Products Liability
On this page we will discuss product liability lawsuits involving injuries caused by the BioZorb implant. The BioZorb is tissue marker implant that it used in breast cancer surgical procedures such as lumpectomies. New evidence showing that the BioZorb causes serious health problems and injuries has prompted a growing number of lawsuits against the manufacturer, Hologic.
This page will explain who is eligible to file a BioZorb lawsuit and what our lawyers think the potential settlement value of these cases will be. Our national product liability lawyers are accepting BioZorb lawsuits across the country. Contact us at 800-553-8082 or contact us online for a free consultation.
About the BioZorb
The BioZorb implant is a medical device used primarily as a tissue marker in lumpectomy surgeries for breast cancer patients. The BioZorb is composed of a bioabsorbable spiral with small titanium clips. The spiral part of the BioZorb is supposed to gradually and harmlessly dissolve inside the patient’s body within 1 or 2 years. The titanium clips do not dissolve and are supposed to remain permanently implanted.
The BioZorb implant is designed to help surgeons and radiologists precisely target and monitor the area where breast tissue was removed, aiding in radiation therapy alignment and follow-up imaging. In addition to providing a guide-post for targeted radiation therapy, the permanent BioZorb titanium clips can also provide a long term marker for any future surgical procedures.
The BioZorb is manufactured by Hologic, a large medical device company that specializes in healthcare tools for the treatment of breast cancer and other female health conditions. One of the major issues that has emerged with the BioZorb is the way Hologic has marketed the device.
Hologic’s marketing materials claim that the BioZorb will help improve the cosmetic outcome of lumpectomies by filling the tissue void. So instead of having a large depression in the breast where the tissue was removed, the BioZorb will supposedly help fill that empty space to make the breast look more natural after the procedure. The problem is that the BioZorb is NOT approved for this type of cosmetic use.
BioZorb Causes Serious Complications and Injuries
Recent evidence has emerged which shows that the BioZorb does not perform as designed and can actually cause a number of very serious health complications and injuries. The serious complications and injuries linked to the BioZorb implant include:
- Chronic Pain: The biggest issue with the BioZorb is that it tends to cause patients to suffer chronic pain at the implant site.
- Scarring: The BioZorb has been shown to cause significant scarring and scar tissue accumulation in the area surrounding the implant site. This can cause pain, discomfort and long-term aesthetic issues.
- Infection: Infection at the site of the BioZorb implant is another major complication linked to the device. Implant site infection can lead to very serious and long-term complication and required additional surgeries.
- Migration: The BioZorb implant frequently moves out of its intended implant location after the surgery. This complication is referred to as migration and it can cause major problems.
- Erosion: Erosion occurs when the BioZorb implant device pushes outward and breaks through the skin, causing intense pain and risk of infection.
In addition to causing chronic pain and discomfort, these complication often require further medical treatment and sometimes further surgical treatment.
FDA Public Safety Warning About the BioZorb
The FDA issued a Public Safety Warning about the BioZorb implant in February 2024. The FDA issued a notice to patients and healthcare providers, highlighting a significant risk of serious health complications linked to the BioZorb implant. According to the FDA, adverse event reports reveal that BioZorb may lead to complications such as infection, fluid buildup (seroma), device migration, erosion (where the device breaks through the skin), pain, discomfort from the device’s presence in the breast, rashes, and other issues potentially related to prolonged resorption time.
The notice emphasized that many of these complications can be harmful and may require additional treatment, including surgery to remove the device. It also clarified that BioZorb is FDA-cleared solely as a radiographic marker for specific sites in soft tissue; it is not approved for tissue space-filling or cosmetic enhancement purposes.
BioZorb Lawsuits
Like any medical device manufacturer, Hologic has a legal duty to ensure that its products are safe when used as designed. When products are not safe as a result of a negligent defect, manufacturers can be held accountable for injuries caused by the product. A negligent defect can come in the form of a design flaw, a mistake in the manufacturing process, or a negligent failure on the part of the manufacturer to provide adequate safety warnings to consumers (and doctors).
In the case of the BioZorb, Hologic can be liable based on both negligent design flaws in the BioZorb and negligent failure to warn doctors and patients about known risks and complications with the product. Below are detailed summaries of the various allegations against Hologic in the BioZorb lawsuits:
- Failure to Warn: The BioZorb device’s Instructions for Use (IFU) lack essential information about potential issues, such as non-absorption, formation of hardened masses, and long-term complications. While the IFU indicates that the device may absorb within one year, some plaintiffs report instances where it failed to absorb, resulting in painful and sometimes disfiguring outcomes. Additionally, the device was marketed with claims of improved cosmetic results and enhanced post-surgical recovery benefits, which were not supported by clinical data and exceeded the scope of the FDA’s clearance.
- Design Defect: The BioZorb device’s spiral, helical shape, combined with its bioabsorbable polylactic acid material, may contain inherent flaws. These design aspects, including its shape and composition, have been linked to complications such as infection, migration, and heightened radiation exposure, which not only pose serious risks but can also require further surgeries. Plaintiffs argue that this significant risk-benefit imbalance should have been addressed by the manufacturer.
A growing wave of BioZorb implant lawsuits are being filed against Hologic across the country.
Who Is Eligible to File a BioZorb Lawsuit?
Anyone who had a BioZorb device implanted and subsequently suffered from health complications directly linked to the implant is eligible to file a product liability lawsuit and get financial compensation. To bring a successful BioZorb lawsuit, prospective plaintiffs will need to obtain medical records showing that they had the BioZorb implanted. They will also need additional medical records evidencing the complications and injuries that were subsequently caused by the BioZorb implant.
Report BioZorb Problems to the FDA
Anyone who has experienced problems or health complications with the BioZorb implant after their surgery should report those issues directly to the FDA. Issues with the BioZorb can be reported through the FDA MedWatch Voluntary Reporting Form.
BioZorb Class Action
The BioZorb injury lawsuits across the country will most likely be consolidated into a class action MDL (Multidistrict Litigation). In an MDL, a large number of individual cases are consolidated together before a single judge and then these cases go through a combined fact discovery phase.
At the end of this consolidated discovery phase, a handful of sample cases are selected and prepped for jury trials, which are called “bellwether trials.” The outcomes of the bellwether test trials are supposed to facilitate global settlement negotiations. In most MDLs, however, a global settlement deal is brokered before any bellwether trials are held.
How Much Will BioZorb Lawsuits Be Worth?
Although it is very earlier to accurately predict the settlement value of BioZorb cases, we can make early projections based on settlements in prior medical device mass torts. Given the allegations in the BioZorb lawsuits, our attorneys anticipate individual settlements could range from $150,000 to $500,000 per plaintiff if the cases achieve favorable outcomes. For cases involving serious injuries—such as substantial scarring, multiple surgeries, or considerable emotional distress—settlements could potentially exceed $500,000.
Contact Our BioZorb Lawyers
If you suffered injuries or post-implant complications associated with a BioZorb implant, contact our product liability lawyers today 800-553-8082 or contact us online.