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Pain after Biozorb marker implantation and radiation treatment

I was diagnosed with DCIS, had a "partial mastectomy" in August 2016, and the surgeon implanted a Biozorb marker during the operation. The Biozorb is/was supposed to be reabsorbed by my body in a year, but that didn't happen, and it will take longer. In December of 2016, I had radiation therapy on my breast. Now, almost a year after surgery and 6 months after radiation, I have had pain in my back directly behind the radiated breast which comes/goes, pain under my arm, and the site of the surgery is still very tender and sore. When I put my arm over my head on the left side, I feel a tight, painful pulling sensation. The surgeon tells me I am not the only one complaining of this, and my radiation oncologist is sending my for scar tissue release physical therapy which will begin next month. Has anyone else had experience with the Biozorb marker and pain related to it?

Amy

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Comments

  • Mancos
    Mancos Member Posts: 1

    Hi Amy - I had a Biozorb marker implanted in October of 2015 and I can still feel it and it is still tender, but only to the touch, not when I raise my arm. I did have pulling pain right after the surgery but it went away after I got some PT/massage directed to the scar tissue. Hope you feel better soon! - Chri

  • Georgia1
    Georgia1 Member Posts: 188

    Amelia, I had biozorb inserted at surgery and have not had any related pain. Honestly I couldn't feel it at all for awhile, maybe because my breast was puffy and it was the underarm pain related to the lymph node removal I was focused on. I'm now six weeks post-surgery and can feel it when I sleep on that side, but no pain. Start radiation right after Thanksgiving so will post after that is complete but so far it did help cosmetically and seems worth it. My pain and pulling feeling was all related to the sentinel node biopsy and stretching exercises helped a lot.

  • Family11
    Family11 Member Posts: 2

    Mine was put in June 2015, not dissolved yet. This is very painful still, told it's the radiation that causes the pain. I feel the biozorb and if touched or bumped very painful.


    Marie

  • Family11
    Family11 Member Posts: 2

    Mine was put in June 2015, not dissolved yet. This is very painful still, told it's the radiation that causes the pain. I feel the biozorb and if touched or bumped very painful.


    Marie

  • moderators
    moderators Posts: 7,813

    Family11, thanks for sharing, and sorry you are still experiencing pain! Have you discussed this issue with your doctor? Maybe worth trying physicial therapy as well?

  • Ds4idi
    Ds4idi Member Posts: 3

    I had a very bad experience with the Biozorb device. Almost 3 months after placement I was just going to start radiation when my breast started to itch from the inside. It felt like bugs crawling around inside my breast. Then a lump appeared which turned a horrible purple and red. I had three different kinds of antibiotics then my doctor said she would remove the device. I opted for a complete mastectomy as I found out if you have radiation it is very difficult to have reconstruction on radiated breasts. My breast tissue had retracted and my nipple was twisting in a weird direction. After the mastectomy the pathology came back that I had granulomatous inflammation, foreign body type. Due to my original surgeon no longer accepting my insurance I have had to go to another surgeon and am now having reconstruction. All this has been very stressful and I am in the 14th month from diagnosis. I am having one last surgery in Feb and hopefully will be done 😊. I don’t think there’s has been enough research into the side effects of this device. I wish I hadn’t nevertheless hadn’t it and just got the complete mastectomy in the first place

  • DandelionHair
    DandelionHair Member Posts: 7

    wow! That sounds terrible. How frustrating. I haven't met many others with Biozorb. Mine is fine but I have a large hard lump in my breast. It is scary but I've had to tune my worrying out as I would go crazy otherwise. It's hard and lumpy. I've had another mammogram and they said this lump was ok. I'm sorry about your sit

  • DandelionHair
    DandelionHair Member Posts: 7

    wow! That sounds terrible. How frustrating. I haven’t met many others with. Biozorb. Mine is fine but I have a huge hard lump in my breast. It is scary but I’ve had to tune the worrying out as I would go crazy. It’s hard and lumpy. I’ve had another mammogram and they said it was ok. I’m sorry about your sitstuo

  • brandim2018
    brandim2018 Member Posts: 1

    I had a lumpectomy Oct/18 and radiation the whole month of November. I am now having NEW pain in my breast and it feels like it is coming from the biozorb implant area. It burns and just plan hurts. Called surgeon but no one has called me back yet. It may be something that i will just have to wait out and will hopefully go away. Glad i am not the only one though that is having pain still.

  • josieo
    josieo Member Posts: 140

    Hi all,

    Like Georgia, I received a Biozorb as part of my lumpectomy and have not had many problems with it. It was initially startling to feel it, as my original cancer was not palpable, but it was not really painful, and it has been steadily shrinking. As I think about it, the original claim of “dissolving within a yea” seems hopeful vs. realistic. This has probably caused more distress and confusion for many patients.

    Although I was initially diagnosed with invasive cancer, during my surgery a large amount of DCIS was discovered and removed. The total amount of tissue removed would have resulted in significant deformity, and the Biozorb allowed my surgeon to rearrange my tissues, and also provide a directional marker for my radiation treatment. So I am the type of patient that this device was designed for. But I recognize that may not be everyone else’s situation.

    My advice is to continue to monitor and discuss with your medical professionals. They in turn can be a source of information for the manufacturer and for the medical community.

    here’s another place where comments have been placed re Biozorb:

    https://community.breastcancer.org/forum/68/topics/860299?page=2#idx_46

    Strength, support, and good health to everyone

  • Teddycake
    Teddycake Member Posts: 7

    Hi All.

    Let us help future women who might get this device put in their bodies without proper discussions pre-surgery or at least force the maker to address the problems with their device. My radiation oncologist said the device made no difference to him and he thought it was unnecessary for his treatment for me. Again I am so happy that it was removed. I would rather lose my nice looking breast than have pain! Although, now I look tough with my surgery breast...so don't mess with us cancer survivors! Thanks to my surgeon, I am feeling so much better

    FDA info:

    Best to email questions on medical devices than to call DICE@fda.hhs.gov

    Complaint forms are online but I am not allowed to post the link. So go to their website, search "forms for reporting to FDA". Then I believe the correct form for us is "FDA Form 3500B".

  • cowgirl13
    cowgirl13 Member Posts: 774

    Why do they even use these devices? Sounds terrible.

  • Poptart2
    Poptart2 Member Posts: 2

    Hi everyone I just finished my radiation the end of January. I did have the Biozorb placed when they did my lumpectomy. Now I am having these outward stretch marks. My breast is swollen and I have pain. I am not sure what it is. I do have an appointment with my Cancer Dr Tuesday morning but I am not sure if anyone else has experience this and if it is normal.

  • Poptart2
    Poptart2 Member Posts: 2

    I just finished radiation in January of this year. I am having pain with my biozorb. Nothing in my back just in the breast. It is larger then the other and it is painful when I put my bra on. If I lay on that side at night. It has been 6 months out of radiation and still is painful. Do you have any suggestions? Thanks Theresa

  • Georgia1
    Georgia1 Member Posts: 188

    Hi there Poptart. Yes, for most of us with the Biozorb device, pain while sleeping on that side is perfectly normal at six months. I used a pillow under that breast to help, and tried to sleep on the other side; I think it was about 10 months in that I could sleep well on either side.

    Even without a Biozorb to help cosmetically, a lot of women experience pain well after lumpectomy. What worked for me was 1) stretching exercises and 2) switching bras every day so that one day would be a sports bra, the next day a supportive bra with wide straps, the next day my favorite black bra, etc. It helped to not have constant pressure on the nerves damaged in surgery I guess. I did not have stretch marks after radiation but my breast was swollen for several weeks before it resolved. So all good topics for you to talk to your oncologist and surgeon about at your follow-up visits. Hope this helps.

  • dawndw
    dawndw Member Posts: 3

    I had a biozorb implanted during my lumpectomy in October 2016, over three years ago. It still hasn't dissolved, I have had chronic pain, in different forms and talked to 10 different Drs about it because it really affects my quality of life. My radiologist made it sound like it was all in my head and my surgeon did research to find that post-surgery and radiation pain is much more prevalent and lasts longer ( 5-10 years) then previously thought. How do they not know this? Because the pain was not just around the biozorb she didn't feel removing it would necessarily help so it should be the last ditch effort. A friend of mine told me about hyperbaric oxygen treatments. I went back to my surgeon who said she didn't know that much about it (?, she is the head of breast surgery at a major, prestigious hospital). However, she said it couldn't hurt and gave me the referral to their hyperbaric department who diagnosed it as late effect radiation damage. So I have just completed 10 out of 30 sessions. The biozorb, which seemed to have quit dissolving and has been about the same size for a year and a half has definitely started to dissolve substantially, along with the little lumps of fat necrosis that was surrounding it. For the first time since my surgery in 2016 I can roll over on my side and not be woken up by the pain. Also, the chronic inflammation and pain by my sternum have almost completely gone away. They said that the actual radiation injuries don't usually show improvement until around session 18-20 so I am hoping that I will show improvement with the other pains as well and I think from what has happened so far it will probably finally dissolve this biozorb that I was originally told would dissolve within a year. I personally don't think enough research and studies were done before approving this device so that women could make an informed choice. However, moving forward, if your Dr has not talked to you about Hyperbaric oxygen treatments for radiation effects, ask them about it. I'm seeing improvement and will update at the end of my treatments.

  • C61bones
    C61bones Member Posts: 1

    I had a partial lumpectomy on October 8, 2019. At the time ofmy 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 dissolved 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, 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 am was. If I had known the truth regarding Biozorb, I would have never allowed this object to be implanted in my breast. Now because of it, I am going to have no breast... My surgery is July 2nd 2020. If there’s a lawsuit, I will join the suit. Christina P

  • moderators
    moderators Posts: 7,813

    Welcome, C61bones! We're so sorry for what you've been through, and continue to experience. You are right about being at your most vulnerable following a diagnosis, and it's dismaying to hear that you were not presented with enough information to make your decision. We sincerely hope your upcoming surgery goes well, and that your recovery is swift. We're all here for you, please let us know how it goes on Thursday.

    The Mods

  • Sularyan
    Sularyan Member Posts: 3

    Please keep us posted.

    Am having a terrible side effect a month after radiation finished over and around incision and biozorb implant.

    Started with red hot and very painful 2 inch by 3 inch area around incision. Immediately went on 10 days 500 mg cephalexin antibiotic 4 times a day. In a few days area hardened to almost a solid rock with a hard border. Most bizarre thing I've seen. Scary. Surgeon said it's inflammation. See him again in 2 days. Pain subsided but is still there. Area is red and darkened now. Am concerned about infected seroma or allergic granulomatous inflammatory reaction. Am on day 5 of antibiotics. Have tried hot compresses and deep tissue massage with a little improvement. Will keep you posted.

  • Pkitty
    Pkitty Member Posts: 2

    I'm very concerned about Biozorb. I had a bilateral mastectomy with reconstruction in January 2020. I had DCIS in my right breast but caught it early enough so I didn't require radiation treatment. My mother had it and her mother died from it and I tested positive for the PALB2 gene. It was a very emotional and difficult decision to make but I didn't want to keep worrying-so I did the bilateral mastectomy. I had wonderful surgeons but it was still deeply emotional and scary.

    I am a medical device-product liability/med mal attorney so I really researched the heck out of my surgery and what would be implanted-but some of the stuff was so new-I had to just trust and leap. I came across these posts about Biozorb and have checked this particular device out. I am horrified at what many of you have gone through. We are most vulnerable when we find out we have breast cancer and must quickly come to terms with removing a part of our body to survive. It's overwhelming. I am very interested in protecting women from this device. If any of you would be willing to speak with me privately about your experience so I can really evaluate this--I would greatly appreciate it. So far, what I have found is related to the device--NOT our surgeons' fault--even if some of them stink at explaining things. I have found doctors often get snowed by device resps and don't mean to do harm.

    If any of you are willing to speak with me-please let me know.

  • Rutli36
    Rutli36 Member Posts: 1

    Hello - I currently do not have the biozorb implanted, but am facing the decision regarding my upcoming lumpectomy for DCIS. I do not feel comfortable about having this put into my body, but my surgeon is promoting it. Any information you can give would be greatly appreciated and help me make my final decision.

    Thanks,

  • cowgirl13
    cowgirl13 Member Posts: 774

    Personally, I would not consider it, but then I prefer to err on the side of caution. Just reading these posts is enough for me. Easy for your surgeon to say as he wouldn't have to live with side effects.

  • shelley17
    shelley17 Member Posts: 2

    I had a BioZorb placed in December 2018 after having a large mass removed that the doctor thought was cancer but wasn't. The BioZorb called me constant pain, discomfort and disfigurement. I had the BioZorb removed in December 2019 and have had ongoing issues ever since. On 2/11/2021 I had the 8th surgery on that breast and will need at least two more. I feel that all of my issues stem from the BioZorb. I had no idea I had other options, as that was never explained to me. I am willing to speak to you @PKitty if you are interested. I feel like the BioZorb is a huge disservice that has been pushed on women with not enough research.

  • moderators
    moderators Posts: 7,813

    Hi Shelley17-

    We're so sorry to hear about your experience! We can't imagine how difficult and traumatic it has been. We hope you're recovering well from your surgery, and we're thankful for your voice.

    The Mods

  • shelley17
    shelley17 Member Posts: 2

    I had a BioZorb placed in December 2018 after having a large mass removed that the doctor thought was cancer but wasn't. The BioZorb caused me constant pain, discomfort and disfigurement. I had the BioZorb removed in December 2019 and have had ongoing issues ever since. On 2/11/2021 I had the 8th surgery on that breast and will need at least two more. I feel that all of my issues stem from the BioZorb. I had no idea I had other options, as that was never explained to me. I am willing to speak to you @Pkittyif you are interested. I feel like the BioZorb is a huge disservice that has been pushed on women with not enough research.

  • Cole63
    Cole63 Member Posts: 1

    Hi Amy, I am having the exact same issue but mine is on the right side. Had lumpectomy in May 2020 and the one week of radiation twice a day in June 2020. After a painful breast exam November 2020 I started having the same pain that has gotten worse. Now it’s March 2021 and 7 doctors later I am seeing a pain specialist. I’m considering having the biozorb removed. I was wondering if your still having pain??

    C

  • Fallybear
    Fallybear Member Posts: 2

    I had the same thing happen to me with the Biozorb. Lots of pain, I was told it used to fill space, never wound up having radiation, so they can't blame the pain on that. I had it removed. I have been in contact with an attorney regarding a product lawsuit against Biozorb. How can we contact each other outside of this forum?

  • Fallybear
    Fallybear Member Posts: 2

    I had the same issues with the Biozorb and have sought legal counsel. How can we contact each other outside of this forum?

  • Cobaltblue2474
    Cobaltblue2474 Member Posts: 3

    Im having my biozorb removed. I had it since 2019. Has not dissolved at all and in severe pain. Also causing immune issues

  • kah67
    kah67 Member Posts: 1

    My lumpectomy with biozorb marker and radiation was done in October 2016. The lump has finally disappeared this year. I too have had much pain in and around the placement area only getting relief by stretching my arm way over my head. I have also been experiencing the radiating pain in my armpit and my back directly behind the radiated area. The effected breast is continued to slowly shrink over time. I am hoping this will all subside now. But wonder if there has been any damage to the tissue in and around the entire area. I am confused, is it the effects of the biozorb not disolving for so long or the after effects of the radiation?