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**dutch girl** · 03-25-2010, 12:50 PM

Hello Noah,

i am in the same boat as your friend,i had a Esophyx first that failed and 7 months later i had a nissen on top of it....
now i found out that the Esophyx should have bin removed first before they performed the nissen because the anatomy of the stomach should be as close to normal to make a proper wrap.
i felt better though after the nissen but the result was never how it should be,now i am back to my old situation after feeling much better for 18 months.
DTanna is recovering right now from the nissen after a failed Esophyx but in her/his case they removed the Esophyx first before they performed the nissen.

how is your friend doing right now??
can you give me more details about how long he is post op Esophyx and nissen.

**DTanna** · 03-25-2010, 04:47 PM

Well I can't say that I am surprised by any of the FDA developments involving Endogastric. It seems terribly unethical to have malfunctions and not make it be known. So this means people were having procedures done while their devices were potentially harmful?

Hey there dutch girl....hope you are feeling well. I have been hit and miss. Some days I feel pretty good...other days not so good. It is so frustrating that it takes months and maybe years to find out where you stand with this procedure. I know there is a bit of a language barrier...but I just want to clarify so you don't get the wrong impression when it comes to your surgery. They were not able to remove the esophyx before my nissen. They did a takedown procedure. I assure you that I still have the T-fasteners in me just like you unfortunately do. They do work with the failed esophyx first before doing the nissen. I am going to get my operative report from the hospital and see if I can explain it to you better after reading that. I hope you...and everyone....are doing really, really well!

**Noah** · 03-25-2010, 06:41 PM

thanks dutch

hi dutch girl -

you've helped a lot of people - I've read your posts and you really know this stuff - so good for you for taking the time and sharing what you know - kudos

my friend is better than before and had the esophyx last year, it failed and most recently the nissen -

I just don't know how many esophyx's have failed- the data? -and whether or not future options are really limited or not - just read their brochure distributed for doctors today and they say clear as day, does not limit future treatment options -

but then I read posts like yours:

"found out that the Esophyx should have bin removed first before they performed the nissen because the anatomy of the stomach" -

does that mean that you have been limited in someway because of the failed esophyx and b/c the fasteners are still in you? that's why i'm getting so confused?

thanks again dutch - keep helping other people

**Noah** · 03-28-2010, 02:21 PM

Did anyone's esophyx procedure malfunction?

the FDA warning letter to endogastric solutions appears to have dealt with malfunctions of the esophyx2 on 8/12/09 and 7/29/09

I know my friends also malfunctioned or failed (doctor allegedly threw the first one away or something)

anybody hear about any other malfunctions, not failures? if so what is malfunctioning? is it just the fasteners becoming undone? or is it a malufunction of the machine during the procedure? here's what the first part of the FDA warning letter was about - (see link above)

FDA warning letter:

"On Aug 12 ... your complaint report states the side of the helical retractor "caught the esophageal 1/3 of the way out" during attempted removal of the device requiring a biopsy forceps to loosen the helical retractor enough for removal of the device."

"on July 29, 2009, you received a complaint concerning the EsophyX2 involving injury to the proximal end of a patient's esophagus during removal of the device. This was reportedly caused by a pin exiting the posterior side of the tissue mold between the junction of the elbow and the first link."

any other stories like this?

thanks

**dutch girl** · 03-29-2010, 04:35 AM

Originally posted by DTanna View Post

Well I can't say that I am surprised by any of the FDA developments involving Endogastric. It seems terribly unethical to have malfunctions and not make it be known. So this means people were having procedures done while their devices were potentially harmful?

Hey there dutch girl....hope you are feeling well. I have been hit and miss. Some days I feel pretty good...other days not so good. It is so frustrating that it takes months and maybe years to find out where you stand with this procedure. I know there is a bit of a language barrier...but I just want to clarify so you don't get the wrong impression when it comes to your surgery. They were not able to remove the esophyx before my nissen. They did a takedown procedure. I assure you that I still have the T-fasteners in me just like you unfortunately do. They do work with the failed esophyx first before doing the nissen. I am going to get my operative report from the hospital and see if I can explain it to you better after reading that. I hope you...and everyone....are doing really, really well!

Hello DTanna,
good to hear you are doing so well,i know recovering can be frustrating...
sorry about the language barrier,but for me a take down or removal means the same....they try to get back the anatomy of the stomach as close to normal before they perform the nissen.
in my case the surgeon who did the nissen offerd me a second Esophyx in the first place but i did not wanted that,so he performed the nissen but did not touch the Esophyx....he just left it alone maybe because of a lack of experience with a takedown i don`t know.
i only know that a redo works best if the stomach is back to normal before they do a redo,i talked to Dr.Aye with some help from my friend Kelleigh to make sure there was no language barrier

take care DTanna and keep us posted about your progres

**dutch girl** · 03-29-2010, 04:41 AM

Originally posted by Noah View Post

hi dutch girl -

you've helped a lot of people - I've read your posts and you really know this stuff - so good for you for taking the time and sharing what you know - kudos

my friend is better than before and had the esophyx last year, it failed and most recently the nissen -

I just don't know how many esophyx's have failed- the data? -and whether or not future options are really limited or not - just read their brochure distributed for doctors today and they say clear as day, does not limit future treatment options -

but then I read posts like yours:

"found out that the Esophyx should have bin removed first before they performed the nissen because the anatomy of the stomach" -

does that mean that you have been limited in someway because of the failed esophyx and b/c the fasteners are still in you? that's why i'm getting so confused?

thanks again dutch - keep helping other people

Hi Noah,

yes all fasteners are still inside,infact they did not touch the Esophyx when they performed my nissen and that was wrong....
you asked about mailfunctioning,i only know my friend had 3 loose fasteners hanging around in the inside of her esophagus with no function,when they removed them it left perforations in the esophagus,they performed the nissen richt away and now she is doing fine

they first did a takedown for every person who had a nissen after the Esophyx and all the people are doing fine....only one person needed dialation 5 times.

**Noah** · 03-29-2010, 04:20 PM

thanks Dutch

thanks dutch - that helps -

any other information you have would be great -

I'm not sure i understand the whole 'takedown' or what "needed dialation 5 times" means though?

thanks again!

**DTanna** · 03-29-2010, 05:13 PM

Hey dutch girl! Glad to hear you are doing okay. I have a question for you. When you said that Dr. Aye said, "that a redo works best if the stomach is back to normal before they do a redo" are you talking about having the nissen done after the esophyx? You do not mean doing a redo of the esophyx procedure right? I spoke to Dr. Aye as well after my esophyx failed and he told me something along those same lines if you are meaning having a nissen after a failed esophyx. I hope you didn't take offense to the language barrier comment...its just hard to understand what everyone means with all of this "reversal, repairable, take down, removed" talk. It is hard to understand all of the terminology sometimes and I just wanted you to know that I am in the same boat as you. Did Dr. Aye give you any other good advice...are you planning on a trip to see him? I so hope you can get all of your problems taken care of

**dutch girl** · 03-31-2010, 03:47 AM

Originally posted by Noah View Post

thanks dutch - that helps -

any other information you have would be great -

I'm not sure i understand the whole 'takedown' or what "needed dialation 5 times" means though?

thanks again!

Hi Noah,

i ment with the takedown to undo the Esophyx procedure,remove the fasteners when possible and bring back the stomach as close as posible back to it`s normal anatomy,you need the stomach tisseu to make a proper wrap for the nissen.
there is one person that had a nissen done after a failed Esophyx but his wrap was done to tight,food got stuck in his esophagus so he needed dialation 5 times....still the food is not going down properly for him so he needs dialation again

now he is on liquid meals and verry frustrated!!!

**dutch girl** · 03-31-2010, 04:03 AM

Originally posted by DTanna View Post

Hey dutch girl! Glad to hear you are doing okay. I have a question for you. When you said that Dr. Aye said, "that a redo works best if the stomach is back to normal before they do a redo" are you talking about having the nissen done after the esophyx? You do not mean doing a redo of the esophyx procedure right? I spoke to Dr. Aye as well after my esophyx failed and he told me something along those same lines if you are meaning having a nissen after a failed esophyx. I hope you didn't take offense to the language barrier comment...its just hard to understand what everyone means with all of this "reversal, repairable, take down, removed" talk. It is hard to understand all of the terminology sometimes and I just wanted you to know that I am in the same boat as you. Did Dr. Aye give you any other good advice...are you planning on a trip to see him? I so hope you can get all of your problems taken care of

Hey there DTanna,

You did not offend me at all,it`s good to get things clear to avoid confusion

My sweet friend Kelleigh penned a letter for me about my situation to Dr.Aye and here`s what he said:

Hi – haven’t heard a lot of detail on this issue except that antireflux surgery has been done successfully after Esophyx (per Dr. Kraemer). In general, reoperative antireflux surgery works best when the previous repair is completely undone so that the anatomy is as close to normal as possible before reconstructing. The 2 most well-known esophageal surgeons in her area are Bernard Dalmagne and Tony LeRut, both in Belgium. She should find the best expert her system will allow her to access – the premier esophageal surgeon in the area.

i hope this info helps,it sure did for me to get a proper understanding of things.

How are you doing DTanna??
are you eating solids already,does food get stuck???
reflux??tell me all about it

**DTanna** · 03-31-2010, 05:34 AM

Hello to all. Since we are on the subjct, I just ran across another FDA Adverse Event Report dated 07/29/09 pertaining to an esophyx procedure. In this report "User did not allege any problem with the device or procedure". But after the patient had a fever and high white blood count "a barium swallow found two holes in the gi tract area" that was discovered 3-4 days after the esophyx procedure was done. This ended up with the patient having a nissen fundoplication "due to continuing leakage into the stomach". Here is the link:

[url]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1475016[/url]

Announcement

FDA Warning Letter about EsopyX 3/12/10

FDA Warning Letter about EsopyX 3/12/10

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