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Internal Gastric stimulator or gastric pacing |
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In 2003 when large numbers of gastric bypasses were being done and
consequently, a high incidence of complications were being observed, a
much higher complication rate than formerly thought, the IGS, a pacemaker
like device seemed to hold great hope for obesity surgery. Pacemakers for the stomach are not new. They have been used for a condition known as gastroparesis (stomach does not empty) for at least a few years with a modicum of success (apparently not enough to make it the standard treatment however). And of course we are all familiar with heart pacemakers. The IGS procedure was invented by Dr Valerio Cigaina, a Italian surgeon and his first patient was his secretary who had about 40 lbs to lose and did it successfully, he claims with the IGS. Her smiling face was one often seen in the promos for this device. Unfortunately after many unsuccessful trials in the USA, the hope for the IGS has somewhat died. Americans CAN go to Europe to get one but it's expensive ($50,000) and follow up might be difficult to obtain in the USA. What the IGS was supposed to do is stimulate the nerves of the stomach to prevent or slow the stomach from emptying after eating, causing patients feel "full" for longer and thus eat less.
Trouble is, the IGS does NOT work for most people. In the trials the average weight loss was 10-25 lbs, some did not lose any weight at all and only a very few, about 3 patients lost a significant amount of weight (and one of the significant weight losers lost weight by becoming ill with cancer and complications of the IGS). Most of the patients in the trials converted to other procedures to lose their weight.
Like pacemaker patients, IGS patients must follow certain restrictions with MRIs and scans (i.e. have the pacer turned off before they have any type of radiographic testing done). The pacemaker used in the IGS carries the same risks as the heart pacemaker, some of which are
No one likes to even mention this but of course, anything with a battery runs a small risk of battery related problems i.e. leakage etc. These are very rare but can, I suspect, be nasty when they happen. There are some additional issues with the IGS which do NOT exist with the heart pacemaker. The electrical current generated by the IGS is significantly greater than that provided by a heart pacemaker i.e. 10 times the intensity or more. Besides sometimes causing the patient discomfort when the pacer is stimulating, (patients complained of numbing or strange feelings in their arms), this also means that the IGS burns batteries a lot faster than heart pacemakers do. IGS batteries need to be replaced every 9-12 months - this requires a small surgery.
Surgeons were warned in the instructions for doing the surgery, that the leads must be placed very carefully or else, perforation of the stomach can occur. They also were told to immediately scope for gastric perforation after placing each lead. The companies manufacturing the IGS components tried hard to create a public need by media spin, but the ongoing poor results in the trials caused the media to greatly lose interest in the device. Most of the WLS surgeons who were involved in the trials, lost interest as well, except for one who runs most of the trials going on now and gets many customers for gastric bypass and adjustable lap band from dissatisfied IGS patients.
Media coverage of the trials portrayed them as promising:
Here is a study which appeared in Obesity Surgery Journal in April of 2002 - the inventor of the IGS was the author of this article. Last I heard he was still offering them in his practice in Switzerland for $50,000 per patient placement:
Notice that the cohort reported on in these two articles, was very small and the follow up was less than 3 years. Like so many other things, the reality is considerably less exciting than the promos were. According to the Medtronic site, no new trials are being started in the USA at present. (The Transneuronix website is apparently down and "transneuronix.com" is being forwarded to Medtronic now). The Medtronic focus is on many other types of electronic devices although people can still obtain information on the IGS for obesity (which Medtronic calls the "GES" or Gastric Electrical Stimulator) http://www.medtronic.com/obesity/ Articles in peer reviewed journals about IGS/GES
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The
great advantage of it was the no "messing" with the digestive system at all
(i.e. no stomach stapling or rearrangment of the bowels or even banding) which
sounded good after more and more gastric bypass horror stories emerged (and even
some not so nice stories about the adjustable lap band which is the safest
obesity surgery available at present).
The
poor track record in weight loss is not the only problem with the IGS.
There are several repercussions which can make the patients very uncomfortable.
For one, it can cause a medically induced case of GERD, causing patients to
suffer heartburn, and acid reflux (which if happens at night and it gets into
the lungs, it not only can really HURT but can in the most severe cases, cause a
type of pneumonia). It also raised the risk for Barrett's esophagus.
Also
patients and providers complained that the IGS was much more difficult to
program than the heart pacemaker (it's programmed with a device which which lies
on top of the skin). If it was programmed to release too little current,
it had no effect on the patient but programming it to release a lot of current
caused discomfort in other areas when the IGS was stimulating the stomach.
The happy medium apparently was never reached in many patients.