Beyond Stomach Stapling: What's New and Better

 It seems so unfair. People who devote themselves to exercise and diet programs shed about 10 percent of their weight, and they regain as much as two-thirds of it a year later, according to the National Institutes of Health. Drugs aren't much help, and their side effects make many doctors hesitant to prescribe them. Which makes bariatric surgery—using staples or bands to reduce the stomach from a wine bottle to a couple of grapes—the clear winner for people who are morbidly obese: A 2004 study published in the Journal of the American Medical Association found that patients lost an average of 61 percent of their excess weight. And the majority keep the weight off.

Gastric bypass surgery adds years to people's lives, too. In 2007 The New England Journal of Medicine reported that obese individuals who went under the knife decreased their risk of dying within the following decade by 40 percent.

Still, of the 15 million Americans who qualify for the procedure, only 1 percent will actually get it, mostly because of concerns about safety: "Infection, bleeding, and intestinal obstruction are real risks, and weight loss results aren't always permanent," says Ron Palmon, MD, a clinical instructor in the division of gastroenterology at New York's Mount Sinai School of Medicine. "There's a definite need for a less invasive alternative." That need has not gone unnoticed in the halls of science and venture capitalism, and several groups are vying to be the next big thing in obesity treatment. Some researchers are developing ways to help those who regain the weight after a bypass. Others are ignoring the stomach altogether, looking for brand-new ways to fool the body into shedding pounds.

Mildred Coleman, 58, of Columbus, Ohio, started as a bariatric surgery success story. After a lifelong struggle with obesity, in 1996, weighing 383 pounds, she took the leap and had her stomach stapled. In total she lost 237 pounds. Then, two years ago, everything changed. She had fulfilled a major goal by enrolling in college, but her studies interfered with her efforts to exercise and diet. "My freshman 15 was more like a freshman 40," she says.

When Coleman visited Dean J. Mikami, MD, an assistant professor of surgery at Ohio State University, he wasn't at all surprised: "Stomachs stretch," he says. "Over time, eating just a little too much of even the healthiest foods will add volume and gradually undo the benefits of surgery."

Luckily, Mikami could suggest a different approach for Coleman. He had worked on clinical trials for a device called StomaphyX—it's like a tiny sewing machine that is lowered into the stomach from the mouth. Guided by an endoscope, a doctor can use StomaphyX to gather up folds of stomach tissue and stitch them together, shrinking the stomach. Average weight loss at six months is about 20 percent of a person's excess weight.

Facts About Bariatric Surgery

• In 1998, 13,386 Americans underwent bariatric surgery.
  In 2007, 205,000 did.
• The average loss after surgery is 61 percent of excess body weight.
• Twenty percent gain weight back.
• Bariatric surgery cures type 2 diabetes in three out of four patients and eliminates high blood pressure in three out of five patients.

Coleman was sold on the idea, and in the spring of 2007 she became the first person to use StomaphyX after its official FDA approval. By fall she'd lost those 40 pounds. "I felt like I'd regained control," she says. Since then hundreds of bariatric surgery patients have undergone the process—it's often done on an outpatient basis—and their results have been impressive enough to tempt some doctors to offer the procedure to people who haven't had bariatric surgery. That's not a good idea with the current technology, says Theirry Thaure, president and CEO of EndoGastric Solutions, the company behind the StomaphyX. "This product is not designed to work on a stomach that hasn't been bypassed." Thaure is currently developing a version of the StomaphyX for first-time patients. It could hit the market as early as 2010.

If all goes according to plan, we will have another nonsurgical option close behind: the EndoBarrier. This is a gastrointestinal liner that doctors insert through the patient's mouth and past the stomach so that it covers the first two feet of the small intestine. The theory is that when food has less contact with the digestive tract, your metabolism speeds up. Initial clinical studies bear this out: Average excess weight loss on the device is about 20 percent after three months, 30 after six. Patients are currently being studied to 12 months, and early results suggest they may lose as much as 40 percent of their excess weight. And within one week of getting the EndoBarrier—before any weight loss occurred—patients with type 2 diabetes went into remission (the same thing happens after the far more invasive gastric bypass surgery). Researchers believe our hormonal regulation of blood sugar changes when food skips the first part of the intestinal tract, causing diabetes to go into remission. "There's no doubt that the presence of something inside your digestive system is signaling your brain," says Nadey Hakim, MD, a British bariatric surgeon studying the temporary insertion of a fluid-filled balloon to reduce stomach volume and trigger weight loss. "It's beyond a feeling of fullness; hormonal changes really happen."

Scientists have been puzzling over the gut's mysterious interaction with the brain for decades. In the early 1980s, researchers experimented with an ulcer treatment that involved cutting the vagus nerve—it connects the gut with the brain and conveys hunger messages. The doctors found that their patients suddenly started losing weight. But as an ulcer treatment the surgery didn't pan out, and the weight loss findings weren't pursued.

Twenty years later, two doctors are picking up the thread. Robert Lustig, MD, a professor of clinical pediatrics in the division of endocrinology at the University of California, San Francisco, has been studying weight loss associated with the vagus. He's been severing the nerve surgically, but he has now teamed up with EndoVx, a startup company looking to block the vagus by "frying" it with an ultrasound machine. The product is still in development, but Lustig's research so far is promising. "We found that for the vast majority of those who were obese, severing the nerve spurred a loss of 20 percent of their excess weight."

EndoVx will have competition: Mark Knudson, a Minnesota-based physiologist, also plans to target the vagus nerve but by a slightly different method. Knudson's device, called Maestro, works like a pacemaker for the stomach. Two electrodes are laparoscopically placed on the vagus nerve, where they electronically disrupt the nerve's signals for five minutes and then pause for the same length of time before starting up again. Within nine months, studies show, patients can drop about 30 percent of their excess weight. The company is now recruiting for its last clinical trial, and if all goes well, that product will also be available by 2010.

With three of the five devices rolling out in the next three years, this race is just heating up. Whichever approach takes off, one thing is certain: Patients struggling with obesity have plenty to be hopeful about.

Sara Reistad-Long lives in New York and has written for Esquire and The New York Times.