Spatz3 Adjustable Balloon

How does it work?

The Spatz3 Adjustable Balloon is a medical grade, saline-filled gastric balloon that rests in the stomach cavity and decreases appetite by occupying approximately a third of the stomach volume.

In addition, with the gastric balloon in place, the stomach empties more slowly, keeping you feeling full longer.

The Spatz3 Adjustable Balloon is inserted during an outpatient procedure that takes about 20 minutes and is performed under sedation. No incisions or hospitalization required. You’ll be home within a few hours.

The Spatz3 Adjustable Balloon is a tool to aid weight loss and will yield the best result when used in conjunction with diet, exercise and a behavior modification program.

The amount of weight you lose will depend on how closely you follow your diet and adopt long-term lifestyle changes. Average weight losses of 16 kg after 6 months and 25 kg after 12 months are reported with the Spatz3 Adjustable Balloon. Depending on your initial weight and your motivation, significantly greater weight losses have been achieved.

Can it work for me?

Over the past 30 years, more than 100,000 people have lost an average of 10-30 kg of weight with the assistance of gastric balloons. Your individual motivation and willingness to comply with dietary changes and behavior.

modification are important factors in your ultimate success with the Spatz3 Adjustable Balloon.

Patients with certain medical conditions cannot be approved for Spatz3 Adjustable Balloon implantation. The decision to undergo gastric balloon therapy must be made in consultation with a qualified physician.

What To Expect

Prior to Gastric Balloon Insertion

To ensure maximal success, your doctor will determine exactly which pre-screening assessments will be required in your case. Pre-screening assessment may include any or all of the following: a patient information profile, dietary evaluation, psychological consultation, routine blood tests, chest X-ray and ECG.

To prepare for the insertion, you will be instructed to fast from midnight prior to your procedure.

Insertion of the Gastric Balloon

Most patients have the gastric balloon inserted while under sedation, unless there is a specific clinical reason to proceed differently. The gastric balloon is inserted endoscopically and placed in the stomach, then inflated with saline. You will be discharged and able to return home within an hour.

The gastric balloon can easily be deflated and removed, if required, at any time.

Adjustment Procedure

If you experience excessive or prolonged nausea, vomiting or pain, the gastric balloon volume can be diminished with an adjustment procedure.

If your appetite increases, or weight loss plateaus or ceases, the gastric balloon volume can be increased with an adjustment procedure.

The gastric balloon volume can be changed with a 15-minute endoscopy procedure. Preparation requires a liquid diet for 3 full days prior to adjustment followed by fasting from midnight the night before.

Adjustments will be made while you are under sedation. As with the insertion procedure, you’ll be discharged within an hour.

Removal Technique

After 12 months, the gastric balloon will be removed with endoscopy, again with the help of sedation. Preparation requires a liquid diet for 3 full days prior to the procedure followed by fasting from midnight the night before. Following removal, you will be discharged within an hour.

Risks and Complications

With any surgical or medical intervention there are always going to be risks and some complications. Although many are very rare and every effort is made to reduce or prevent them, you need to be fully aware of their existence in order to make an informed decision. Among the risks are:

  • Nausea and vomiting
  • Bloating
  • Peptic ulcer
  • Diarrhea
  • Reactions to sedation
  • Aspiration Pneumonia
  • Esophageal/gastric perforation
  • Gastro-Esophageal reflux
  • Deflation of the gastric balloon and intestinal obstruction

Post Insertion

For the first 3-5 days following gastric balloon positioning, you may feel uncomfortable and nauseated. This will pass and every effort will be made to reduce these side effects. You will be offered medication to settle your stomach and relieve the nausea. It is important to take the medication prior to the onset of nausea.

For the first 3 days after insertion, you will begin a liquid-only diet, slowly progressing to a semi-solid diet. Within a week, you’ll be able to resume eating normal textured foods.

Along with the gastric balloon, you will be enrolled in a corresponding behavioral modification program. Attendance at these sessions, learning the behavioral modification principles and compliance with them are of paramount importance to your weight loss success.

How It Works

The Spatz3 Gastric Balloon has 2 components:

The Balloon

The Spatz3 Adjustable Balloon is a medical grade, saline-filled gastric balloon that rests in the stomach cavity and decreases appetite by occupying approximately a third of the stomach volume. In addition, with the gastric balloon in place, the stomach empties more slowly, keeping you feeling full longer.

The Inflation Tube: Unique to the Spatz3 Gastric Balloon

The unique retractable inflation tube allows your doctor to make adjustments to the volume of your balloon while it remains in your stomach. These volume adjustments increase your chances of achieving success with the balloon.

Advantages of the Spatz3 Adjustable Intragastric Balloon over Ordinary Intragastric Balloons

Approved for one year implantation – twice as long as other gastric balloons!

Spatz is proud to announce its approval for one year intragastric balloon implantation. Due to the risk of complications, other gastric balloons are restricted to 6 months of use. The Spatz3 balloon is a unique, high-quality injection molded balloon. In our studies, the Spatz3 has been proven safe enough to remain in the stomach for 12 full months. This success allowed the regulatory authorities to approve an extension of implantation of the Spatz3 balloon from 6 months to one year.

Our clinical trials have reported an additional 7-12 kg weight loss following volume adjustments.1-4

It is important to be aware that the first few days with an intragastric balloon can be uncomfortable. You’ll need to overcome unpleasantness and nausea while your body adjusts to the balloon. In a small number of cases, despite real determination, some patients are just unable to manage. Instead of abandoning the patient’s investment in their weight loss program, the physician can perform a simple endoscopy to remove some fluid from the balloon. This adjustment allows the treatment to continue. Our studies have reported improved tolerance of the balloon, yet weight loss continues after a reduction of the balloon volume. Later, when the patient’s body has acclimated, another endoscopy procedure can be performed to increase the gastric balloon volume.

Adjustability is just one of the features that make the Spatz3 Adjustable Balloon System a clear standout in the growing field of non-surgical weight loss therapies.

Adjustability

As the name implies, the Spatz3 gastric balloon is adjustable in size – even once it’s been placed inside your stomach. After the first months of successful weight loss, your body acclimatizes to the balloon and standard intragastric balloons begin to lose their effectiveness. In fact, studies have shown that, with today’s gastric balloons, 80% of the weight loss occurs in the first three months.

Simply leaving the gastric balloon in longer does not increase weight loss significantly. Physicians have told us that they would like to be able to add volume to the balloon – to “top it off”, encouraging similar levels of weight loss in the coming months. The unique Spatz3 Adjustable Balloon System allows the physician to perform a simple 15-minute outpatient procedure to add fluid to the balloon at any time. Each volume addition produces a fresh effect, facilitating renewed weight loss and increasing your chances for weight loss success.

Easier to Use

The easier a product is for the physician to use, the safer it is for the patient. The Spatz3 Adjustable Balloon System has a unique insertion facilitator to ease the insertion procedure for physicians, resulting in a safer procedure for you.

  1. Brooks J, Kowalczyk Z, Al Awadhi S, Al Falasi M, Mason J, Bene L, Machytka E, El Asala S, Puig-Divi V. First reports of the new Spatz 3 adjustable balloon system. UEG13-LB-5540
  2. Brooks J, Srivastava ED, Mathus-Vliegen EMH. Adjustable Intragastric Balloons: One-year results in 73 consecutive patients in the UK. OBSU-D-13-00254
  3. Machytka E, Brooks J.Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct; 21(10):1499-507.
  4. Lopez-Nava G, Gostout C, Nebreda J, Brooks J. A new adjustable intragastric balloon: the first patient experience in Spain. UEGW11-5345

FAQ

How do intragastric balloons work?

The saline-filled balloon occupies about one third of the stomach cavity. This decreases the quantity of food that the stomach can hold. The presence of the balloon also interferes with stomach emptying, such that food stays in the stomach longer. Together, these effects promote diminished appetite and early satiety with lesser food quantities.

How is the Spatz3 balloon different than other intragastric balloons?

The Spatz3 intragastric balloon has several advantages.

  1. 1) It is adjustable, which means it is dynamic and can be changed as your needs and appetite changes.
  2. 2) It is approved for 1 year implantation time. The first balloon to have both of these advantages.

Leaving a balloon in the stomach longer without changing the volume of the balloon is not likely to produce greater weight loss. The longer implantation time also gives you longer behavior modification time which yields longer lasting behavioral changes.

How is the Spatz3 balloon procedure performed?

A standard endoscopy with sedation is performed. If no abnormalities are found, the gastric balloon with anchor is inserted via the mouth into the stomach – all under sedation. Once inside the stomach, the balloon is filled with sterile saline through a small filling tube attached to the balloon.

Placements of the balloon and adjustment procedures take approximately 15- 20 minutes, after which patients are monitored for approximately 1 hour and then sent home.

Who is the intragastric balloon suitable for?

The intragastric balloon is designed to assist with weight loss in people who ideally have 10 kilograms or more of weight to lose, or those individuals with a BMI greater than 27.

It is also used for people who are not suitable candidates for weight loss surgery. The use of the balloon may assist in reducing weight prior to any surgery, therefore reducing the risks associated with surgical procedures. The Spatz Gastric Balloon is the ideal noninvasive alternative to gastric bypass surgery, lap band surgery and other bariatric surgeries.

How long does the Spatz balloon stay in the stomach?

The Spatz Intragastric Balloon can be placed in the stomach for a twelve month period.

While you are using the balloon, your physician will prescribe a course of oral medication to reduce your stomach acid (this may reduce the possibility of stomach irritation and damage to the balloon).

How much weight can I lose with the gastric balloon?

It is important for you to understand that the intragastric balloon is a tool to aid weight loss and must be used in conjunction with diet, exercise and a behavior modification program. The amount of weight you lose and maintain will depend on how closely you follow your diet and adopt long-term lifestyle changes. Average weight losses of 16 kg over 6 month periods have been reported with the Spatz stomach balloon. Average weight losses of 25 kg have been reported over 1 year with the Spatz balloon.

What are the possible side-effects associated with the intragastric balloon?

It is very likely that the presence of the balloon in the stomach will cause nausea, vomiting or abdominal pain, of varying intensity, for a few days after placement. Your physician will prescribe medication to help minimize these potential effects, but these can persist during the first week.

There exists the possibility that you will lose only a small amount of weight or lose no weight at all while using the balloon. Of course, your commitment to dietary and behavioral changes will determine your success.

There is also a chance that unhealthy, uncontrolled weight loss will occur and create adverse health consequences. Be sure to speak with your physician about this.

Will I be able to feel the balloon in my stomach?

There will be discomfort during the first few days after the procedure. From then on, the intragastric balloon will give you a feeling of fullness.

How long will it take to recover after the procedure?

You should plan at least three days of inactivity to recover from the procedure. You will be able to resume normal activity sooner or later than this depending on how quickly your body adjusts to the stomach balloon.

Does the gastric balloon require frequent visits to my doctor after the procedure?

The follow-up program is critical to success of the balloon and in learning new lifestyle skills. You will meet with your Doctor several times over the course of the year. It is most important to meet with your dietician/nutrition counselor at least twice-a-month while the gastric balloon is in place. Patients who follow up weekly have greater success! During this time your progress will be evaluated and you will learn valuable principles of health, nutrition and exercise that will provide you a foundation for long-term success.

How often will my balloon volume be adjusted?

When you feel less balloon effect (resumption of appetite) or when weight loss diminishes, you can have your balloon volume increased. Gastric balloon effect diminishes after 2 to 4 months, which is when you can expect to have your first balloon adjustment. It can be done as often as needed with a simple endoscopy procedure. The balloon volume can also be decreased in cases of balloon intolerance.

How will the intragastric balloon be removed?

The Spatz3 Intragastric balloon is removed in the same way it was placed, via the esophagus and mouth using endoscopy under sedation. The balloon can be deflated using the inflation tubing or via puncture using a needle catheter.

Will the intragastric balloon limit my activities?

During the first week of the procedure you should not plan any heavy activities. Once your body has adjusted to the balloon you can continue your normal activities. Starting a regular exercise program is highly recommended and will improve your success.

Can I drink alcohol?

Alcohol in small amounts is fine. Alcohol consumption raises the risk of ulceration.

Can I eat anything I want? Are there any food restrictions?

You will not feel like eating as much as you used to. In addition, if you eat fatty foods or sweets, you may feel unwell. Excessive overeating while the gastric balloon is in place can prove dangerous.

The results may vary.

Our team

Dr. Arnoldo Cavazos

Pneumologist

 

Alondra Montalvo Sánchez

Administrative Assistant

 

Anabely López Rodriguez

Coordination of patients

 

Oscar Salas MD

Cardiologist

 

Rubén Aguirre Gutierrez MD

Endoscopist

Spanish

Elda Maltos Tamez MD

Anesthesiologist

Spanish

Spanish