An adjustable gastric band, implanted laparoscopically, led to significant weight loss among moderately obese patients, researchers reported.
In a prospective cohort study, more than four patients in five had lost more than 30 percent of their excess weight after a year, according to Robert Michaelson, MD, PhD, of Northwest Weight Loss Surgery in Everett, Wash., and colleagues.
And two-thirds of patients were no longer obese, having lost, on average, 65% of their excess weight after receiving the so-called laparoscopic adjustable gastric band (LAGB), the research team reported online in Obesity.
The data for the study were the background for the 2011 FDA approval of the so-called Lap-Band system for use in patients with a body mass index of 30 to 39.9 who have at least one obesity-related comorbid condition, the authors noted.
The system, made by Allergan, of Irvine, Calif., had previously been approved only for people with a BMI of 40 or greater, or at least 35 with a severe comorbidity.
The Allergan-sponsored study by Michaelson and colleagues was intended to examine the safety and effectiveness of the device in more moderately obese patients.
But the study needs careful examination because its effect is to more than double the potential patient pool, argued David Arterburn, MD, of the Group Health Research Institute in Seattle, and Melinda Maggard, MD, of the University of California Los Angeles.
And in an accompanying commentary article, they argued that it has "significant potential for bias," including potentially selective recruiting and lack of blinding.
They also noted that the study was financed by the company that makes the device and all the authors were paid for their work "again raising the concern of bias in collecting and interpreting the results."