Help! I need advice with BION.

[KarenIC]

Hello everyone! I'm new to this website. I've been suffering with IC for 16 years. I was diagnosed 4 years ago. After trying many treatment options for my IC, I decided to enter a clinical trail for BION last February. 10 weeks after BION was implanted, the device malfunctioned and my doctor had to remove BION. My doctor has a lot of problems removing BION. The device shattered into several pieces during the 2 hour surgery. Because of all the scar tissue caused by the surgery, the left side (the side where BION was)
was "compromised" and my doctor told me that if I wanted to implant again, it would have to be on the right side. Some pieces of BION (7 microscopic pieces) are still in my body because they were to tiny to be removed. My doctor gave me a choice of either implanting BION again or trying Interstim. I don't want Interstim at all. I know there are alot of problems with that device. While I had BION, I definitely noticed a decrease in my pain. I really didn't have an improvement with frequency yet, but the device was only working for 10 weeks. I really want to give BION another try. How unlucky can I be that BION malfunctions again after 10 weeks and then shatters upon removal? My family is totally against me getting BION implanted again after so much failure with the device. What should I do? Is it crazy to implant BION again. I have no other treatment options left and I'm suffering with frequency and Pelvic Floor Dysfunction (High Tone) along with vulvodynia. I need all the advice I can get. Thank you so much.

[Katrina]

:welcome: to the ICN! You came to the right place! That definitely sounds like some bad experiences. My thoughts on all implants is that the having a great doctor is the key to success...So you may want to research doctors before you try again.

I hope someone else here can help you more! :grouphug: Hope to see you around!

http://www.ic-network.com/handbook/ this is an essential link for everyone with IC. It is very informative on meds, living with IC, and self help....take a look!!!

http://www.ic-network.com/forum/showthread.php?t=7562 this is thread of pain relief the second page has attachments I believe the last attachment is the list of pain relief ideas.

http://www.ic-network.com/forum/showthread.php?t=11535 This is newbie kit from the oldies to the newbies
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[Annie2]

Hi, Karen! :welcome: to the ICN. I am sorry to hear you have suffered so long from IC, but am glad you found us. This website is full of valuable information and helpful, supportive people.

I have no experience with the Bion and don't feel qualified to comment on it. Another of our members, ICLori, is participating in the Bion trials, however, and has had great success with the Bion. I am sure she would be glad to discuss the Bion with you. Hopefully, she will see this thread and jump into this discussion soon. If not, you might want to send her a private message.

Again, welcome aboard!

[ICLori]

Hi, Karen, (((HUGS)))

I am so sorry you've had so many problems with the Bion. I am fortunate that mine has not malfunctioned. Like you said, it has helped me with pain (I'd say about a 25% reduction in pain) and more dramatically with frequency (reduced that to about half of what it was.)

I know it's a difficult decision to make, as to whether or not to try it again on the other side - I'm here to listen and support you in whatever decision you make. I am so sorry that the device shattered inside you when they tried to extract it. To be honest, I have been a bit worried about how they would get this thing out of me in five years - but I figured, I just have to cross that bridge when I come to it.

Are you having any pain or other symptoms from the small bits left in place? Is there danger of infections? Are you able at this time to undergo an MRI if you should need one, or do the small bits left in place preclude you from having this diagnostic procedure?

That would suck if they could never get the bits out and they interfered with MRI's etc.

Gosh I'm just so sorry you've had this horrid experience. I hope that it is not the norm. This is such a new device, I just don't know enough about it to know how common this problem is.

Blessings,
Lori

[icsonja]

I am sorry for all the problems you have had. It is scary for me as I have just begun the first part of my bion clinical trial. I wonder if they told you why the device shattered, and why did you need the first one redone, what malfunction it was?
Lori seems to be doing good with her bion and I hope to follow her footsteps, but thank you for reminding us this is NOT a regular IC treatment and only should be considered after EVERTHING else has been tried, which in my case includes interstim.
Let us know what you decide,it is such a hard place to be ,I am so sorry.
Sonja

[KarenIC]

Hi Lori,

Thank you so much for listening and for your support. It's wonderful to have someone to talk to about BION. To answer your questions, to begin with, my
doctor told me that the tiny microscopic pieces that were left inside of me broke off from the ceramic (white part?) of BION and that they were imbedded into fatty tissue. Therefore, there is no chance that the pieces will ever move or migrate. Also, there is no chance of infection. I asked my doctor if I could get an MRI with the pieces left inside of me, and she said that I definitely could. There wouldn't be any problem with that at all.

I'm still deciding about whether to re-implant on the right side. My doctor called me the other day and wants to know what my decision is. The reason I like the idea of BION so much is that, like Interstim, it helps with Pelvic Floor Dysfunction, besides helping with frequency and, for you me anyway, with pain also. I have high-tone PFD (Pelvic Floor Dysfunction) which causes me to have a very poor unirary stream and retention. Also, like you, I go to the bathroom usually 30 times a day. I only considered BION after failing all other treatments. I was on ELMIRON for 1 year and 3 months with no improvement in symptoms. I also took many other oral meds, had instillations, tried physical therapy with myofascial release of trigger points, and I also entered a clinical trial for RTX two years ago with no improvement. I have great faith in my doctor. She is wonderful. I can't blame her for the BION malfunction. The engineers at Advanced Bionics told me that the device had "hardware failure." That's all they could tell me at the time. Maybe if the engineers could have received my BION in one piece, they may have been able to find out why it failed. But since it broke into pieces, they probably couldn't get much information from it, if they ever did receive the pieces from the explant.

I'll close now because I have to go to work. I'm a Recreation Therapist at St. Mary Hospital in the Rehab. Dept. (Hoboken, NJ). I'll let you know if I decide to implant again.

Thanks so much for listening.
Take care Lori.

KarenIC

[KarenIC]

Hi Sonja,

Thank for your support and for listening. It's wonderful to have you and Lori to discuss BION witth. Sometimes, I feel so alone. To answer your question about why BION malfunctioned-------BION malfunctioned towards the end of my trip in Italy last June. I had a Complete Charge with the BION, but shortly after that, during the 5-second on cycle, the device was givng me intermittant stimulation, it felt like it was pulsing on and off about 4 times with the 5-second on cycle instead of a constant stimulation for 5 seconds.
During the night, I awoke and felt no stimulation at all from the BION. That's when I knew something was really wrong with the device and I staring panicking. Here I was in Italy and I had no clue about what was happening to the device. Thank God I was coming home in two days! BION was now taking 3 hours to reach a Complete Charge, and then, after 15 minutes, the whole charge was gone. It seems that the BION battery couldn't hold any charge at all anymore. If the device was turned on while I was charging it, the charge went right out and I couldn't charge it past 1 bar, and then, it totally died and I couldn't charge at all. The engineers at Advanced Bionics said that it was "hardware failure", whatever that means?

As to why Bion shattered upon removal, my doctor doesn't know why. She told me before the explant surgery that the procedure could take a few minutes or one hour depending on where the device was hiding. She never expected that the device would shatter. They had a very difficult time removing the device. I hope the engineers find out why my BION failed and why it shattered so it won't happen again. Now I'm deciding if I want to give BION another chance and re-implant on the right side.

I'll let you and Lori know if I decide to implant again. Thanks for your support.
Take care, Sonja. I'll write again soon.

Bye for now.
KarenIC

[ICLori]

Hi, Karen, thank you so much for letting us know what happened. I think it's vital for those of us who have had the Bion in, to share our experiences with other patients who might be considering it. And like ICSonja pointed out, this surgery is only to be considered after every other treatment has failed - it's not the first thing to try because there certainly are risks involved! I'm so glad that you cared enough about your fellow IC'ers to post this so they/we could be warned of potential hazards.

I don't want to say what I might do in your situation because I don't want to risk influencing your decision in any way. I just wanted to say, though, that whatever treatment options you decide on, I wish you the best of luck and I know they will be the right decisions for you.

I pray every day for a cure for this disease for all of us.

Thank you for being brave enough to participate in this trial and the RTX trial - I am so sorry you have had so many disappointments in treatment. I wish you good luck in the future and hope that a treatment will work for you that will give you a good quality of life back.

I'm here if you'd ever just like to chat or anything. Sometimes it helps to just not feel alone.

Blessings, Lori
P.S. Thank you, too, for answering my questions! I am very glad that you will be able to have an MRI if you should need one, and that the fragments left behind are unlikely to cause any problems.

[icsonja]

Do you ever feel as if you know someone without ever meeting them? I guess since we are all in the same boat, it feels like we have known each other. I know that if yoy have progressed to bion you havetried everything else. In fact that is a factor in being accepted into the trial, so I know we have all had our disappointments and ups and downs.
I am a little scared, not about the surgery, that is a day I am looking forward to, but my fear is that bion won't work for me, like with interstim, I had such high hopes and BAM down I came, I have had alot of depression post stim due to expecting more than i got and not expecting such pain. It took me way down and that is what scares me about bion, what if it doesn't work ,then what?
I have tried everything except Botox (which there is NO way I can afford) so what do I do if bion has some awful complication too?
My stim works for the reason it is in there, or it did until migration, so I know the science works, but the side effects I didnt even dream of. That is my fear.What if it fails for me too.
I just don't know how I will cope with that.I am hanging an awful lot on bion.So I will pray and do exactly as the researchers tell me and.............?
Thanks for letting me vent this out, it is the one thing I cant seem to tell my family, they are so happy about bion, but we were about interstim too. I just am afraid the bubble might burst.
Sonja
PS : Thank you so much for all the info you both have given, it means the world to me.

[KarenIC]

Hello Lori and Sonja.

I decided to implant Bion again because, as I mentioned earlier, it did help with my pain and pelvic floor dysfunction. Given more time, I know it would have helped with the frequency also. I called my doctor and told her my decision.

Tonight, when I got home from work, there was a message on my answering machine. My doctor told me that the Bion study was "on hold right now," and they were not doing any PST's on anyone right now. She didn't know when the study would be up and running again. But she hopes that it would be within the next month, but she doesn't know for sure.

Obviously, I'm devastated. Bion was the only treatment that gave me some relief from my IC symptoms. I can only hope that the study will eventually be resumed and I can have Bion implanted again. If the study doesn't resume or allow any new implants, I don't know how I will treat my IC to get some relief.

I just wish I know why the study was on hold. My doctor probably won't give me that information.

I'm going to call my doctor in a month to ask her if the study will be resumed.
I'll let you know any new developments.

Take care.
KarenIC

[ICLori]

Hi, Karen, I am so sorry that the study is on hold right now.

I know that sometimes there are delays because so many people have signed on that they have more patients than they have operating times...could that be the case here? I'm puzzled by this - I'm keeping my fingers crossed so much for you that they will be able to get you in to have the Bion reimplanted. I know how disappointed you must be right now.

As far as I know, the study hasn't been halted or anything like that...boy I'm really curious now....I feel so bad for you but I do have hope that this will resolve itself somehow within a month or two and you will get on the schedule to be re-implanted.

I'm keeping my fingers crossed for you.

I'm always here if you would like someone to talk to.

Is there anything at all that can give you some pain relief while you are waiting for the schedule to open back up on the study? Are you able to get some pain relief through opioid medications or Ultram? (I find that Ultram helps me, but some IC'ers don't find relief from Ultram.) I know how awful it is to live with untreated pain - I am hoping so much that there is something that your doctor can prescribe for you until you are able to have the Bion implanted again.

Blessings, Lori

[KarenIC]

Hi Lori,

Thank you so much for your words of support. It means the world to me.
I don't know what to think about this situation. My doctor called me on November 2 to ask me if I wanted to reimplant again and I gave her my decision a few days later. Then on November 15, she tells me that the study is on hold. I don't know what happened within those 2 weeks.

I'm thinking that maybe it has something to do with what happened to me (the malfunction and then the bion shattering upon removal). I don't know.

My fear is that part of the study will be stopped and they won't allow any new implants. The part that's really unfair is that I'm not a new participant in the study. I entered the study last January and I would still have my Bion if it didn't malfunction in the first place. I should at least be allowed to have
my Bion again.


Bion was the only treatment that gave me some relief from the pain. I tried so many different types of oral medications with no relief. I have taken Percocet, but it doesn't really agree with me; it gets me really dizzy and I wouldn't be able to function at work.

Thanks again Lori for your kind words and support.

I'll let you know if I have any new information on the study. I'm keeping me fingers crossed too!

Take care.
KarenIC

[KarenIC]

Hi Sonja,

I'm not sure that you saw my post to Lori from November 17, but I told her that my doctor has informed me that the BION study is on hold right now and she isn't sure when it will be up-and running again. She's hoping that it's within the next month, but she isn't sure.

I'm very disappointed with this new development. I was concerned about you also when I heard the news. I'm not sure if you had BION implanted yet. But if you didn't, how does this news affect you? Will you still be able to get implanted on schedule or do you, like me, have to wait until the study resumes again, hopefully within the next month?

I'm praying that the study will resume very soon. If I know of any new developments, I will certainly let you know. Until then, be optimistic, and I know that eventually we will be able to get the implant.

Take care.
KarenIC

[icsonja]

HI all I have not heard at all about the BION being stopped,I have been in hospital due to interstim infection, but no one has contacted me about not going to Daallas,could it just be at one research center? I am going to contact my study coordinaotr right now ans see whats up.
Sonja

[KarenIC]

Hi Sonja,

I'm sorry to hear that you were in the hospital because of an Interstim infection. I hope you're feeling much better!

It's been 1 month now since my research coordinator told me the Bion study was on-hold. I keep praying every day that she'll call me with good news that the study was up-and running again. I left her a message 1 month ago and asked her why the study was on hold, but she never returned my call with a reply. Oh well!

Please let me know if it's only my research center that has Bion on-hold, or if this has affected all of the centers. I'm really curious and desperate for any news on this situation.

Hopefully, you and I will be able to get implanted soon. Until then, Happy Holidays and Happy New Year!

Love.

KarenIC

[icsonja]

HI Karen and Lori, it is Sonja, I just got an email from my study cordinator and she said she doent know of any halt on the study anywhere, but she called and checked with advanced bionics and she said that "we are a go" there is no stopping the program I am in , I don't have any clue why you have been put on hold.But maybe you should contact advanced bionics about your study. I hope all will go well for you.
I am still on at home IV therapy,I have to get rid of this stubborn staff infection that started from my stim and then on the 28th of this month it will come out and I will have to stay in hospital for about 5 days on IV antibiotics and have drains in . What is so amazing about this whole thing is my stim site on the outside lookes great, but underneath it is an incubator for infection, so I hope others will be careful of any symptoms they may be having even if all looks ok.
I will post again to let all know how it is going.
Sonja

[KarenIC]

HI Sonja,

Thank you for letting me know about the status of the BION study. I am very happy for you that Bion isn't on-hold at your research center and that you'll be able to be implanted soon. That's great news!

I hope that my center resumes the study very soon because I'm feeling much worse for the past 6 months that I've been without BION. My IC pain and Pelvic Floor Dysfuction have gotten very bad.

On top of all of this, my surgical wound from the BION EXPLANT SURGERY from August 24 hasn't healed-up yet! I'm having drainage and a little blood from the wound, along with a small lump and some pain. I saw my gynecologist today and she said that it looks like a fistula or a sinus. She wants me to call my research doctor and tell her about it, to see if it has to be evaluated. It even hurts to sit or walk at times. The wound should have healed up by now.

Thanks again for keeping me up-to-date with any information you have about the status of the study. I appreciate it very much!

I hope your infection clears up very soon. Let me know when you set a date to implant BION. I wish you all the luck in the world with the implant.

Happy Holidays, Happy New Year, and feel better soon!


Love,

KarenIC

[icsonja]

Karen so sorry to hear about your troubles, I will be thinking of you every day as you ans Lori are my guides thru bion territory.
Sonja

[patricia1]

To the 3 of you, Thank You....Thank you so much for your frankness, honesty and basically telling like it is.....Hopefully the research they are doing now will lead to better results with the Bion than the Interstim. I have the Stim and you may or may not no my story and problems with it, but you give me hope that there is something else out there one day that maybe I will be able to try..... :kissing:

[icsonja]

HI all, I had my interstim removed the 28th of Dec and after 4 days in the hospital and five drains needed, I got to come home 2 days ago. I am very sore, but it seems as is the pain is lessening especialy in my legs and tail bone.
It did reqiure 21/2 hours to remove and repair the pouch site.
So now I will wait and see how things go.
By the way I kept my stim and am seeking legal advice.
Sonja

[patricia1]

Hi and I am glad you are finally home. When they removed mine in May and did my revision it took about as long as yours did. I got to come home though, although looking back maybe I should not have. I hurt so bad the next morning and was so stiff I could hardly move. It took me a good month or longer to get over the surgery. Hope you feel better soon.

[KarenIC]

Hi Sonja,

I'm so glad to hear that you are home with the Interstim finally out! I was thinking of you all day on the 28th and praying that you were OK. Thank God you are home and have begun the healing process.

I'm still waiting for the Bion study to resume and with each day that goes by, my patience is becoming thinner and thinner! I'm so tired of waiting for the phone to ring. Seven months with no IC treatment! When will this study get going again?

Do you have a date set to implant Bion? I bet you can't wait for that day to come! With the Interstim out, you are one step closer to Bion. Good for you!

I wish you a very speedy recovery and keep me updated on your implant date.

Take care and I'll write again soon.

Love,

KarenIC

[icsonja]

HI all ,and thanks for all the kingd words and your thoughts and prayers, it helps so much to know you all are out there understanding and supporting me. I only hope I can return the favor to you someday.
I am doing MUCH better now, the stim pain is almost all gone, I have not had to take morphine since the first few days post op, and I was needind 160mg a day prior to surgery to help and all that did was take the edge off, it was an awful pain, and so long and goodbye to rubbish!!
I did lose qite a bit of weight in the past two weeks, but I am gettting my sea legs back and mentally I feel much more positive, pain can sure play with your brain, can't it?
I wish you all the most painfree day possible and again my thanks to you.
Sonja

[ICLori]

Sonja, I am so glad you are doing better! You are in my prayers!

I hope so much the Bion helps you a great deal! If you still have pain after having the Bion put in, please remember my posts about misoprostol (cytotec) - and the posts others have made about Cyclosporin A - don't give up hope, these less typical remedies might hold out hope.

Blessings,
Lori

[KarenIC]

Hi Sonja,

I was thinking of you and wondering how you are feeling with the Interstim out. I hope you are doing well. Feel better soon!

Love,

KarenIC

[icsonja]

Hi again, three weeks post op from stim removal and I am so happy I had it taken out!!! The difference in pain is huge, I am back to my " normal" IC pain, which is bad enough, but add on the excruciating pain of a stim gone bad.... and no pain med is strong enough.
I am calling to set up my Bion first apt. today, since I have not been able to control symptoms by diet or meds since stim has been out. I was hoping I could but, no such luck.
My surgical sites looks great my surgeon did a great repair job, and my stiches are almost all dissolved, so I suppose its time to get some more...lol
Thanks for all your support and I will keep you updated.
Sonja