After breast cancer surgery, patients trust that the devices used during their procedure will support their recovery—not create new problems. The BioZorb is a three-dimensional spiral device with titanium clips that was implanted during lumpectomies and partial mastectomies to mark the surgical site for future radiation targeting. But for many women, the BioZorb became a source of severe pain, infection, and disfigurement—complications made worse by allegations that the device was marketed for uses the FDA never approved.

What Is the BioZorb and What Went Wrong

The BioZorb was manufactured by Hologic and cleared by the FDA as a radiographic marker—essentially a device to help doctors identify the surgical site on imaging scans. However, Hologic allegedly marketed the device as a tissue filler that could improve breast shape after surgery, a use that was never approved by the FDA.

Patients implanted with the BioZorb have reported severe and persistent pain at the implant site, infections requiring additional surgery, device migration and erosion through tissue, scarring and breast disfigurement, and emotional distress from complications during an already difficult recovery from cancer treatment. In 2024, the FDA issued a Class I recall of the BioZorb—the most serious type of recall, reserved for devices that pose a reasonable probability of serious adverse health consequences.

Who Can File a Claim

Women who received a BioZorb implant during breast cancer surgery and experienced pain, infection, device migration, disfigurement, or other complications may be eligible to pursue a claim against Hologic. Over 120 patients had filed lawsuits as of early 2026, with initial trials completed and additional cases proceeding through the courts.

Compensation Available

BioZorb injury claims may include compensation for medical costs of treating complications, revision surgeries to remove or address the device, pain and suffering, emotional distress and disfigurement, lost wages during extended recovery, and future medical monitoring. The legal theories include design defect, failure to warn, manufacturing defect, negligence, and breach of implied warranty.

Breast cancer patients have already endured enough. If a defective device made your recovery harder, you have the right to seek accountability. Beverly Wilshire Law APC can evaluate your BioZorb-related complications at no cost. Call (310) 424-5566 or email info@bevwilshire.com for a free consultation—we’re here to guide you in the right direction.