The REALIZE™ Adjustable Gastric Band (REALIZE Band) is a weight loss device that helps a person eat less and lose weight. It promotes weight loss in a healthy manner and is considered a safe and effective treatment for morbid obesity. It is placed into the body by a bariatric surgeon using minimally-invasive laparoscopic surgery. The device consists of a silicon band, tubing, and an injection port. This method of weight loss does not involve any cutting, stapling, or rerouting of the stomach or intestines and does not alter the body's natural digestive system.

Overview

The REALIZE Band is manufactured by Ethicon Endo-Surgery, a division of Johnson & Johnson. It was originally marketed outside of the United States as the Swedish Adjustable Gastric Band (SAGB), where it has been available commercially since 1996. It entered US clinical trials in 2003, and was approved in 2007 by the FDA for use in the United States.

• The REALIZE Band was the first gastric band to be approved for use outside of the United States, but the second gastric band to be approved in the US.

The REALIZE band was developed by Obtech Medical of Switzerland during the 1980's. It was originally placed into the body with open surgery, because laparoscopic surgery was not yet common. As laparoscopic surgery techniques evolved and improved, the band was modified for laparoscopic placement. It has been successfully implanted laparoscopically since 1994. Obtech Medical and the SAGB patent was purchased by Ethicon-Endo-Surgery in 2002. The name REALIZE Band was chosen for marketing in the United States.

The original REALIZE band has undergone a few design changes to improve the overall safety and performance. The newer features were added to reduce the incidence of slips and erosions of the band. Based on patient studies, the slippage rate is low (less than 2 to 3%) and the erosion rate is low (less than 1%).

REALIZE Band Specifications:

• Product material is a strong, flexible silicone
• Size is adjustable to fit various body sizes
• Gastric band liner is a low-pressure smooth inner balloon with a 360 degree fill capacity
• Fill volume is 9cc (1.8 teaspoons)
• Access port is low-profile (½")
• Self-clamping system attaches port to muscle wall

Adjustments

One of the unique features of the adjustable gastric band surgery is the ability to adjust the amount of restriction on the stomach opening. This allows for personalized treatment on a patient to patient basis. The gastric band is usually placed into the body unfilled, to allow the body to adjust to the changes and heal from surgery before further restriction is added.

The first adjustment is made approximately 4 to 6 weeks after surgery. Saline is added or removed from the gastric band with a special needle via the access port that is placed under the abdominal muscle wall during surgery. Special tubing connects the port to the gastric band.

The amount of fills varies between patients, but on average:

• First year: 4 fills
• Second year: 2 fills
• Third year: 2 fills

Patient Support

Patient support has been shown to contribute greatly to the success of weight loss surgery. One of the benefits offered with the REALIZE Band surgery is the patient support program, called REALIZE mySUCCESS. The program provides online access for patients to healthy, band-friendly recipes, a personalized weight loss tracker, integration with a patient's bariatric program, and interactive tools, including a food diary, body image diary, exercise tracker, and daily reminders. The program is instrumental in promoting long-term success after bariatric surgery.

Weight Loss Results

The REALIZE Band helps a person lose excess weight by controlling hunger and restricting how much food can be eaten at any one time. Weight loss occurs at a safe and steady rate, about 1 to 2 pounds per week, with very good long-term results.

According to REALIZE Band patient weight loss results, after the primary bariatric weight loss period of three years:

• Over 80% of patients lost 42% of their excess weight
• 35% of patients lost 50% of their excess weight
• 10% of patients lost 75% of their excess weight

LAP-BAND vs. REALIZE Band

The LAP-BAND and REALIZE Band are the only two types of laparoscopic adjustable gastric bands (LAGB) approved for use in the United States. The method of weight loss and overall results are similar between the gastric bands, but they vary in their construction and design.

Similarities:

• Approach: They promote weight loss by controlling hunger and restricting food intake.
• Results: They have very similar results for excess weight loss, body mass index reduction, resolution of diabetes and hypertension, and rate of complications.
• Adjustment: They both are adjusted via a port that is attached to the abdominal muscle wall.

Differences:

• Port: REALIZE Band has a lower-profile port than the LAP-BAND
• Port Attachment: REALIZE Band uses a self-clamping system and the LAP-BAND is anchored with stitches to attach to the abdominal muscle wall
• Gastric Band: The REALIZE Band has one smooth inner balloon reservoir for the saline solution, whereas the LAP-BAND has seven baffled mini-reservoirs
• Band Size: The REALIZE Band is available in one universal, adjustable size, and the LAP-BAND is made in two different sizes, either standard or large
• Fill Volume: The REALIZE Band has a fill volume of 9cc, and the LAP-BAND is either 10cc for the standard or 14cc for the large

Many bariatric surgeons consider the LAP-BAND and REALIZE Band to be equal in results and that they are both successful bariatric options. Overall, having two gastric band options benefits bariatric patients, as it allows bariatric surgeons to choose the one that is best for a patient based on the patient's size and anatomy.

Ongoing Innovation

REALIZE continues to develop and improve their gastric banding system with a focus on patient safety and comfort. In 2009, the REALIZE Band-C was introduced, designed with the same successful high-volume, low-pressure system as the original band, but with improved design features.

The REALIZE Band-C offers: streamlined, pre-curved design for easier placement; expanded adjustment range to accommodate larger patients; widest band available at 23mm, to decrease slippage potential; radiopaque band and tubing, to enhance visualization under fluoroscopy; and changes to the locking mechanism to ease placement and allow intra-operative repositioning.

Related Articles