The Safety Profile for LAP-BAND Surgery

The rates of obesity in general and of morbid obesity in particular have increased rapidly in the US and in other industrialized countries in the past 20 years. Morbid obesity is defined a being 100 pounds or more overweight or having a BMI of 40 or greater. As morbid obesity has increased, so has the frequency of bariatric surgery. New weight loss surgery procedures utilizing laparoscopic technology have decreased the risks associated with bariatric surgery and appear as safe as intensive dieting.

Bariatric surgery provides the most durable weight loss for morbid obesity

Morbid obesity has proved very difficult to treat through traditional interventions like diet, exercise, and weight loss medications used either alone or in combination. According to long-term weight loss outcomes data compiled by government health agencies, the most durable weight loss for morbid obesity is achieved with bariatric surgery. The serious side effects of malnutrition, dehydration, and chronic diarrhea associated with early bariatric surgery procedures limited their utility. Introduction of the Roux-en-Y procedure, a combined restrictive and bypass approach, in the late 1990s, created fewer long-term nutritional problems and fewer complications, and thus, revived interest in bariatric surgery and led to a rapid increase in bariatric surgeries in the past decade. Still, complications like dumping syndrome, which includes vomiting, reflux and diarrhea; complications resulting from the surgical joining of the intestine and stomach such as leaks or strictures; abdominal hernias; infections, and pneumonia remain fairly common when bypass is involved.

Overseas experience with LAP-BAND® bolsters US confidence

The number of bariatric procedures rapidly increased from 6,868 in 1996 to 45,473 in 2001 and to an estimated 160,000 in 2005.

While American surgeons were performing an increasing number of Roux-en-Y procedures, a new technique known as Laparoscopic Gastric Banding (LAP-BAND^®) was becoming popular in Europe and Australia. No cutting or stapling of the stomach or gastrointestinal re-routing is involved in the LAP-BAND procedure. The LAP-BAND procedure is performed laparoscopically, eliminating the need for a large surgical incision. Consequently, patients recover quickly and with minimal pain. Because the gut remains intact, there are few nutritional side effects other than weight loss, and if need be, the procedure is fully reversible. Laparoscopic Gastric Banding is considered the safest, least invasive, and least traumatic of all weight-loss surgeries.

Considerable experience with the LAP-BAND procedure has been gained abroad and confidence in its safety and efficacy has grown. Application of this technique in less overweight individuals has even been investigated.

Allergan, manufacturer of the LAP-BAND System, references The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIPS) 2002 publication as evidence of the superior safety achieved with the LAP-BAND procedure. Laparoscopic adjustable gastric banding surgery is associated with a mean short-term mortality rate of around 0.05%, compared to 0.50% for gastric bypass and 0.31% for vertical banded gastroplasty.

The University of California, San Diego Medical Center website provides the following comparison of complication rates seen after LAP-BAND and gastric bypass procedures to demonstrate the safety of LAP-BAND.

LAP-BAND effective for mild to moderate obesity?

Further evidence of the effectiveness and the safety of the LAP-BAND procedure comes from a new study comparing LAP-BAND with an intensive diet approach in people with mild to moderate obesity, a group not generally considered to have enough health risks to warrant being exposed to the risks of bariatric surgery.¹

Eighty (80) adults with mild to moderate obesity were randomly assigned to LAP-BAND surgery or an intensive weight loss program that included a very low-calorie (500-550 calories/ day) full-liquid diet for 12 weeks, weekly medical monitoring and behavioral change classes, and use of the weight loss drug Orlistat^® during the transition back to conventional foods as well as for maintenance.

At the 6-month point, patients in both groups had lost similar amounts of weight and experienced comparable improvements in their health. But at the 2-year point, patients in the intensive diet group had regained weight, whereas patients in the LAP-BAND group had continued to lose weight. The LAP-BAND patients also experienced significantly better health and reported a higher quality of life. The number of adverse events was equivalent between the two groups. While it is important to confirm these findings through additional research, it is strong evidence of the safety and effectiveness of the LAP-BAND procedure. People who do qualify for bariatric surgery can choose the LAP-BAND option with confidence.

¹ O’Brian P. E., et al. Treatment of Mild to Moderate Obesity with Laparoscopic Adjustable Gastric Banding or an Intensive Medical Program. American College of Physicians, 2006, 625-634.