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Unknown risks

Lack of long-term data worries some observers Add to ...

A gastric band is just what it sounds like: an inflatable silicone band placed around the top portion of the stomach to create a pouch that restricts food intake.

It has become increasingly popular in the United States in recent years, and results in reasonable weight loss. The procedure is considered less invasive and risky than gastric bypass.

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Banding could also be an especially attractive option for teens, say proponents, because it is reversible, whereas bypass is not. The 30- to 60-minute procedure, typically performed with a laparoscope, might require one night in the hospital but can also be done on an outpatient basis.

But certain data show gastric bands are less effective and more problematic for teens than adults, said Dr. Thomas Inge, chair of a U.S. government study to assess bariatric surgery in adolescents called Teen Longitudinal Assessment of Bariatric Surgery, or Teen-LABS for short.

The Teen-LABS study aims to determine if adolescence is the best time to intervene with surgery. It was launched in 2007 and is expected to report results in about five years.

In more than one in five teens in another study, Dr. Inge noted a high rate of "symmetric pouch dilation" - a complication in which the small pouch created at the top of the stomach by the band gets bigger, allowing patients to consume more food.

This issue was reported in the journal Obesity Surgery, and later in the Journal of the American Medical Association.

"We await the U.S. trial data, PMS (post-marketing surveillance) data, and confirmation from non-industry-run trials to make final recommendations," said Dr. Inge, who is the surgical director of the weight loss program for teens at Cincinnati Children's Hospital.

As Dr. Inge and others are quick to point out, trials that studied how teens fared with a gastric band over the short term have been few, and those that were conducted show the device generally is safe and effective, with a relatively low risk for complications or death.

But there is a dearth of long-term data on the outcomes from gastric band surgery. And that worries Dr. Mary Brandt, an investigator in the Teen-LABS study, among other experts.

"I think there's a fundamental problem with putting a rigid plastic object around a moving organ. You're asking it to stay in place and not erode over a long period of time," said Dr. Brandt, who is also director of the pediatric surgical program at Texas Children's Hospital in Houston.

"I'll be happy to reverse my position as soon as I see 10- or 20-year data. Unfortunately, that's not something that industry is excited about funding."

She acknowledged a bias against gastric bands, citing a Swiss long-term follow-up study of 167 adults that showed the band failed almost a third of the time after 10 years. About a fifth of the patients required another operation.

And while fewer than 8 per cent reported complications in the 30 days following surgery, more than 40 per cent had problems after a decade.

Long-term complications included the erosion and slippage of the band, both of which might require another operation, and a dilation of the esophagus, which could result in difficulty swallowing. Infections around the port that sits below the skin and allows the doctor to add or remove saline with a syringe to tighten or loosen the band, as well as leaks, were also common.

"Bands are definitely safe in the short term and definitely work in the short term. What we don't know is about the long term," Dr. Brandt said. "I'm not saying it should never be used. We just have to be more careful about how we're using it."

The Swiss study of adults who had gastric banding, published in Obesity Surgery, came to the same conclusion. Because of complications, the need for another operation, and long-term failure rates, gastric banding should be performed in "selected cases only" until more data are available, it said.

Another group of 276 adults who underwent gastric band surgery had similarly disappointing results in a long-term Austrian study published in the same journal.

Only a little under 54 per cent of the patients still had their original band after nine years, with nearly 18 per cent having the original replaced with a new one and nearly 29 per cent having it removed. Of those who no longer had any band, more than half had a second bariatric operation.

 

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