BioZorb – A New Implantable Device Delimiting Surgical Site After Breast Cancer Lumpectomy

BioZorb – A New Implantable Device Delimiting Surgical Site After Breast Cancer Lumpectomy
biozorb_purpleDuring the 32nd Annual Miami Breast Cancer Conference in Miami Beach, Florida, held between Feb. 26 to March 1, new innovative and challenging surgical, medical and radiation approaches were presented that promote the understanding of state-of-the-art treatments within each therapeutic area and collaborative work in the clinic. During the conference Dr. Steven Schonholz from the Noble Hospital, Massachusetts, presented a scientific poster with the BioZorb tissue marker a new implantable device that specifically delimits the surgical site of tissue removal (lumpectomy) in three dimensions in patients with breast cancer. Dr. Schonholz is the Director of the Center for Comprehensive Breast Health at Noble Hospital and was the first physician in Massachusetts to use BioZorb during his clinical practice. The BioZorb tissue marker was developed by Focal Therapeutics. It has 6 titanium marker clips distributed in a 3D pattern inside a bio-absorbable coil that enables the delivery of a more focused radiation therapy with lower amount of radiation reaching the healthy tissues. By delimiting the surgical site, this device improves visual confirmation for therapy planning, patient positioning and follow-up. BioZorb is compatible with virtually all forms of radiation therapy and is frequently used in the breast. The coil can be reabsorbed by the body w
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13 comments

  1. Marsha Schmit says:

    Has anyone had issues with breast swelling and infection after placement of biosorb even months after it has been placed? And even arm swelling periodically?

    • Hanni says:

      I had this BioZorb coil implanted 3 weeks ago after a lumpectomy. It is causing me constant pain. I don’t see any complaints anywhere else, and I can’t believe I’m the only one experiencing this non-stop misery. If I change position at night and my breast moves it causes a sharper pain. I wear a snug sports bra to bed to try and prevent any movement, but also have to use small pillows to hold everything in place. It is getting worse instead of better. And yes, I have swelling. Something is not right with this device!

      • Candice says:

        No, you arent the only one experiencing pain with this damn thing! Reading your words reflect what I am going thru as well. Mine was put in the beginning of Oct 2018, its now March 2019 and I can say its just finally starting to feel a bit better, though that area is still sore. I wear a sports bra to bed so I can sleep partially on my side like I used to and yes, I also sleep with a small pillow to make it more comfortable. First mammo since surgery in April and I’m dreading it!

    • Dawn says:

      I have had pain for over two years with this device. If you look on the breastcancer.org community there are threads of other people who have also had major problems with this device. I have seen several Dr’s about this and gone back to my original surgeon and the only options I seem to have is to either have another surgery to have it removed or try to wait it out and hope it eventually goes away. This device should never have been approved without more research and testing.

  2. Gloria says:

    I have not experienced an infection. However, my surgeon said the BioZorb would be absorbed in a year, then 18 months and now she says 24 months. At times it is uncomfortable and during a mammogram there is pain.
    Thank you

  3. Hanni says:

    The BioZorb was finally removed because of the severe pain and inflammation I was experiencing. I had to undergo another surgery. The pathology of the surrounding tissue indicated a granuloma. My body was rejecting the BioZorb. Now that it is out all my pain is gone. I am very upset that I needlessly suffered, especially when I specifically questioned the surgeon about reactions to this implant, pre-surgery. He said there were none. That is obviously untrue. Something is not right with the push to insert this invasive device.

  4. Sarah says:

    I had a lumpectomy in Oct. 2016. A Biozorb device was implanted. I have had cellulitis 3 times since then and my activities are severely limited. If I work in my garden, wash the dog, handle a 20-lb turkey, mop the floor, etc. I am in severe pain afterwards often for several days. I believe it is this implantation that is the problem. I think my doctor may believe so as well, as he mentioned that he had removed the device from 2 previous patients- yes another surgery. I am also concerned that since I initially received a letter from my insurance company saying they would of course pay for my lumpectomy, they were denying the part of the claim that involved the Biosorb as it was not yet generally accepted medical practice. Will they pay for its removal? I somehow doubt it.

    • VERONICA says:

      IHAD A LUMPECTOMY IN JUNE 4,2018,A BIOZORB WAS IMPLANTED,ON JUNE 18,2018I HAD A SECOND SURGERY ON THE SAME BREAST TO REMOVE A SMALLER LESION THRU THE SAME INCISION INCSION WOULD NOT HEALED ,HAD THREE MONTHS WOUND THERAPY ,THEN RADIATION FOR 21 TREATMENTS,1 MONTH LATER I DEVELOPED AN ABCESS. MY SURGEON SAID I MAY HAVE TO HAVER THE BIOZORD REMOVED IF THIS CONTINUES, I AM NOW RECEIVING IV ANTIBOTICS

  5. Carol Finley says:

    I had a similar device implanted during a lumpectomy two years ago and now pieces of it are exiting through the original incision. More pieces are still trying to exit, so I have made appointment with doctor. This is painful.

  6. Clear Sky says:

    I had my lumpectomy on May 9th and the BioZorb was placed in the cancer cavity. (I do not have large breasts and we caught it very early, thank goodness for 3D mammograms.) The tumor was only 1.2cm, so I may have had a smaller model of the BioZorb implanted.
    I was given a treatment plan of 20 radiation treatments, no chemo, 15 full breast and 5 directed to the cancer cavity (BioZorb).
    I have not experienced any issues or pain with the BioZorb implant. I actually have trouble finding its location. The radiation has caused some discomfort…redness, swelling, fatigue, itching, lack of a bra towards the end has not been appealing. (I was defiantly patriotic over the 4th of July with the red and blue markings on my chest.)
    I continue with the expectation that the BioZorb will provide positive benefits:
    • Identifying the exact location for direct radiation to the tumor site.
    • Creating a “platform” for the scar tissue to fill the tumor cavity and help return the breast to a natural structure. (However at my age, I do not think anyone would care to examine them.)
    • Visibility of the titanium clips during future mammograms allow the radiologist to recognize the location of the removed tumor.
    I understand that my conditions are not the same as everyone, however I want to share my perspective and experience, thus far with BioZorb.

  7. Therese C. Cleary says:

    Geez are there any POSITIVE comments about this device? I am looking to have this device implanted very soon.

    • Dawn says:

      I would definitely question having this device put in. I very much wish I hadn’t allowed this to be put in.
      I am still in pain almost three years later and the only remedy seems to be another surgery. My oncologist also has told me that it a couple of cases she knew where it was removed they found that it was actually hiding cancer cells screening tests. Do a search for biozorb on Breastcancer.org community site for threads on other peoples experience with it.

  8. Nancy Harvey says:

    LADIES!!!
    I urge you to report your medical issues to two sources:
    1) FDA’s Medwatch: https://www.accessdata.fda.gov/scripts/medwatch/
    2) Focal Therapeutics: https://focalrx.com/, the manufacturer of the BioZorb 3D bioabsorbable marker.

    PLEASE report your issues!! Your doctors should have been reporting these, but they clearly have not. Your clinical adverse events are not visible in the FDA complaint database. Because of this, the BioZorb 3D marker implant looks safe to the public. Maybe it is, but it is critical that you let FDA and Focal RX know about your clinical issues. This is the only way to ensure that the implant is safe for the public. Reporting also ensures that doctors and insurance companies are aware of potential issues with this implant.
    Please report your issues!!!

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