Patients across the country are filing lawsuits related to complications from the BioZorb breast marker implant, alleging severe injuries and long-term harm caused by the device. The ongoing BioZorb lawsuits highlight the risk of serious injury associated with these implants, including pain, infection, and other life-altering complications. These product liability cases raise serious concerns for breast cancer patients that medical devices intended to assist in recovery could instead cause suffering and irreversible damage.

At Olsman MacKenzie Peacock, we are committed to holding manufacturers accountable when their products fail. BioZorb breast marker implants are used in breast cancer treatment, but they have been identified as potentially dangerous medical devices due to the risk of injury or death. If you or a loved one has experienced adverse effects following the implantation of a BioZorb device, you may be eligible to file a BioZorb breast marker lawsuit.

Contact us today at 1-800-366-8653 to schedule a free consultation today with an experienced BioZorb breast marker injury attorney.

What Is the BioZorb Breast Marker?

The BioZorb breast marker is implant device used in breast-conserving surgeries such as lumpectomies for breast cancer treatment. The BioZorb device is a three-dimensional coil made of a bioabsorbable material and six titanium clips, intended to help radiation oncologists target the area where a tumor was removed. It is designed to remain in the body temporarily, with the coil expected to be absorbed within a year or two, while the metal clips remain permanently.

BioZorb breast markers initially showed promise as a tool to improve radiation therapy precision and aid in cosmetic outcomes, the device was widely adopted by surgeons. However, increasing numbers of patients report experiencing serious complications well after implantation. The FDA issued a warning letter to manufacturer, Hologic, Inc., and a recall of unused BioZorb markers was initiated as part of a medical device recall. Issues such as marketing defects, failures in the supply chain, and questions about the business responsible for the product have also been raised in connection with these devices.

What Types of Reported Injuries and Complications Are Associated With BioZorb Marketing Implantation?

Plaintiffs in BioZorb Breast Marker lawsuits allege a range of injuries, including:

• Chronic pain at the implantation site
• Severe pain
• Inflammation and infection
• Skin erosion and tissue damage
• Device extrusion (when the device protrudes through the skin)
• Disfigurement and scarring
• Catastrophic injury
• Need for revision or removal surgeries

Many women report that the device did not dissolve as intended and instead caused their bodies to react negatively over time. The presence of the metal clips and the surrounding scar tissue have led to long-term complications requiring ongoing medical treatment.

Numerous BioZorb injuries and adverse events reported to the FDA highlight the risks associated with this device. In some cases, patients required surgical removal of the BioZorb marker to address complications. In others, the device migrated or became encapsulated in hardened scar tissue, exacerbating pain and rendering removal procedures more dangerous.

Personal Stories Fueling Legal Action

Lawsuits filed in multiple states include testimony from individuals who describe experiencing years of pain, unexpected surgeries, and changes in their appearance due to complications with the BioZorb implant. Numerous lawsuits filed against Hologic, and the first BioZorb trial is scheduled to begin soon, which could significantly impact future litigation and settlement negotiations.

Other BioZorb lawsuits are progressing in various states, highlighting the broader context of the BioZorb trial process and the ongoing legal strategies being developed as more patients come forward.

What Is The Legal Basis for BioZorb Lawsuits?

The legal claims surrounding the BioZorb device are based on product liability—an area of law that holds manufacturers and distributors responsible for placing defective or unreasonably dangerous products into the hands of consumers.

Product liability law applies to a wide range of products, including prescription drugs, recreational vehicles, and other consumer goods, not just medical devices. This means that manufacturers of any defective product, whether it is a drug, a recreational vehicle, or a medical device, can be held responsible for injuries caused by unsafe or defective products.

Common claims in BioZorb Breast Marker lawsuits include:

• Design Defect: Plaintiffs argue that the BioZorb marker was defectively designed in a way that posed a foreseeable risk of harm.
• Manufacturing Defect: Some claims allege that specific units were flawed due to errors in the manufacturing process.
• Failure to Warn: Many lawsuits assert that Hologic failed to adequately warn physicians and patients about the risks associated with the device, including the potential for serious side effects and long-term complications.

In these cases, product liability attorneys play a crucial role in helping victims pursue compensation and hold manufacturers accountable. A BioZorb injury attorney can provide specialized legal representation for patients facing device-related complications, guiding them through the litigation process and helping them understand their legal rights. When a BioZorb injury client engages with our firm, they do not face upfront costs, as we provide zealous representation on a contingency-fee basis. We also advance litigation expense while a case is ongoing, which are typically covered by a settlement or jury award.

Michigan Law on Product Liability

In Michigan, product liability claims are governed by the Michigan Product Liability Act (MPLA), which consolidates all legal theories into a single cause of action. The MPLA allows consumers to seek damages for injuries caused by defective products, including medical devices. Under MCL 600.2945 et seq., plaintiffs must demonstrate that:

• The product was not reasonably safe for its intended use;
• A safer alternative was available;
• The risk of harm was foreseeable;
• The defect was a proximate cause of the injury.

Michigan law imposes a high burden of proof, particularly when it comes to medical devices. Plaintiffs often rely on expert testimony and documented patterns of failure to meet this burden. As experienced product liability lawyers, we regularly work with medical and engineering experts to build strong, evidence-based cases on behalf of injured patients.

Federal Law and FDA Considerations

The U.S. Food and Drug Administration (FDA) cleared the BioZorb marker through the 510(k) premarket notification process, which allows medical devices to enter the market if they are “substantially equivalent” to an already approved product. Importantly, 510(k) clearance is not the same as FDA approval and does not guarantee that a device is safe or effective.

This distinction has become critical in BioZorb lawsuits, as plaintiffs argue that Hologic marketed the product without conducting long-term safety testing and failed to inform users of potential complications.

BioZorb Marker Lawsuits and FDA Recall

The landscape of BioZorb marker lawsuits shifted dramatically following the FDA’s recall of the BioZorb device in October 2024. This recall, classified as a Class I recall—the most serious type—signaled that the device posed a reasonable probability of causing serious adverse health consequences or even death. For breast cancer patients who received the BioZorb marker during surgery, this regulatory action underscored the potential dangers associated with the device and validated the concerns raised in product liability lawsuits.

The recall was prompted by mounting reports of serious injuries and complications, including chronic pain, device migration, infection, and the need for additional surgeries. As a result, many patients who suffered harm from the BioZorb device are now pursuing product liability lawsuits against Hologic, Inc., the manufacturer. These BioZorb marker lawsuits allege that the device was defectively designed and that the manufacturer failed to adequately warn both patients and healthcare providers about the risks.

For those affected, the FDA recall strengthens the legal basis for seeking compensation. If you or a loved one experienced serious injuries or complications after receiving a BioZorb marker, you may be eligible to file a product liability lawsuit. These legal actions not only seek justice for individual patients but also aim to hold manufacturers accountable for the safety of their medical devices.

BioZorb Class Action Lawsuit

A BioZorb class action lawsuit offers a way for multiple breast cancer patients harmed by the BioZorb device to join and pursue justice collectively. In this type of litigation, plaintiffs allege that the BioZorb marker was a defective medical device that caused serious injuries and complications, such as chronic pain, infection, and the need for revision surgeries. By consolidating their claims, affected individuals can seek financial compensation for medical bills, lost wages, pain and suffering, and other damages resulting from injuries caused by the device.

The BioZorb class action lawsuit also highlights the critical importance of regulatory compliance and the manufacturer’s duty to provide adequate warnings about potential risks. The FDA recall and the subsequent wave of BioZorb recall lawsuits demonstrate the consequences when manufacturers fail to prioritize patient safety or to warn consumers about known dangers. As these lawsuits progress, they serve as a reminder to the medical device industry of the need for transparency, rigorous testing, and clear communication with both doctors and patients.

In addition to the class action, individual product liability lawsuits are being filed against Hologic, Inc. These cases may be based on strict liability, design defect, or failure to warn, and seek compensation for a range of losses, including medical expenses and lost wages. Working with a product liability attorney who has extensive experience in medical device litigation is essential to ensure your rights are protected and increase your likelihood of recovering compensation for your injuries.

The ongoing BioZorb litigation has far-reaching implications for the medical device industry and for patient safety standards. It underscores the necessity for manufacturers to provide adequate warnings and to comply with all regulatory requirements. For breast cancer patients and their families, understanding your legal options is crucial. If you have suffered injuries caused by the BioZorb marker, seeking legal representation from an expderienced product liability attorney can help you pursue the financial compensation you deserve and hold the responsible business accountable.

Why Product Liability Cases Matter

Product liability cases serve a vital role in ensuring consumer safety. They allow individuals harmed by defective devices to seek compensation for:

• Medical expenses
• Lost wages and future earning capacity
• Pain and suffering
• Emotional distress
• Disfigurement
• Costs of additional surgeries or treatment

These lawsuits also hold manufacturers accountable and can lead to changes in product design, labeling, and testing requirements.

In cases involving BioZorb implants, successful litigation may result in a BioZorb settlement, providing financial compensation for patients who experienced complications without the burden of going to trial.

BioZorb Litigation Status

As of mid-2025, BioZorb lawsuits are in early stages. There is a growing number of patient lawsuits being filed, with many plaintiffs citing medical complications and product defects as the basis for their claims. The ongoing BioZorb recall lawsuits highlight the safety concerns surrounding the device. While no multidistrict litigation (MDL) has yet been formed, attorneys across the country are gathering evidence and preparing to file claims on behalf of affected individuals. As more cases come forward, consolidation may occur, especially if a pattern of injury and corporate negligence is established.

Who May Be Eligible to File a BioZorb Breast Marker Lawsuit?

You may be eligible to file a claim if:

• You underwent breast-conserving surgery in which a BioZorb marker was implanted;
• You suffered complications such as chronic pain, inflammation, infection, skin erosion, or other serious adverse events;
• You experienced post-surgery injuries, including device failure or migration;
• You required additional surgery to remove or revise the implant;
• Your quality of life has been negatively impacted due to the device.

How Product Liability Law Firm Olsman MacKenzie Peacock Can Help.

Bringing a product liability case requires a detailed investigation into your medical history, the product’s design, and relevant safety records. A product liability law firm like Olsman MacKenzie Peacock can help you pursue a product liability claim with the support of a dedicated legal team. We can assist by:

• Reviewing your medical records and surgical history
• Consulting with medical professionals to assess injury causation
• Gathering manufacturer documentation and regulatory filings
• Filing your claim within Michigan’s statute of limitations (typically 3 years for product liability actions)
• Seeking full compensation for your losses

Frequently Asked Questions (FAQ) About BioZorb Breast Marker Injuries & Lawsuits

What is the BioZorb breast marker made of?

The BioZorb marker consists of a bioabsorbable spiral structure and six titanium clips. The spiral is intended to dissolve over time, while the clips remain in the body.

What are the common complications associated with the BioZorb implant?

Reported complications include chronic pain, tissue damage, infection, implant migration, disfigurement, and extrusion through the skin.

Can I sue if my BioZorb device has not caused problems yet?

Lawsuits are typically based on injury. However, you may have a claim if you have developed symptoms or have been advised to undergo additional surgery.

Is there a recall on the BioZorb breast marker?

As of this writing, there is no formal recall. However, the increasing number of legal claims has drawn attention to potential design flaws and lack of sufficient warning.

How long do I have to file a lawsuit in Michigan?

Michigan’s statute of limitations for product liability cases is three years from the date of injury or discovery of the injury. Early consultation with an attorney is essential.

Do I need a product liability lawyer to file a BioZorb claim?

Given the complexity of medical device litigation and Michigan’s legal standards, working with a product liability lawyer is strongly recommended to ensure your case is properly investigated and presented. A BioZorb injury attorney experienced in product liability can help you gather evidence, meet filing deadlines, negotiate with companies, and pursue the compensation you deserve if you have suffered complications from a defective product.

What kind of compensation could I receive?

Compensation may include medical costs, lost income, pain and suffering, emotional distress, and other related damages. Each case is evaluated based on the facts and impact on the individual.

Schedule A Free Consultation With An Experienced Michigan BioZorb Breast Marker Injury Lawyer Today!

If you or someone you love has experienced complications from a BioZorb breast marker implant, Olsman MacKenzie Peacock is here to help. As a product liability law firm with decades of experience, we are dedicated to advocating for the injured, ensuring that those harmed by defective medical devices receive the justice and compensation they deserve.

Our attorneys represent individuals throughout Michigan and beyond in complex product liability matters. We offer compassionate, thorough representation and do not collect fees unless compensation is recovered. Schedule your free consultation today to discuss your legal options.

Call Today for a Free Consultation With An Experienced BioZorb Injury Lawyer.

To discuss your potential BioZorb Breast Marker lawsuit, contact our office at (800) 366-8653 to schedule a free, no-obligation consultation. Let us evaluate your case and explain your legal rights under Michigan and federal law.