Intragastric (Stomach) Balloon Weight Loss Procedure
Dr. Joe Cribbins and Dr. Steve Hamn are bariatric (weight loss) surgeons located in Plano, Texas who have been providing the ORBERA™ intragastric (stomach) balloon weight loss procedure since the Federal Drug Administration (FDA) approval in the United States. The following clinical indications and contraindications were taken from intragastric (stomach) balloon devices previously approved and currently being used in other countries.
Intragastric balloon procedure is an innovative weight loss procedure which involves placing a soft, deflated, silicone balloon placed inside the patient’s stomach through the use of an endoscope. Placement of an intragastric balloon is a non-surgical, minimally invasive procedure that is performed on an outpatient basis. The balloon placement takes only about 20-30 minutes and requires minimal recovery time. The intragastric balloon is approved for use in in the United States, Canada, Mexico, Australia, India and several European and South American countries.
Once the intragastric balloon is endoscopically inserted, the empty balloon is filled with sterile saline. The balloon takes up space in the patient’s stomach, limiting food intake and reducing feelings of hunger. The intragastric balloon remains in place for 6 months, during which time the patient should participate in a behavior modification program and a medically supervised diet. After 6 months, the balloon is removed during another short endoscopic procedure.
Qualifications for the Intragastric Balloon Procedure
The Intragastric Balloon Procedure is ideally suited for patients who:
- Have a BMI of over 27.
- Have been unable to achieve their weight loss goals through diet and exercise.
- Are uncomfortable with, or ineligible for, other types of weight loss surgery.
- Are willing to participate in a medically supervised diet and behavior modification program.
- Are considered to be at least 25 pounds overweight.
Conditions that would prevent a patient from having the Intragastric Balloon Procedure include:
- Previous gastrointestinal surgery
- Any inflammatory disease of the gastrointestinal tract
- Potential upper gastrointestinal bleeding or other congenital anomalies
- Large hiatal hernia or structural abnormality in the larynx or esophagus
- Any condition that would hinder endoscopy
- Unwillingness to participate in the supervised diet and behavior modification program
- Drug or alcohol addiction
- Pregnancy or breastfeeding
- Past or present psychological disorders
- Regular use of anticoagulants, aspirin, anti-inflammatories, or any other gastric irritant
The Intragastric Balloon Procedure is ideal for patients who are moderately overweight and want to begin with a less invasive weight loss procedure. Patients who are ready to start a healthy, new lifestyle that incorporates regular exercise and dietary modifications will benefit greatly from a managed weight loss program. Sustained weight loss is achievable with the assistance of our support team. Our team is committed to your long-term weight loss success.
Initial Visit for Your Intragastric Balloon Procedure
The decision to have an Intragastric Balloon Procedure will be based on several factors:
- Your medical history
- Your weight loss goals
- Previous methods attempted to lose weight
- Your commitment to our team’s Managed Weight Loss Program
- Your comfort level with the Intragastric Balloon Procedure
The Day of Your Intragastric Balloon Procedure
Before your intragastric balloon placement, you should avoid food and liquid for 12 hours, as you will be slightly sedated during the procedure. The deflated balloon will be inserted into your stomach through the mouth, and then filled with a sterile saline. The procedure is generally uncomplicated and lasts 20-30 minutes. You will regain awareness quickly and be monitored until your doctor discharges you (usually a couple of hours). Someone will need to be available to drive you home. You will be given detailed instructions on your aftercare.
After Your Intragastric Balloon Procedure
After the placement of the intragastric balloon, most patients experience some gastric discomfort, nausea, or vomiting for a few days. This is normal, as your digestive system is adjusting to the presence of the intragastric balloon. You will be given medications to help you manage these symptoms.
You will be restricted to a liquid diet for 3 days, during which you should drink plenty of water. Other acceptable liquids include:
- Thin soups or broths
- Foods that should be avoided include:
- Any solid food
- Carbonated drinks
- Ice cream
- Fatty foods
After the first few days, you can transition to semi-solid foods (thicker soups and fruit purees), then gradually to solid foods. The length of time for this transition depends on how your body is adjusting to the process. Don’t rush. Be sure your body is comfortable before you move into the next phase of eating.
As soon as you feel well enough (usually about 2 weeks), you may start the exercise program agreed upon with your doctor before your procedure. You will meet regularly with your support team to receive nutritional training and to monitor your progress. Over the next 6 months, this will be an important part of your successful lifestyle change. For patients following the managed weight loss programs, the average weight loss during the first 6 months is 30-40 pounds.
Removing Your Intragastric Balloon
Removing the intragastric balloon is a similar process to when it was inserted. You should refrain from solid foods for 24 hours and liquids for 12 hours before the procedure, as you will be sedated. First your doctor will remove the sterile saline from the balloon, then the deflated balloon. The process should take 20-30 minutes and you will be observed for a time afterward to ensure that you are able to be released. Someone will need to be available to drive you home.
After the Intragastric Balloon is Removed
The 6 months after the intragastric balloon is removed are critical to your successful weight loss outcome. Our professional support team will work with you every step of the way. We will continue to meet with you on a regular basis, providing support, advice, and answering any questions or concerns that may arise. We are committed to helping you achieve and maintain your weight loss goals, so you can live life to the fullest enjoyment with your new body.
If you would like to learn more about weight loss, please contact our office at 214-501-1333.
US Pivotal ORBERA™ Clinical Trial
Dr. Cribbins and Dr. Hamn are bariatric surgeons who have been following the FDA investigation and FDA approval of the ORBERA™ Intragastric Balloon Procedure, which has been used internationally for years as a clinically accepted weight-loss treatment. In May of 2015, Apollo Endosurgery, Inc., a leader in minimally invasive endoscopic surgical products for gastrointestinal procedures, presented results from the ORBERA™ Pivotal Trial. During the trial, patients with a BMI (body mass index) of 30-40 were randomly placed in either a treatment group or a control group in a 1:1 ratio. The treatment group (125 patients) received the ORBERA™ Intragastric Balloon and participated in a 12-month behavior modification program. The control group (130 patients) participated in the 12-month behavior modification program without receiving the ORBERA™ Intragastric Balloon. The treatment group attended regular office visits throughout the 12-month period, having the balloon removed after the 6th month. 78.4% of the treatment group and 71.5% of the control group completed the study.
Findings From the ORBERA™ Intragastric Balloon Pivotal Trial
During the clinical trial, ORBERA™ Intragastric Balloon recipients showed significantly more weight loss than the control group. Even after removal of the balloon, the ORBERA™ patients showed improvement in weight-related quality of life and improved eating habits. Details of the ORBERA™ Intragastric Balloon Pivotal Trial include:
- At 6 months, the ORBERA™ patients had a mean of 40% Excess Weight Loss (EWL). 72% of ORBERA™ patients had at least 25% EWL.
- At 6 months, the ORBERA™ patients lost over 2 times the amount of weight lost by the control group.
- At 6 months, the ORBERA™ patients had a mean Total Body Weight Loss (TBWL) of 10.54%. TBWL for the control group was 4.71%.
- At 12 months, the ORBERA™ patients lost significantly more weight than the control group, and maintained the weight loss after the removal of the balloon.
If you would like to schedule an appointment with one of our physicians at the Texas Center for Obesity Surgery in Plano, please complete an online appointment request or call our office at 214-501-1333.