Controversy surrounds latest form of approved obesity surgery
• Graphic: A band around the stomach
Advertiser staff and News services
When you weigh 404 pounds and have failed at every diet you've tried, it's hard to ignore the promise of permanent weight loss with a simple surgical procedure.
"I was skeptical," recalls Eddie Leake, a 51-year-old Wilmer, Texas, man whose weight passed the 400-pound mark last year. "But after 30 minutes, I was talked into it. The only reservation I had was about having surgery in a Third World country."
Leake says he has lost 126 pounds since undergoing the newest kind of obesity surgery, called the Lap-Band Adjustable Gastric Banding System, at a clinic in Monterrey, Mexico. At the time, the procedure wasn't done in the United States.
"I'm not hungry anymore," says Leake, whose 6-foot-4 frame now supports 278 pounds.
And now there is no need to leave the country to have the procedure. In June, the U.S. Food and Drug Administration approved U.S. marketing of the Lap-Band system. A band filled with saline solution is locked around the upper portion of the stomach to decrease the size of the gastric pouch. Increasing the saline decreases the amount of food that can be digested.
Some surgeons are eagerly setting their sights on the 10 million Americans who are considered severely obese. But the procedure is controversial. Some doctors say the operation is fraught with problems, including infections that follow surgery and Lap-Bands that slip out of place, requiring a second operation. And many patients do not experience weight losses as significant as Leake's, according to the U.S. clinical trials of the product.
"The big concern is that it is so simple to put in, that every doctor who does laparoscopic surgery will do it as patients line up to get them," says Dr. Daniel B. Jones, a Dallas surgeon who specializes in another form of laparoscopic obesity surgery called Roux-en-Y Gastric Bypass, which permanently divides the stomach and reroutes the small intestine. "There has to be a commitment to follow-up care."
The Lap-Band, unlike other surgeries to treat obesity, requires ongoing adjustments by a physician. A spokesman for BioEnterics says the problems in studies seem to correlate with the inexperience of doctors working with the device.
For Leake's Lap-Band surgery, small incisions were made in his abdomen to insert a clamp-like silicone band around the top of his stomach. The band is filled with a saline solution, squeezing the opening to his stomach and progressively reducing the amount of food he can digest. Recently, he had a doctor add more solution in hopes of losing another 40 pounds or so.
In Hawai'i, Kaiser Permanente Medical Center, which has been a leader in gastric bypass surgery (better known as stomach stapling) for obesity, is not using the Lap-Band method because physicians feel there's not enough research yet to show it gives patients prolonged weight loss, said Dr. Sasha Stiles, lead physician for Kaiser's regional weight management program.
"Evidence shows these (Lap-Band) devices are not as good as the surgery," said Stiles, who believes the surgery is still a better choice for lasting weight loss for those with severe obesity problems. However, the center will continue to assess the new technique.
At Honolulu's Straub Clinic & Hospital, Dr. John Balfour, a general surgeon, is looking at the new method with caution. "It's beautiful because it's simple," he said, "but in the U.S., there hasn't been very much experience with this at all."
At this point Balfour said he doesn't consider the Lap-Band method as durable or effective as gastric bypass.
"If a patient tends to be a sweet-eater, they tend to out-eat it," he said. Because the bands are just restrictive, if a patient filled up on high-calorie sweets, the system could be ineffective.
"Probably five percent or less would be candidates," he said.
In all, 299 U.S. patients underwent Lap-Band surgery at eight medical centers that tested the device. On average, the patients lost 36 percent of their excess body weight over three years. By comparison, an Australian study showed that excess weight loss averaged 68 percent for patients who had the band for four years.
The cost of Lap-Band surgery has been estimated at $20,000; it is not yet known whether insurance companies will pay for it. Doctors are expected to make a strong case for the band's medical necessity, showing how weight reduction improves other health problems commonly experienced by severely obese people, including asthma, high blood pressure, cardiac distress and elevated cholesterol.
