Intragastric Balloons and Potential Risk of Gastric and Esophageal Perforation, Pancreatitis, and Overinflation

Starting date:
April 17, 2019
Posting date:
April 17, 2019
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-69610

Last updated:

Audiences

Healthcare professionals in hospitals, including hospital chiefs of medical staff, departments of surgery, emergency medicine, gastroenterology, bariatric medicine, family medicine, and other relevant departments.

Key messages

  • Health Canada is aware of Canadian and international reports of various complications, including some with a fatal outcome, associated with the use of intragastric balloons for weight loss therapy.  These complications include gastric perforation, esophageal perforation, acute pancreatitis, and spontaneous balloon overinflation.
  • Healthcare professionals are advised to consider these possible complications during the diagnostic work-up of patients implanted with intragastric balloons who present with severe abdominal pain, nausea and vomiting.
  • Health Canada is working with relevant device manufacturers to update the labelling for intragastric balloons to include details about these potential risks.

         

Issue

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.

Products affected

Medical Device Name Manufacturer Device Licence Numbers

(*device no longer licensed in Canada as of February 2019)

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

Background information

Intragastric balloons are fluid or air-filled medical devices placed in the stomach to act as a space-occupying device. They are temporary devices (6 or 12 months maximum use, according to the licence) used for weight loss along with other measures (diet, exercise) in obese patients.  They are inserted and removed endoscopically.  At the time of the safety review, 4 models of intragastric balloons were licensed for sale in Canada.  All were fluid-filled devices, with the first model being licensed in 2006. At present, 2 models of intragastric balloon remain licensed in Canada.

Though there is some evidence to show the potential effectiveness of these devices in contributing to patient weight loss, Health Canada is aware of various complications associated with these devices including gastric perforation, esophageal perforation, acute pancreatitis, and spontaneous balloon overinflation.

At the time of the review, there were 4 adverse events that had been reported to Health Canada that were associated with the use of intragastric balloons. Two of these 4 reports were international and 2 reports were Canadian. One of the international reports involved gastric wall injury and bleeding at the time of device insertion and inflation. The other international report involved a perforating gastric ulcer that occurred 10-days after intragastric balloon implantation.  In both international cases patients recovered after the intragastric balloons were removed. The 2 Canadian reports involved deaths but there was not enough information to confirm the exact cause of the deaths.

A review of the medical literature revealed 26 cases of gastric perforation associated with intragastric balloons, including 6 deaths.  Most cases were reported to have occurred between 9 days and 5 months after placement (overall range from several hours to 22 months after placement) and predominant symptoms at presentation were severe abdominal pain and nausea. Almost all cases required urgent surgical intervention (laparoscopy or laparotomy).  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.

Two detailed cases of esophageal perforation associated with intragastric balloon therapy were found in the literature. One was associated with a difficult balloon insertion and one with a difficult removal; both patients recovered.  Other cases of esophageal perforation related to intragastric balloons, including one fatality, were found in a review of international adverse event databases. Esophageal perforation is a known, but very rare risk associated with both diagnostic and therapeutic endoscopy of the upper gastrointestinal tract.

Seventeen confirmed cases of acute pancreatitis associated with intragastric balloons were found in the literature. Severe abdominal pain, nausea and vomiting were the most commonly reported symptoms. Cases were reported to have occurred between one day and 11 months after balloon insertion. Most patients were treated by endoscopic balloon removal while two patients required surgery.  All patients recovered. Acute pancreatitis is believed to occur in these cases through mechanical pressure exerted by the balloon on the pancreas through the gastric wall.

Only one detailed case of spontaneous overinflation of an intragastric balloon was found in the literature. The event was confirmed by radiographic imaging. The balloon was removed endoscopically and the patient recovered.  Mention of other balloon overinflation cases was found in the literature, but no other cases were described in detail. International adverse event databases were also found to contain multiple reports of this complication leading to early removal of the intragastric balloon.

Who is affected

Information for consumers

Intragastric balloons are air or fluid-filled devices inserted into the stomach for 6 or 12 months to take up space in the stomach and help as part of a weight loss program.

There have been international reports of tears or punctures to the stomach and esophagus, inflammation of the pancreas, and unexpected overinflation of the balloon in patients who are 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.

Information for healthcare professionals

Post-market reports have demonstrated the potential for gastric perforation, including some deaths, in association with intragastric balloon therapy. Cases of esophageal perforation, acute pancreatitis and spontaneous balloon overinflation have also been reported. The events have been reported to occur anywhere between several hours to many months after balloon insertion.

Implanting physicians should consider this information in the discussion of risks and benefits with prospective patients prior to balloon placement. Patients need to be made aware that they should seek urgent medical care if they develop symptoms of severe abdominal pain, nausea and vomiting while the balloon is in place.

Physicians should monitor patients carefully for the entire time the intragastric balloon is used.

Healthcare professionals are advised to consider these possible complications during the diagnostic work-up of patients using intragastric balloons who present with significant upper gastrointestinal symptoms.

Action taken by Health Canada

Health Canada is working with medical device manufacturers to update the safety information (labelling) for intragastric balloons to include details about these potential risks. Health Canada is also communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website. This communication will be further distributed through the MedEffect™ e Notice email notification system as well as social media channels including LinkedIn and Twitter.

Health Canada will continue to monitor safety information involving intragastric balloons, 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 and when any new health risks are identified.
 

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare providers and consumers reporting adverse reactions and medical device incidents. Any cases of perforation, acute pancreatitis or other serious or unexpected incidents in patients receiving intragastric balloons should be reported to the device manufacturer or Health Canada.

Any suspected adverse incident can be reported to:

Regulatory Operations and Enforcement Branch
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675

The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate (MHPD)
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738