WEDNESDAY, July 11, 2001 (HealthDayNews) -- A silicone stomach cuff touted as a way to help extremely obese people lose weight may not be as effective as its recent approval suggests, according to some of the surgeons involved in the clinical trial.
Published data from Virginia surgeons shows that the Lap-Band, which controls the volume of food that enters the stomach, has a high failure rate and doesn't help many patients shed pounds. Two other surgeons also express doubts on the cuff's effectiveness based on their trial results.
"I'm not sure that the risk-benefit is in favor of this device," says Dr. Harvey J. Sugerman, chief of general and trauma surgery at the Medical College of Virginia in Richmond and leader of the research. "We have two spectacular results out of 36 patients," says Sugerman, whose group published their findings in the June issue of the Annals of Surgery.
The Food and Drug Administration approved the device last month for people with a BMI of 40 or higher, a BMI of 35 or above and at least two symptoms of obesity, or those who weigh 100 pounds more than their estimated ideal -- a benchmark for being "morbidly obese."
An FDA spokesperson says the agency considered the sum of evidence, including the data from the Virginia center, in reaching its decision.
Sugerman and his colleagues found that the Lap-Band failed in 15 of the 36 patients in whom they installed the device between 1996 and 1998. Their hospital was then serving as one of eight U.S. centers for a large clinical trial sponsored by the Lap-Band manufacturer, BioEnterics, of Carpinteria, Calif.
What's more, he says, eight of the 21 patients who still have the adjustable bands want them taken out. Most patients opted to abandon the bands because they weren't losing weight, the surgeon says, and many chose to have a different procedure to bypass the stomach. Others, however, suffered infections, leaky rings, slipped bands and other technical complications with the devices, he adds.
Overall, only four patients in the Virginia trial lost 50 percent or more of their excess weight, or dropped to a body mass index (BMI, a ratio of weight to height) below 35. Blacks in the study generally did worse and lost less weight than whites, the researchers say, though why that's true isn't clear.
Pre- and post-operative tests on 25 patients also showed an alarmingly high rate of esophageal problems, with 18 (71 percent) developing abnormal widening of the food tube. Of those, almost three-quarters suffered "prominent" vomiting, heartburn and digestive trouble, the researchers say.
"We're worried that there may be some really massively dilated esophagi, and that could be a problem," says Sugerman, who adds that he will no longer perform Lap-Band surgery because of the risks he perceives.
Dr. Robert McIntyre Jr. also ran a clinical trial of the Lap-Band at the University of Colorado in Denver, and has similar feelings about the device.
Of the 25 patients who received the bands, a third had to have them removed, a third did not lose much weight, and a third did reasonably well, he says. McIntyre says he was approached by BioEnterics to organize a second round of testing but declined.
Although some surgeons like him were in favor of a three-to-five year study of the procedure, McIntyre adds, regulators used only three years of data to make their decision.
"In that sense, one could make the argument that it was [approved] a little bit prematurely," he says, adding that is a "soft opinion" not based on an inside knowledge of the regulatory process.
Dr. Michel Gagner, who led a trial of the device at New York's Mount Sinai Medical Center, says he, too, found the Lap-Band lacking. "The band is not a perfect device, and it may not give the results of weight loss that people are looking for," he says.
Gagner's group operated on about a quarter of the patients in the 299-subject, eight-center trial. "If you define success as a BMI of 30, we had only one," he notes. Overall, a quarter to a third of Gagner's patients required a second operation, such as a stomach bypass.
Gagner says he's surprised that FDA officials didn't contact him about his center's results before approving the Lap-Band. "They never asked my opinion and they should have. I'm so surprised that they didn't go to each center and talk to the surgeons. It's ridiculous."
Unlike Sugerman, however, Gagner says he's not opposed to offering select patients the procedure.
"For those with lower BMI and those who need a short procedure, it may be interesting as an interim" measure, he says. Whatever the case, he adds, "I think we need more study."
Last June, an FDA advisory panel voted to discourage approval of the cuff, which has been available in Europe since 1993, calling for more evidence of its safety and efficacy.
Sugerman says he traveled, uninvited, to that meeting to speak against approval of the device. His group also sent the FDA an advance copy of their journal article in April or May of this year, he says.
In a statement provided to HealthScout, BioEnterics defended Lap-Band's safety and utility.
"There have been over 300 published studies on the Lap-Band, and over eight years of experience with it," the company says. "The vast majority of the studies have shown very positive results. FDA considered all the data available, including the significant benefits of having this less-invasive option available for severely obese Americans."
Lap-Band's product label says the device is intended only for severely obese adults who have failed to lose weight by "conservative" methods, including supervised dieting, exercise, and behavior modification. "Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives," the company says.
According to the FDA, the average patient in the U.S. trial lost 36 percent of their "excess weight" over three years, and 62 percent of subjects shed at least 25 percent of those extra pounds. A press release from BioEnterics says the device produces an average weight loss of between 35 percent and 68 percent
Some surgeons say one reason for the more favorable results among European patients may be healthier eating habits. Many Europeans are aghast at the nature -- and large size -- of the typical American diet.
The company says more than 60,000 people worldwide have used Lap-Band, which employs an adjustable strap to limit the amount of food that enters the stomach. Surgeons install the device laparoscopically, making key-hole incisions through which they can place the cuff around the upper stomach. The price tag on the procedure is $14,000 to $26,000, including the implant.
Denise DesChenes, a spokeswoman for BioEnterics, says the Virginia surgical team's results might have been worse than other those from other study centers because of the relatively small number of patients who received the Lap-Band there.
And some surgeons do say practice makes, if not perfection, than at least improvement. Dr. Louis Martin, a Louisiana State University physician who has installed almost 90 Lap-Bands in two trials with the device, says his center has become more proficient, and seen better results, with experience.
"I think we got better and better at helping people lose weight and at reducing side effects," says Martin, who supports the procedure.
What To Do
To learn more about the Lap-Band, visit BioEnterics Corp. or the
Food and Drug Administration.
