Adjustable Band Comparison
Comparison Between Brands of Laparoscopic Adjustable Gastric Bands: Lap Band versus Realize Band
To understand if there are any significant differences between the two brands of Laparoscopic Adjustable Gastric Bands (LAGB) currently available in the United States it is important to go back and review the history of how the technique for LAGB insertion and the bands themselves have evolved. The two current brands of LAGB available are the Lap Band© manufactured by Allergan and the Realize Band© manufactured by Ethicon Endosurgery Inc.
The LAGB’s have evolved and undergone design changes over time to reduce the incidence of certain complications such as band slippage, band erosion and balloon or port issues, and as the surgical technique was modified from the Peri-gastric technique for placement to the current Pars Flaccida placement. The bands have become wider and longer, holding more saline but in a lower pressure balloon, and are now pre-formed in a semi circle or full circle to facilitate proper placement on the upper stomach.
The initial technique for LAGB insertion was the Peri-gastric technique where the band was placed directly on the wall of the stomach through a tunnel dissected through the surrounding fat and connective tissue. The LAGB was completely filled in the operating room with the patient asleep using a pressure device (gastrometer) to determine the proper volume for each patient. Immediately after surgery there was a lot of post op vomiting and band intolerance due to the sudden dramatic change in patients’ gastric opening and as a result the early band slippage rate was high, averaging almost 10% in most studies. The bands’ position directly on the surface of the stomach also made slips more common and also led to a higher risk of the band eroding into the lumen of the stomach, becoming infected and requiring removal of the band system. The design of the band also contributed to the higher erosion rate due to its narrow width and high pressure balloon system which placed more pressure on the stomach wall.
The changes which occurred over the past decade include switching to a Pars Flaccida technique, manufacturing a wider and longer band with a high volume low pressure balloon, pre-forming the bands’ shape to mold to the stomach, and leaving the band empty initially and performing small slow band fills in the office over time. The Pars Flaccida technique involves placing the band further from the stomach wall so a layer of fat and connective tissue lies between the band and stomach wall there by reducing the risk of slippages and erosions. The bands must be longer to be placed further away from the stomach, and the band width was increased to improved surface area in contact with the stomach which reduced the risk of slippages. The wider balloon also resulted in less pressure on the wall of the stomach reducing the risk of erosions. An added benefit of larger balloon which held more volume of saline was it was easier for the surgeon to make adjustments with less chance of error when you add 2-3 cc instead of ¼ to ½ cc. The pre formed balloon and band avoided kinking of the balloon and band which could cause leaks in the balloon at the site of creases or band fractures and failures. All these modifications have reduced the complications from slippages and erosions substantially over the past decade with slippage rates around 5% instead of 10% and band erosions of 1% versus 3% previously.
The Lap Band© was probably the first Adjustable Gastric Band and was developed by Dr. Kuzmak in the United States around 1983, but at that time it was inserted via an open incision. It wasn’t until 1994 that the device began to be inserted laparoscopically in Europe. I participated from 1998-2001 as part of the FDA “B” trial in the clinical evaluation of the initial Lap Band© prior to its approval for general use. It was finally approved by the FDA for unlimited insertion in the United States in 2001 after a 3 year clinical trial and I have been inserting LAGB’s since that time as part of my practice. The initial Lap Band© was narrower than the current band and held only 4 cc of saline, so small adjustments were more difficult to control. The band was pre-shaped, but the balloon wasn’t initially. Over time the Lap Band© has under gone multiple design changes (five) to improve its’ function, including now pre-shaping the balloon with a segmented shape to prevent the balloon from creasing and creating a leak at that site.
The current Lap Band© system we utilize is wider and available from Allergan in two sizes: an AP Large which has a larger diameter and holds 14cc of saline, and an AP Standard with a slightly smaller diameter and holds 10 cc of saline. The AP Large was designed to place around super morbid obese patients (BMI > 50) and males who generally have a larger stomach and more fat around the upper stomach or fundus where the band is positioned. If the band is too tight, even empty, then patients will not be able to eat and will have chronic vomiting and acid reflux and will lead to an erosion. Near the same time that Dr Kuzmak was developing the Lap Band© in the United States, Drs’ Hallberg and Forsell in 1985 in Sweden were developing an adjustable gastric band called the Swedish Band©. The Swedish Band© was wider than the Lap Band© with a larger balloon under low pressure, but was not preformed into a circular shape. The rights to the product has been purchased by several companies over the years, but was finally bought by Ethicon Endosurgery Inc. and brought to the United States for a 3 year FDA approved clinical trial and was approved for general sale and utilization in 2007. The product was renamed the Realize Band© and it has under gone several design changes and is currently available in two forms as the Realize Band© and the Realize C Band©.
The Realize C Band© system we utilize is now preformed into a “C” shape to conform to the shape of the stomach, however the balloon is not segmented or pre shaped. We are frequently asked if there is any difference between the two current commercially available LAGB systems in the United States and the answer in my opinion and backed up by a detailed comparison in the literature is: NO! Keep several things in mind if you chose to search for answers to this question. At least half of what you read on the internet is wrong. There is a big difference in hard cold facts and marketing. The best documentation I can give you is a large study called a “Meta Analysis” which is the “Gold Standard” for documenting the validity of scientific studies and they compared the two products by looking at over 4592 studies published on LAGB’s. They found 129 valid studies involving 28,980 patients who under went a Lap Band© or Swedish Band© procedure between 1998 and 2006 and they found no difference between weight loss, resolution of diabetes or hypertension, or complications between the two LAGB systems. Review the study yourself at Surg Obes Relat Dis 2008;4:174-185.