Re: Info IGS and seeking info: Intragastric Balloon (not in U.S.) (Very Long Post)

[Guest guest]

>>Jill wrote:

>>Subject: IGS

>>I'm in the research phase of WLS. I know that so far,

>>Ds would be my surgery of choice. However, I just came across

>>this term- " Implantable Gastric Stimulation System " .

Hi Jill and all,

This gives me a chance to delurk temporarily - thank everybody for being here -

and maybe finally be able to give back instead of just taking all the knowledge

everyone shares so generously. And ask a question.

For Jill, and others who were interested, a summary of what I learned about the

implantable gastric stimulator (sometimes called the " gastric pacemaker " ), when

I researched it half a year or so ago.

1. It's not available and does not yet have FDA approval. There were clinical

trials being run, but I think they may be over and I don't think they are

accepting new patients (half a year is a long time in terms of development of

new technologies). It will probably be available by the end of 2001.

2. Its significant advantage is that it is minimally invasive: there is no

manipulation of major organs such as the stomach, liver, etc., and it goes

without saying that there's no cutting into the stomach. It can usually be done

laparascopically. It is minor surgery (about an hour). I don't remember if it is

an outpatient procedure, probably needs one night in hospital.

3. The device is similar to a cardiac pacemaker. It has three parts: a small

box (seems to be about the size of a tiny powder compact, the kind you slip into

an evening bag), a lead (a wire, in case others are as technically illiterate as

I was ...), and a programmer (a remote-control type device).

4. The procedure: The pacemaker is inserted just below the surface of the

skin, at the abdomen. The lead runs from the pacemaker to the inside of the

stomach wall. (The programmer remains outside.)

5. The action: The pacemaker sends electronic pulses to the stomach wall

through the lead. The programmer is used to control the pace (obviously) and

strength of the pulses.

6. The effect: These electronic signals to the stomach wall somehow (therein

lies the mystery ...) induce a sense of satiety.

A good summary can be found here:

http://www.obesity-diet.com/anglais/actualites/avril01.htm

My conclusion, after reading whatever was available online, is that the device

shows promise, but it's not the answer for those of us who need help right now.

Anyone who can wait three or four years may be able to benefit somewhat, but

even then the effectiveness of the device may not be developed to its fullest

potential. The real promise of this device is for the next generation. When I

was reading the articles, I had this optimistic visions that in the future,

satiety disorders (the precursor, for many of us, to the weight gain ...) will

be treated as matter-of-factly as diabetes, or even as simply as fitting a pair

of glasses or contact lenses. As soon as a child is diagnosed with a satiety

disorder, the device will be implanted. If the constant desire to eat never gets

a chance to develop, just think of all the trauma that can be avoided: how many

of us, even if we weren't obese as children, have been struggling all our lives

with the constant desire to eat, and have felt that the fault was within us, and

that we just weren't applying enough self-discipline, etc. Imagine if this were

diagnosed in a routine medical examination at a young age, and treated

immediately?

Coming back to earth, there isn't too much concrete information about the

effectiveness of the device, whether short or long term. IIRC, patients in the

studies ultimately lost up to about 1/3 of their excess weight, and the weight

loss was at a gentle pace (8-10 lbs a month). It seemed to me (don't remember

the exact stats, but I remember drawing this conclusion) that when it first

becomes available, it would be most effective for people with lower BMIs - maybe

that group of people who are just under morbidly obese, and who are losing the

grip on the constant struggle not to gain any more weight. This may help them

get back down from that danger zone just before MO, and then will continue to

regulate their satiety level, so that cravings don't rage out of control and

they have that " breathing space " that lets them make, and stick to, better

lifestyle choices.

All this, just my impression from what I read online. If you do a keyword

search, you can find more information - not a huge amount, but there are some

preliminary studies and reports. Gastric pacemakers are also used in treating

diabetes, so if that's the keyword you used for your search, be sure the article

you're reading refers to pacemakers used in treating obesity.

And now, my question. I live in Israel and hope to have a BPD/DS with Dr. Gagner

in about four months. I have a BMI hovering around 60 and I have had previous

abdominal surgery, so even without additional significant co-morbids it's still

a somewhat complicated case. My doctor here is very supportive, and we've been

trying to think of what can be done during this waiting time to improve the

chances that the BPD/DS can be completed in one step, and as a lap procedure.

Yesterday, she told me that the Israeli Ministry of Health has just approved the

intragastric balloon for treatment of obesity. This balloon is an improvement

over the gastric balloons that were in vogue for a while in the 80s, but fell

out of use after some cases of severe bowel obstruction when ruptured balloons

didn't pass through the intestine to be eliminated normally. The new balloons

have all kinds of failsafe features to minimize complications, and in fact, from

the material I've found online, this has been the case so far.

The intragastric balloons are recommended for " temporary weight loss, " and one

of the main target populations for the device are individuals with serious

morbid obesity who require surgery (not necessarily bariatric), and who must

lose weight prior to the surgery so as to lessen the surgical risk. One study

specifically looked at the use of intragastric balloons prior to weight loss

surgery, with good results.

The balloon is inserted in an endoscopic procedure. Once in place, it is

inflated with a saline solution. It contains a dye that functions as a warning

signal. If the balloon is weakened, ruptured or punctured, the dye is released

and immediately shows up in the urine - when you pee bright blue or bright

green, you know you have to call your doctor or head to the ER right away.

AFAIK, this complication did not occur in any of the patients during the Israeli

trials. If it is punctured and deflated, it generally passes through the body

and is eliminated normally in a bowel movement, but of course this must be

monitored to ensure that any bowel obstruction is treated immediately. If there

were no problems, the balloon is removed in any case, after six months, in

another endoscopic procedure - again under a local anesthetic, outpatient basis.

If indicated, a new balloon can be inserted. The effect of the balloon, I would

imagine, is that it gives you the feeling that your stomach is full. Side

effects are usually minor - nausea for a couple of days, maybe vomiting until

you adjust and learn what and how to eat. If the side effects persist and are

unbearable, the device is removed. I believe that was the case with one trial

patient, who had persistent vomiting.

From what my doctor told me and from what I've read, weight loss is usually not

spectacular and dramatic, especially in comparison with the dramatic drop that

occurs immediately after weight loss surgery, particularly BPD/DS. But keeping

in mind that the balloon is not supposed to be a replacement for WLS, the

overall results are good: after 3 to 6 months of treatment, weight loss ranging

from about 15 to 24 kilo (approx 30 to 50 lbs.), with a BMI drop of 5.3 points.

It is considered a " temporary " weight loss device because as soon as the balloon

is removed, the body just returns to its normal state - i.e., unless the patient

goes on to another weight loss procedure, or is capable of maintaining the

lifestyle changes even without the balloon, the weight will be regained.

The objective of using a gastric balloon isn't to replace WLS, at least not at

this stage of its use. But it is effective in getting the BMI down just enough

to reduce the risks of further surgery (and even a weight loss of 30 lbs. makes

everyday living that much easier). If it works, it could mean the difference

between having BPD/DS in one stage as a lap procedure rather than in two stages,

or as an open procedure. That is what my doctor here is aiming for. She

suggested - and it's not a bad suggestion, I think - that if I find the device

works well for me, that I tolerate it well and I lose weight at a nice pace

without undue struggling, I should keep it in as long as possible, for the full

six months, and perhaps even longer (replacing it after six months). Her

rationale is the more weight I can lose before heading for BPD/DS, the safer it

will be - and I'll get to the finish line in about the same time. With a BMI of

60, I have a long road ahead of me in any case - I can lose 100 lbs and probably

still be a good candidate for BPD/DS. Of course, what was left unspoken but

hovered in the air was the hope that perhaps the balloon will be enough, maybe

it'll work well enough so that eventually I will decide to forego surgery.

Trying to function in the summer heat in the Mideast with a BMI of 60, that

doesn't seem within the realm of possibility right now. If it were up to me, I'd

climb right up on Dr. Gagner's operating table this afternoon. But on another

level, as enthusiastic and hopeful as I am about the BPD/DS, I try not to lose

sight of the fact that it is such an incredibly major surgery (especially

because of previous abdominal surgery), with such incredibly major consequences,

I have to keep an open mind to any reasonable alternative right up to the last

second before they put me under. When I'm up there on that table, I need to know

that I have thoroughly considered every other alternative and that BPD/DS is

absolutely the only option that I can envision.

And my question is whether anyone on the list - not in the U.S., I suppose,

because it isn't available there - has heard of the intragastric balloon or has

been treated with it prior to weight loss surgery, and if so, would you share

your personal experience? Of course, I'd also be very interested in hearing

general opinions about this.

Many thanks for being here, for sticking with me if you got down this far, and I

hope the info on the pacemaker is helpful.

Aviva