The FDA has recently approved a new gastric balloon device. It is designed specifically for adults who want to lose weight. The dual gastric balloon is made up of two separate balloons that are inserted into the stomach and are then filled, without any surgery being necessary. It is a temporary measure that can stay in place for around six months. Removal is also non-surgical.

The ReShape System

The FDA believes that the system works by filling up a space in the stomach, thereby making the patient feel full. It does not understand exactly how this works, but because it does not change any part of the stomach’s anatomy, the FDA has decided to approve it. The system has already been used successfully in other countries for some 17 years.

In order for the balloon to be as successful as possible, patients must also follow a diet and exercise plan. They must do this when the device is in place, and for six months after removal as well. The procedure itself takes only about 30 minutes and is done under local anesthetic on an outpatient basis.

The Procedure

The balloons, which are deflated, are inserted into the stomach through an endoscope in the mouth. Once in place, the balloons are filled with saline. The endoscope is then removed. Removal of the balloon is done in a similar fashion.

Candidates

The balloon is suitable for specific candidates. This includes:

• People over 18; and
• People who have a BMI of between 30 and 40 kg per square meter; and
• People who have unsuccessfully tried to lose weight through conventional measures; and
• People who have at least one comorbidity illness like diabetes, high blood pressure or high cholesterol.

Results

In trials, the average weight lost achieved after six months was 13.4 lbs, which equates to 6.8% of their body weight. The control group, who had a mock endoscopy and hence did not know they did not have the balloon inserted, lost an average of 7.2 lbs, or 3.3% of their body weight. After removal, the group with the balloon was able to keep around 9.9 lbs off their original weight.

Some side effects do exist, however. These include:

• Nausea and vomiting
• Headaches
• Muscle pain
• Indigestion
• Stomach ulcers
• Abdominal pain

Some rare but severe complications include:

• Allergic reactions
• Infections
• Tearing of the esophagus
• Heart attacks
• Breathing problems

The device has not been approved for people who have had any type of gastrointestinal or bariatric surgery in the past, or those who have specific types of gastrointestinal illnesses. It is also not suitable for pregnant women or those who take aspirin daily.

Physicians have welcomed the FDA approval, stating it ‘fills a significant gap’ in the market. It is a method that allows for far greater weight loss than diet and exercise alone, while being much less expensive and dangerous than full bariatric surgery. The treatment is seen as truly revolutionary and it is hoped it will make a significant difference to the obesity epidemic that continues to plague our country.