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For thousands of breast cancer survivors, the journey after surgery should have been one of healing and recovery. But for many who received a device called BioZorb, the aftermath has instead meant unexpected pain, repeat surgeries, and lingering uncertainty.
BioZorb was introduced as a promising tool to help women maintain breast shape after lumpectomy. Marketed as a small, dissolvable plastic coil that would gradually be absorbed by the body, the device was supposed to support tissue healing and improve cosmetic outcomes. In reality, many patients found that BioZorb didn’t dissolve as intended. Instead, it broke into fragments or hardened inside the breast, leaving behind painful reminders of their fight with cancer.
Stories from women across the country paint a troubling picture. Patients have described searing pain, infections, and even necrosis (dying breast tissue) tied to BioZorb implants. Some endured constant sharp, stabbing sensations. Others faced complications so severe that they ultimately underwent mastectomies—losing breasts they had hoped to preserve.
One woman, after two years of suffering, had 24 plastic shards surgically removed from her chest. Even after removal, she was left with scarring, pain, and the constant fear that more fragments remained.
BioZorb’s story also highlights deep flaws in how medical devices are approved in the United States. Most “moderate risk” devices—including BioZorb—reach the market through the FDA’s 510(k) pathway, which requires no human clinical trials. Instead, manufacturers only need to show their product is “substantially equivalent” to something already approved.
In BioZorb’s case, that comparison was made to tiny metal markers used to track tumors—not to anything resembling the thick plastic coil actually implanted in patients.
Even worse, hundreds of complaints from patients and doctors went unreported to the FDA for years, despite the legal requirement that they be disclosed within 30 days. Only after lawsuits began in 2022 did many of these reports finally come to light.
In 2024, after mounting reports and federal scrutiny, BioZorb was finally pulled from the market. The FDA issued a safety communication warning that the device could cause serious injuries, including infection, erosion, and complications that required additional medical treatment. While no deaths were reported, the agency made clear that BioZorb was linked to significant harm.
Yet the fallout continues. Tens of thousands of women still live with BioZorb implants inside their bodies. For many, the pain, uncertainty, and medical risks remain ongoing.
At Napoli Shkolnik, we represent patients harmed by defective medical devices. If you or a loved one received a BioZorb implant and have experienced pain, infection, repeat surgeries, or other complications, you are not alone. Legal options may be available to help you recover compensation for your injuries and hold manufacturers accountable.