Safety Information

U.S. Residents:

Not for sale in the United States.

CAUTION: Investigational device limited by Federal (United States) Law to investigational use.

E.U. Residents:

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The Obalon Gastric Balloon System (the “System”) is indicated for temporary use for weight loss in overweight and obese adults with a BMI of 27 or greater who have previously failed a supervised weight control program. The Obalon Gastric Balloon system is intended to be used in conjunction with a diet and behavior modification program.

Up to 3 Obalon Gastric Balloons may be placed in the stomach across a 3-month (12-week) period based on the individual’s weight loss progress and satiety levels.

The maximum placement period for the Obalon Gastric Balloon(s) is 3 months (12-weeks) and all balloons must be removed at that time or earlier.

CONTRAINDICATIONS

Use of the System is contraindicated in individuals with the following known conditions:

  • Anatomical abnormalities of the upper gastrointestinal (GI) tract
  • Functional disorders of the upper GI tract
  • Inflammatory and other pathophysiological conditions of the GI tract
  • Chronic or acute use of medications known to affect integrity of the GI tract and/or weight
  • Prior GI tract surgeries excluding uncomplicated appendectomies
  • Untreated hypothyroidism or untreated Cushing’s disease or syndrome
  • Severe, unstable/uncontrolled medical conditions of major organ systems
  • Alcohol and/or illicit drug abuse
  • Undergoing chronic steroid or immunosuppressive therapy
  • Pregnant or breastfeeding or intention of becoming pregnant during the study
  • Type 1 diabetes mellitus
  • Must not undertake scuba diving or travel in an unpressurized airplane cabin.
  • Allergies to products/foods of porcine origin
  • Untreated Heliocobacter pylori infection

CAUTIONS

DO NOT place more than 3 balloons in one patient across the 3-month therapy cycle. Results of more than 750 cc of volume are unknown with the System.

Do not place more than one device simultaneously. Risk of intolerance due to too much initial volume may occur.

Patients reporting a loss of satiety, increased hunger, and/or weight gain should be examined by radiograph, as this may also be a sign of balloon deflation. Endoscopic visualization might be required if the state of inflation cannot be determined radiographically. Evident balloon deflation may require early balloon removal.

The risk of balloon deflation is significantly higher with balloons that are left longer than 12 weeks.

Each patient should be monitored closely during the entire term of treatment in order to detect the development of possible complications. Patients should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, esophageal injury, and other possible complications that could occur, and should be advised to contact their physician if these symptoms worsen over time or persist for more than 24 hours.

Patients with undiagnosed motility issues may experience an event where the capsule fails to transit past the gastro-esophageal junction into the stomach. In this event the Balloon Capsule will need to be retrieved endoscopically.

For persons with diabetes, weight reduction can reduce insulin resistance and improve response to insulin and oral anti-diabetic medications. Adjustments of insulin/oral medication may be required. The patient should be advised of this potential benefit, and should continue to monitor their blood glucose and follow-up with their physician before, during and after use of the Obalon Gastric Balloon System.

COMPLICATIONS

The following events may be associated with use of Obalon Gastric Balloons:

  • Gastro-esophageal reflux
  • Indigestion
  • Stomach pain
  • Constipation
  • Stomach cramps
  • Diarrhea
  • Nausea, vomiting
  • A feeling of fullness, bloating, and/or heaviness in the abdomen
  • Gastric ulceration
  • Anxiety during swallow
  • Psychological intolerance of the balloon presence
  • Esophageal laceration or bleeding
  • Insufficient or no weight loss
  • Failed capsule transit from esophagus into the stomach during device administration

Other events that have been seen with other similar devices could also be associated with use of the Obalon Gastric Balloon:

  • Injury to the lining of the stomach as a result of direct contact with the balloon or as a result of increased acid production by the stomach may occur. This could lead to stomach ulcerations and/or bleeding or perforation.
  • Spontaneous balloon deflation and resulting passing through the intestines could result in bowel obstruction. Bowel obstructions can result in death. Bowel obstructions may result in the need for gastroscopy procedure or other surgical removal means. The risk of balloon deflation is significantly higher with balloons that are left longer than 12 weeks.

Complications of routine endoscopy include:

  • Adverse reaction to sedation or local anesthetic
  • Abdominal cramps or discomfort from the air used to distend the stomach
  • Sore or irritated throat following the procedure
  • Bronchial Aspiration (of liquid or food if present in stomach during balloon removal procedure)
  • Cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems)
  • Digestive tract injury or perforation
  • Excessive Sweating
  • Hypotension
  • Laryngospasm