Orbera Stomach Balloon

WHAT IS ORBERA™ STOMACH BALLOON

Orbera gastric balloon is placed endoscopically – it does not require any incisions or surgery. As a completely non-invasive procedure, Orbera is perfect for patients who have exhausted all traditional methods of weight loss, but are not ready for a more invasive procedure such as the lap-band or gastric sleeve.

Orbera Gastric Balloon - Inflated and Deflated

Orbera is a soft yet durable silicone balloon intended to help patients to lose weight over a period of six months. Orbera is placed endoscopically, which means it’s a great solution for patients who are not willing or ready for a minimally-invasive weight loss surgery.

Similar to a lap-band surgery, stomach balloon is recommended to those with a BMI between 30 and 40. The device works by filling space in the stomach and limiting its capacity to hold large portions. Patients who decide to undergo Orbera procedure feel full faster and eat less, which allows them to lose weight easier than if they tried on their own.

The Orbera intragastric balloon can hold anywhere between 400 and 700 ml of fluid. Depending on how big your stomach is, the surgeon will decide how much saline is needed. The intent is for the balloon device to occupy approximately two thirds of the stomach’s capacity.

Orbera™ Placement Step-by-Step

  1. Endoscope and filling tube with the balloon are led down the esophagus*
  2. The filling tube with an Orbera balloon are positioned in the stomach
  3. The Orbera balloon is filled with saline fluid
  4. The filling tube is removed closing the balloon
  5. The endoscope is removed

More Details About Orbera Placement

Even though Orbera is done noninvasively, to prevent potential discomfort patients are mildly sedated before the procedure or fully anesthetized if requested. Once the patient awaiting Orbera placement is sedated, the physician will guide an endoscope and a filling tube with an attached intragastric balloon via the patient’s mouth, down the esophagus, and into the stomach. While guided down into the stomach, the balloon is deflated and wrapped around the filling tube.

After the Orbera stomach balloon is well positioned, the surgeon proceeds to fill the balloon with saline 60 ccs at a time. When the surgeon determines that the balloon occupies the optimal amount of space in the stomach, he pulls out the filling tube which effectively seals the balloon. Finally, the endoscope is removed as well and the patient is transferred to recovery. In total, it takes approximately 20 minutes to half an hour to perform the Orbera procedure.

What is the recovery after Orbera™ gastric balloon?

After Orbera placement, you will be taken to the recovery room. It usually takes about two hours before patients are ready to return home. Because the procedure is performed under anesthesia, we ask our patients to have someone available to take them home after the procedure. With no cutting or stapling involved, patients undergoing Orbera can go back to their regular activities as soon as the next day after the procedure. 

LIMITATIONS ON PHYSICAL ACTIVITY

After the balloon implantation, patients may experience a feeling of fullness, and during more vigorous activities, movement of the balloon.  In the first weeks following the procedure, balloon’s movement may cause a discomfort and/or nausea. To prevent that from happening, during your first week after getting the Orbera we advise you to limit strenuous activity and let your body get used to the gastric balloon.

SIDE EFFECTS

Initial side effects of the gastric balloon, such as nausea, can be prevented or significantly decreased with appropriate medication. DayOne Health stomach balloon patients receive medication to counteract these side effects while still in a recovery room. Balloon patients are also provided with prescription refills for the weeks following the procedure.

Is there a special diet related to stomach balloon procedure?

As a DayOne Health patient, you will have an unlimited access to our bariatric dietitian trained in gastric balloon’s best diet practices. Diet support will be provided both prior to the gastric balloon placement and up to one year after the procedure.

Diet before balloon insertion

Patients who are interested in the gastric balloon, will be asked to undergo a week of liquid diet prior to the implantation of the device. Over the period of four weeks after the procedure, you will be asked to slowly progress your diet from liquids to regular solid meals.

Diet after balloon placement

During your participation in our gastric balloon weight loss management program, you will learn how get the most out of your balloon, and how to modify your habits to succeed after it’s removed. Most dietary restrictions during your time with the gastric balloon will pertain to limiting:

 portion sizes

 starchy carb intake

 acid promoting foods

What are the side effects of Orbera™

gastric balloon?

Immediately following the procedure you may feel nauseous or even need to vomit. This is normal, and as mentioned, the symptoms may persist for the first week after the procedure. Here are some side effects experienced by patients immediately following the Orbera procedure. Listed gastric balloon side effects should resolve within the first week after the implantation of Orbera device, but in some cases, the side effects spontaneously reappeared in later months and resolved on their own soon after.

Orbera side effects - statistics

Gastric balloon side effect prevalence, as reported in Orbera clinical study:

  • Nausea – reported by 87% of patients   
  • Vomiting – reported by 76% of patients
  • Abdominal pain – reported by 58% of patients
  • GERD – 30% of patients

Nausea after Orbera

In 90% of patients all gastric balloon side effects when present, were reported as mild to moderate. However, when looking at these statistics patients should have in mind the fact that patients participating in the clinical study did not receiving any antiemetics (anti-vomiting and nausea medication) during the trial. Patients who currently decide to undergo the stomach balloon procedure, are provided with medication that significantly decreases the prevalence of gastric balloon side effects.

How is Orbera™ gastric balloon removed?

  1. Endoscope is led down the esophagus
  2. An aspiration needle with tubing is inserted down the working channel of the endoscope
  3. Gastric balloon is punctured with an aspiration needle
  4. Orbera is deflated via aspiration needle tubing
  5. The aspiration needle is removed and grasper is led down the endoscope
  6. Gastric balloon gets pulled out with an endoscope via esophagus

More Details About Orbera Removal

Orbera gastric balloon has to be removed from the stomach six months after implantation. The removal will take approximately 30 minutes and will be performed under a full anesthesia by a trained bariatric surgeon. Like the placement of gastric balloon, Orbera removal is performed endoscopically i.e. via the mouth. During the removal procedure, the surgeon will lead the endoscope down the esophagus. Once the endoscope is in the stomach, the surgeon will insert the aspiration needle down the endoscope’s working channel. Next, the bariatric surgeon will puncture the Orbera and insert the needle into the stomach balloon to suck out the fluid. After complete deflation the surgeon will use a grasper to retrieve the balloon. Then, he will start to slowly retract the endoscope and pull the deflated balloon out via the esophagus.

Patients who decide to undergo the stomach balloon procedure must agree to the balloon’s removal at the end of the six months period. Following the gastric balloon removal, you will lose the feeling of fullness you’ve had when the balloon was present and that is why it is important that you stay in touch with your bariatric dietitian for at least six following months. At DayOne Health we provide our patients with dietary support and follow up care for a whole year following the original stomach balloon procedure.

Important ORBERA™ Intragastric Balloon System Safety Information:

The ORBERA™ Intragastric Balloon System is a weight loss aid for adults suffering from obesity, with a body mass index (BMI) ≥30 and ≤40 kg/m2, who have tried other weight loss programs, such as following supervised diet, exercise, and behavior modification programs, but who were unable to lose weight and keep it off.

To receive ORBERA™ you must be willing to also follow a 12-month program, beginning with the placement of ORBERA™ and continuing for 6 months after, that includes a healthy diet and exercise plan. If the diet and exercise program is not followed, you will not experience significant weight loss results; in fact, you may not experience any weight loss.

Losing weight and keeping it off is not easy, so you will be supervised throughout this program by a team of physicians, physiologists, and nutritionists. This team will help you make and maintain major changes in your eating and exercise habits.

ORBERA™ is placed for no more than six months. Any time that the balloon is in the stomach for longer than six months puts you at risk for complications, such as bowel obstruction, which can be fatal.

Some patients are ineligible to receive ORBERA™. Your doctor will ask you about your medical history and will also perform a physical examination to determine your eligibility for the device. Additionally, at the time of placement, the doctor may identify internal factors, such as stomach irritation or ulcers, which may prevent you from receiving ORBERA™.

You must not receive ORBERA™ if you are pregnant, a woman planning to become pregnant within six months’ time, or breast-feeding.

Complications that may result from the use of ORBERA™ include the risks associated with any endoscopic procedure and those associated with the medications and methods used in this procedure, as well as your ability to tolerate a foreign object placed in your stomach. Possible complications include: partial or complete blockage of the bowel by the balloon, insufficient or no weight loss, adverse health consequences resulting from weight loss, stomach discomfort, continuing nausea and vomiting, abdominal or back pain, acid reflux, influence on digestion of food, blockage of food entering the stomach, bacterial growth in the fluid filling the balloon which can lead to infection, injury to the lining of the digestive tract, stomach or esophagus, and balloon deflation.

Important: For full safety information please visit orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.

CAUTION: Rx only.