Lawsuit Information Center
This page provides a comprehensive overview of the BioZorb lawsuit and the potential legal and financial implications for plaintiffs who have suffered due to this medical device.
The FDA classified Hologic’s notification to healthcare providers as a Class I recall, indicating a serious risk of injury or death. This recall highlighted numerous complications, including device migration, infection, and other adverse reactions.
The BioZorb implant, designed as a post-lumpectomy tissue marker for breast cancer patients, has been associated with severe complications, including chronic pain, scarring, and the need for additional surgeries. Despite its promise to aid in recovery, the device has led to outcomes that were not fully disclosed by its manufacturer, Hologic
Our lawyers will delve into the background of the device, the legal allegations surrounding its use, and how our attorneys will make way-too-early predictions of possible BioZorb settlement amounts and jury payouts.
If you suffered complications related to a BioZorb implant device, you want act quickly. Call our attorneys today at 800-553-8082 or contact us online. There is no cost to you unless you get compensation for the harm done to you.
BioZorb Lawsuit Update
The BioZorb Marker lawsuits continue to quickly evolve in a very short time.
January 9, 2025: Big Win for Plaintiffs
The court’s ruling is that it is up to a jury to determine the responsibility of this medical device manufacturer to provide adequate warnings about potential risks associated with BioZorb. This ruling applies to only one plaintiff. But the outcome carries broader implications. This same judge is the one that will be making a call on other cases.
December 29, 2024: Cases Moving Towards Trial
BioZorb lawsutis are moving forward at an encouraging speed. Judge Burroughs has initiated a bellwether process to prepare representative claims for early trial dates.
In July 2024, Judge Burroughs ordered both parties to select 10 BioZorb lawsuits for a Discovery Pool, with each side designating five cases. These cases have since undergone depositions, medical record exchanges, and other discovery to identify four cases for the initial bellwether trials.
Now, a proposed case management order identified the following four cases for the trial pool:
- Case 1 involves a plaintiff who underwent a lumpectomy in October 2020 during which a BioZorb marker was implanted. The plaintiff later experienced complications, including lymphedema, a persistent wound, recurring staph infections, and a broken piece of the marker protruding from the skin in 2022, requiring surgical removal.
- Case 2 involves a plaintiff who received a BioZorb implant during a lumpectomy in June 2021. The implant failed to absorb into the body, requiring a subsequent mastectomy to remove the device. This would seem to be a very strong claim.
- Case 3 involves a plaintiff who received a BioZorb implant in May 2018. The device caused severe pain and discomfort as it protruded from the chest, leading to its removal in May 2022.
- Case 4 involves a plaintiff who received a BioZorb marker in June 2020 and has since reported complications, including pain, scarring, fibrosis, and an inability to sleep comfortably. The implant has not yet been removed.
The parties have proposed a random selection process to determine the trial order by January 17, 2025. Trials are expected to last approximately three weeks each, with the first trial scheduled for September 8, 2025, and the second in January 2026.
December 19, 2024 – Recall Notice
The FDA updated the recall notice yesterday.
December 17, 2024: Five Plaintiff Lawsuit Filed
Five breast cancer survivors from Washington, Illinois, Maryland, and New York brought claims against Massachusetts-based Hologic, Inc., alleging injuries caused by the company’s BioZorb Marker. The plaintiffs, who underwent lumpectomies or partial mastectomies, report severe complications including pain, infection, device migration, scarring, disfigurement, and emotional distress. These issues, they claim, required additional surgeries and caused permanent physical and psychological harm.
The lawsuit, filed in federal court in Massachusetts, asserts that Hologic failed to adequately warn patients and healthcare providers of the risks associated with BioZorb, including prolonged resorption times, migration, and increased radiation exposure. Additionally, the plaintiffs contend that the company promoted unapproved uses of the device, including improving cosmetic outcomes and aiding radiotherapy. The plaintiffs seek compensatory and punitive damages for the harm they have suffered.
December 12, 2024: BioZorb Class Action Lawsuit
Next year, it is certain plaintiffs’ lawyers will see a BioZorb class action lawsuit or, more specifically, an MDL. While the terms “class action” and “MDL” are often used interchangeably, they are distinct legal mechanisms.
A class action consolidates claims into one lawsuit with a single trial, representing all class members as a unified group. In contrast, a multidistrict litigation (MDL) centralizes individual cases before one court for pretrial proceedings, such as discovery and motions, but each case retains its individuality and can proceed to separate trials. MDLs are often used in product liability cases like BioZorb because the claims share common questions of fact, but the damages and circumstances vary significantly for each plaintiff, requiring individual trials or settlements. This distinction is crucial, though it is frequently misunderstood, even by those following the litigation.
We do not have an MDL right now. But the judge who has been assigned these cases in Boston is treating the 100 plus cases that have been filed as if there was a consolidated action.
December 10, 2024: Bigger Picture
The BioZorb lawsuits point to systemic issues in how medical devices like the BioZorb Marker are brought to market. Allegations that Hologic marketed the device for unapproved uses and failed to provide adequate warnings raise concerns about whether corners were cut in the rush to profit from a vulnerable patient population. The FDA’s subsequent recall and safety communications suggest these risks were foreseeable, yet not properly addressed.
December 9, 2024: Off-Market Uses in Focus
Plaintiffs’ Biozorb Marker lawsuits drill down on allegations of off-label promotion. This is a critical yet often overlooked aspect of medical device litigation but it will take center stage in this litigation. While the FDA approved BioZorb for radiographic marking, the device was allegedly marketed to fill tissue gaps and improve cosmetic outcomes—claims the FDA explicitly did not approve. This discrepancy raises the question of whether patients were unknowingly subjected to unapproved uses of a device that introduced unforeseen risks. These suits will dive into how off-label marketing practices can blur the lines of responsibility, leaving patients to suffer the consequences of decisions they were not fully informed about.
December 7, 2024: FDA Calls for Reporting on Adverse Events
The FDA reiterated the importance of patients and physicians reporting adverse events related to the BioZorb Marker. Through its MedWatch Online Voluntary Reporting System, the FDA seeks to collect data to assess the full scope of complications associated with the device. This step emphasizes the regulatory body’s heightened concern over the product’s safety profile and highlights the growing need for transparency in medical device monitoring. Experts believe this increased oversight could play a significant role in setting new standards for post-market surveillance of medical devices.
December 1, 2024: Balancing Innovation with Safety
The BioZorb Marker lawsuits reflects a broader challenge in healthcare: balancing innovation with patient safety. While advanced devices like BioZorb promise improved outcomes, they must undergo rigorous testing to ensure those benefits outweigh potential risks. When complications like migration and infection arise, it is often the patients—already in vulnerable states—who bear the burden. This lawsuit is a reminder that the pursuit of innovation should never come at the expense of transparency, safety, or the well-being of those the device is intended to help. The court’s handling of this case may serve as a benchmark for future litigation in the medical device field.
October 26, 2024: FDA Issues Safety Communication
The FDA released a Safety Communication advising healthcare providers and consumers to discontinue the use of BioZorb Markers due to serious risks, including migration, pain, and infection. This announcement followed mounting reports of adverse events and underscored the regulatory agency’s recognition of the device’s failure to meet safety standards. With growing concerns about the long-term effects of such devices, the communication has prompted renewed discussions about how manufacturers disclose risks to providers and patients.
October 23, 2024: Hologic Announces Urgent Device Recall
Hologic, Inc. issued an urgent recall of all unused BioZorb Markers and BioZorb LP Markers. The recall cited a range of adverse outcomes, including rashes, fluid buildup, device migration, and in some cases, the need for surgical removal. For patients and their healthcare providers, this recall marked a turning point, as it confirmed the severity of the risks that had previously been suspected but not officially acknowledged. Analysts suggest that this recall will likely lead to significant financial and reputational challenges for Hologic.
September 28, 2024: Court Allows Plaintiffs’ Claims to Proceed
U.S. District Judge Allison D. Burroughs denied Hologic’s motion for summary judgment, enabling the claims to move forward. This decision was pivotal, as it affirmed the plaintiffs’ right to pursue their allegations that the BioZorb Marker’s defective design caused significant harm. This ruling also put additional pressure on Hologic to either prepare for protracted litigation or consider settlement negotiations to avoid prolonged courtroom battles.
August 20, 2024 – “Sort of” BioZorb Class Action Lawsuit
June 5, 2024: Experts Raise Concerns Over BioZorb Testing
Several industry experts voiced concerns that the BioZorb Marker may not have undergone adequate real-world testing before its release. These perspectives were shared during a healthcare conference where panelists emphasized the importance of simulating diverse patient scenarios during pre-market testing. This raised questions about how medical devices are approved and whether regulatory agencies should require more rigorous real-life testing protocols.
May 15, 2024: 510(k) Approval
The BioZorb recall puts a familiar spotlight on the 510(k) process. Unlike the more rigorous Premarket Approval (PMA) process,, you do not need clinical trials if the device is deemed “substantially equivalent” to existing products. is that a good idea for complex devices like BioZorb? (No.)
The reliance on 510(k) approval is central to many medical device lawsuits, as plaintiffs argue that the process allows manufacturers to sidestep critical testing. In BioZorb lawsuits, attorneys are scrutinizing whether Hologic took advantage of this expedited pathway, bypassing necessary safeguards to prioritize speed to market over patient safety.
For plaintiffs, the FDA’s shifting position serves as a double-edged sword: it bolsters claims of inadequate testing while also providing the defense with a potential argument that the device met regulatory standards at the time of approval. You can be sure Hologic will try to take cover under the FDA’s umbrella of approval in every BioZorb lawsuit that is filed.
May 1, 2024: FDA Classifies BioZorb Recall as Class I
The FDA officially classified the BioZorb recall as a Class I recall. This is big deal, it is the most severe category, reserved for situations where use of a device could cause serious injury or death. This classification served as a stark warning to both medical professionals and patients, further escalating scrutiny of the device’s design and regulatory compliance.
February 26, 2024: Hologic Issues Medical Device Safety Notification
Hologic issued an initial safety notice to patients and healthcare providers, acknowledging potential risks associated with the BioZorb Marker, including device migration and infection. This early notice set the stage for further investigations into the device’s safety and signaled the beginning of what would become a large-scale recall and legal battle.
The BioZorb Device
The BioZorb device, manufactured by Hologic, Inc., is an implantable marker designed to assist breast cancer patients following a lumpectomy. BioZorb is a three-dimensional, bioabsorbable structure composed of polylactic acid (PLA) with six titanium markers embedded in a spiral or circular design. These titanium clips serve as radiopaque “targets,” enabling radiologists to pinpoint the location for focused radiation therapy.
While BioZorb was cleared by the FDA for marking breast tissue sites post-surgery, Hologic has marketed the device beyond these bounds, promoting its benefits for filling tissue space and improving cosmetic outcomes—claims the FDA has not approved. This marketing has raised significant concerns, especially as BioZorb’s advertised benefits have led patients to expect better results in both radiation targeting and cosmetic recovery.
In fact, these off-label promotional claims are now at the heart of the BioZorb lawsuit. Patients like the plaintiff received this device believing it would resorb naturally and pose no long-term health risks. Unfortunately, that has not been the case for many women. Complaints of persistent pain, hardened masses, non-absorption, and the formation of scar tissue at the implantation site have become all too common. Worse yet, these complications can mimic the symptoms of new cancerous growths, leading to ongoing emotional trauma and distress.
FDA Public Safety Warning About BioZorb
The FDA has issued two critical notices concerning BioZorb’s risks. In February 2024, the FDA released a public safety notice regarding the BioZorb. The FDA notice warned patients and health care providers that there was a significant risk of serous health complications associated with the BioZorb.
The FDA noted that adverse event reports have indicated that the BioZorb can cause a number of complications, including: including infection, fluid buildup (seroma), device moving out of position (migration), device breaking through the skin (erosion), pain, discomfort from feeling the device in the breast, rash, other complications possibly associated with extended resorption time.
The FDA classified Hologic’s notification to healthcare providers as a Class I recall, which is a big deal. This indicates a serious risk of injury or death. The safety notice warned that many of these complications can be harmful and require additional treatment of surgery to remove the device from the patient’s body.
The safety notice further explained that the BioZorb has only received FDA clearance for use as a radiographic marker for sites in soft tissue. It has NOT been cleared or approved for use to fill space in tissue or improve cosmetic outcomes.
BioZorb Lawsuit
Manufacturers of medical devices or implants, such as the BioZorb, have a legal obligation to ensure that their products are safe for their intended use. When a product is unsafe due to a defective design, a manufacturing flaw, or a negligent failure to warn about certain risks, the manufacturer can be held responsible for injuries caused by that product.
The BioZorb lawsuit is centered around an implantable device designed to serve as a three-dimensional marker for soft tissue sites after breast cancer surgeries like lumpectomies. With its spiral structure made from a bioabsorbable compound, the device includes six titanium radiopaque clips intended to guide radiation therapy. It works. But plaintiffs in these cases are alleging that instead of integrating seamlessly into their recovery process, BioZorb has caused painful scarring, infection. These complications were not adequately disclosed and that is the foundation of this litigation.
BioZorb’s design, compounded by misleading marketing, has left many patients unprepared for the realities of their post-implantation experience. Biozorb lawsuits against Hologic assert that the company failed to adequately warn patients and doctors about the potential for serious complications, such as chronic pain, tissue inflammation, disfigurement, and device migration.
Plaintiffs argue that Hologic’s instructions for use (IFU) lack critical warnings about BioZorb’s slow or incomplete absorption and omit necessary information about increased radiation dosing risks, which can lead to visible skin damage. In marketing BioZorb as a space filler and cosmetic enhancer, Hologic is also accused of promoting off-label uses without disclosing the risks, potentially leading doctors to recommend the device without a full understanding of its safety profile.
The manufacturer of the BioZorb, Hologic may well be required to compensation victims for injuries caused by BioZorb due to complication associated with the implant. Anyone who had the BioZorb implanted and subsequently suffered complications that were caused by defects in the design of the BioZorb or shortcomings in the instructions for the BioZorb can file a product liability and get financial compensation.
A growing number of BioZorb lawsuits have already been filed across the country. Hundreds and possibly thousands more are expected to be filed moving forward as new patients suffer complications and injuries.
BioZorb Injuries and Complications
The BioZorb device, intended to aid in breast tissue marking and healing, has instead caused significant harm to many patients. One of the most critical issues involves the device failing to naturally resorb as promised, leading to additional invasive surgeries for removal. These surgeries often result in permanent disfigurement, scarring, and ongoing emotional distress.
Our firm is actively investigating claims and accepting cases from individuals who have experienced the following injuries or complications linked to BioZorb implants:
- Infection: Severe and sometimes recurring infections at the implant site.
- Fluid Buildup (Seroma): Accumulation of fluid around the implant, causing discomfort and requiring medical intervention.
- Migration: Instances where the implant moves out of its intended position, leading to additional complications and corrective surgeries.
- Erosion: The implant breaking through the skin, resulting in pain and visible disfigurement.
- Delayed or Failed Reabsorption: The device not resorbing as intended, leaving a palpable lump, chronic pain, or requiring surgical removal.
BioZorb Legal Allegations and Theories of Liability
In the BioZorb lawsuits, the plaintiffs are bringing claims under several legal theories, including failure to warn, design defect, and negligence. At the core of these allegations is the argument that Hologic knew—or should have known—about the potential risks associated with the BioZorb device, but failed to adequately warn physicians or patients.
- Failure to Warn: The instructions for use (IFU) provided with the BioZorb device lack critical information regarding the potential for non-absorption, hardened masses, and long-term complications. While the IFU suggests that the device may resorb within one year, plaintiffs have reported cases where the device failed to resorb at all, leading to painful and sometimes disfiguring outcomes. Moreover, the marketing of the device included claims about improved cosmetic results and post-surgical recovery benefits that were not substantiated by clinical data and were beyond the scope of the FDA’s clearance.
- Design Defect: The spiral or helical shape of the BioZorb device, along with the bioabsorbable polylactic acid compound, may be inherently flawed. The design elements, such as its shape and material, have been shown to contribute to complications like infection, migration, and increased radiation exposure, which are not only dangerous but can also necessitate additional surgeries. This presents a significant risk-benefit imbalance, one that plaintiffs argue should have been addressed by the manufacturer.
- General Negligence: Hologic’s failure to adequately test and monitor the performance of BioZorb, as well as its decision to promote the device for off-label uses, has resulted in harm to patients. The plaintiffs claim that had the company adhered to reasonable standards of care, many of these complications could have been avoided or mitigated.
BioZorb Lawsuit Settlement Amounts and Jury Verdict Predictions
Understanding the potential financial outcomes of the BioZorb lawsuits are crucial for plaintiffs weighing their legal options. While it is still early in the litigation process—way too early, actually—our lawyers take what we know from similar medical device lawsuits to make early predictin on settlement amounts and jury payouts in these lawsuits.
Settlement values in medical device cases generally vary depending on the severity of the injury, the level of negligence proven, and the potential for punitive damages. Based on the nature of the allegations in the BioZorb lawsuit, our lawyers think individual settlements could range from $150,000 to $500,000 per plaintiff if these lawsuits are as successful as we hope. For cases involving severe injuries, such as extensive scarring, multiple surgeries, or significant emotional distress, settlement compensation may exceed $500,000. In multi-plaintiff settlements, such as those seen in multidistrict litigation (MDL) consolidations, total settlement funds could reach into the tens of millions of dollars.
Jury verdicts can be more unpredictable but also significantly higher than settlements in cases where plaintiffs can demonstrate a clear connection between the BioZorb device and their injuries. If a jury finds that Hologic acted with gross negligence or willful misconduct—particularly in light of the alleged off-label promotion—verdicts could reach over $1 million or more per plaintiff. If a jury finds there are punitive damages, really the sky is the limit. In cases where the plaintiff has suffered permanent disfigurement, or the BioZorb device caused symptoms that mimic a new cancerous growth, jury verdicts would likely be in the millions.
Contact Us About a BioZorb Lawsuit
If you suffered complications related to a BioZorb implant device, contact our national product liability lawyers today at 800-553-8082 or contact us online.