Bernheim Kelley Injury Lawyers Investigating BioZorb Injury Claims & Taking New Clients Nationwide
FORT LAUDERDALE, FL – April 22, 2025 –
Correction, August 2026: This release originally misstated the date of the FDA’s Class I recall classification and described BioZorb as intended for radiation targeting. The FDA classified the recall as Class I on December 18, 2024, and has stated that it never cleared BioZorb for use as a radiation treatment marker. Those passages have been corrected. The remainder of the release appears as originally published.
Editor’s note, August 2026: This release reflects the BioZorb litigation as it stood in April 2025. Hologic has since settled the cases that were on file. Bernheim Kelley continues to investigate and file new BioZorb claims. For current status, see our BioZorb lawsuit page.
Bernheim Kelley Injury Lawyers is actively investigating claims related to BioZorb® marker complications and is now accepting new clients. Many patients who received BioZorb markers after breast cancer surgery have reported serious complications, including pain, infection, device migration, and scarring. Patients who suffered injuries from BioZorb markers or had to undergo additional surgeries may have the right to seek compensation and hold Hologic® Inc. accountable through a lawsuit.
BioZorb was cleared by the FDA in 2012 as an implantable marker for identifying soft tissue sites on future imaging. In clinical practice it also came to be used to help target radiation therapy after lumpectomy, a use the FDA has stated it never cleared or approved.
Reports indicate that the BioZorb implant’s polylactic acid (PLA) component, designed to dissolve over time, can instead cause inflammation. Additionally, the permanent titanium marker has migrated or eroded through tissue in some cases, causing painful and dangerous complications. It has been found to cause health issues such as rashes, seroma (fluid buildup), chronic discomfort, and more. Many patients have required additional surgeries to remove the device.
It has been alleged that Hologic was aware of the risks associated with delayed resorption and migration but continued to market the device aggressively. The FDA has also cited Hologic for failing to report serious injuries in a timely manner. This raises questions about the company’s accountability and handling of patient safety. Their inaction may have further compounded the harm done to patients.
“This device was marketed as a solution, but for too many patients, it’s become a never-ending nightmare,” said Jesse Bernheim, CEO and Trial Attorney at Bernheim Kelley Injury Lawyers. “Patients deserve answers and accountability—and we’re determined to fight for them.”
Hologic recalled unused BioZorb markers in 2024, expanding the recall to all lots on October 24, 2024. The FDA issued a safety communication the following day advising against use of the device, and on December 18, 2024 the agency classified the recall as Class I, its most serious category, reserved for products that may cause serious injury or death.
The recall affected over 53,000 devices distributed between April 29, 2019, and April 1, 2024. At the time of the 2024 recall, the FDA reported 71 injuries associated with BioZorb markers, including pain, infection, device migration, and complications requiring additional medical treatment, including device removal.
Bernheim Kelley Injury Lawyers encourages anyone who has suffered complications from a BioZorb marker to seek legal representation. The firm is now accepting new clients and offering free case evaluations to determine whether patients may have a viable claim for compensation.
Bernheim added: “Patients trusted this device to help them, not traumatize them further. We’re investigating these cases to hold Hologic accountable and help patients regain their dignity and hope.”
If you or a loved one has suffered complications from a BioZorb marker, you may be entitled to compensation. Contact Bernheim Kelley Injury Lawyers today for a free case evaluation and to learn more about your legal options.
About Bernheim Kelley Injury Lawyers
Bernheim Kelley Injury Lawyers is a law firm with decades of experience representing clients in mass tort, product liability, and personal injury cases. Founded by Jesse Bernheim, Esq., the firm has secured over $1 billion in verdicts and settlements on behalf of clients nationwide.
Earning recognition for delivering excellent, individualized legal representation, Bernheim Kelley Injury Lawyers is dedicated to protecting the legal rights of those who have suffered harm due to negligence. They believe that Real Justice goes beyond compensation to restore dignity, peace of mind, and confidence in the future for victims and their families.
Every case is different and must be judged on its own merits. Prior results do not guarantee a similar outcome.