Risks and Complications – Intragastric Balloon

Intragastric balloon therapy, like all medical and surgical procedures, does carry risks and can result in unpredictable events and complications. A patient’s choice to undertake any medical procedure should be based upon an assessment of the risks relative to the potential benefits. The risk of certain complications may be dependent upon your individual circumstances and medical history, and as such your doctor will discuss with you the potential risks and complications, as well as the potential benefits, prior to committing to this kind of treatment.

Some of the risks associated with intragastric balloon therapy include:

Endoscopy Related Risks

  • Anaesthesia Risk: The anaesthesia required for the procedure to implant, adjust or remove the intragastric balloon involves risks of complications, injury and, in rare instances, death.
  • Aspiration: Regurgitation of stomach fluids or food into the lungs can occur during balloon implantation, adjustment or removal. While severe aspiration is unlikely, it can cause pneumonia, respiratory failure requiring support with a breathing machine, and even death. It is important that you follow the fasting instructions provided before each procedure to minimise the risk of aspiration. If food is found in the stomach at the time of procedure, the procedure will be aborted and you will be responsible to cover the cost of the aborted procedure.
  • Significant Bleeding: Significant bleeding after an endoscopic procedure is uncommon. Bleeding may occur during endoscopy or immediately afterwards. A blood transfusion may be necessary in these rare circumstances. Repeat endoscopy or surgery to stop bleeding may be necessary.
  • Stomach or Oesophageal Injury: Injury to the stomach or oesophagus is a rare complication that can cause life-threatening complications and may require emergency surgery for treatment, a prolonged hospital stay, a long period of nothing to eat, prolonged antibiotic requirements, organ failure and even death.
  • Organ Failure: In rare circumstances, organ failure may occur following intragastric balloon placement. This may include failure of the kidney, heart, lungs or liver.
  • Admission to Hospital: Complications of the therapy, procedure or anaesthesia may require admission to hospital. In some cases, surgery may be necessary to treat a problem or complication from the intragastric balloon.
  • Deep Vein Thrombosis (DVT)/Pulmonary Embolism: Blood clots after endoscopic procedures are uncommon. Blood clots that form in the legs, or elsewhere, and break off and travel to the heart and lungs may cause death.
  • Other Complications that may be common: Allergic reactions, headaches, itching, medication side-effects, damage or irritation of the vein where intravenous medications were given, heartburn/reflux, anaesthetic complications, injury to the bowel or vessels, gas bloating, aspiration of gastric contents into the lungs.
  • Death: The mortality rate of the gastric balloon procedure is low, estimated at less than 1 in 10,000.

Gastric Balloon Related Risks

  • Post-Procedure Symptoms: These are common in the first few days after balloon placement, and patients may experience stomach cramps, stomach pain/discomfort, nausea, vomiting, acid reflux with heartburn / indigestion, minor bleeding in the oesophagus, and a feeling of fullness or bloating. You will be prescribed medications to assist in controlling these symptoms and it is important that you purchase these medications and take them as directed. If these symptoms persist or worsen, you should contact the clinic immediately (including by the 24-hour patient support number outside of business hours). Rarely, patients may additionally have symptoms of diarrhea, sore throat, excessive salivation, gas or belching, hiccups, constipation, gastrointestinal hypermotility, oesophageal dysmotility, aspiration, hyperventilation, gastritis, halitosis (bad breath), indigestions, or dizziness.
  • Ulceration: Patients may form an ulcer in the stomach, oesophagus, duodenum and/or intestine resulting from the presence of the intragastric balloon. This may need to be treated with further medication while the balloon is in place. Ulcers may need to be diagnosed, monitored or treated by way of additional endoscopic procedures (under anaesthesia) and may require early removal of the intragastric balloon.
  • Dehydration: Some patients may become dehydrated after balloon placement and need to have intravenous fluids administered.
  • Pancreatitis: The presence of the intragastric balloon may cause inflammation of the pancreas. Mild cases of pancreatitis may resolve with or without treatment, but severe cases can cause life-threatening complications. Pancreatitis may require early removal of the intragastric balloon.
  • Balloon Intolerance: Approximately 5% of patients do not tolerate the presence of the intragastric balloon. These patients will experience prolonged nausea, reflux and/or abdominal pain requiring early removal of the balloon.
  • Balloon Deflation: The balloon could deflate at any point after administration. In some cases, the deflated balloon can pass through the intestines and be expelled with the stool. In rare cases, it can cause an obstruction in the stomach or in the intestines, requiring surgery for removal. For this reason, the saline used to inflate the balloon is stained with a blue dye, called methylene blue. Should the balloon deflate, you will likely notice that the dye turns your urine blue-green in colour. You may also notice a change in your appetite, or a loss of sensation of the balloon. If you suspect the balloon has deflated, you should contact the clinic immediately (including by the 24-hour patient support number outside of business hours). In most cases, you will be booked to have the balloon removed endoscopically within 24-48 hours.
  • Gastrointestinal Injury: The balloon may rub against the stomach causing bleeding or a tear (perforation) or hole. Gastric perforation is a serious complication that can occur in up to 1-in-2500 patients. Endoscopy and/or surgery, with removal of the balloon, and repair of the area of bleeding or injury is likely to be required for treatment. Patients with a history of prior gastrointestinal or bariatric surgery are contraindicated for any intragastric balloon procedure.
  • Balloon Removal: Early removal of the gastric balloon may be needed to treat complications. The procedure to remove the intragastric balloon may itself be associated with complications. The intragastric balloon must be removed after the indicated time-period specified by the balloon manufacturer and by my physician/surgeon. This will require an additional endoscopic procedure for its removal. Complications related to exceeding this time period can be serious and life-threatening.
  • Psychiatric Complications: Although most people experience improvements in their mood, some may experience worsening states of depression, which could lead to suicide. Some patients also experience anxiety from the foreign body within their stomach. Patients taking psychiatric medications must disclose this treatment to their physician/surgeon, and should have the dosage and effectiveness of these medications monitored carefully by their prescribing physician.