The BioZORB device is used as a “target” for radiation therapy. The designers created the device to resorb in the body while leaving behind tiny radiation markers.
However, many have reported complications with the device. Over the past year, the FDA has uncovered numerous medical device injury complaints and allegations that the device fails to absorb, causes a heightened foreign body reaction in patients, and migrates and protrudes, which necessitates intensive removal surgeries. Patients have received a lack of information regarding the device, which has led to serious consequences.
BioZORB Marker for Breasts Cancer Patients
Many who have been diagnosed with breast cancer are also recipients of the BioZORB device. Some were told that the marker would dissolve quickly in their body. Others were told that there were few or no side effects with the device. Many believed that it was the best decision for them.
Unfortunately, this was not the case for many of these patients. Here are some stories of breast cancer patients who have had bad experiences with the BioZORB device.
Patient Amy
Amy is an example of a patient who had a bad experience with the Biozorb marker. In August 2016, Amy received her DCIS diagnosis. During her “partial mastectomy” surgery, she had the marker implanted.
Her doctor told her that the marker would be absorbed in her body within a year. Unfortunately for Amy, this was not the case. Amy still has pain in her back, under her arm, and soreness on the site of the surgery. She also claims to feel a pulling sensation when she reaches her arm over her head.
Amy reported her side effects to her surgeon, and the surgeon told her that others have reported similar complaints.
To help with the pain Amy feels, she is being sent for scar tissue release physical therapy. Although some relief may come from this, it is still unknown.
Patient X
Another woman (patient x) with breast cancer who received the BioZORB device has spoken out. Patient x claims that almost three months after placement, her breast were starting to itch from the inside. She claims that the itch felt like “bugs crawling around inside my breast”. She also had a purple and red lump.
After taking three different kinds of antibiotics, she was told that the she needed device removal surgery.
Because patient x had complications with the device before starting radiation, she is able to have a complete mastectomy. It is difficult to have reconstruction on radiated breasts. If the side effects from the device appeared after the radiation had started, Patient x would be in a very different situation.
After patient x had her mastectomy, her doctor told her that she had granulomatous inflammation. This type of inflammation is caused by a foreign body type. Patient x had now been diagnosed with breast cancer for 14 months. This is much longer than she was expecting after the BioZORB implantation.
Patient x states that there has not been enough research into the side effects of this device. She regrets her decision to have the device implanted rather than having the complete mastectomy.
Patient Dawn
Another woman named Dawn shares her experience with the BioZORB implantation. She shares that she had a biozorb implanted in October 2016 during her lumpectomy. Her doctor told her that there were a few different marker devices to choose from, and he would use the one that provided the best accuracy, and would dissolve in about a year. After nearly 4 years, the device still had not dissolved and she felt pain and a “poking” sensation. For years after, it felt like the device was still in her. Even to this day, she still has a painful lump in the surgical area. This has taken a toll on her quality of life.
Dawn has now learned that pain after the surgery can last 5-10 years. She was under the assumption that the pain would only last a year.
When Dawn began starting hyperbaric oxygen treatments, these reduced her pain, and she can now roll over on her side without being woken up by pain. Her chronic inflammation and pain has gone down, but is still not resolved.
Dawn now believes that the manufacturer of the device not conduct enough research and studies before approving the device. Dawn did not receive the right information to make an informed decision. She fears that this is the same for many other women in her position.
Patient Christina
Another patient that had a lumpectomy is Christina. Her partial lumpectomy was on October 8, 2019. When Chrisina’s son asked about the side effects of implanting the BioZORB device, her surgeon said “none and it will dissolve in a year”.
Christina went back a month later with concerns about the device. She requested the device be removed because it was causing her pain and was uncomfortable.
She told her doctor that she could not sleep on either side and the pain came directly where the device implantation was. There was also pain in her back and arm. The pain was so severe that Christina wanted the device removed immediately. Besides physical pain, Christina was also experiencing anxiety and depression from the BioZORB device.
After the device failed Christina, she opted to receive a total mastectomy, which will remove all tissue. Christina feels her options were limited. After she got her diagnosis, Christina wanted the cancer removed as soon as possible. She thought that placing the BioZORB device was the best decision.
Christina wishes she had known about all the problems with the device prior to her surgery. She explains that if she was given all the information and the truth regarding Biozorb, she would have never gotten it. Her decision to have the object implanted is the reason she will have no breasts.
There are more stories about the pain after bioZORB marker implantation and radiation therapy treatment.
Keep Current Concerning BioZORB
Understanding BioZORB: Benefits, Complications, and Concerns
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How Can We Help?
KBA is currently investigating the BIOZORB Medical Device Recall. We have written about Problems/ Lack of Warnings with the device. BIOZORB Medical Device Recall
If you or a loved one has had a bad experience with the device, Contact Us. Our law firm has vast experience in Defective Medical Devices. Our attorneys can help you with your specific case.