Title : FDA Approves Weight Loss AspireAssist stomach pump to fight obesity
link : FDA Approves Weight Loss AspireAssist stomach pump to fight obesity
FDA Approves Weight Loss AspireAssist stomach pump to fight obesity
The Food and Drug Administration approved a new and unusual loss device Tuesday weight :. An external pump that turns over part of the stomach contents into the toilet
Some critics have called "assisted bulimia" but the device approved for use in very obese patients, helps lose, on average, more 12 percent of body weight -. Much more than pills or most diets
device is considered minimally invasive and includes a tube from inside the stomach to a port outside the abdomen. The pump can be connected to the outside port as necessary to remove about one third of the stomach contents at once.
Aspire Bariatrics King of Prussia, Pennsylvania, which makes the device has a video about it here.
Clinical trials showed patients lost an average of 46 pounds during the first year and another couple pounds to 50 pounds of weight loss for the second year.
"The AspireAssist device should not be used in patients with eating disorders, and is not intended to be used for short periods when they are moderately overweight," the FDA said in a statement.
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"It is intended to aid in weight loss in patients aged 22 years or older who are obese, with an index body mass 35 to 55, and who have failed to achieve and maintain weight loss through no non-surgical therapy lose weight. "
Dr. Shelby Sullivan, Washington University in St. Louis, who helped test the AspireAssist and several other medical devices, says it is a good choice for extremely obese . She is opposed to criticism descriptions of how the device works.
"There is no such thing as bulimia or assisted medical bulimia," Sullivan told NBC News. Bulimia is an eating disorder defined by overeating and then purging, however often forced vomiting.
"Patients eat less with this therapy then they did before," she said. "People think that patients can eat whatever they want and then suck and that just is not true. It has to be sufficiently liquid and particles must be small enough to pass through the tube."
The device joins a growing list of new ways to help Americans lose weight, diets carefully controlled for surgery and batch of products that make the smaller stomach indeed.
diet drugs do not work too well and doctors are reluctant to prescribe them. This new device is the first to remove food that people have eaten before it can be digested.
The need is growing. The latest data from the Centers for Disease Control and Prevention shows that 38 percent of American adults are obese , while 17 percent of teenagers fall into that category.
"The AspireAssist approach helps to provide effective control of the absorption of calories, which is a key to weight control therapy beginning," said FDA's Dr. William Maisel.
Related :? What diet drug is more effective
"Patients should be monitored regularly by your provider health care and must follow a program of lifestyle to help develop healthier and reduce your calorie eating habits, "he added.
The company has not said how much it will charge for the device, which is on the market in Europe. A surgeon will also need to implant the device in a short endoscopic procedure, and the cost can vary according to the center.
"Patients require frequent monitoring by a health care professional to shorten the tube as lose weight and abdominal circumference, so that the disk is held flush against his skin. Medical visits frequent are also necessary to control the use of the device and weight loss and to provide advice on lifestyle therapies, "the FDA said.
Side effects include indigestion, nausea, vomiting, constipation and diarrhea.
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Obesity is calculated using mass index body (BMI) - a measure of height to weight - which is a score of 30.
people are considered overweight when their BMI hits 25.
Someone who is 5 feet 5 inches and weighs 149 lbs has a BMI of 24, considered a healthy weight. Add a pound and the same person has a BMI of 25 is considered overweight. At 180 pounds this person has a BMI of 30 is considered obese.
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