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Linx system surgery Part 3 of 3

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Posted 10/12/2011 12:18 AM (GMT 0)
Hi PPI-LESS.. My information is not the same as yours. a) The USA FDA has no objection whatsoever to US citizens going to other countries for treatment. Certainly, they do not control what procedures we can get overseas. b) I was able to arrange for a consultation with a UK specialist without a problem.
Posted 10/12/2011 12:38 AM (GMT 0)
hmm that is strange, if the folks from healthierweight (therefluxcentre.com) are offering to meet with you. Anyway - may be they've changed their policy - good luck and do let us know how it goes! Thanks.
Posted 10/12/2011 7:52 PM (GMT 0)
GaMan - make sure that you find out from them if they are willing to proceed with the surgery beyond the consultation that they are offering you.

If you look at this FAQ page:
linxrefluxsurgery.com/is-linx-reflux-surgery-for-me/faqs

at the bottom there is this Q&A:

Do you accept international patients?
We welcome enquiries from overseas but very much regret that we are unable to offer the LINX device to enquirers from the USA at present. Please refer to www.toraxmedical.com for updates.
Posted 12/18/2011 10:49 AM (GMT 0)
PPI-LESS,
Are you in the uk?
What's stopping you from having the proceedure?
If you did go ahead and it was successful would you take the time to tell us of your post op experience?
Conversely if the proceeedure didn't work would you let us know?
Posted 12/18/2011 3:41 PM (GMT 0)
bloodaxe

I do not believe PPI is from UK or this member would not be questioning the ability for USA citizens to be treated in London.  PPI posted, "Clinics in England are refusing to promote or offer this procedure to the US citizens since it is not approved by the FDA here yet."

That is not the same as US allowing citizens to seek surgery abroad. 

There is lots of good info in this thread so perhaps some of your questions are in some of the older posts.

Kindly,

Kitt 

Posted 12/24/2011 1:38 AM (GMT 0)
I have contacted one group in the UK and they will NOT offer the procedure to any US Citizen.  Not sure how the FDA can inhibit our rights like that, but apparently they can.  There is a surgeon in Italy that is offering it, though.  And I wonder, do they offer to fix a larger HH before they place the linx?  If not, I would imagine the linx is pretty inefficient if it is being puched through the chest cavity....
Posted 12/24/2011 3:45 AM (GMT 0)
the odds are at least 50/50 that it aint the fda standing in the way but possibly just the brits are gonna take care of their own citizens who are standing in a rather long line for this procedure i would imagine

but hey i could easily be wrong...would be interested to see any news reporting or fda statements indicting our gov has interfered with that sacred cow.... the so called "free market"

i wonder if surgeons who practice fondiplication, the PPI drug makers and the company behind TIF ... i wonder if they lobby fda to hold off on linx approval

best wishes
mt
Posted 12/24/2011 4:57 AM (GMT 0)
Good points MT. I would not be shocked if the FDA denies the Linx, even with its shown success rates. Why? Do you know how much the pharma companies would lose year in and year out? Billions upon billions of dollars!! Money talks.
Posted 12/24/2011 5:19 AM (GMT 0)
I'll tend to disagree here a bit. Even if Linx is approved, I doubt those who can manage their GERD with the meds (and they make up a very large %) - are going to rush to get this done. So, the pharma companies are not being threatened in any significant way here.

I think the current situation with the Linx probably has some historical precedences (angelchik being the most similar one) - which is why FDA is likely taking its time to evaluate to make sure that longer term use of the device does not cause issues such as erosions, migrations etc.

When I communicated with the clinics in the UK, they said that none of the EU clinics are supposed to offer this to the US citizens and that a few cases from the clinic in Italy will get looked into by the FDA.

Now, I don't think there are any laws being broken here .. so if the Italian clinics are willing to offer ... they will .. and I am sure they'll get the US patients to sign all kinds of waiver forms before they do offer it.

It looks like the UK clinics don't want to get into the bad side of the FDA. FDA probably does not want to have to deal with patients with these implanted devices from overseas that start showing up with issues / problems in the short term.
Posted 12/24/2011 8:10 PM (GMT 0)
Trust me, most of it is financially driven.  The Linx would be the easiest device/procedure to implement and, potentially (if needed) reverse.  Prilosec is the leading drug of choice in America right now.  There are MANY people who would lean to a simple device insertion over paying thousands of potential dollars on medicine.
Posted 12/24/2011 8:22 PM (GMT 0)
Most folks are afraid of anything remotely close to surgery...myself included. Even though medication doesn't make financial sense over the long term compared with surgery, to most people, it is a fair compromise.

BTW, I can not take PPIs because of side effects. My concession to have the TIF surgery was a stretch for me.

-Bruce
Posted 12/24/2011 9:14 PM (GMT 0)
Totally agree Bruce ... if I could take the meds, I would be popping them like candies!
There is absolutely no comparison between the ease of being able to pop a pill to getting cut open (even if laproscopically) and getting a magnetic foreign object placed on top of the soft tissue of your esophagus ...
Posted 12/24/2011 10:35 PM (GMT 0)
PPI-LESS-

You it on what my concern is about the device. I have found out personally how delicate the esophagus really is and wonder if there is going to be any long term negative effect on the esophagus.

Take care,
Bill
Posted 12/25/2011 12:43 AM (GMT 0)
Getting a key hole procedure with a magnetic bead implanted is far, FAR, less hassle than either a Nissen (open or laparoscopic) or even a TIF. There are plenty of people out there that, given the choice, would opt for a minor (and in most cases will be outpatient) procedure versus dealing with PPI's and their long-term effects (bloating, poor digestion, EoE, etc.).
Posted 12/25/2011 12:46 AM (GMT 0)
And PPI, are you really assuming that it is as simple as "popping a pill"? Come on now, lets not forget the potential serious side effects that are now being documented with long-term PPI use and/or acid suppresion (see cancer, polyps, eosinophilic esophagitis, other allergic issues....the list is growing by the year).
Posted 12/25/2011 5:18 AM (GMT 0)
i agree with those who say the linx is not a sure thing and i have said so in the past, altho i think there is much positive going for it so far.

i know what the elastic in my socks do to my ankles after one day...deep marks and sometimes restricted blood flow from the constriction of the top, tightest band of elastic

im willing to wait and see how the linx does in time

meanwhile...the barretts sits there at the z line and occasional i burn

ps

i still wonder whether or not the PPI-pharma interests, the surgeons who do fundos and TIFs, and others, try to push back against the linx for reasons of self interest...just wondering...no proof

best wishes to all for a Merry Christmas
mt
Posted 12/26/2011 11:31 PM (GMT 0)
I dunno MT, but it is an interesting question to ask for sure. I guess none of us will ever know, but I am certainly eager to see if the linx works. Also, if it is approved, could it work for people who had had previous fundo's already?

Hope you had a Merry Christmas.
Posted 1/17/2012 3:49 AM (GMT 0)
I am new to this forum, well any forum in fact. I had the Linx System implanted in the US in July of 2009. Since then my life has been forever changed. It has POSITIVELY allowed me to live my life completely differently and without worry of GERD. I have struggled with GERD my entire life, I am now 26 and had suffered from GERD for all 23 years until I had the device implanted. I had been on protonix, bottles and bottles of tums, and every other medication you can be on for as long as I can remember, and they had little effect. Turns out my lower esophogeal scphincter was essentially non-existent. It just didn't work. I constantly had acid in my throat and mouth and was unable to sleep lying down. It truly controlled my life, I ate very little and only certain things, all though even water would give me heart burn.

Since the surgery, my life has been great, no more worry about spicy foods, ethnic foods, or any food for that matter. I have had 0 symptoms since the day of implant, and have had 0 complications. I was released from the hospital the day of the procedure and had a full meal for lunch that afternoon. It is certainly been a life changing device and am very privelaged to have been apart of this study. I hope that someday it is approved for full distribution in the US so that other people who suffer as severely as I did can get help they can't get from medications.

Feel free to ask any questions you may have. I am 100% for this device.

(also on travel note that has been brought up year or two ago, I have been all over the world multiple times and never had any problems)
Posted 7/17/2012 7:35 AM (GMT 0)
I'm so excited to see some of the posts on this forum. I am new to any forum as well. I just got the Linx implant on Wed. of this week! I have had GERD problems on and off for over 24 years. I am already laying flat with just one pillow (like a normal person) and am eating soft foods. No waking up at night so far. Eating is a chore so far but I am surprised that I can fruits, toast and other things. I had an issue with a bean burrito getting stuck last night and a bagel today. It didn't last long. For those who don't know, the Linx was FDA approved in February of 2012. My doctor is out of USC LA but comes down to Hoag Hospital in Newport Beach once a week. I had to go to USC to have it done and I did have to spend one night in the hospital.
Posted 7/18/2012 4:42 PM (GMT 0)
3girls,

Congratulations on a successful outcome. I'm glad to see one more person satisfied with the LINX procedure :) I'm reading all the posts by people who had LINX implanted so please keep us up to date on further improvements! Best of luck to you!
Posted 7/18/2012 8:21 PM (GMT 0)
One week since surgery. I'm feeling more like myself and have stopped taking the tylonal/codiene a couple of days ago. I'm taking liquid ibuprofin (mostly for my shoulder ache). It's still difficult to swallow but I'm powering through. Breakfast is the trickiest meal...guess the linx is 'warming up'. I'm already noticing that my voice is better. I'm a vocal music teacher so that is important to me. I never realized that my hoarseness was GERD related. I thought it was just overuse. It is a little of both I think. Will report more!
Posted 9/4/2012 10:37 PM (GMT 0)
AntZag, Shooz, LinxBeliever, 3girls, where are you. How have you been feeling with your Linx. How about an update. We need to hear from others that have had the implant . Look forward hearing from you and wish you the best of health and enjoyment in life. Bumper.
Posted 9/15/2012 4:42 PM (GMT 0)
I'm doing quite well with it. I just started teaching again (music teacher) and am amazed as to how much better and stronger my voice is. Singing is effortless now. I thought that I had wrecked my voice because I have been teaching so long (22 years). I did not realized that my reflux was burning my vocal chords. I am reaching high notes that I haven't been able to sing for YEARS. This is just a bonus for me because that is not why I had the surgery. I am still having residual pain from the surgery which masks as heartburn. I will see my surgeon on Monday and will ask what that is about. I am sleeping flat and haven't taken any meds for it in a month. I kind of screwed up when I took a cruise a couple of weeks ago. I thought that I was fine with everything but the alcohol and rich foods were too much and I had pain. I eliminated alcohol, sodas and went to easier to chew foods (just no steak or nuts) and now I am fine. I'm not getting any 'hang ups' with my food (where it gets stuck) and am now can swallow some small pills. It is a good thing because I'm getting sick of the icky liquids and chewable forms of pills. My surgery was July 11. So...doing well with it!
Posted 9/15/2012 11:49 PM (GMT 0)
3girls,
gland that you are feeling good. Do you still get heartburn? Do you get pain where the device is? When you were on your cruise did you get a lot of heartburn from the alcohol and rich foods?
Posted 10/4/2012 3:13 AM (GMT 0)
I don't get heartburn anymore!! And...no more medications (PPIs) either. I had some residual pain from the surgery but that is almost gone now (it felt a little like heartburn but it wasn't). It takes time for the tissue around the band to form into scar tissue and heal. The only thing I cannot do is sodas. I'm eating and drinking everything else including pills. Their are some great you tube videos about this surgery.
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