By Melinda Beck in the Wall Street Journal
The Food and Drug Administration has recently approved a host of new weight-loss interventions that make millions more people eligible for obesity treatments.
Among the devices are balloons that inflate inside the stomach and leave less room for food, electrical impulses that trick the brain into thinking the stomach is full and a tube that lets people drain out some of their stomach contents after meals.
The new interventions don’t require major surgery and are reversible; several are aimed at the estimated 60 million Americans who are only moderately obese, with a body-mass index of 30 to 40.
In contrast, most traditional bariatric surgeries such as gastric bypass involve permanently altering the gastrointestinal tract and are generally reserved for the roughly 18 million people with a BMI of 40 or more, or 35 with an obesity-related health issue like Type 2 diabetes.
Obesity experts say the new techniques help fill a large gap in treatment options between lifestyle interventions—such as diet, exercise and weight-loss drugs—and bariatric surgery.
The ReShape gastric balloon is inserted down a patient’s throat with an endoscope and inflated with saline in the stomach, where it leaves less room for food. Photo: ReShape Medical Inc
“We had lots of patients contacting us with BMIs between 30 and 40 and we had nothing to offer them, and many people who are candidates for gastric bypass are petrified of the surgery,” says Shawn Garber, director of the New York Bariatric Group, a large surgical practice. The new options, he says, “are a great way to help these patients jump-start a diet.”
Studies show bariatric surgery can help people lose as much as 70% of their excess weight, or the amount above a person’s ideal weight. Still, less than 2% of people eligible for the procedures undergo them.
Although data is still limited, weight loss with the new interventions appears to be less dramatic than with bariatric surgery, but superior to diet and exercise or medications. Costs of the new techniques range from $6,000 to $25,000. They generally aren’t covered by insurance, unlike bariatric surgery, which many states require insurers to cover for qualifying patients.
The most popular of the new approaches so far is the intragastric balloon, which has been used in Europe for years. It is inserted down the patient’s throat with an endoscope, then inflated in the stomach with saline to about the size of a grapefruit, leaving less room for food. After six months, the balloon is removed to minimize complications, with six more months weight-loss counseling.
Patients are advised for the first few days to consume only clear liquids to minimize nausea and other discomfort. Within a week, they can resume normal eating, but many say they quickly feel full.
“I’m eating about half of what I used to eat,” says Mayda Melendez, a family physician in Bear, Del., who has lost 27 pounds—and the need for blood-pressure medication—since having a balloon inserted in February.
Lotta Bosnyak, before losing 150 pounds in one year with the AspireAssist, which lets users drain out part of their stomach contents after meals.
Lotta Bosnyak has kept her excess weight off for three years. She still uses the AspireAssist after dinner to help keep her food intake down.
The biggest risk is that the balloon will deflate on its own and form a blockage in the intestines. One version, the ReShape, uses two attached balloons as a precaution. Both it and the Orbera balloon contain a blue dye marker that is visible in users’ urine if a balloon deflates.
In U.S. clinical trials reported to the FDA, Orbera users lost an average of 21.8 pounds in six months on the balloon and kept off 19 pounds at one year. ReShape users lost 14 pounds and kept off 9.9 pounds.
AspireAssist, which won FDA approval in June, has stirred controversy. A small tube is placed in the patient’s stomach via an endoscope and connected to a disk-shaped port implanted in the patient’s side. About 20 minutes after a meal, the patient drains out as much of the stomach contents as the tube can reach, generally about 30%.
Some critics dismiss it as “yucky,” or possibly facilitating bulimia, but obesity experts say the device changes users’ eating habits because they must chew everything thoroughly to prevent clogging the tube. “It gives the brain time to recognize satiety,” says Kathleen Crothall, chief executive of Aspire Bariatrics LLC, the manufacturer. “And it helps break the cycle of mindless eating.”
In a clinical trial reviewed by the FDA, patients using AspireAssist for a year lost 31.5% of their excess weight on average, compared with 10% for control patients who received lifestyle therapy alone. Complications from the device were minimal.
Lotta Bosnyak had the AspireAssist implanted in Sweden in 2012 and lost 150 pounds in the first year. Four years later, she says she still uses it in the evenings to help maintain her current weight of 170 pounds on her 6-foot-tall frame. “I like to go to bed on an empty stomach,” says Mrs. Bosnyak, 52, who now lives in Delray Beach, Fla. She says she no longer needs medication for diabetes, high blood pressure or depression. “I have my life back,” she says.
With vBloc therapy, doctors use minimally invasive surgery to attach electrical leads to the vagus nerve, which links the stomach with the brain, and connect them to a pacemaker-like device implanted under the skin near the abdomen. Intermittent electrical pulses aim to interrupt the usual hunger signals to the brain and help maintain a feeling of fullness.
The vagus nerve block, made by EnteroMedics, is a pacemaker-like device that sends intermittent electrical pulses, blocking hunger signals between the stomach and the brain.
The device typically runs for 12 hours a day, but can be adjusted to provide help when patients need it most. “If you never eat breakfast, you can start it at 11 a.m. and run it until 11 p.m.,” says Dan Gladney, chief executive of EnteroMedics Inc., which makes the system. Possible side effects include nausea, pain and heartburn.
In a clinical trial, vBloc users lost 26% of their excess weight on average after 12 months, not much more than a control group that had it inserted but not turned on. By 18 months, however, vBloc users had kept off most of their lost weight while the control group didn’t.
Robert Armstrong, 36, an attorney in Plano, Texas, had the vBloc implanted in June and says he initially felt “a localized shock” in his stomach every few minutes. After the initial setting was adjusted, he says he now senses only a mild tightening in his stomach, which makes him feel less hungry. He lost 12 pounds on a strict diet required to prepare for the surgery and has kept them off so far.
“I’d like to use this as a bridge to change my lifestyle,” says Mr. Armstrong, who hopes to lose 60 pounds.
Several other weight-loss procedures are being studied, including balloons that can be swallowed like pills, self-inflate in the stomach and disintegrate on their own. Researchers are also testing a tunnel-like sheath that lines the inside of the small intestine, reducing how much food can be absorbed.
Whether the new interventions will help patients keep weight off for the long term isn’t known.
“People should understand that none of these should be a stand-alone treatment,” says Louis Aronne, director of the weight-control center at Weill Cornell Medicine and NewYork-Presbyterian in New York City, which offers many of the new options. “You can’t just use one of these devices and eat whatever you want.”