Beginning in 2012, Biozorb was marketed as a tumor bed marker to assist in radiation treatment in treating Ductal Carcinoma In Situ (DCIS). These devices were commonly used by doctors in the treatment of DCIS from 2012 until 2019.
What is Biozorb?
Biozorb, made by Hologic, Inc. Biozorb has been FDA approved since approximately 2012. It is a tumor bed marker developed to assist in targeted radiation treatment following lumpectomy for Ductal Carcinoma In Situ (DCIS). The marker comes in several sizes and is, as its name implies, designed to bioabsorb into the body within 12 months of implant. The company implies it is effective in cosmetic aspects by creating a scaffold upon which to re-approximate remaining breast tissue. Beginning in 2019, Blue Cross Blue Shield of North Carolina, stated it would not cover the device and labeled it “experimental”. One 2019 peer reviewed article, actually states that Biozorb “has not demonstrated value, given its relative high cost and lack of clinical advantage scientifically over the use of surgical clips.” The researchers also found that “a smaller marker or avoidance of utilization of the marker is recommended if a paucity of overlying tissue exists.” (A novel, adaptable, radiographically opaque, multi-plane continuous filament marker for optimizing tissue identification, radiation planning, and radiographic follow-up; 2019 Journal of Gland Surgery).
Are you a patient who was treated for DCIS? Did you doctor implant Biozorb? Do you suffer from severe pain and discomfort? If so, you may be entitled to significant compensation for your injury.
Injuries appear to be, seroma development, pain at the site and often radiating into the entire surgical breast, and sometimes rib cage and back. Patients complain of a hard lump that is quite painful to the touch, often making wearing a bra painful, and inability to sleep on the affected side. Patients also report deformity of skin and scar over the device, sensitivity, itching and reddening of the skin. Almost all patients report that the Biozorb device is NOT bioabsorbing in 12 months, and many report it staying intact for over 2.5 years. Many patients are so uncomfortable that they seek to either have the device removed or opt for a mastectomy to remove the entire breast. Some report it making the affected breast markedly larger than the non-surgical breast.
I had a partial lumpectomy on October 8, 2019. At the time of my consultation, the surgeon told me she would be inserting a Biozorb implant. When my son asked what are the side effects, she said “none and it will dissolve in a year.” A month after my surgery, I went back to her and requested the Biozorb be removed as it is very painful and uncomfortable. I cannot sleep on either side, the pain is all over the Biozorb, my back, and my arm. I cannot live with this object in my body, it’s very painful and uncomfortable. This is worse than the less than 1cm lump that she removed. Besides the pain, it’s also causes me anxiety and depression. I have a huge lump and if anything bumps into it, I see stars. Unfortunately due to this implant, I will be going through a total mastectomy as this will remove it once and for all. I am not very please with my original surgeon, as she did not give me any options. I was under a lot of stress after finding out I had breast cancer and my biggest concern at the time was finding a solution and getting the cancer out of my breast. I wish I had known about all these problems prior to my surgery, but when a person is first diagnosed, we are at our most vulnerable, I know I was. If I had known the truth regarding Biozorb, I would have never allowed this object to be implanted in my breast.
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