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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. Potential risks include death, acute pancreatitis, ulceration, perforation, bleeding, gastric outlet obstruction, aspiration pneumonia, bowel obstruction, balloon hyperinflation nausea, vomiting, and abdominal pain or discomfort. Discuss these risks and others with your doctor. CAUTION: Rx only.
ReShape vBloc™ is for weight loss in adults with BMI of 40–45 kg/m2 or 35–39.9 kg/m2 with related health conditions. ReShape vBloc is implanted surgically, which carries risks. Side effects include pain at the implant site. ReShape vBloc is not for persons who will need an MRI or have certain medical conditions. Talk to your doctor to see if ReShape vBloc is right for you. CAUTION: Rx only.
RESHAPE, RESHAPE LIFESCIENCES, ReShape Balloon™, the ReShape Balloon Logo, ReShape vBloc™, the ReShape vBloc Logo, ReShape Vest™, and the ReShape Vest Logo are trademarks of ReShape Lifesciences, Inc.
