Health Canada says it is aware of Canadian and international reports of complications, including deaths, associated with using intragastric balloons for weight loss.
Doctors temporarily insert intragastric balloons — medical devices filled with fluid or air — endoscopically in the stomach to help with weight loss along with diet and exercise changes in people who are obese.
“A Health Canada safety review confirmed a potential risk for gastric perforation, esophageal perforation, acute pancreatitis and spontaneous balloon overinflation associated with the use of intragastric balloons in weight loss therapy,” the department said in a notice to healthcare professionals on Wednesday.
The complications includes punctures to the stomach and esophagus, inflammation of the pancreas, and unexpected overinflation of the balloon in patients who’ve used intragastric balloons.
Health Canada advised healthcare professionals to consider those complications if patients implanted with intragastric balloons show severe abdominal pain, nausea and vomiting.
Health Canada said that at the time of the review, there were four adverse events that had been reported to Health Canada that were associated with the use of intragastric balloons — two international and two Canadian.
The Canadian reports involved deaths but there was not enough information to confirm the exact cause of the deaths.
The international reports include tears or punctures to the stomach and esophagus, inflammation of the pancreas, and unexpected overinflation of the balloon in patients using intragastric balloons.
“Patients should urgently seek medical care if they are using an intragastric balloon and experience symptoms related to these complications such as severe abdominal pain, nausea and vomiting,” Health Canada said.
The medical literature also includes cases of gastric perfusion associated with the devices.
Health Canada said it is working with medical device makers to update the safety information for intragastric balloons.
|Medical Device Name||Manufacturer||Device Licence Numbers|
|Orbera System Intragastric Balloon||Apollo Endosurgery Inc.||72168|
|Spatz3 Adjustable Balloon System Insertion Kit||Spatz Fgia (Israel) Ltd.||93172|
|*Endball – Systeme de Ballon Intra-gastrique||Endalis||90070|
|*Reshape Medical Intragastric Balloon||Reshape Medical||84060|
(*Device no longer licensed in Canada as of February 2019.)
The devices are licensed to use for six to 12 months maximum.