The 'gastric balloon' health tourists: How obese Americans are travelling to Canada for new weight-loss surgery
not approved in the U.S.
20:50 GMT, 10 April 2012
Americans eager to lose weight are crossing the border in growing numbers to be fitted with an intragastric balloon.
The balloon, which is filled with liquid and left in the stomach for up to six months, is not approved for use in the U.S., though it is available in Europe, South America and other parts of the world.
Instead of waiting for the clinical trials required before approval is given by the Food and Drug Administration, Americans are undergoing the operation in Canadian clinics just over the border.
Quick fix: The balloon hasn't been approved by the U.S. so American's who want to lose a significant amount of weight are travelling to Canada instead
The balloon is intended to decrease appetite by occupying about one third of the stomach volume, as well as by slowing down stomach emptying.
The patient is anesthetized, and the
balloon is inserted through the esophagus, and removed after six months in a relatively noninvasive
While it appears to be a quick fix for fast weight loss, the reported combination of potential risks and small benefits has ensured there is no intragastric balloon currently on the market in the U.S.
The intragastric balloon appeals to
people who want to lose a significant amount of weight,
but are not heavy enough to qualify for gastric
bypass surgery or adjustable gastric band surgery.
'Patients who are obese are very vulnerable. They’re desperate to find something that works'
The balloon is also an option for
extremely obese people who need to lose enough weight to be considered
for more invasive procedures, serving as short term weight reduction before
planned extensive postoperative hernia operations.
Although the surgery is noninvasive, it is not cheap costing $8,000 for
insertion and removal of the device after six months.
Since the balloon’s introduction in Canada in 2006, Americans account for nearly a third of patients undergoing the procedures in Canadian clinics.
Proving its widespread popularity despite American reviews deeming the use of the balloon having 'no medical and economic justification' when it is used as a simple weight loss tool.
FDA officials said that the agency
'reviews medical devices to assure American patients that they are safe
Benefits: The balloon is an option for extremely obese people who need to lose enough weight to be considered for more invasive procedures (stock photo)
'Many countries will approve medical devices without first
having to demonstrate that the technology is effective,' he reiterated.
Studies of the balloon have reported weight loss ranging from 13 to 34 pounds on average, with some individuals losing up to 50 pounds.
Patients often gain weight again after the device is removed, though long-term studies are limited.
Dr Robin Blackstone,the president of the American Society for Metabolic and Bariatric Surgery, said that people who need to lose a moderate amount of weight may do just as effectively with a more conventional diet and exercise approach, given the risk of complications.
Dr Blackstone is also involved in a clinical trial of a balloon in the U.S., and said patients who are obese are very vulnerable.
'They’re desperate to find something that works, and it’s important for people not to offer things that aren’t well established,' she warned.
The weight loss that patients can expect is modest at best, with the balloon an option only for those who have less than 50 pounds to lose, or for extremely obese people who need to lose weight to be accepted for bariatric surgery.
As well as its lackluster record, patients can suffer severe nausea and vomiting during the first few days or week after placement.
On rare occasions, the balloon, usually filled with blue liquid, can rupture. The liquid will turn patients’ urine green, which is how they are alerted to a problem.
A ruptured balloon can obstruct the intestines, or it can perforate the abdomen, which can be life-threatening, with other complications including infections and ulcers.
As with any weight loss tool, the success of the intragastric balloon depends on lifestyle changes, including a better diet and increased physical activity.
Maintaining those changes is critical to maintaining the weight loss after the balloon is removed.