FDA has approved a new dual gastric balloon device designed to help adult obese (BMI= 30-40 kg/m2) patients lose weight. ReShape Dual Balloon address a significant gap that exists between diet and exercise on the one hand and weight loss medications and surgery on the other.
The US Food and Drug Administration (FDA) has noted that the ReShape Integrated Dual Balloon System works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood. The device comprises two balloons that are inserted into the stomach and inflated without the need for surgery. The device is meant to be a temporary measure and should be removed after 6 months. Removal is also via a non-surgical procedure.
The Dual Balloon does not alter the anatomy of the stomach.
How Does it Work?
The device is inserted during an outpatient visit. The procedure lasts no more than half an hour and is performed while the patient is under mild sedation. A trained physician inserts the deflated balloons using an endoscope. This is a tube with a camera on the end that goes into the mouth, down the throat and into the stomach. The camera allows the physician to guide the placement of the deflated balloons.
Once in the stomach, the physician inflates the balloons by filling them with a sterile salt solution and a blue dye (methylene blue). If a balloon breaks, blue dye will appear in the patient’s urine. When it is time to remove the balloons, they are first deflated then removed using another endoscopic procedure.
To help achieve and maintain weight loss, patients implanted with the Dual Balloon are advised to follow a medically supervised diet and exercise plan both while the device is in place and then for 6 months after it is removed. The device is for obese adults whose body mass index (BMI) lies in the range 30-40 kg/m2. It is intended for patients who have not been able to lose weight through diet and exercise alone and is limited to those with one or more obesity-related conditions such as high blood pressure, high cholesterol and diabetes.
How is it Different?
The dual balloon is different to single balloons. It is designed to fit the natural shape of your stomach, helping you feel full without over-stretching the stomach. Its advantages include:
- Helping you lose weight: the total volume of both balloons is 900 ml of saline – more volume than single balloons, which typically have a volume of 400–700 ml in one balloon.
- Comfort: the dual-balloons are designed to fit the curve of your stomach, so they don’t over-stretch your stomach to minimize discomfort.
- Effectiveness and safety: each balloon is filled and sealed independently, so in the unlikely chance a balloon deflates, the other balloon will hold the device in place until it can be removed.
When should it not be used?
The device should not be used in patients who
- have had previous gastrointestinal or bariatric surgery
have gastrointestinal inflammatory disease- have potential upper gastrointestinal bleeding conditions
- have a gastric mass
- have a large hiatal hernia
- have structural abnormality in the esophagus or pharynx
- have serious esophageal motility disorders
- have severe coagulopathy
- have hepatic insufficiency or cirrhosis
- have serious alcoholism or drug addition
- have serious or uncontrolled psychiatric illness or disorders
- are pregnant or are breastfeeding or plan to become pregnant
- have ever developed too much serotonin (serotonin syndrome) and are currently taking any drug known to affect serotonin levels
- take use aspirin, anti-inflammatory agents, anticoagulants, or other gastric irritants daily
- are known or suspected to have an allergic reaction to materials in the device
- are unwilling or unable to participate in a medically-supervised diet and behavior modification program
- take prescribed proton pump inhibitor medication for the duration of the device implant
Reshape Dual Balloon is intended to be used while a patient participates in a diet and exercise plan supervised by a health care provider.
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