What Is the BioZorb Lawsuit About?
The BioZorb Marker is a surgical device used in breast cancer treatment to mark the site of tumor removal. It’s designed to aid in radiation targeting and post-surgical imaging while gradually being absorbed by the body over time.
However, many patients have filed BioZorb lawsuits claiming their implant failed to resorb as intended, causing serious complications like device migration and erosion — which is when the device breaks through the skin.
Since 2015, nearly 400 complaints have been filed by patients and their health care providers, ultimately resulting in a recall of the BioZorb Marker.
Affected patients may be able to file a BioZorb lawsuit against Hologic® Inc., the manufacturer of this device, for not adequately warning them about potential risks.
At Sokolove Law, we have over 45 years of experience seeking justice for patients harmed by dangerous medical devices and medications. Let us fight for the compensation you deserve.
Get the Help You Deserve
Our experienced attorneys may be able to file a BioZorb lawsuit and fight for compensation on your behalf. See if you qualify now.
About the BioZorb Recall Lawsuit 2025
In October 2024, Hologic issued a voluntary recall for all unused BioZorb Marker and BioZorb LP Marker devices, requesting these devices be returned.
The U.S. Food and Drug Administration (FDA) classified this recall as a Class 1 recall, the most serious type. This classification means that the device may pose a significant risk of serious injury or death.
The FDA has advised that patients who currently have a BioZorb implant don’t need to have it removed if they’re not experiencing complications.
Patients and health care providers should continue to monitor for any potential issues linked to BioZorb devices and report their concerns to Hologic or the FDA immediately.
Complications Linked to BioZorb Markers
BioZorb Markers are designed to help breast cancer patients who have undergone surgery to remove a tumor. However, when these devices don’t resorb as intended, they may cause serious health issues.
BioZorb complications and adverse events reported by patients include:
- Discomfort or sensitivity around the device
- Devices breaking through the skin (device erosion)
- Devices moving from their intended position (device migration)
- Fluid buildup (seroma)
- Infections
- Pain
- Rash or skin irritation
- Sensations of the device being present in the breast
Some patients have received additional treatment as a result of these complications, including undergoing surgery to remove their BioZorb Markers.
A BioZorb lawsuit settlement can help patients pay for medical bills, lost wages due to missed work, and more.
Who Can File a BioZorb Lawsuit?
You may be able to file a titanium breast marker lawsuit if you or a loved one:
- Had a BioZorb Marker or BioZorb LP Marker implanted
- Experienced complications like device migration or erosion
- Had surgery or plan to as a result of these complications
There’s only a limited amount of time to file a BioZorb lawsuit due to state laws called statutes of limitations. Once this deadline passes, you won’t be able to take legal action for your injuries again.
Call (800) 995-1212 now to find out if you may qualify for compensation from a BioZorb lawsuit. It costs nothing to speak with us.
BioZorb Lawsuit Updates & Latest News
As of April 2025, over 120 patients have filed lawsuits against Hologic for injuries caused by BioZorb Markers. Find out the latest news on BioZorb lawsuits as this litigation continues to move forward.
1. First BioZorb Lawsuits Selected for Trial | April 2025
The first BioZorb lawsuits selected for bellwether trials involve four women who received the implant following a breast cancer diagnosis.
Their complaints include:
- Failure of the device to dissolve
- Infections
- Pain and inflammation
- The device breaking apart and pushing through the skin
- Undergoing surgery to remove the implant due to complications
How these trials play out may set the tone for other Biozorb lawsuits and the possibility of settlements.
2. Preparation Underway for BioZorb Trials | March 2025
Lawyers for both sides are actively preparing for the first BioZorb trial, which is set to begin in September 2025. The outcome of this initial trial could have a significant impact on the direction of the litigation.
A win for the plaintiff may encourage Hologic to consider offering victims a settlement, rather than face the risk of additional losses in future trials.
3. Deadlines Set in Biozorb Lawsuit | February 2025
The court has set key deadlines for attorneys on both sides:
- Plaintiffs must submit their expert reports by March 25, 2025
- The defense must submit their expert reports by April 28, 2025
An expert report is a detailed analysis provided by medical or scientific professionals to support each side’s claims in the case.
As attorneys representing victims prepare for the first BioZorb lawsuit trials, they’ll likely use medical evaluations, scientific studies, and expert testimony to strengthen their arguments linking the device to injuries suffered by patients.
4. Hologic’s Motion for Summary Judgment Denied | January 2025
Hologic filed a motion for summary judgment, alleging insufficient evidence to support a plaintiff’s claims against them. If approved, the BioZorb lawsuit would end before trials even began.
The claims in question included:
- Negligent Failure to Warn (Count I)
- Negligent Design Defect (Count II)
- Breach of Implied Warranty of Merchantability (Count III)
- Negligence (Count IV)
The judge denied the motion for summary judgment on counts I, II, and IV, allowing BioZorb lawsuits against Hologic to proceed in court.
5. FDA Sends Warning Letter to Hologic | December 2024
On December 18, 2024, the U.S. FDA sent a warning letter to Hologic revealing that inspectors had found multiple violations of manufacturing practices related to BioZorb Markers, including failures in:
- Corrective action: Hologic didn’t properly review complaints to detect or address issues with their product.
- Design validation: The company didn’t adequately test or verify that the device would be safe and effective in real-world conditions before releasing it to the market. This includes not accounting for variations in anatomy or soft tissue types among patients.
Because of these violations, BioZorb implantable radiographic markers may be considered adulterated or unsafe under federal regulations.
6. Hologic Voluntary Recalls BioZorb Markers | October 2024
On October 24, Hologic voluntarily removed all BioZorb Markers from the medical device market. The company also asked that health care facilities return any unused BioZorb Markers to them.
Hologic’s recall notice reported that they’d received 399 complaints involving BioZorb Markers. Of those, 188 complaints were associated with adverse events, which involve more serious injuries.
7. Judge Orders Lawyers to Select First Cases for Trial | June 2024
The judge overseeing the BioZorb litigation has ordered both parties to select five cases each, for a total of ten cases, to potentially serve as the first lawsuits to go to trial. These cases will be shared between both sides for review.
These initial trials, known as bellwether trials, are used to help determine how a jury might respond to the arguments presented in BioZorb lawsuits. The outcomes of these cases may also determine the potential value of BioZorb settlements and guide discussions.
8. FDA Issues Class 1 Recall for BioZorb Implants | May 2024
The FDA has issued a Class 1 recall for BioZorb implants, which is the most urgent type of recall that can be issued by the FDA.
Class 1 recalls are reserved for products the agency believes have the potential to cause serious or even fatal injuries.
Reasons for the recall included reports of device migration and erosion, pain, infections, and other complications — some of which resulted in the device being removed.
9. Hologic Releases BioZorb Safety Notification | February 2024
Hologic released a letter informing patients and health care providers about potential safety concerns with the BioZorb Marker and BioZorb LP Marker.
The company was made aware of complaints involving device migration, device erosion, infections, and other issues — some of which required patients to have their devices removed.
10. Five Women File Lawsuits Against Hologic | March 2023
In March 2023, five women filed a lawsuit against Hologic in the U.S. District Court for the District of Massachusetts. These women reportedly experienced health complications caused by the device.
The case, Stine et al. v. Hologic, Inc., alleges that the company failed to warn patients and doctors about potential complications associated with their BioZorb Markers.
11. BioZorb Lawsuit Filed for Device Complications | May 2021
In 2019, Kelly Nelson underwent a partial mastectomy to treat stage IV breast cancer. Her surgeon implanted a BioZorb Marker to assist with post-surgery radiation. However, she later experienced severe pain from the device.
After 18 months, Nelson had the BioZorb Marker surgically removed. It had not dissolved as expected, and the removal left her permanently disfigured. She filed a lawsuit against the device’s manufacturer for the harm she experienced.
How to File a Titanium Breast Marker Lawsuit
While taking legal action for BioZorb injuries may feel overwhelming, our team is here to support you throughout the entire process.
At Sokolove Law, we can handle every step of filing a titanium breast marker lawsuit on your behalf if you have a case.
Our BioZorb recall lawyers can help:
- Determine your eligibility to take legal action during a free case review
- Gather evidence like medical records and device design details to show your injuries were caused by a BioZorb Marker
- File your titanium breast marker lawsuit before any deadlines
- Negotiate a BioZorb settlement with the defendant(s)
If a settlement is unable to be reached, our team is prepared to present your case in court and seek compensation from a trial verdict.
What to Look for in a BioZorb Attorney
A BioZorb attorney can help make the legal process as easy and stress-free as possible, so you can focus on your recovery. However, not all lawyers have what it takes to fight for the justice you deserve.
When choosing a BioZorb lawyer, look for someone who has:
If you suffered an injury from complications with your BioZorb Marker, our attorneys may be able to help you pursue financial compensation from a titanium breast marker lawsuit.
Get Help from Our BioZorb Lawsuit Lawyers
You shouldn’t have to suffer physically or financially due to the negligence of a company like Hologic. Companies should know the dangers their products pose before they reach the public.
At Sokolove Law, we’re committed to helping patients who have been harmed by medical devices, including those injured by BioZorb Markers.
Our team has recovered over $1.6 Billion for families impacted by dangerous medical devices and pharmaceutical drugs.
There are no upfront costs or hourly fees to work with our BioZorb lawsuit lawyers. We only get paid if we secure compensation for you.
Call (800) 995-1212 now or fill out our contact form to see if our team can fight for everything you deserve.
BioZorb Class Action Lawsuit FAQs
Is there a BioZorb class action lawsuit?
Over 120 BioZorb lawsuits have been filed by patients claiming they suffered complications after their device failed to resorb as intended, sometimes causing the implant to migrate or break through the skin.
While there’s no BioZorb class action lawsuit at this time, affected patients can still file individual lawsuits against the marker of this product and seek compensation for their injuries.
Call (800) 995-1212 now to see if you may be eligible for a BioZorb lawsuit settlement.
Who makes BioZorb Markers?
BioZorb Markers are made by Hologic Inc., a Massachusetts medical technology company focused on women’s health.
Founded in Massachusetts over 45 years ago, Sokolove Law has helped countless individuals harmed by dangerous medical devices and corporate negligence.
Contact us now if you experienced serious complications from a BioZorb device. We may be able to help you file a titanium breast marker lawsuit against Hologic and pursue the compensation you deserve.
Have BioZorb Markers been recalled?
Yes. In October 2024, the manufacturer of BioZorb Markers issued a recall for all unused devices. The FDA has classified this as a Class 1 recall, which is the most serious type.
The recall followed hundreds of patient reports detailing complications, including device migration, erosion, infections, and other serious issues.
Titanium breast marker lawsuits have been filed nationwide over the BioZorb recall, with affected families seeking justice.
What are the complaints about BioZorb?
Patients have reported their devices failed to dissolve as intended, leading to serious complications. In some cases, the implant reportedly protruded through the skin, resulting in pain and disfigurement.
Other complaints about BioZorb Markers have included device migration, infections, and fluid buildup around the implant.
Call (800) 995-1212 now to find out about your legal options if you were injured by a BioZorb Marker. You may be eligible for compensation from a titanium breast marker lawsuit.
How much does it cost to work with a BioZorb lawsuit lawyer?
At Sokolove Law, there are no upfront costs or hourly fees to file a titanium breast marker lawsuit with the help of our BioZorb lawyers.
We work on a contingency-fee basis, which means you pay nothing unless we secure compensation for you.
