FDA says, do not use BioZorb. https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication
The Dangers of BioZorb – Dealing with a BioZorb Device Complications and Removal
BioZorb is an implantable device that doctors primarily use after a breast cancer lumpectomy surgery. The device helps with radiation therapy by serving as a marker for the lumpectomy surgical site for better targeting during the radiation treatment. The device consists of a spiral scaffold made of bioabsorbable material, with several titanium markers embedded within it. The scaffold is supposed to dissolve over time, leaving behind only the titanium markers. This is where the problem lies: in many cases, the BioZorb device does not resorb as it is designed to, and instead forms a hardened “lump” or scarified mass that is painful. In many cases, the undissolved marker actually protrudes through breast tissue, causing severe pain and infections at the surgical site.
How BioZorb is Used in Breast Surgeries
Surgeons typically use BioZorb during lumpectomies or partial mastectomies. The device is placed in the breast cavity where the tumor was removed. It is believed that the company also markets the device as a product with cosmetic benefits in that it also helps holds the shape of the breast tissue during healing while it dissolves naturally over time. However, the device is not approved as product with cosmetic benefits, and the same properties of the device that can cause it to “hold its shape,” also, unfortunately, cause it to fail, harden, migrate, and turn into a “mass” in some patients.
Unfortunately, BioZorb removal surgery can be a difficult process, as these markers become embedded in tissue and are not always easy to extract without complications. In some severe cases, patients actually elect to undergo a mastectomy instead of going through one or more device extraction procedures.
BioZORB Device Complications
If you experience pain, discomfort, swelling, or visible lumps at the surgical site, the BioZorb marker might be causing an issue, particularly if you have stubborn or persistent symptoms. Infections or allergic reactions can also occur. Always consult your doctor if you have any of these symptoms.
If you are one of the unfortunate patients who suffer from BioZorb device complications and had to have the device removed, follow your doctor’s post-operative care instructions closely. You may need to rest, avoid strenuous activity, and monitor the surgical site for any signs of infection or complications. Always keep your follow-up appointments to ensure proper healing.
If you have an attorney and have encountered surgery to remove the BioZorb device, the attorney can take steps to preserve the pathological evidence (the extracted device) before the hospital throws it away. If preserved, the removed device can become important evidence in your case.
How KBA Attorneys Can Help If a BioZorb Device Has Harmed You
At KBA Attorneys, we understand the physical and emotional toll that complications from BioZorb can take. If you have experienced issues with a BioZorb removal, you don’t have to go through it alone. Our legal team is here to help you hold the manufacturers of BioZorb accountable for any harm caused.
We have extensive experience in handling medical device litigation, and we will work tirelessly to secure the compensation you deserve. Whether you’ve suffered from pain, infection, or complications due to titanium breast markers, we will guide you through the legal process and fight for your rights. Contact us today for a free consultation.