Summary Safety Review - Intragastric balloons - Assessing the potential risk of inflamed pancreas, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2019-04-17

Product

Intragastric Balloons

Potential Safety Issues

Inflamed pancreas, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation)

Key Messages

  • Intragastric balloons (IBs) are fluid or air-filled medical devices placed in the stomach to act as a space-occupying device. They are devices for temporary use (6 or 12 months maximum, according to the licence) for weight loss along with other measures (diet, exercise) in some overweight or obese patients. All IBs available in Canada are fluid-filled devices.
  • Health Canada completed a safety review on the potential risk of inflammation of the pancreas, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation) in patients using fluid-filled IBs. This review followed Canadian and international reports of these complications (including deaths), in patients being treated with IBs.
  • Health Canada's review of the available information has confirmed a link between the use of fluid-filled IBs and all of the risks previously mentioned. In most cases, removal of the device is required. Of particular concern are IB-related cases of esophageal and/or stomach wall perforations, which can potentially cause death and typically require emergency surgical treatment.
  • Health Canada will work with the medical device manufacturers to strengthen the device safety information (Instructions for Use) for all fluid-filled IBs by including these potential risks. Health Canada will also publish a Health Product Risk Communication to raise awareness of these risks and will continue to monitor the safety and effectiveness of these devices.

Overview

Health Canada reviewed the potential risks of inflammation of the pancreas, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation) when fluid-filled intragastric balloons (IBs) are used as temporary implants to help with weight loss in some overweight or obese individuals.

IBs are medical devices for temporary use (6 or 12 month maximum use) that are inserted and removed using a tube with a camera and light (endoscope) placed down through the mouth, throat and esophagus into the stomach. They give the feeling of fullness and are used for weight loss along with other measures (e.g. diet and exercise) in patients above a certain body mass index (BMI).

Use in Canada

  • Intragastric balloons (IBs) are medical devices licensed in Canada as devices for temporary use that help with weight loss in patients above a certain BMI (typically 27 or more).
  • There were 4 IB systems licensed for sale in Canada at the time the scientific review was carried out. All were fluid-filled devices and regulated as class III medical devices. The first of these models was originally licensed for sale in Canada in 2006. At the time this Summary Safety Review was finalized, 2 IB systems remained actively licensed in Canada.

Safety Review Findings

  • At the time of the review, Health Canada had received 2 domestic and 2 international reportsa of side effects related to the use of IBs. One report described a hole (perforation) of the stomach, and another case described an injury to the stomach wall during device insertion. The other 2 reports involved deaths in IB users. However, there was not enough information in these 2 reports to confirm the exact cause of the deaths.
  • Health Canada also looked at the medical literature related to IB side effects. There were 17 cases of pancreas inflammation found and confirmed by blood testing and x-rays. Most patients were treated by device removal and all recovered. The literature suggests that the injury is caused by mechanical pressure placed on the pancreas by the IB via the stomach wall.
  • There were 2 cases of esophageal perforation found in the literature - 1 after a difficult device insertion and 1 after difficult device removal. Both patients recovered. Perforation of the esophagus is a known, rare complication that can occur during a procedure with an endoscope, regardless of whether an IB is involved.
  • There was only 1 detailed case of unexpected overinflation of an IB found in the literature. The event was confirmed by imaging, the balloon was removed, and the patient recovered. Mention of other balloon overinflation cases was found in the literature, but no other cases were described in detail. International databases were also found to contain multiple reports of this complication leading to early removal of the IB.
  • A total of 26 literature cases of stomach perforation in IB patients were found, including 6 deaths. Patients who appeared to be at higher risk included those who did not use their prescribed heartburn medications and those who had previously undergone stomach surgery. The estimated risk of a stomach perforation spanning the full thickness of the stomach in IB users is believed to be 0.1 to 0.2%, but the frequency of partial thickness injuries (ulcer) to the stomach wall is likely higher. Overall, perforation of the stomach is a serious complication and most cases required rapid and significant surgical intervention beyond simple removal of the balloon. The literature suggests that cases of severe stomach pain in IB users should be considered as possible stomach perforations until proven otherwise.

Conclusions and actions

  • Health Canada's review of the available information has confirmed that there is a link between the use of intragastric balloons (IBs) and cases of pancreas inflammation, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation). Most cases require removal of the balloon. Cases of esophageal and/or stomach perforation can potentially cause death and typically require emergency surgery to repair.
  • Health Canada will notify medical device manufacturers to make sure that the Instructions for Use of all IB devices sold in Canada includes details about these potential risks. Health Canada will also publish a Health Product Risk Communication to increase awareness of these potential risks, as well as assess results from ongoing studies.
  • Health Canada will contact manufacturers to work together to update the Instructions for Use of IBs. If manufacturers or industry associations require more information at this time, they are encouraged to contact the Therapeutic Products Directorate (hc.tpdgeneral-generaldpt.sc@canada.ca).
  • Health Canada will continue to monitor safety information involving IBs, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if any new health risks are identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of this device both in Canada and internationally.

For more information, contact the Marketed Health Products Directorate.

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