Obesity
The National Institutes of Health (NIH) estimate that about two-thirds of adults – 133.6 million people – in the U.S. are overweight or obese,1 while almost 5% of adults – 15 million Americans – are considered extremely obese.2 Obese adults are at increased risk of type II diabetes, hypertension, stroke, certain cancers, and other dangerous conditions.3
The NIH estimates that being overweight or obese leads to $117 billion in medical spending a year, with $61 billion in direct costs and $56 billion in indirect costs.4
As obesity rates continue to rise, patients are increasingly seeking surgical weight loss options. Bariatric surgery aids weight loss by restricting food intake and, in some operations, altering the digestive process. The Roux-en-Y Gastric Bypass Procedure (RYGBP) is the most commonly performed bariatric procedure, estimated to account for approximately 65% of weight loss surgeries performed in the U.S.5
A study from the Agency for Healthcare Research and Quality (AHRQ) found that the number of bariatric surgeries grew by 400 percent between 1998 and 2002.6 In 2007, an estimated 205,000 people with morbid obesity in the U.S. will have undergone bariatric surgery7 and these numbers are expected to grow. Only 1% of the clinically eligible population is currently being treated for morbid obesity through bariatric surgery.8
A major retrospective study published in the New England Journal of Medicine showed that gastric bypass reduced the risk of death in extremely obese patients by over 40% by lowering the incidence of diabetes, coronary artery disease and cancer.9
ABOUT ROUX-EN-Y GASTRIC BYPASS
The Roux-en-Y gastric bypass procedure involves creating a small stomach pouch out of a portion of the stomach and attaching it directly to the jejunum, bypassing a large part of the stomach and duodenum. The stomach is made very small to restrict the amount of food that can be consumed. The opening between the stomach pouch and the small intestine (called the stoma) is also made very small to slow the passage of food from the stomach. These restrictions help the patient feel full and limit the amount of food that can be eaten. In addition, by altering the path of the intestines, consumed food bypasses the duodenum so fat absorption is substantially reduced.10
Most patients obtain excellent weight loss after gastric bypass surgery. However, the long-term failure rate after Roux-en-Y gastric bypass is 20 to 35 percent.11 In super obese patients (BMI≥50Kg/m2), this failure rate can be even higher.12 A number of studies suggest that patients may start to regain weight due to the gradual enlargement of the surgically altered small stomach pouch and stoma.13 When the stomach pouch and stoma gradually enlarge, the feeling of fullness is no longer present, patients can eat larger meals and weight regain occurs.14
Previously, patients who regained weight after gastric bypass had limited treatment options. Laparoscopic or open procedures to reduce the enlarged pouch or stoma are technically very challenging for the surgeon and present a higher level of surgical risk to patients than the original bypass surgery.15
New Incisionless options to reduce the size of a patient’s stomach pouch and stoma may provide important advantages to patients, including, reduced risk of wound infection, hernias, and adhesions, as well as less post-operative pain, faster recovery time, and no abdominal scars.