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.
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
Our firm is currently investigating and accepting BioZorb cases involving the following injuries or health complications which have been linked to the BioZorb:
- Infection
- Fluid Buildup (seroma)
- Migration (implant moves out of position)
- Erosion (implant breaks through the skin)
- Complications from delayed reabsorption
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.