Frequently Asked Questions
What is obesity?
Obesity is associated with a high BMI (body/mass index) and can lead to a variety of health risks.
What is BMI?
BMI is a commonly used measurement that helps doctors assess your weight and health. It is calculated by using your height and your weight.
How will the ReShape Procedure help me lose weight?
The ReShape Procedure can help you lose weight by working in two ways. First, the balloons take up room in your stomach so there’s less space for food. You can still eat the healthy foods you enjoy but in smaller quantities, and the balloons act as built-in portion control. Second, the balloons make you feel full and less hungry between meals.
What is unique about the ReShape design?
Only ReShape dual balloon technology uses two connected saline (salt water) filled balloons. The dual balloons were designed to hold a higher volume of saline, and therefore take up more room in the stomach than a single balloon. Additionally, the balloons were designed to sit in the stomach in a way that mirrors the natural curvature of the stomach, so they may enhance comfort when in place.
Finally, the connected, dual balloons were designed to enhance safety. In the unlikely event of a balloon deflation, the second balloon maintains the position of the device in the stomach, preventing it from migrating into the intestines, where it may require surgical removal.
How are the balloons inserted in the stomach?
The dual balloons are gently inserted together through the mouth (endoscopically). Your procedure will be performed by a highly trained physician in about 20 minutes in an outpatient setting. During the procedure, you will be comfortably sedated under light anesthesia. Since there is no surgery, the procedure does not require incisions or permanent changes to your anatomy.
How soon can I return to work or other activities after the balloons are inserted?
Because the ReShape Procedure is non-surgical, the recovery is much shorter than with traditional weight loss surgery. After the procedure, your medical team will observe your health and typically send you home within a few hours.
You will likely experience nausea, vomiting, and pain, and may experience bloating, diarrhea, and cramping while your body adjusts to the presence of the balloons. These symptoms are normal and should be expected. Your doctor can prescribe medication to minimize any discomfort.
The length of time it takes to adapt to the balloon varies from person to person. Many people return to work after just a few days, but you should speak with your doctor about how soon to return to work and other physical activities.
Will I need to follow a special diet while the balloons are in?
For the first few weeks, eating and nutritional recommendations will be provided to help you enjoy a comfortable recovery. Then, along with your coaches, you’ll determine a healthy approach to ongoing nutrition that supports weight loss without leaving you feeling deprived
Will I be able to feel the balloons once they are inside me?
Some patients report that they can’t feel the balloons at all, while others say they do.
Will I need to limit my activities while the balloons are in?
After you’ve adjusted to the balloons, you’ll be able to return to all the same activities you enjoyed before the procedure. In fact, your coaching team will encourage you to try new activities that are fun and support your healthy lifestyle.
Is ReShape safe?
Yes, the ReShape Procedure and dual-balloon design has FDA approval in the U.S. The balloons were designed to promote tolerability and minimize the risk of deflation or migration, and they include a visual safety indicator as well.
What will happen if a balloon deflates?
The ReShape balloons have a very low risk of deflation. The saline used to fill the balloons is tinted blue, which acts as a visual indicator in the event of deflation. If you see blue-green urine, you should immediately contact your doctor.
Do I have to participate in the coaching to be successful?
Coaching is a core component of the ReShape Procedure. The coaching you receive is tailored to your individual needs and goals. Besides teaching you about healthy eating, exercise, goal setting, and behavior modification, the ReShape coaching keeps you accountable and on track.
Many ReShape patients credit the coaching with helping them maintain their weight loss after the balloons are removed. Read our testimonials or view patient videos to learn more about the role of coaching in ReShape success.
Can the balloons stay in longer than six months?
No, with the ReShape Procedure, the balloons can stay in your stomach for only six months as a safety precaution. It is critical to schedule your six-month appointment for balloon removal.
How will the balloons be removed?
The removal of the balloons is very similar to the insertion. The balloons are first deflated, then gently removed together through the mouth (endoscopically). You will again be comfortably sedated under light anesthesia. Your procedure can be performed in about 20 minutes in an outpatient setting.
How much does the ReShape Procedure cost?
Costs will vary by region and physician. Affordable payment options are available. Talk to your doctor about payment and financing options.
Indications: The ReShape Integrated Dual 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 Integrated Dual 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 Integrated Dual 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. 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 Integrated Dual 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), infection, pneumonia, and respiratory distress. Potential risks associated with the ReShape Integrated Dual Balloon include ulceration, perforation, abdominal pain, nausea, vomiting, bloating, belching, heartburn, dehydration, and sore throat. These complications may be severe enough to require early removal of the ReShape Integrated Dual Balloon. Although the ReShape Dual 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.
Important: For full safety information please talk with your doctor, or call ReShape Customer Support at 844-YES-RESHAPE.
CAUTION: Rx only.