Dr. Ajay Goyal
SUMMIT, New Jersey – Ajay Goyal, MD, FACS Medical Director of Bariatric Surgery at Overlook Hospital in Summit, New Jersey, is one of the first surgeons in New Jersey to add the REALIZE™ Band to his surgical weight loss program.
The United States Food and Drug Administration (FDA) approved the REALIZE™ gastric band, a surgical implant for weight reduction and improvement in obesity-related health conditions, such as type-2 diabetes, on September 28th, 2007.
The REALIZE™ Band is an innovative device intended for use in weight reduction for patients with morbid obesity and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. It is for use in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs.
In the multi-center U.S. clinical trial of 276 patients with the REALIZE™ Band, patients who completed the three-year U.S. clinical trial (n=228) lost an average of 42.8 percent of their excess body weight. Thirty-five percent of patients who completed the three-year trial lost 50 percent or more of excess body weight and 10.5 percent lost 75 percent or more of excess body weight. The most commonly reported adverse events after surgery during the U.S. clinical trial were nausea, vomiting, constipation and gastroesophageal reflux (GERD). Only nine (3.3 percent) patients experienced a serious adverse event that was considered unanticipated and related to the REALIZE™ Band.
The REALIZE™ band has been used outside the U.S. by more than 100,000 people for weight reduction since 1996. During gastric band surgery, the REALIZE™ Band, a silicone band, is placed around the stomach. This creates two chambers in the stomach, an upper stomach that is small and a lower stomach. The upper stomach has a tiny hole in which food can slowly drip down into the lower stomach.
Ed Phillips, M.D., FACS, lead researcher in the REALIZE™ Band trial and Director for the Center of Minimally Invasive and Bariatric Surgery at Cedars-Sinai Medical Center located in Los Angeles, California asserts: "This rigorous clinical trial showed patients using the REALIZE™ Band experienced significant weight loss within the first year, which remained steady over three years."
The researchers also noted that patients experienced improvement in a number of areas in their lives including better health, improved social functioning, better mental health, increased ability to complete daily activities, and reduced body pain.
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About The REALIZE™ Band
The REALIZE™ Band, which is marketed under the name Swedish Adjustable Gastric Band (SAGB) outside the U.S., has been commercially available outside the U.S. since 1996 and has been used by more than 100,000 patients worldwide to help manage their weight.
In a gastric band procedure with the REALIZE™ Band, a soft, adjustable silicone band is wrapped around the stomach to create two chambers – a small upper stomach with a narrow opening to the lower stomach. After the procedure, the upper stomach can only hold about four ounces of food, which limits food intake, makes patients feel full faster and longer, and slows digestion.
Once the band is in place, surgeons attach the REALIZE™ Injection Port to the abdominal wall underneath the skin. Using the REALIZE™ Injection Port Applier, this can be completed in less than a minute, thereby decreasing time under anesthesia. The REALIZE™ Injection Port allows doctors to inject or remove saline to tighten or loosen the band. The tighter the band, the more quickly the upper stomach fills up and the less food a person can eat. Adjustments are made periodically based on the patient’s individual needs.
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