Exploring Potential Lawsuits Related to the BioZorb® Breast Tissue Marker
- Joey Terry
- 1 hour ago
- 6 min read
Breast cancer treatment often involves a combination of surgery, radiation, and systemic therapy. To guide radiation therapy after breast-conserving surgery (lumpectomy), surgeons sometimes implant markers that help oncology teams precisely target the surgical site. One such device was the BioZorb Breast Tissue Marker, a 3D bioabsorbable implant designed to indicate where the tumor had been removed.
While the device was originally marketed as helping clinicians and improving patient outcomes, it later came under intense regulatory and legal scrutiny due to reports of serious complications, failures to resorb as intended, and inadequate warnings to patients and healthcare providers.
In recent years, numerous patients have filed BioZorb breast tissue marker lawsuits alleging harm caused by the device. Alongside the legal battles, a crucial technical and medical aspect has emerged: medical case analysis is a cornerstone in proving causation, documenting injuries, and shaping legal strategy.
What Is the BioZorb® Breast Tissue Marker?
BioZorb® is a 3D bioabsorbable implantable marker designed to help clinicians target the precise location of a tumor bed after breast-conserving surgery (lumpectomy). The marker is placed in the surgical site so that radiation oncologists can more accurately deliver radiation therapy to eradicate residual cancer cells and spare surrounding healthy tissues.
The intent was that the device would help radiation teams more accurately target treatment while minimizing exposure to healthy tissue. However, reports from clinicians and patients suggested the device did not always perform as advertised. Some patients reported that it did not resorb as expected, and in some cases, it caused pain or other complications. Its three-dimensional spiral structure was meant to provide enhanced imaging visibility for X-rays and CT scans.
In 2024 and 2025, the U.S. Food and Drug Administration (FDA) issued a series of safety communications and recalls for the BioZorb devices, including a Class I recall, the most serious type due to risk of serious injury.
What Happened: FDA Safety Alerts and Recall Actions
The FDA first issued a safety communication regarding the potential risks of BioZorb markers in February 2024, warning about timely adverse events such as infection, pain, device migration, and other serious complications.
Later, in March and October 2024, Hologic, the manufacturer, issued recalls of the device, with the October recall removing all unused BioZorb products from the market. The FDA classified these recalls as Class I, indicating a reasonable probability that using the devices could cause serious injury or death.
Reported complications included:
Pain and chronic discomfort
Device migration from the original surgical site
Erosion through surrounding tissues
Fluid buildup (seromas)
Infections
Inflammation and scar tissue formation
Device failing to resorb as intended
These regulatory actions laid the groundwork for patients to challenge the device legally and question whether proper safety studies and warnings were provided.
The Legal Landscape: BioZorb Lawsuits Against Hologic
As patients experienced complications and medical professionals recognized safety concerns, legal claims began to proliferate. By mid-2025, nearly 200 lawsuits had been filed against Hologic in U.S. courts alleging harm caused by BioZorb markers. These cases are being consolidated for pretrial proceedings in federal court, a step often taken in complex product liability litigation to promote efficiency and fairness.
Common Legal Claims in BioZorb Lawsuits
Plaintiffs typically raise multiple product liability theories, including:
Defective Design
The claim here is that the device was inherently unsafe, particularly the bioabsorbable PLA (polylactic acid) material and its failure to dissolve as intended.
Failure to Warn (Inadequate Labeling)
Lawsuits allege that Hologic did not adequately warn patients or surgeons about the risk that the device might not resorb properly or could cause serious complications.
Negligence
Plaintiffs contend Hologic failed to exercise reasonable care in designing, testing, marketing, and monitoring the device.
Breach of Warranty
Some claims argue that the device did not meet the promises made by the manufacturer regarding safety and performance.
Emotional Distress and Additional Damages
Many claim compensation for pain, suffering, and other damages resulting from complications and additional surgical procedures.
Legal experts note that outcomes in these cases may hinge on individual medical evidence and expert testimony, where medical record review becomes indispensable.
Current Status of Litigation
As of late 2025, hundreds of lawsuits have been filed in state and federal courts across the U.S. by patients alleging harm related to BioZorb®. Many of these cases share similar allegations, particularly device failure to resorb and resulting complications. Importantly:
Multi-District Litigation (MDL) Potential
Legal experts believe that these claims may eventually be consolidated into a Multi-District Litigation (MDL). An MDL is a centralization procedure where cases with common legal questions are transferred to one federal court to streamline discovery and pre-trial motions.
Although, as of early 2025, no MDL had yet been officially established, observers consider consolidation likely due to:
Volume of cases
Common factual issues (same device and manufacturer)
Shared legal theories (defective design, failure to warn)
MDLs benefit both plaintiffs and defendants by reducing repetitive litigation, clarifying core factual disputes, and often speeding up resolution. If an MDL is later formed, it may lead to coordinated settlement discussions or bellwether trials that could shape outcomes across cases.
Potential Litigation Outcomes
BioZorb litigation is still developing, but possible outcomes include:
Settlements: Many product liability cases resolve before trial, with compensation ranging widely depending on the severity of injury and strength of evidence.
Bellwether Trials: Early test cases may proceed to trial to give both sides benchmarks for value. These trials influence settlement negotiations in other cases.
Consolidated Litigation: Many cases are being coordinated in federal courts, which streamlines discovery and pretrial proceedings.
Experts note that how well medical record evidence supports causation and damages will influence outcomes in both trials and settlement negotiations
The Importance of Expert Witnesses
In product liability cases involving medical devices, expert witnesses are vital. These experts, often surgeons, radiologists, biomedical engineers, and other specialists, explain to the court:
How the device was intended to work
Why it may have failed
Whether the manufacturer should have known about risks
How complications relate to the device
However, experts can only opine effectively if they have accurate and complete medical records. Review teams prepare records in digestible formats that help experts focus on core issues rather than sifting through volumes of data.
Need help reviewing medical records for a Biozorb breast tissue maker lawsuit Claims? Partner with us.
Why Medical Record Review Services Matter
In any product liability lawsuit, particularly those involving medical devices the strength of a plaintiff’s case depends heavily on medical documentation and expert interpretation. This is where medical record review services come into the picture. Medical record review services involve:
Collecting all relevant patient medical records, including surgery reports, imaging studies, progress notes, hospital discharge summaries, and radiation therapy documentation.
Organizing records chronologically and by medical event.
Analyzing treatment sequences and correlating device-related injuries to clinical outcomes.
Providing expert summaries that attorneys and judges can use to determine causation and damages.
These services are often carried out by clinicians, nurses, or trained legal nurse consultants who understand both medical terminology and legal standards.
The Role of Medical Record Review in BioZorb Litigation
Medical record review services play a central role in BioZorb litigation because each plaintiff’s claim depends heavily on demonstrating a clear, medically supported timeline of events. Complications involving the BioZorb® breast tissue marker, such as pain, infection, device migration, seroma formation, or failure to resorb, must be tied directly to the implantation and subsequent treatment. This is where professionally conducted medical reviews, including a detailed medical chronology, become essential.
a. Establish Device-Related Injury
A strong lawsuit must show that the injury or complication (e.g., infection, additional surgery, device migration) was caused by the BioZorb marker. This requires careful review of:
Timeline of symptoms
Imaging reports showing device status
Surgical notes documenting the removal of the device
Without meticulous record review, causation can be difficult to establish in court.
b. Assess Whether Warnings Were Adequate
Medical records can reveal whether patients were informed of risks before implantation and whether providers documented informed consent, which can directly impact failure-to-warn claims.
c. Support Expert Testimony
Medical experts rely on properly organized records to support their opinions in depositions or at trial. Well-prepared summaries from medical record reviewers make experts’ jobs more efficient and persuasive.
d. Calculate Damages
Full accounting of medical costs, including additional procedures, radiation therapy impacts, and follow-up care, depends on accurate and complete record review.
For attorneys, retaining professional reviewers helps turn complex clinical data into compelling evidence.
Conclusion
The BioZorb® Breast Tissue Marker litigation highlights the complex intersection of medical innovation and patient safety. While the device was designed to improve cancer care, regulatory recalls, adverse events, and mounting lawsuits reflect serious concerns about its performance and warnings. For plaintiffs, medical record review services are indispensable, transforming clinical data into evidence that supports legal claims. These services strengthen cases by organizing records, assisting expert testimony, and clarifying the link between the device and injuries.
As litigation continues to unfold, individuals affected by BioZorb markers should stay informed, seek appropriate legal and medical guidance, and understand the role that medical documentation plays in securing justice and accountability.
For more information about our Biozorb breast tissue maker lawsuit review and summary services. Contact us at +1 (903) 765-6073 or email us at support@medicolegalrequestllc.com.
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