OstomyCure TIES System - Any success stories or feedback?

With the TIES® Solution, the patient can live a life without the need to constantly wear an ostomy bag.

The solution is a titanium port with a lid and is implanted in place of the conventional ostomy. The lid bears a hatch that allows the evacuation of the waste without removing the lid. A bag holder that does not touch the skin allows the fixation of the bag when the waste needs to be evacuated. It also prevents skin complications.
This solution allows the patients to exercise their needs when it suits them, in contrast to the conventional stoma that continually empties itself into a bag, causing discomfort, noise, and smell.

https://ostomycure.com/ That's the website

Holy crap!! WTF?? More data please. Never heard of this. Oh let's get this party started! 3 2 1-

Looks like a fake. No incisions on that body.

The guy who posted this is located in Portugal (sp)... and I just chatted with him online. He said there are hundreds of people in the UK and Sweden with it, but he doesn't personally know anyone. Sure, trials out there are plenty, but we need to get a hold of those people, get input. It is in its infancy for sure. America won't see this thing for years though. I can understand how it works, but I know my intestine. Uncovering that hatch or cap is a blowout for me, so this will be an interesting topic. Yeah, no surgical scar on that body... they want to show you the nice and neat thing. In theory, I believe something like this is possible. The website said it was in the works for several years, I think. Hm, time will tell. I thanked the guy for posting this. I mean, really!!!! This is hot off the press!! - Warrior

That's what I found on YouTube, warrior:

https://www.youtube.com/results?search_query=TIESC2AE+Solution   :-)

You sure did! Holy crap! Thanks. It was posted almost a year ago. Feb 2019. Where are the patients at? Only two replied on YouTube. Gotta see it and hear it from the people end, not sales end. Thanks again.

Warrior.

Hello Everyone, and thanks to dada12 for drawing this device to our attention. Doesn't it sound wonderful!  I have been on their website and copied a press release (below) for those who are interested. 

My main concerns would be with what looks like a form of 'mesh' to hold it in. Other forms of mesh were hailed as a miracle solution to many problems - until they had been field-tested by human guinea pigs and found to be disastrous for some people. Another concern would be regarding parastomal hernias. In the question and answer section of their website they briefly say that hernias are 'possible' (I read into that -'probable'). but it does not say how this would affect the device. 

I have put myself on their mailing list for updates on their research data, so hopefully some of the concerns will be addressed as the research progresses. 

Best wishes

Bill

For Immediate Release
Significant news for Ileostomy patients from OstomyCure AS
Today the first patient was enrolled in the TIES03 study of the OstomyCure Transcuteous
Implant Evacuation System (TIES®). A 64-year-old female from the UK had the TIES port
successfully implanted in a procedure that took less than an hour with no complications.
“We see the TIES® Solution as a potential step change for ileostomy patients, providing
them with a better quality of life” said Prof. David Jayne, who performed the procedure at
St. James in Leeds. He continued, “We are delighted to be participating in the TIES® C03
study, as part of the NIHR MedTech in Surgical Technologies, to undertake a rigorous
evaluation of this exciting new technology. There is a large demand for the TIES® device
from our patients, but we need to be sure that it is safe and effective. In TIES® C03, we will
be able to monitor and track the performance of the TIES® Solution, which is absolutely
crucial for us. The wellbeing and safety of our patients is our main objective.”
Patients who are candidates for the TIES® typically suffer from Crohn´s disease, ulcerative
colitis or other inherited intestinal diseases, but are often otherwise young and active. With
the TIES® Solution, a previous Ileostomy can now be managed and controlled. About 22.000
patients annually receive an Ileostomy in Europe, and an estimated 260,000 live with
ileostomies today. The TIES® procedure will also be available both for new and existing
ileostomies.
“The TIES® Solution does not reverse an ileostomy, but it can give back the freedom to live
an almost normal life with a chronic condition,” the CEO of OstomyCure AS, Dr Ben
Broennimann states, and continues, “We are confident that the TIES® Solution works and
that the continent solution it offers represents a tremendous improvement in patient
quality of life. With the initiation of our multi-centre study of 200 patients, primarily in the
UK and Sweden, we intend to scientifically prove our claim”.
“We also believe we will be able to quantify a significant health economic benefit for the
TIES® Solution over the traditional bag systems.” continues Dr. Ben Broennimann and
adds “About 60 % of ileostomates today experience some level of often severe skin
problems, along with leakage, unwanted odour and general discomfort. The TIES®
Solution allows a tight stomal seal with no skin contact, which should significantly reduce
these problems.”
About OstomyCure AS:
OstomyCure AS is a Medical Technology company headquartered in Oslo, Norway. The
company develops a revolutionary technology; Transcutaneous Implant Evacuation System,
The TIES® System.

I first read about it 3 or 4 years ago in an IA journal over here in the UK. It wasn't available here at the time. There is definitely not 100's of people in the UK with one as it only started to be trialed in the UK in the middle of 2019. I did hear about a man who was having one, but haven't heard any more since he had surgery.

That has "blow out" written all over it for me. I imagine it would also have to have a capability for an open flow pouch; there are instances where you're unable to vent the ostomy and at some point your gut would pop from the backup. Only the rectum was designed to act as a reservoir.

Dave

Hi Bill,   first time I've heard of this and sounds revolutionary for me. I've also put myself on email for updates.   Maureen  

I can't imagine this device for colonoscopy folks but I'm curious about the entire concept.  Hope to learn more.

Thanks Dada,

Mike

I can see it to a point of where no need for bag, but there are way too many issues that come to mind when you don't use an attached bagging system. This thing is metal, and suppose you bend to tie a shoe? I'm sure it's secure, but as someone else said, your small intestine is not designed as a reservoir. And I believe that's true. So, are they trying to sell you on the idea that your small bowel will grow, expand, and become a reservoir? I just don't get it. All for the sake of having no bag? Well, you still got a bag.

Need to carry it, and it seems there is some time where you have to hook it up and when it's wide open. Geez, naw. I think I will keep my bag for now. Can always get a smaller bag and just throw it away faster than using this system. But it's a good start for a design. I wanna talk to the trial people though, not salespeople or a doctor developer.

Yes, the first implanted TIES patient in the UK

Hello Warrior.

Thanks for your comments on this post as I agree with you that I would  "wannna talk to the trial people though.. not sales people or a doctor developer". 

There are many other aspects of this concept that need exploring so I hope to do that in-verse in the near future. Thankyou for the prompt in this regard

Best wishes

Bill

U S Clinical Studies for TIES are scheduled for the end of 2023

Hi

I am in Sweden and have been waiting for a catch up on non-elective surgeries to catch up to do the ties implant, to my knowledge there has been only a small amount done here in Sweden and the were removed due to complications after the surgery which had nothing directly to do with the implant, but it was removed to take away further risk to the patient. I've been told the implant is very fine mesh and can be easily compressed within the body so no risk to compression or bending. also the feeling you get when time to empty is that feeling you get when you have too much cake to eat. I've searched high and low for reviews and feedback but so far come up empty on that. i also have been told by my doctor/surgeon that everybody is different and not everyone would be suited to this implant same as how frequent you would need to empty would come down to the patient and their body's function.

I aslo would like to add i think this implant would be a positive as you would no longer rely on bags and the skin products to survive every day.

Hello MrGrey. 

Like many other people with stomas I was very interested in the concept of TIES and requested more information at the time –which was now some time ago. All I could find out was from their advertising, which I always tend to be wary of.

Thank you for your post. which hints at certain complications after surgery for 'some' patients where the implants had to be removed to reduce further risk to the patient.  You also mention the difficulties in finding reviews and feedback. 
The TIES advertising suggested going on a mailing list to be kept up to date. 
I requested to be put on this list a long time ago and have not heard anything at all.

Along with what we already know about the problems of using mesh in other clinical procedures and, given this present  scenario, I would be extremely sceptical about the efficacy of the TIES system.
There is another potential factor which needs to be explored, and that is the fact that we do not seem to have had any positive or negative feedback from anyone who has had this procedure done (apart from the one guy who is being used in their advertising, whom we can presume is being paid for this role)!  

This lack of communication makes me suspicious that those who opt to have the procedure done may be bound by a ‘gagging’ clause in their ‘contracts’. So the only feedback the public might be getting would be from those where the procedure has worked. As there only appears to be one of these at present, and the guy has not appeared for an update a since the original advert, we would not know whether the whole enterprise is just a sales gimmick.

What I am particularly interested in is feedback from those patients where the procedure has gone wrong. A whole host of questions arise in this regard surrounding aftercare, putting right any wrongs, compensation for clinical negligence/malpractice, and freedom of speech for the potential ‘victims’.

I do a lot of experimenting with stoma stuff and am well-aware that not everything I invent or develop works for me, let alone other people. However, I do get very enthusiastic about my new ideas, and ‘IF’ I was to try to market them at those early stages of development, (which I would not) the advertising would probably look very similar to that which we witness about the TIES system.

When it come to personal health and contemplating surgery, it is my belief that ‘all’ the evidence should out in the open and above board, so that competent decisions can be made by the potential patient about whether to opt for or out of these procedures.
In the case of the TIES trials, my impression is that this is not happening, so the cliché ‘BUYER BEWARE’ becomes even more pertinent.

Please let us know how this one pans out for you.

Best wishes

Bill

Hi Bill

I did find some stuff regarding Studie results for the ties system and it was about leakage in different levels and skin issues on test patients. i do think you are correct in the idea that the people in the Studie are stopped from making publications about the product, hopefully it is a good product and helps all of us, fingers crossed

Hello from the First UK Patient to be implanted 19 May 2019 AND EXPLANTED 06 September 2019 with the version III of the 3D printed / machined titanium TIES device.Without PrejudiceTHERE IS AN IMPORTANT UPDATE AS TO PATIENT SUITABILITY FOR ACCEPTANCE - now appearing on the Ostomycure.com site: TIES IS NOT SUITABLE FOR ANY PATIENT WITH A CROHN'S DISEASE DIAGNOSISThe Manufacturer's Group Insurance has and is funding repair surgery of the first UK Trial female patient - i.e., Me - following Legal Representation.This novel Concept is in the very early stages of development - The Marketing Website is a proponent of conceptual excellence - A Concept which has yet to be proven - hence the Clinical Trials. Clinical Trials are specifically that - a means of TRIALING A NOVEL DEVICE AND TRIALING THE SURGICAL TECHNIQUES EMPLOYED TO GAIN EXPERIENCE... Just because a human patient is involved does not mean that the product, its use, and its deployment is proven to work: The reality is UNDER INVESTIGATION and as a result of all adverse events more understanding is being added to the body of research.It is my intention to publish timeline photographs for the public domain so as to provide a balanced understanding of what risks may/do exist.Notwithstanding my own experience, I wish TIES research the success it deserves - as any innovation is, by definition, an evolving process - which may or may not result in the desired solution. Perhaps my own experience and contribution has helped 'protect' the vulnerable CROHN'S DISEASE PATIENT - irrespective of whether there are any active symptoms of the disease. Positive intention does not necessarily overcome a real risk - ASK MANY QUESTIONS IN DEPTH TO TRY AND DETERMINE YOUR OWN PERSONAL RISK FACTORS and balance your personal medical profile very carefully - with the aid of your own independent Consultant when considering a lifestyle marketing 'opportunity' being presented to you.Good luck to both the Patient Base and the TIES development Teams - without whom, innovation remains unexplored.JayneAugust 2023