ReShape Gastric Balloon – New Weight Loss Procedure

Last week, FDA approved gastric balloon to be offered as a new weight loss procedure for those struggling with weight in the US. The balloon has been offered as a weight loss option in Europe, Australia, and South America since 1990s. Now, with FDAs recent decision, gastric balloon will soon be also available to all qualified patients in the US.

What is a gastric balloon?

 

A gReShape Gastric Balloonastric balloon is a noninvasive weight loss procedure aimed at helping patients to decrease their portion sizes by placing one to three air or fluid filled balloons inside the stomach. The number of balloons and what they are filled with depends on the type of a gastric balloon a patient decides to get. The recently approved ReShape Integrated Dual Balloon System, consists of two fluid filled balloons and is the only gastric balloon currently approved by FDA for use in the US. Differently than any other gastric weight loss surgery, gastric balloon does not require a surgery to place or remove. Both placement and removal procedures are performed endoscopically (via mouth), take less than 30 minutes, and can be done on outpatient basis.

ReShape Integrated Dual Balloon System Device

Who can get a gastric balloon?

 

Gastric balloon is intended for patients with a BMI between 30 and 40.  In real terms, this means patients who are on average 30-100 lbs overweight would qualify as gastric balloon patients. The balloon is as a temporarily implanted weight loss tool and is meant to remain in the stomach for up to 6 months. During that time, patients are recommended to work on their eating habits and exercise regimen to keep the weight off or even to continue losing weight once the balloon is removed. The gastric balloon studies submitted to the FDA, show an average weight loss among gastric balloon patients to be about 30 lbs. With that in mind, the procedure is best suited for patients within the lower obesity range who are not ready for surgical weight loss options such as lap-band surgery.

 

Who shouldn’t get a gastric balloon?

 

If you already had an open or laparoscopic bariatric surgery, unfortunately you are not a candidate for the gastric balloon procedure. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease will also exclude you from the list of potential gastric balloon candidates. Many esophageal or gastric changes such as issues with motility (swallowing) of esophagus, strictures, gastric masses, severe reflux, or large hernia may also disqualify you as a gastric balloon candidate. In addition, if you are suffering alcohol and/or drug addiction you are also not a candidate. Patients deciding for gastric balloon have to also be aware and prepared to undergo balloon removal after six months, and during the six months they have the balloon, they need to follow diet recommendations and follow up with their weight loss clinic. If you are unable to comply with those requirements, or suffer psychological disorder that would make you unable to comply, that would also negatively impact your chances of receiving treatment with gastric balloon.

How does gastric balloon work?

 

Gastric balloon is intended as a temporary tool to help patients feel less hungry and full faster. Balloons used historically had a volume anywhere from 250 to 1,055cc. Depending on the type of a gastric balloon, the surgeon will place one or more gastric balloons at the same time or over the period of two to three months. The balloon can be filled with fluid or gas to take up space in the stomach. The ReShape Dual Balloon specifically, the only FDA-approved balloon as of now (Aug 3rd, 2015), consists of two 450cc connected balloons filled with blue dyed saline. Together, the two balloons take up space of about 4 cups of fluid, occupying about three quarters of the stomach.

With limited stomach space, patients report feeling less hungry and needing smaller portions. The device is meant to stay in the stomach up to 6 months, after which time it is removed endoscopically. Patients who undergo gastric balloon procedure are advised to come for regular follow up visits with their surgeon and participate in nutritional counseling. The balloon is meant to help patients improve their eating habits and prepare them to continue the good work after gastric balloon is removed. Those who decide to get a gastric balloon should not consider their new eating habits a diet, but a change in lifestyle that is aimed at becoming healthier and preventing future weight gain.

 

How is gastric balloon placed?

 

Independently of which kind of a gastric balloon you are getting, all are placed endoscopically and usually by a gastric surgeon. Nevertheless, depending on the balloon technology the procedure itself may slightly vary. In the case of ReShape balloon, the surgeon will introduce the balloon with a catheter tube via mouth into the stomach. A the time, the two balloons will wrapped around the catheter and deflated. Once in the right position, bariatric physician will fill the balloons with the right amount of blue dyed fluid. Once gastric balloons are full, the balloon surgeon will remove the catheter and leave the two gastric balloons connected in the stomach. The balloons are filled with a dye for patient safety. In the case of balloon perforation, the blue dye will show up in the urine letting the patient know to contact a physician. Despite the fact that balloons remain connected, they are separately sealed. In other words, in the case when one balloon becomes deflated, the other will stay intact while preventing the deflated one from moving down the digestive tract. The gastric balloon is placed under mild sedation and does not require any stapling, cutting, or any type of surgery.

Reshape Balloon Placement

Reshape Balloon Placement – Courtesy of Daily Mail, UK

Warning signs and side effects of gastric balloon

 

The warning signs and side effects listed in this section are specific to ReShape Integrated Dual Balloon System. If you had or are planning to get a different type of a gastric balloon, please contact your physician specializing in the type of the gastric balloon you are have or your are planning on getting.

 

Common side effects of gastric balloon include:

 

  • nausea, vomiting, and stomach cramping – especially during the first week following the procedure – are a normal side effect following gastric balloon placement and removal
  • Feeling of bloating – especially after weight loss
  • Limited stomach capacity causing patients to have to take small sips when drinking and smaller bites when eating

Warning signs and serious complications of gastric balloon include events largely related to balloon rupture. Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications. Each patient should be instructed regarding signs and symptoms of balloon deflation, gastrointestinal obstruction, ulceration and other complications which might occur. The most common sign of gastric balloon deflation is the presence of blue green dye in urine, increase in appetite, and stalled weight loss. Patients are urged to contact their physician as soon as possible if the suspect their gastric balloon to be ruptured. If not treated immediately, ruptured balloon can be passed down the digestive tract causing bowel obstruction and infection. Signs of infection are usually nausea, cramping, fever, vomiting and diarrhea.