Hard lump after biozorb
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Thanks, Josie,
I lost a lot of breast tissue, also, so that may be why the Biozorb was placed, in addition to marking the area for radiation and follow up mammograms. Glad it will feel better over time.
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Eleven months in and my Biozorb is the same size, and aches if I lie on it or move a lot.I was the first pt at my big mammogram center to have a mammo with one in. The day before, the company had sent techs to teach the mammogram center what it looks like and how to try and read the mammo around it!
This was an experiment, with me as the guinea pig, but not presented to me as new or as research. If I had known the Biozorb has no longterm outcomes data on whether it interferes with tumor detection, and can be a painful foreign body lasting over a yeat, I would have said no, especially as I was not planning XRT and did not care about cosmetics. Why did she use it, other than to practice? The BS gives me BS, but I will not have surgery to get it out unless pain gets worse or infection, I just worry how mammo can detect recurrence of a small tumor and it might be missed.
But maybe my chronic pain would have worsened with a divot without a Biozorb, who knows!
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Hi Chronicpain,
I read your note and wanted you to know that I heard your concerns, and that as a fellow Biozorb patient I do care.
I think you have raised some logical concerns, and agree that because the product is new (yes, only a few years of use), there is not the data (YET) to establish reabsorption rates. But it will have to be collected, as without it both surgeon’s and patients will lose confidence in the product.
The other info I did find told me that the Biozorb is made from the same material used in dissolvable sutures, so in theory it should dissolve and also it should not interfere with future mammograms, ultrasound, or other detection tests. I haven't yet had my follow up mammogram, was told I would have mine at year end. Will it hurt? Maybe. Will the Biozorb inhibit tumor detection? I hope not. But as none of my tests showed what all was going on until the surgeon opened up my breast, I fall back on his eyes, his hands, his skill and experience making the difference. I trust him and am at peace with it.
I sense from your writing that your BS is not the best communicator. She sounds rushed, and she may not be realizing how she comes across to you. If she were to give you the time to truly hear and understand your concerns, I think that would help. She should see it as her own learning experience.
Can you make another attempt to try to get her attention? Could she possibly put you directly in touch with the Biozorb people? I can’t see a reason why you couldn’t get some info from them
At some point, you may decide that the relationship is not working for you, and that’s ok. You are the patient- your needs are the priority. What else do you know about other BS at your center? Can you quietly ask around, see if there are others you could work with more comfortably?
Darn it, Biozorb, just start DISSOLVING!
Hang in there...
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Hi all. I haven't posted since May so just reporting in that after one year I can no longer feel the Biozorb "lump" even if I press the spot with my hand. So I'm guessing it has been reabsorbed. I'll have my 12-month mammogram in a couple of weeks (I'm a bit late) and will ask the tech if they can still see it; they're supposed to see only the metal pins at this point, to be able to spot where the tumor was. Since the "skin" of the Biozorb device is cellulose it should be dissolved and invisible but we'll see.
Good luck to all; my experience has been pretty good.
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Thank you for your kind and sage input, JosieO
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chronicpain,
Apologize for not responding to this sooner. For some reason I could not remember where this thread was (DUH) and the search function did not pull it up with the word Biozorb.
Keep us posted. My very best wishes to you.
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I don’t even need to finish reading your rant it has been two years the bizorb is still there not going away and it is not going to dissolve. The company in my opinion lies to the drs. Let’s put it this way the Hospital that I had my surgery is not using them anymore. I have a feeling a lot of hospitals are not using them anymore. I am going to an orthopedic Dr right now because my shoulder hurts two me my surgeon as much as she is good insist nothing is wrong I mustn’t have some type of shoulder injury. So once I am done now with that I plan to go back and see if I cannot talk her into taking it out I think it isn’t wreaking havoc on my right side.
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I am also from San Jose, CA. Wonder if we had surgery at the same location? It is two years for me as well, and though I think the lump is smaller and softer, it is still there.
Amy
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CDolphin:
I did do physical therapy for my biozorb, and I do think it helps. My therapist also gave me home stretches to do.
Amy (aka Amelia 66)
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Hi: Haven't been on in awhile, but glad I did today. I thought I was alone in questioning the biozorb implant. My lumpectomy was July 2017. Radiation 30 rounds ended in Oct. 2017 March of 2018 I developed a seroma near the implant site and that was drained 4X. After antibiotics, the seroma has cleared leaving behind a depression where I did not have one before. 3D mammogram came back clear. Site is hard and sometimes painful. Recent check up my BS says in another year this biozorb should dissolve. Evidently it is sutured to tissue. Had I known this was new, I would not have agreed to have it placed. At the time before surgery you are reeling from all the information and my BS said this was terrific and acted as scaffolding for tissue to adhere to. Perhaps it was too large? I found it difficult to get a clear answer to how many patients this device has been used and if any other patients have had problems. I go back in another six months for my second 3D mammogram. I have empathy with everyone in that the manufacturer stating this will dissolve in a year in not accurate. So we have false expectations and no one wants another procedure to have it removed. I'm trying to stay positive and be thankful for the problems I don't have. I am taking Letrozole to deplete any estrogen produced by fat. This medication will raise your cholesterol.. Now I have to add a statin to bring it down. You are all aware of the side effects of these medications on our bones. Good to know I am not alone. Sending good vibes to all for positive results on upcoming mammograms.
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Zircon
I received a Biozorb implant April 2017. This has not dissolved in 2 years and has been painful the last six months. Six weeks ago my incision opened up and a fragment of this device began protruding, so I pulled it out. One week later I pulled out another piece. I have contacted new surgeon at another hospital and am now scheduled for surgery to remove the remaining parts.
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Annette and Zircon, I am so sorry you are having such a hard time. My own experience was terrific, but I had a very experienced surgeon at a breast cancer center who had used it many times before. I hope things get better for you.
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Annette: This is a very scary prospect. Your body is amazing at rejecting a foreign object and pushing it out. I feel a ridge as well, and often wonder if it too will burst out. This must have been very difficult for you. I am curious what your original surgeon said when this happened? Good for you being so brave. I wish you well on your upcoming surgery. You must be on antibiotics as an open wound is never a good thing. Please keep me posted on your outcome. I wonder if the piece you pulled out was sutured to tissue? I would write to the manufacturer of Biozorb on this. Everyone is unique is response to surgery. I hope you heal well and find relief.
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Annette and Zircon, I am sorry for what you have experienced with the Biozorb. Like Georgia, I can’t say that I have experienced problems with mine.
No question that it felt hard, although mine felt flat vs. round. I can also say that mine continues to get smaller, but more slowly than the manufacturer suggests. (I’m coming up on a year anniversary of my lumpectomy) I never felt distinct pieces in my breast
I was grateful for it, because I had more cancerous tissue than was initially detected by mammogram, ultrasound, and biopsy. I know now that the total amount of tissue needing to be removed was much more than even the surgeon anticipated. Most of the tissue was at the top of my breast and extended back and behind the nipple.
I do know that without the Biozorb my breast would have looked very deformed and unnatural. Because my surgeon is highly experienced, I knew then and believe now that he took the best possible action to preserve a more natural looking breast.
I continue to hope that mine will slowly dissolve with no problems.
But I would certainly document your experience and concerns to the manufacturer. There needs to be clear data on the patient experience and risks vs. value. Patients and surgeons need to be able to make the most informed choice possible.
Continued best wishes to both of you.
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Well, I had another mammogram and another visit with the BS, now at 15 months post Biosorb insertion, The major mammography center doc says she has seen only four patients with a Biozorb, counting me ( I was the first they saw, July 2018). In three of the four women, it is not resorbing over a year out. Mine is not getting smaller, either, though as a chronic pain patient, I am learning to live with it, along with my other pains.
At this point the BS could no longer insist it would sorb within a year, so now she said “ two years.” No data to base this on, is just pushing it out now. She kept coming back to how good the cosmetic result looks. I said yes, cosmetics are fine, but I reminded again that never had great interest in cosmetics and had told her, was more worried about pain.
I gave her the unofficial info from the big mammo center she sends me to, 75% not resorbing in the small sample size ( small because most surgeons did not use it) for her information, and she was silent. I reminded her again of the posts here, though unofficial. She had no interest in going to read them, to learn. She would not answer if she is still putting them in.
The small company which marketed it is meanwhile bought out, no longer exists.
She casually and dismissively said, “Well, I can take it out if you want.” I told her that given my chronic pain and all the time it took me to recover from my surgery, I would only do that if I have infection, intolerable pain, or new information from surgical meetings that it risks triggering other problems, like implants can, or interfering with BC recurrence assessment, and must be removed. I asked her what she heard at BS meetings one way or the other. No answer.
The mammo doc said theoretically it should not interfere with BC recurrence detection as even without Biozorb there is a lot of scar tissue that looks different on mammo. Theoretically. For a stage I tumor, you would need a big sample size of women, long term, to do a proper statistical study on this, that will not happen.
Last night I woke from a busy dream with the breast hurting more than usual at the Biozorb site, but it turned out it was just my cat, poking and kneading on it, perhaps thinking it was a little baby mouse to pull out of its den.
Next mammo is in July, then another surgical followup with the BS who only does breast surgeries, all day, every day, so she is not a novice, and has a great reputation. Meanwhile it is there every day, throbs with more intense exercise or house cleaning, hurts with pressure . Just another thing to deal with, another consequence of the aging, broken body and the repair jobs it has had. I am now 65, retiring soon, too many problems, too many doctor visits.
I have not gone to another surgeon yet because I have two other unrelated body parts (ear canal supposedly needs a graft for resurfacing, and the uterus is prolapsing) that are causing problems and taking up my time, and I have been researching what to do about them and how to find proper docs. The last two visits with two different ear docs, one who wants to do surgery but cannot say why, the other who does not but cannot say why not, it was apparent they had not even called up their last note on me in the electronic medical record, as they did not know me with my complicated history from Adam, guess it was too much trouble, or maybe they knew they write nothing of note down and treat everyone the same anyway, do not listen, just like the BS, but still bill insurance hundreds of dollars for ten minutes, i.e., behave in the typical one size fits all rushed modern medicine style.
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Hi chronicpain,
Appreciated reading your update, and sorry the news was not more positive.
I think you did a good job of presenting your questions to your BS in a factual, professional way. It’s unfortunate that she did not follow up from last time, and do more research on her own. Even a sincere “I don’t know” would have been more appropriate than silence or defensiveness.
Agree that undergoing another surgery at this point would not make a lot of sense. You actually presented a good, evidence-based set of thoughts supporting your considerations.
As harsh as it can sound, there are still doctors out there who can get defensive and closed when patients engage them in serious and logical questions. But that is really their issue, not yours. You, after all, are the patient. Your health, your concerns, and your choices should be front and center-period. You have to advocate for yourself, and that is what you are doing.
No question that a well structured study on reabsorbtion of Biozorb would be welcomed by patients, help to educate other surgeons, and contribute in a positive way to the use of this product. And if the study were to show otherwise- well, then maybe these things should rightfully impact use - or not- of this device.
Will be interesting to see what the new owners do.
Agree fully that reabsorbion in a year most likely is a hope vs a fact.
But I will continue to hope that yours does start to shrink and also to become less painful/uncomfortable.
In my own case, I do have the occasional twinge if I hit my breast or twist myself strangely while exercising. I am about nine months out from my surgery and while I can feel that mine continues to get smaller, it’s not fully dissolved. At my last mammogram the radiologist comments indicated that it could be clearly seen, had not shifted out of place, and appeared to have done it’s job. Given the large amount of cancerous tissue removed and it’s location, in my case it was a good decision.
Continued best wishes to you.
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Hi Annette: Have you had the Biozorb removed? Curious to see how you did and what your new surgeon said about the device. How much of it was left? If after my next 3D mammo, I may get a second opinion and have this removed as well. Thanks - hope you are doing well.
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I too had this implanted into my right breast after a lumpectomy. Things were not right from the start. My breast was very painful and then horrible things started to happen. My breast turned purple and red around the sight of the implant and after numerous antibiotics and different doctors opinions it my surgeon said to take it out. My breast was beginning to pucker and twist. I elected to have a complete mastectomy and my breast has never felt better. I notified the fda and they have been great. They have taken this seriously and I urge anyone that has had any type of reaction to report it as I don’t believe the doctors are.
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please report all problems with the Biozorb to the FDA. They need as much data as possible as they are looking into the side effects.
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I complained to my plastic surgeon about this hard lump. He told me that it may be a combination of scar tissue and the biozorb. He said it should absorb, but then said if it is still there in a year, he would take it out! I am not sure that I want surgery again to remove it, and said that if it is safe to keep it in, I my just live with it. He said that may not be a good idea?
Has this thing been tested extensively before putting it inside our bodies? I have checked the manufacturer’s site and they just say it is FDA approved, but my daughter is a medical researcher and she said that does not mean much.
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Hi Irishgirl. Yes, the biozorb device has had multiple rounds of testing, and it worked great for me. But training for surgeons is another story! They need to know when to use it and when not to; what kind to use; etc. For example, there is a flatter biozorb device to use if the area they're removing is near the surface, but their hospital may not stock it.
In my case, my surgeon warned me absorption would take more than a year, and indeed I could kinda feel it for 15 months. But the cosmetic results were great.
And god no, you should not consider surgery to remove it! Id it's truly bothering you in six months it would be way better to get a second opinion from a more experienced surgeon. Best of luck to you.
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Thanks, Georgia1. I saw my Oncologist today, and she was unfamiliar with the Biozorb. She promises to do research.
I have to say that cosmetically, my breast looks terrific. I most likely would have a disfigured breast, but it looks pretty good right now. I guess patience is required and I will give it time. It feels weird, but I can’t say it actually hurts. Just feels like something is stuffed in my boob. We will see how it goes. I am concerned about mammograms and possible masking of tumors, but as long as I keep bringing it up, maybe folks will listen
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Just cking in Annette to see if in fact you had surgery to remove the Biozorb. Hope all is well. Love to hear how you made out. I go for second 3D mammo in July. I too feel a hard lump and was told the Biozorb had not fully dissolved. Happy Spring!
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Almost 18 months, Biozorb has not shrunk one bit, hurts with exercise and lying on it,, and remains annoying, but I cannot stand the idea of going through another surgery to take it out. It is a daily reminder of the cancer.
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had my six month post surgery mammogram last week and I could tolerate most of it, but they were unable to pull and compress the area where the Biozorb is without causing pain. The radiologist said she could not see the Biozorb because of this and she “hopes” that in the next six months I will be less sore and swollen so that they could capture it because that is the surgical site.
The good news is no “microcalcifications” seen, so everything is good.
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I am calling the FDA! I have been telling as many breast surgeons as possible about how painful and how the cancer grew back inside the stupid thing and wasn’t seen on any radiology test (mammo, ultrasound, and mri) until it popped a 7mm part outside of it. Inside the device was a 10mm part of the tumor which wasn’t discovered until my second surgery. I called the company and had an appointment to speak to one of their “doctors” who blew off my phone call appointment. Healthcare needs to stop being a for profit business where basically we are used as guinea pigs to make money. I only found 3 doctors that care throughout this ordeal and one of them is the surgeon who put the Biozorb in me. She said after hearing my story that she will never use it again and is informing all the surgeons she knows not to use it. She saved my life with the surgeries.
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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".
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I'm sorry you are having this experience. Do you mind sharing what your original diagnosis was? If not, totally understand and I will respect your privacy. I was the one who started this thread a while ago-- over a year and a half ago- and my biozorb implant is still there. I had a low grade DCIS but your story is what keeps me up at night. Hope you are well. And thanks.
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I had a lumpectomy in 2017, no lymph node involvement and chose against chemo and radiation. The device was put in me and was painful. It pulled at my chest wall. At my 6th month mammo and ultrasound nothing was seen. At my 1 year MRI (my breast are very dense), a 7mm tumor was spotted next to the Biozorb. I had to have another surgery and the surgery it was discovered that the Biozorb had a tumor 10mm in size inside the empty space it made in my breast. After the 2nd surgery, I did radiation this time. Luckily I still had no lymph node involvement. The Biozorb left an empty space for the tumor to grow and also blocked imaging from seeing the tumor. It should not be used
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It has now been a little over 2 1/2 years since I had a biozorb put in during surgery for DCIS. It has not reabsorbed and I still have constant pain and reoccurring inflammation in that area. Now my Dr and an oncologist I met with have told me to make an appointment with my surgeon to discuss this issue. The oncologist told me they have now seen issues of removing the biozorb and finding cancer cells clinging to the device. She was clearly not a fan. I am in the process of making getting insurance to approve my appointment and then going in to see my surgeon. Though I fear my only option to solve the problem is to have another surgery to remove it. Which I dread after the last two. I wish I had been better informed about how little they knew about this implant. I wish I had not had the surgery now after how severely it has affected my quality of life for a condition that may never have become an issue.
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