Study Supports Broader Access to Lap-Band Weight-Loss Surgery
THURSDAY May 2, 2013 -- The Lap-Band weight-loss procedure should not be restricted only to patients who are very severely obese, a new study suggests.
Still, some experts disagreed, saying further research will be needed before the procedure is used in a wider range of patients.
The Lap-Band is a strategy in which an adjustable band is placed around the upper part of the stomach in order to create a pouch. The newly-created pouch restricts how much food a patient can eat at one time and helps reduce appetite.
In 2001, the U.S. Food and Drug Administration approved the Lap-Band for use in patients who are very severely obese (a body-mass index of 40 or higher) and for patients who are severely obese (BMI of 35 to 39.9) with an obesity-related condition such as high blood pressure or diabetes.
BMI is a measurement of body fat based on a ratio of weight to height. Obesity is typically defined as a BMI of 30 or above.
Since the 2001 approval of the device, the FDA has expanded the Lap-Band's approval for use in obese patients with a BMI of 30 to 39.9 who have at least one obesity-related condition (for example, diabetes or high cholesterol levels).
Allergan, the device's maker, funded the new study. In the study, researchers performed the Lap-Band procedure on 149 patients who had a BMI of 35 to 39.9 and did not have an obesity-related condition or who had a BMI of 30 to 34.9 (moderately obese) with at least one obesity-related condition.
One year after undergoing the procedure, nearly 85 percent of the patients had lost at least 30 percent of their excess body weight, with an average excess weight loss of 65 percent. About 66 percent of the patients were no longer obese.
Obesity-related conditions improved for many of the patients, including 64 percent of those with high cholesterol, 59 percent of those with high blood pressure and 85 percent of those with diabetes. Most side effects of the procedure were mild to moderate and resolved within a month.
The patients' results a year after the procedure were maintained or improved at two years, according to the study, which was published online May 2 in the journal Obesity.
"Patients in our study had been obese for an average of 17 years," study author Dr. Robert Michaelson, of Northwest Weight Loss Surgery in Everett, Wash., said in a journal news release. "They tried numerous other weight-loss methods and finally reached out for surgical treatment when they were wary of the repetitive failures at maintaining weight loss."
"The results of this study convinced the FDA that early intervention in the continuum of obesity is the right thing to do: Treat before people go on to develop serious conditions [related to] obesity," Michaelson said.
In addition, the American Society for Metabolic and Bariatric Surgery issued a position statement endorsing weight-loss surgery for patients with moderate obesity who have not had success with non-surgical methods of weight loss.
"The next step is to get the private insurers and Medicare, who continue to rely on guidelines established in 1991, to review the incontrovertible literature, take down the barriers to the necessary treatment for this disease, and offer the hope of a cure to 27 million Americans," Michaelson said.
In an editorial accompanying the study, however, experts said the long-term benefits and risks of this procedure in people with a BMI lower than 40 still need to be determined. They also noted that studies have shown that very severely obese people who have had the Lap-Band procedure often begin to regain weight about two years after the surgery.
There are also concerns that serious side effects are common, including reports of device removal rates as high as 50 percent, said Dr. David Arterburn, of the Group Health Research Institute in Seattle, and Dr. Melinda Maggard, of the University of California, Los Angeles.
The two experts added that, "the study was funded by the device company, who had input into the study design, and all the authors were paid for their work, again raising the concern of bias in collecting and interpreting the results."
Until longer-term data on the benefits and harms of the procedure are available, the use of the Lap-Band procedure in patients with a BMI of 30 to 35 should be limited to clinical trials, they said.
But another expert supported the use of the Lap-Band in people other than the very obese.
"In my clinical experience it is in this subgroup [of less obese patients] that I find the band most effective," said Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York City.
"Many larger patients do not respond to the band making them eat slower, and only have effect when the band is overly tightened," Roslin said. "This leads to issues that ultimately can result in removal. For patients that are smaller, the results, in my opinion, will be better. For those with severe morbid obesity, I find the [stomach] stapling procedures superior."
Posted: May 2013