Accepting New Clients—Contact Us Today for a FREE Case Evaluation
Bernheim Kelley is currently accepting new clients and offering FREE case evaluations to those who believe they were harmed by a BioZorb implant. Real Justice means full and fair compensation for your losses. It also means accountability, closure, and restored dignity, so you can move on and never look back.
Our team of nationally recognized mass tort attorneys brings decades of trial experience, a client-focused approach, and a passion for standing up for those who need to be heard and supported. If you have questions, we’ll help you get answers, and if there’s a path to justice through a BioZorb lawsuit, we’re ready to get started. Call 617-420-1111 or contact us online today.