About the REALIZE® Band

The REALIZE® Adjustable Gastric Band is a safe, effective medical device designed to help people who are morbidly obese lose excess body weight and improve their health. The REALIZE Band has been in use worldwide for more than 20 years. Benefits of the REALIZE Band include significant weight loss and improvements in overall health and quality of life.

How it works
REALIZE Adjustable Gastric Banding is considered a restrictive bariatric procedure, because it limits the amount of food that can be eaten at one time.

The band wraps around the upper part of the stomach, dividing the stomach into two sections: a small upper pouch, which holds about ½ cup of food, and a larger lower stomach. (A normal stomach holds just over 6 cups of food.) The inner side of the gastric band that fits around the stomach is lined with a soft balloon.

After surgery, the band balloon is filled with a safe fluid called saline to increase the tightness of the band around the stomach. The tightness of the band (also referred to as restriction) affects how much food can be eaten and the length of time it takes for food to move from the upper stomach to the lower stomach.

A smaller upper stomach pouch lets patients eat less food at a sitting, and stay satisfied longer. Eating less enables the body to stop storing excess calories and start using its fat supply for energy.

The injection port
The REALIZE Band is connected to the REALIZE Injection Port through soft, plastic tubing. The port is fastened inside the abdomen about 2 inches below the rib cage on the left or right side. The port has a very low-profile design so that it is barely visible under the skin, even after significant weight loss. Saline is injected into or removed from the band through the port. This process is called an adjustment.

Band adjustments
Every patient is different, and each requires individualized amounts of saline to ensure a feeling of satiety after meals, and to ensure that weight loss is occurring at a healthy rate of 1 to 2 pounds per week.

At the time of surgery, the REALIZE Band does not contain any saline. A small amount of restriction is achieved even with an empty band. The stomach needs time to heal from surgery, usually 4 to 6 weeks, before a band adjustment can be performed. Adjustments are a regular part of life after surgery. They take 5 to 10 minutes in a doctor?s office, clinic, or hospital, and do not require surgery.

Weight loss results
Bariatric surgery typically results in a weight loss of 25% to 35% of total body weight, which is well maintained over the first decade.1

In a 3-year U.S. clinical trial, patients with a REALIZE Band lost an average of 40% of their excess weight at 1 year and 43% at 3 years.2

Losing weight isn?t guaranteed after bariatric surgery. Following an exercise routine and eating a proper diet, according to doctor?s guidelines, play a significant role in successful weight loss. Patients who experience the best results from a restrictive procedure are those who learn to eat slowly, eat less, and adhere to an exercise program.

Health benefits
A 3-year U.S. clinical trial showed resolution of the following co-morbid conditions:

  • Type 2 diabetes in 48.7% of patients2
  • High cholesterol in 78.3% of patients2
  • Sleep apnea problems in 94.6% of patients2

In the same trial, patients saw a 22% increase in good cholesterol (HDL) 36 months after surgery.2

Learn more about the benefits of the REALIZE Band.

Quality of life benefits
Clinical studies of laparoscopic bariatric surgery patients found that they felt better, spent more time doing recreational and physical activities, benefited from improved productivity and economic opportunities, and had more self-confidence than they did prior to surgery.1

Placed during a minimally invasive procedure
The REALIZE Band is placed during a laparoscopic procedure, which is performed using small incisions. The procedure does not involve cutting or stapling of the stomach, and does not alter the digestive system. Laparoscopic surgery typically results in shorter hospital stays, faster recovery, smaller scars, and less pain than open surgical procedures. Learn more about the procedure to place the REALIZE Band.

Because gastric banding surgery does not permanently change the anatomy of the stomach and intestines, the REALIZE Band can be removed if necessary. People who have had the band removed, and do not stick with a healthy eating regimen usually gain weight.

Criteria to help evaluate surgical options

Consider the following factors when evaluating weight loss treatment options:

  1. Safety. The safety of a procedure can be indicated by leak rates, complication rates, mortality rates, or the need for secondary procedures to resolve problems.
  2. Effectiveness. The effectiveness of a weight loss procedure can be measured both in short-term weight loss (1 year) and long-term weight loss (3 years or more). Many weight loss procedures have data on short-term results. However, long-term results are a better indicator of a procedure?s effectiveness. Improvements in obesity-related health conditions after surgery, such as type 2 diabetes, high cholesterol, high blood pressure, and sleep apnea, are also good indicators of effectiveness.
  3. Support. Experts agree that bariatric patients need help to lose weight and keep it off, so it is important to be well supported before and after surgery. The surgeon and staff at the surgeon?s office play a vital role in providing support. As such, finding out how they support their patients is important. Bariatric clinics can support their patients in several ways, such as offering support groups for patients and providing access to counselors, dietitians, and nutritionists. Talking with the surgeon?s staff and patients is a good way to find out how much support is offered by the bariatric clinic. In addition, it is important for all bariatric patients to speak with their own friends and family about their willingness to provide encouragement and support.

REALIZE Band patients have an additional support tool available to them, called the REALIZE mySUCCESS® Program. Those interested in the REALIZE Band are advised to ask their bariatric team how REALIZE mySUCCESS® is used as part of a weight loss plan.

REALIZE mySUCCESS® is a Web-based clinical support tool designed to help patients achieve and maintain a healthier weight. It was developed in collaboration with bariatric surgeons, dietitians, and behavior modification specialists. REALIZE mySUCCESS® was designed to meet the specific needs of REALIZE Band patients, such as helping patients progress from a liquid diet to solid foods, finding the right band fit, and keeping patients and surgeons connected so that surgeons can provide patients with personal guidance when necessary. A select set of features is available to anyone before surgery. After surgery, the full features and tools are available only to REALIZE Band patients. Learn about ongoing support after surgery.

Qualifications for REALIZE Band surgery
According to the guidelines established by the National Institutes of Health, weight loss surgery may be an option for people who are:

  • 100 pounds or more above their ideal body weight and have a Body Mass Index (BMI) of 40 or more, or a BMI over 35 in addition to serious co-morbid conditions, such as type 2 diabetes, high blood pressure, and high cholesterol
  • At least 18 years old
  • Motivated to follow a new diet and exercise regimen after surgery

In many cases, patients are required to prove that their previous weight loss attempts have been unsuccessful before bariatric surgery will be approved.

Patients should always discuss obesity treatment options with a doctor. Only the patient and his or her doctor can decide whether gastric banding is an appropriate option for long-term weight loss.

For more information about the REALIZE Band, please visit our sponsor?s Web site, www.REALIZE.com, or request a free REALIZE Band brochure.

Learn more at an information seminar
People considering bariatric surgery are encouraged to attend an information seminar to learn about their surgical options. Seminars are usually conducted by an experienced bariatric surgeon or by members of a bariatric clinic who can thoroughly explain the procedure, discuss the risks and benefits, and answer questions. It is also common for weight loss surgery patients to be there to share their experiences. No commitment is required. Use this seminar finder or call 1-866-300-1818 to locate a seminar.

Patients are often required to attend a surgeon?s seminar before the surgeon will hold a one-on-one consultation to discuss the patient?s surgical options.

© Ethicon Endo-Surgery, Inc. 2009 DSL#09-1077

This information is provided by Ethicon Endo-Surgery, Inc. Ethicon Endo-Surgery is not responsible for any other content on this Web site. The REALIZE® Adjustable Gastric Band is used in morbidly obese adult patients for significant long-term weight loss. It may not be right for individuals with certain digestive tract conditions. All surgery presents risks. Weight, age, and medical history determine your specific risks. Ask your doctor if bariatric surgery is right for you. 

For more information, visit the official site for the REALIZE® Adjustable Gastric Band, www.REALIZE.com, or call 1-866-REALIZE.

Footnotes:

1 Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724-1737.

2 SAGB PMA. P070009.

 

 

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