The Intragastric Balloon is FDA Approved.

In the summer of 2015 the FDA approved the use of intra gastric balloon for weight loss in the United States.  The Gastric Balloon was approved as a weight loss alternative to diet, exercise and surgery. It is approved for patients with a Body Mass Index (BMI) between 30 – 40 Kg/m² with or without co-morbidities like high blood pressure, diabetes, sleep apnea or other obesity related conditions.

The gastric balloon is placed endoscopically without the need of surgery and in most instances under sedation without the need for general anesthesia.  In experience hands the gastric balloon can be placed safely in 10-15 minutes and the patient is discharge home the same day. The gastric balloon has to be removed after 6 months to prevent complications like ulcers, perforation, migration or obstruction.

The FDA approved two types of gastric balloons in the United States.  The ORBERA® Single Gastric Balloon and the ReShape™ Integrated Dual Gastric Balloon.  Both are silicone gastric balloons that occupy a large portion of your stomach to promote earlier and longer satiety with subsequent weight loss.  Many other gastric balloons are available internationally but in the United States only the above mentioned gastric balloons are approved for used.  Approximately 220,000 gastric balloon has been placed worldwide with good results and low complication rate.

How Much Weight Loss?

A recent studies of gastric balloon showed an average of 36-40% EWL (Excess Weight Loss) versus 10-15% EWL in the control group. Both groups were supported by diet modifications and exercise and followed by 12 months. More than 70% of the weight loss at six months was maintained at 12 months.

As expected with the weight loss achieved many patients also benefited of resolution or improvement of co-morbidities related to obesity.  This improvement was greater on the gastric balloon group.  There was also a significant improvement in quality of life.

Adverse Events?

The most common adverse events were seen in the gastric balloon group. The top three adverse events were Nausea (87%), Vomiting (76%) and Abdominal Pain (58%).  Most of this symptoms improved after the first 72 hrs.  In other worldwide studies a 0.02 – 10% of gastric ulcers and a 0.31% of gastric balloon deflation has been observed.  Procedure related mortality worldwide is < 1%.  Some of the mortalities were associated to gastric perforation. Gastric perforations were mainly associated with prior history of gastrointestinal surgery.

Early retrieval is seen in approximately 15% of the patients due to adverse events or intolerance.  One of the studies found that lower volume fill improved discomfort and increased device retention specially in shorter patients.

Are You a Candidate for the Gastric Balloon?

Currently the gastric balloon in the US is approved for patients with a BMI of 30-40 Kg/m² with or without  co-morbidities.  Most institutions will limit the age to 18-65 and will request a nutritional and psychological evaluation.  Other evaluations could be warranted base on the patients clinical history.

Patients with prior gastric surgery are not candidates for gastric balloons as they have higher chances of complications.  Patients with Inflammatory Bowel Disease, prior history of bowel obstruction, gastrointestinal bleeding, dysmotility or delayed gastric emptying are currently been excluded by most surgeons. Also patients with eating disorders or other significant psychological conditions are excluded.

What to Expect Before and After the Procedure?

Patients are required to be on a liquid diet 2-3 days before surgery. All patients will also be started on a PPI (anti-acid medication) for 2 weeks before the procedure and they will continue on it until 2 weeks after removal.

Specific instructions related to diet after the procedure are given to patients and family members that will care for the patient. The follow up is also discussed with the patient, many institutions will schedule the follow up visits and the retrieval date in advance in an attempt to improve patient compliance.  Is important to clearly explained to the patient that the gastric balloon has to come out after 6 months to minimize chances of complications.  Some patients will show resistance to remove the device because good weight loss and worries about weight regained.

Most patients will experience nausea, some vomiting and abdominal discomfort that usually resolves within the first 3 days after the procedure.  Patients are send home on nausea, acid and spasm medications.  A liquid diet will be needed for 7 days after the procedure.  A low calorie, high protein diet follows.  In order to obtained the best results diet and exercise is a requirement.  The gastric balloon is a weight loss tool, it will not do all the work.  The patient should be able to eat normal food, you might not be able to tolerated certain foods.  Some experts in the field recommend not swallowing bubble gum.

Traveling on an airplane is acceptable as soon as the patients feels back to normal. Child bearing age females will undergo a pregnancy test prior to the procedure.  If the patient becomes pregnant after the gastric balloon is placed removal during the second trimester is usually recommended.

Early Removal Situations

As mentioned above pregnancy during treatment is a indication for early removal. In most situations removal during the second trimester is ideal.  If severe nausea and/or vomiting developed during the first trimester requiring hospital admissions or treatment for dehydration, earlier removal might be needed.

Patients needing major surgery, especially abdominal surgery should be consider for early removal.  The specific situation will be discussed with the patients, the anesthesiologist and the surgeon.

Balloon deflation or any trouble with the balloon itself also mandates early removal.  Balloon deflation within the 6 months window is rare but patients that notice any changes in terms of loss of satiety, increase hunger and/or weight regain should suspect balloon deflation.

How Much the Gastric Balloon Cost?

At the time of this publication the gastric balloon is not covered by any insurance carrier.  Most institutions  cash payment fees include the placement and retrieval.  The amount varies by institutions but in average you can expect to pay around 6 to 8 thousand dollars.  The retrieval fee is charged prior to the placement in an attempt to increase patient compliance with the FDA guidelines.

At my institution the price of the gastric balloon is 7,800 dollars. As mentioned above the price includes the placement, removal and 6 months follow up.

Gastric balloons are not new, but advances in technology are making this procedures safer and a suitable alternative to medical and surgical weight loss.

If you made it to the end of this post I will like to thank you for your time and interest.  Please leave a comment below or share this post on social media if you think it will be beneficial to family and friends. Together we can make a difference in somebody’s weight loss struggles.