Important ReShape Balloon™ System Safety Information
Indications: The ReShape Balloon™ System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Contraindications: The ReShape Balloon System is not recommended for patients with conditions that may increase the risk of poor results (e.g., prior gastrointestinal surgery with sequelae, prior open or laparoscopic bariatric surgery, inflammatory diseases of the GI tract, potential upper GI bleeding), who are unwilling to participate in an established medically-supervised diet and behavior modification program, who have alcohol or drug addictions, who receive daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, or who currently are or may be pregnant or breast-feeding.
Warnings: The maximum placement period for the ReShape Balloon is 6 months. The risk of intragastric balloon deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months. The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a sign of balloon deflation. Intestinal obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal. Death due to intestinal obstruction is possible. Patients experiencing symptoms of an intestinal obstruction (e.g., acute onset of abdominal pain, nausea or vomiting) should seek immediate care. Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric ulceration or perforation.
Adverse Events: Placement of the ReShape Balloon requires an endoscopic procedure with sedation. Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), anaphylaxis, cardiac arrest, death, hypoxia, myocardial infarction, gastric and esophageal perforation, infection, pneumonia, and respiratory distress. Risks that have been associated with treatment with the ReShape Balloon include death, acute pancreatitis, esophageal perforation, gastric perforation, ulceration, significant gastric bleeding, gastric outlet obstruction, aspiration pneumonia, bowel obstruction, balloon hyperinflation, need for blood transfusions, emergency endoscopic therapeutic intervention, abdominal pain, abdominal spasms, nausea, vomiting, bloating, belching, heartburn, dysphagia, dehydration, and sore throat. These complications may be severe enough to require early removal of the ReShape Balloon. Although the ReShape Balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction. The risk of intestinal obstruction is increased if the device is not removed after 6 months. If intestinal migration occurs, surgical or endoscopic removal may be required. (06-04-18)
Important: For full safety information please click here, talk with your doctor or call ReShape Customer Support at 844-YES-RESHAPE (1-844-937-7374).
CAUTION: Rx only.
Important ReShape vBloc™ Therapy Safety Information
Talk with your doctor about the full risks and benefits of ReShape vBloc Therapy.
What the ReShape vBloc System Used For: The ReShape vBloc System is for use in helping with weight loss in people aged 18 years through adulthood who are obese, with a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels. Individuals should have first tried to lose weight by diet and exercise in a supervised program within the last 5 years before receiving the ReShape vBloc System.
Contraindications: Do not have the system implanted if you: have cirrhosis (a disease of the liver), portal hypertension (high blood pressure in the veins of the liver), esophageal varices (enlarged veins at the lower end of the tube between the mouth and the stomach) or a significant hiatal hernia (a condition where part of the stomach pushes up or through the diaphragm where the tube between the mouth and the stomach passes through to connect to the stomach); need magnetic resonance imaging (a type of medical imaging that uses strong magnets and pulses of radio waves) or diathermy (a type of medical procedure that heats and destroys tissue); are at high risk for surgical complications; or have an implanted electronic medical device.
Warnings/Precautions/Adverse Events: Seek guidance from your doctor before you undergo a medical or surgical procedure, as interaction of the device with certain medical therapies, procedures or other implanted or body worn medical devices may harm you, cause damage to the implanted device or may turn therapy off. These may include, but are not limited to, lithotripsy (use of high energy shock waves to break up stones), radiation, mono polar electrosurgical instruments (a type of surgical instrument), positron emission tomography scans (a type of medical imaging), radiofrequency ablation (a method of destroying tissue used during surgery), heart pacemakers, defibrillators, neurostimulators, and insulin pumps. Turning, twisting, or manipulating the implanted components may damage the nerves or implanted device. Keep system components charged to prevent damage, which may require surgery to replace the implanted device. The neuroregulator should be fully charged prior to turning it off. The ReShape vBloc System is MR Unsafe, including for patients in which the device was explanted and not all components were removed. Portable outlets or extension cords should not be connected to the AC recharger. Do not immerse external system components in fluid. Keep strong magnets at least 6 inches away from the implanted device. The system may activate metal detectors or other security systems. Strong magnetic fields that emit radio frequency signals may interfere with the function of the system. The neuroregulator and mobile charger should be turned off near metal detectors, other security systems, strong magnetic fields and radio frequency emitting systems. The mobile charger should be turned off while aboard aircraft. Infection at the implant site may occur and could require use of antibiotic medications, surgery, or device explant. Do not modify any components of the system. Safety and effectiveness has not been established for use within a hyperbaric chamber (chamber designed to supply oxygen at a higher than normal air pressure), with external defibrillation, during pregnancy, or for use in patients under 18 years of age. The capacity of the rechargeable neuroregulator battery will diminish over time, requiring longer or more frequent charging. Do not operate the system in flammable environments, or if components appear damaged. Do not cover the mobile charger when in use to prevent overheating and damage. You may not be able to operate the system if you have impaired vision. Make sure all of your health care providers are aware that you have an implanted ReShape vBloc System. The most common related adverse events include pain, heartburn, nausea, difficulty swallowing, belching, and abdominal cramping. (01-16-2018)
For technical issues, please contact your implanting physician/clinic.