Lap Band Alternatives Await FDA Approval
(NEW YORK) -- The majority of complications from weight loss surgery are minor, but none of the procedures are without risk.
More than 90 percent of patients who underwent the same minimally invasive lap-band procedure that New Jersey Gov. Chris Christie revealed he secretly had in February reported at least one complication, according to the Food and Drug Administration.
Tales of bleeding, infection and severe abdominal pain may stop many people who might benefit from surgery from pursuing it as an option for shedding unwanted pounds.
However, the American Society for Metabolic and Bariatric Surgery (ASMBS) tracks alternative weight loss procedures that may one day provide a viable alternative to going under the knife.
Some, like stunning the stomach and intestinal lining with the cosmetic drug Botox to reduce hunger pangs or chemically scarring the intestine to slow digestion, haven't quite panned out, said Dr. Aurora Pryor, who is the chairwoman of the Emerging Technologies Committee for the ASMBS.
Others, such as intragastric balloons, show more promise.
"These are straightforward in how they work," Pryor said. "One is simply inserted into your stomach and inflated so there is less room for food."
Two Brazilian investigations following more than 100 moderately-to-severely overweight patients who had the inflatable device endoscopically implanted, lost an average of 20 percent of their body weight after six months.
Pryor said the balloons can be easily removed and the biggest risk seems to be unintentional deflation. They are available in many parts of the world but the FDA has not yet approved them for use in the U.S.
Morgan Liscinsky, a spokeswoman for the agency, said the FDA does not comment on its ongoing approval processes for medical devices.
Another weight loss method the ASMBS is following closely is the EndoBarrier, a long, flexible tube resembling a plastic bag. The device attaches to the bottom of the stomach and snakes through the first two feet of the small intestine so that food does not come into contact with the intestine itself.
Dr. Holly Wyatt, an endocrinologist with the School of Medicine at the University of Colorado, will oversee one of the 25 FDA EndoBarrier trials of more than 500 people beginning later this year. She said the device is based on the same premise as gastric bypass but doesn't make permanent changes to the stomach's anatomy, thereby avoiding many of the risks.
"By preventing food from coming into contact with the intestinal wall and delaying digestion, it seems to alter the hormonal response and glucose regulation that originate in the intestine," Wyatt said. "We don't fully understand the mechanism but people tend not to eat as much."
The EndoBarrier was approved in Europe, South America and Australia in 2006 and is expected to be approved for use in the U.S. by 2017, company spokesman Dan Budwick said. He added that in foreign clinical trials, average weight loss was 20 percent of body weight in 12 months or less and many patients were also able to reach healthy blood sugar levels and reduce or eliminate the use of anti-diabetes medications.
Pryor noted that one of the more controversial devices on the ASMBS emerging technology list is the AspireAssist pump, which works by sucking the food right out of the stomach so that only about a third of the calories are absorbed by the body. Patients wait 20 minutes after eating, then empty 30 percent of their stomach contents into the toilet through a small, handheld device that connects to a skin-port discretely embedded on the outside of the abdomen.
Calories not digested are calories not absorbed, which, in theory, Pryor said, should lead to weight loss. In a one-year trial of 24 obese patients, patients, on average, lost 49 percent of excess weight, the equivalent of about 45 pounds.
Available in select regions of Europe, including Sweden, since 2011, the AspireAssist is still undergoing trials in the United States, with no word when it may be approved for use in this country.
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