Question:
Has anyone had the gastric pacemaker implanted? Where?
I have been turned down after 4 appeals with insurance company. The Pacemaker is less expensive. Has anyone had it inplanted? Know where it is being done? Any comments on it? I know the cost is about 10k. — Marie D. (posted on December 27, 2004)
December 26, 2004
Isn't that still very experimental? I can't imagine an insurance company
covering it until it is approved by the FDA. You might do a search and
see if you can get in a research study.
University of Mississippi is doing them as a treatment for gastro paresis,
a medical condition that causes paralysis of the stomach and constant
vomiting. cost quoted in the article was 30,000. very experimental and
last ditch effot to prevent some one dieng from the gastro paresis. Maybe
they will do a study on the gastric pacemaker, you should contact them.
***here is an article I found***
there is a link at the bottom to a questionaire to be in a study
http://www.1is2fat.com/gastric_pacemaker_could_help_wei.htm
Gastric pacemaker could help weight loss
People wanting to lose weight may be in for a shock. Literally!
A new type of pacemaker that sends mild electrical pulses to the stomach is
being tested to see whether it can help people control their appetites and
lose weight.
Background
Researchers at the University of Pennsylvania and eight other medical
centers plan to implant the device in about 200 volunteers in a two-year
trial.
Transneuronix Inc. of Mount Arlington, N.J., which has developed the
gastric pacemaker, hopes the results from the trial will lead to marketing
approval from the Food and Drug Administration.
"It is an exciting new development in the surgical field and less
invasive," said Gary Foster, the clinical director of Penn's Weight
and Eating Disorders Program and the principal investigator for the study's
Philadelphia site.
Currently, weight-loss surgery involves shrinking the size of the stomach
to limit the amount of food that can be eaten. It is considered the only
effective way for morbidly obese people to lose weight, long term; about
141,000 people are expected to have the surgery this year.
But these surgical procedures have risks, infection, blood clots, ulcers
and even death. They are also costly, approximately $25,000.
Scott Shikora, chief of bariatric surgery at Tufts-New England Medical
Center who has studied the device for a number of years, said he doesn't
believe it will replace the current surgical weight-loss techniques.
Because it appears to have a good safety profile, it may be well-suited for
patients who aren't candidates for bariatric surgery.
How the Gastric Pacemaker Works
The experimental device - which is called an implantable gastric stimulator
- is a small battery-operated electrical generator about the size of pocket
watch that is surgically implanted in the abdomen. 2 wires connect it to
the stomach wall.
In a similar way that a pacemaker sends electrical impulses to the heart,
the experimental gastric pacemaker gives a small current to the stomach
through 4 electrodes on the wires. The electrical current is activated,
adjusted or monitored by a handheld computer in the doctor's office that
communicates to the pacemaker through a radio signal. (Patients typically
don't feel anything during gastric stimulation, according to the company.)
It is unclear how the electrical current works. It might cause the stomach
to relax and signal a feeling of fullness. It could inhibit stomach
hormones that normally increase appetite. Or it may send a satiety message
to the brain.
Weight Loss Results so far
About 500 people have received the experimental gastric pacemaker in the
United States and Europe since it was first developed in the mid-1990s.
Candy Bradshaw, a 47-year-old Worcester, Mass., corporate manager, had the
device implanted in 1999 as part of an earlier study. She said she has lost
about 100 pounds using it, going from a size 28 to a 14.
"You don't feel the device at all," said Bradshaw, who'd still
like to lose an additional 30 or 40 pounds.
She said the gastric pacemaker makes her feel full more quickly when she
eats, so she isn't tempted to go back for second or third helpings. And one
bite too many, she said, will leave her feeling "Thanksgiving
full."
The device has helped her take a hard look at her food choices and her
lifestyle, Bradshaw said. She now power-walks five to seven miles a day and
watches the amount of food she eats.
"You have to work with this device," she said. "It has
helped me lose weight... . It is not a magic pill."
So far, study results have been mixed.
"After the implantation of more than 200 patients globally, it was
found that some patients responded strongly and lost significant weight,
while others seemed to have little or no response...," Shikora wrote
this year in the journal Obesity Surgery.
In the journal, he said some patients didn't fare well in the early trials
because the wires dislodged, people had abnormal eating behavior, or the
current was too low. Transneuronix also discovered that some people seem to
be predisposed to doing well with the device and has developed a screening
procedure to weed out those who won't.
Weight Loss Implications for the future
"Researchers don't believe there is one cause of obesity," he
said. ".... there is not going to be one treatment that will work for
every patient. Our screen is very much focused on identifying patients who
respond to our therapy."
The device gained marketing approval last year in Europe, he said, but the
company plans to delay its sales push until after the U.S. trial is
complete next year.
For the trial, volunteers need to be evaluated for a range of medical and
psychological issues.
Penn is looking to to enroll 20 to 30 people in the trial. They will
receive the device during a one-hour surgery. But it won't be activated to
begin with in all of them. The study will compare the weight loss between
the group that has the device switched on with those that don't. After 1
year, both of the groups will be able to have the systems activated for 1
year.
All volunteers will take part in a weight-management program during the
study period.
If the study results are positive, "this could be a landmark
breakthrough." Shikora said.
Those interested in participating in the study should go to
www.candidatescreenings.com/SSSPWelcome.asp
— **willow**
December 29, 2004
Hi,
there are groups on yahoo for people who have had or who are interested in
gastricpacing. http://groups.yahoo.com/group/gastricpacerinfo/ There are
other groups, that is just one. Hope this helps, Good luck in your
journey.
Lisa lap/rny 10-23-03
— Lisa H.
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