Restrictive Operations:

Laparoscopic Adjustable Gastric Bands (LAGB, Lap Band©, Realize Band©)

The Laparoscopic Adjustable Gastric Bands (LAGB) are designed to induce weight loss by restricting food consumption. You eat less volume of food and fill up quickly, if you make the right food choices, and that results in reduced calories. The addition of exercise increases calories burned and further enhances weight loss. If you overeat you throw up. The two major brands of bands (Lap Band© manufactured by Allergan and Realize Band© manufactured by Ethicon) which are currently approved by the FDA (Federal Food and Drug Administration) for sale in the United States will be discussed initially together, since there is very little difference between the designs despite what the manufacturer would like for you to believe with marketing campaigns. We will discuss the minor variations between the Bands later in the article.

The Laparoscopic Adjustable Gastric Bands are a modification of the Vertical Banded Gastroplasty procedure which has fallen out of favor in the United States due to its high complication rate and lack of long term success. The major potentially correctable problems with the Vertical Banded Gastroplasty had to do with having all bands the same size which were not adjustable after insertion, and the stapling and cutting of the
stomach. The fixed band size was “one size fits all” and since there is wide variability in patients’ stomach size and thickness; some bands were too tight resulting in frequent vomiting and acid reflux; and some bands were too loose, which resulted in poor weight loss. The stapling and cutting of the stomach created a risk of leaks and infections and altered the anatomy of the stomach which made revisions or conversions difficult.

Placement of a Laparoscopic Adjustable Gastric Band:

Bands can be inserted in some low risk patients in an outpatient surgery center or they can be inserted in a hospital setting as an outpatient or with an over night stay. The decision regarding the best location to undergo surgery should be discussed with Dr Champion, and will depend on a number of factors like your age, overall health and BMI. Even low risk patients who are ideal candidates for an outpatient procedure can have
unexpected issues like persistent nausea or vomiting and require a hospital admission.

Patients are admitted or present as an outpatient to the facility on the morning of surgery after having previously registered and under gone preoperative testing. On the morning of surgery the patient receives preoperative antibiotics to prevent infections and blood thinner and compression boots to prevent blood clots. Patients are placed under general anesthesia for the procedure. We make 6 small incisions and plan on placing the port in the right mid abdomen over the rectus muscle, about half way between your navel and breast bone. The choice of band is usually made in the operating room depending on the size of a patients’ stomach and how much fat is encircling the area. Men and large BMI patients typically require a larger band or an Allergan© AP large. Women or patients with a smaller BMI may use an Allergan© AP standard or Realize© C band. Other than a difference in the length of the bands, the width, band volume, and outcomes between “brands” have never been shown to make a difference in average weight loss or complications.

To insert a Laparoscopic Adjustable Gastric Band the area around the upper stomach and esophagus is exposed and inspected and if any hiatal hernia is detected it must first be repaired to prevent the LAGB from moving up into the chest which can cause it to function poorly. A tunnel is created behind the upper stomach and the silastic band is placed around the stomach like a belt to create a small 20cc pouch with a narrowed outlet. The correct pouch size is measured and calibrated every time by placing a special “sizing balloon” at the top of the stomach and then closing the band around the bottom of the balloon and pouch. The balloon is removed and the band is held in position with several sutures in the stomach wall to reduce the risk of slippages. The inner layer of the band is an adjustable balloon which can be filled or emptied to change the outlet size by injecting saline into a small reservoir (port) which was placed under the skin on the abdominal wall at the time of surgery and is connected to the band by an IV tubing. After the LAGB outlet is tightened sufficiently in 3-4 months the pouch fills quickly with a reduced amount of solid food and empties slowly to relieve hunger and produce a feeling of fullness. Overeating results in pain or vomiting to limit food intake.

When the band is initially inserted we place no fluid in the band until the first post op visit 30 days after surgery to minimize post op vomiting and slippages. Patients undergo a Gastroscopic Exam in the OR where a lighted camera is inserted inside the esophagus and stomach to inspect the position of the band and make sure it is wide open and there were no perforations or leaks in the stomach from insertion. Patients awake and are placed on a liquid diet and if they are an outpatient they typically are discharged home in 1-4 hours with a prescription for pain meds for 5-7 days. If they are an overnight patient they move to a room and are observed to insure they can tolerate liquids and oral pain medications without nausea. The following morning we will perform an upper GI xray to visualize the placement of the band and again insure no leaks or obstructions from the band area. This is useful to compare with future xrays if we are concerned about a slippage. Patients are discharged home to resume home medications and placed on pain meds for 5-7 days (typically Percocet©) and a stomach acid inhibitor (Nexium©) for 30 days to prevent ulcers while everything is healing.

Patients may walk, go up and down steps and drive the car when off pain meds, but no lifting more than 25 pounds for 3 weeks. After 3 weeks there are no restrictions. Some pain, particularly at the port site where the port is sutured to the muscle may persist for up to 6 weeks, but this is typically controlled with Tylenol©. Patients are placed on a liquid diet of 6 small meals with protein supplements for one week and a soft diet of cooked veggies, fish and eggs for 2 additional weeks as the swelling goes down from the surgery. After 3 weeks patient resume regular food, but need to make better food choices by concentrating on meats, colored vegetables and fruit. Simple carbohydrates need to be limited and avoid high calorie liquids, soups, soft mushy foods, desserts and junk food.

Patients need to exercise three times a week of aerobic exercise (means you sweat and pulse increases to at least 120) for 45 minutes per session. Patients return monthly for 3-4 months and under go gradual slow small band fills to allow the band to form scar tissue around it to hold it in place and allow patients to gradually adjust to the gastric restriction to minimize vomiting. While most fills can be performed in the office, some patients may require their fills be done in the hospital under fluoroscopic xray control and be accompanied with an upper GI xray to confirm the outlet size accurately. Patients are then seen at 6 months and one year and then yearly. A small amount of saline may evaporate through the band wall each year and small adjustments and fills may be required yearly. Blood tests are done at 6 months and one year and then yearly to insure good health. We recommend all patients take a good multi vitamin and calcium supplement with extra vitamin D, even though none of the gastrointestinal tract is by passed after a LAGB.

Risks and Benefits of Laparoscopic Adjustable gastric Bands

The Risks of the Laparoscopic adjustable Gastric Bands are:

1 . Risk of slippage of the band around the stomach to an abnormal position which blocks the stomach and results in persistent vomiting, or can even interfere with the blood supply of the stomach and cause a perforation or portion of the stomach to die. This may require deflation of the band or reoperation to revise, remove, or replace the band in a new position.

2 . Erosion of the band into the stomach which becomes infected and requires removal of the band and repair of the gastric perforation. The risk of erosion is increased if patients take certain medications like aspirin, NSAIDS, or steroids, so they should avoid these after surgery if possible.

3 . Port or tubing problems which may require a reoperation to correct.

4 . Esophageal dilatation which will cause problems swallowing and require removal of the band

5 . Mechanical malfunction of the band.

6 . Acid Reflux, chronic vomiting or band intolerance. Many patients report an improvement in acid reflux or Gastroesophageal Reflux Disease (GERD), but it can worsen in others. Some patient’s esophagus will simply not accept a restrictive band near its outlet and will require removal due to chronic vomiting, difficulty swallowing or chronic pain.

7 . Does not limit intake of high calorie liquids or sweets and is easy to defeat. The LAGB success is totally dependent on patients following all the rules and guidelines and exercising regularly.

8 . The LAGB is not a permanent device.

9 . The band requires fluid adjustments performed in a physician’s office or hospital and can be time consuming.

The design of the LAGB and the technique for implantation has undergone several changes over the past 11 years. We were involved with the FDA Clinical “B” trial of the original Lap Band© and began inserting Bands in 1999. The original LAGB in the United States was much narrower and shorter and only held 4 cc of saline, was completely tightened immediately in the operating room, and was placed directly along side the wall of the stomach (called the “peri-gastric” technique). The combination of placing the band directly against the stomach resulted in more slippages and erosions and the immediate tightening of the band also resulted in frequent vomiting which increased the risk further for slips. The narrow bands increased pressure on the stomach wall and made adjustments more difficult. This early band and technique resulted in a band
slippage rate of 10% and band erosions in 3% reported in many studies.

Several developments were made to the design of bands and the technique for insertion which has now decreased the risk of slippages to around 5% and erosions to approximately 1% after LAGB surgery. First, the band was inserted further away from the wall of the stomach, called the “Pars Flaccida” technique which also incorporated some of the fat and fibrous tissue surrounding the upper stomach to reduce the risk of slips and erosions. The Bands were left empty in the operating room to reduce vomiting and allow scar tissue to form and hold the band in place better. The Bands were then filled with slow small fills over the course of several months so patients could adjust gradually to the restriction. Finally, the bands were widened, pre-shaped in a semi circle, and made longer which improved contact with the stomach wall to reduce slips while also reducing pressure on the stomach to reduce erosion risk.

Overall multiple studies have demonstrated that approximately 25% of patients who undergo a LAGB will have it removed for complications such as recurrent slippage, erosion or band intolerance, or due to weight loss failure. The band is not permanent and will wear out in probably 15-20 as a best guess estimate. At that point patients will have several options. They can leave the band and have it not function. They can remove the band, or replace it with a new band, or be converted to another type weight loss surgery.

Benefits of the Laparoscopic Adjustable Gastric Band:

The advantage of the Laparoscopic Adjustable Gastric Band compared to the Vertical Banded Gastroplasty, Roux En Y Gastric Bypass, and Sleeve Gastrectomy:

1). It requires no stapling or cutting of the stomach so this greatly reduces the risks of leaks or infections and is therefore the safest weight loss surgery currently available. The risk of dying from a LAGB is less than 1/1000 (0.1%) where the risk of a VBG, Gastric Bypass or Sleeve Gastrectomy was approximately 1/200 (0.5%).

2). The LAGB is adjustable so it can be loosened or tightened in the office to improve weight loss or reduce vomiting. Adjustments can continue to be made years after implantation and patients can still lose weight years later if they utilize the band restriction and follow the recommended guidelines.

3). The LAGB is more easily reversible since it involved no stapling or cutting of the stomach and there is less scarring.

4). Loss of as little as 10% of body weight can result in improvements in health. Diabetes has been shown to improve in 65% of patients after LAGB and hypertension, hyperlipidemia, sleep apnea, acid reflux and joint issues are often improved or resolve. The improvements seen after LAGB however, are totally dependent on patients losing weight and do not occur otherwise (compared to Gastric Bypass with a metabolic effect
independent of weight loss).

Outcomes of LAGB:

The LAGB patients average losing 50% of their excess weight (their preop body weight minus their ideal body weight) and 50% are “successful” long term (means they keep 50% of their excess weight off for 5 years).

The results of both FDA Clinical Trials on the two current brands of LAGB over a 3 year study were nearly identical with average weight loss of 40% of excess weight.

Who Should Consider A Laparoscopic Adjustable Gastric Band?

The LAGB is most appropriate for patients whose BMI is less than 50. The lower the BMI initially (35-49) and the closer patients are to being only 100 pounds over their ideal body weight has the most success in my experience. The other category which does well with a LAGB are the “big” meal eaters. This means they aren’t snackers and don’t graze on junk food all day and night until they go to bed, but instead tend to eat meats and
vegetables three times a day but in large quantities or amounts. This group tends to do well with any Restrictive Procedure.

Patients who tend to do poorly with the LAGB are patients with a “sweet tooth” who frequently eat ice cream, candy, cookies and simple carbohydrates like potatoes, bread, rice and pasta; or patients who graze all day by eating small handfuls of nuts, chips and other convenience and junk foods. They never over eat and feel full or vomit so they get no benefit from the band, but there is a steady stream of calories through out the day which add up quickly. Keep in mind you must reduce your intake to 1200 calories or less and it can be done and you be satisfied if you make better food choices after Restrictive Operations like the LAGB.

Patients with BMI’s greater than 50 or who weigh more than 350 pounds are generally unhappy with their weight loss from a LAGB.

I strongly advise any patient with Adult Onset Type 2 Diabetes or with high cholesterol or triglycerides to have a Gastric Bypass.