Safety, Effectiveness of Gastric Banding Called Into Question

Veronica Hackethal, MD

May 18, 2017

A new study has called into question the safety and effectiveness of gastric banding.

Over the course of nearly 5 years of follow-up, a study found that almost one in five Medicare beneficiaries who had undergone gastric band placement required reoperation. Researchers also found that Medicare payments for such procedures rose dramatically during the study, and rates of reoperation varied widely across geographical regions.

The study, which is the first long-term national analysis of gastric-band related reoperations in the United States, was published online May 17 in JAMA Surgery.

"Taken together, these findings indicate that the gastric band is associated with high reoperation rates and considerable costs to payers, which raises concerns about its safety, effectiveness, and value," write first author Andrew Ibrahim, MD, from the University of Michigan in Ann Arbor, and colleagues.

In 2001, the US Food and Drug Administration approved laparoscopic gastric band surgery for treating morbid obesity, which resulted in as many as 96,000 gastric bands placed annually, according to the authors.

Recently, the the US Food and Drug Administration expanded the indication for gastric banding to include patients with a body mass index above 30 kg/m2, making an estimated 19 million Americans eligible for the procedure.

Over the years, however, problems with safety and effectiveness contributed to a decrease in popularity, Dr Ibrahim and colleagues note. Gastric band malfunctioning can happen when the device erodes into the stomach or slips down and causes obstruction. In other cases, the device can simply fail to result in enough weight loss. Regardless of the reason for the failure, reoperation may be necessary to replace or remove the band.

Studies have reported reoperation rates ranging widely from 4% to 60%. However, most of these studies were short-term and may not represent the US population as a whole.

To evaluate longer-term gastric band-related reoperation outcomes and costs, Dr Ibrahim and colleagues conducted a retrospective review of administrative claims data for 25,042 Medicare beneficiaries who had gastric band placement between 2006 and 2013. Within these cases, they used procedural codes to identify patients who underwent reoperations for band removal, replacement, or revision to a different procedure, such as gastric bypass or sleeve gastrectomy. Included patients were 82.61% white and 72.45% female, with a mean age of 57.56 years. Results were adjusted for age, sex, race/ethnicity, comorbidities, and year of operation.

During a median follow-up of 4.5 years, 18.5% (n = 4636) of patients underwent 17,539 reoperations, for an average of 3.8 procedures per patient. The most common reoperations were band removal (41.8%), followed by band replacement (28.6%). Nineteen percent needed a different type of operation, including gastric bypass and sleeve gastrectomy.

Rates of reoperation varied widely across hospital referral regions (lowest quartile average, 13.3% vs highest quartile average, 39.1%).

During the follow-up period, Medicare paid $470 million for laparoscopic gastric band–associated procedures, of which $224 million (47.6%) went toward reoperations.

Moreover, the proportion of gastric banding expenditures that went toward reoperations increased during the study, from 16.4% in 2006 to 77.3% in 2013.

The authors note that other studies, including a recent meta-analysis, have called into question the effectiveness of gastric banding for weight loss.

"While this study did not specifically study weight loss as an outcome, the findings here do support concerns about the gastric band effectiveness, as nearly 1 in 5 patients who underwent a reoperation subsequently underwent a different bariatric procedure," they write.

The authors note several limitations, including the use of administrative claims data that may have not identified all patient confounders and postoperative complications. Also, the study included only Medicare beneficiaries, and the results may not generalize to younger, non-Medicare populations.

Nevertheless, they conclude: "Among Medicare beneficiaries undergoing laparoscopic adjustable gastric band surgery, reoperation was common, costly, and varied widely across hospital referral regions. These findings suggest that payers should reconsider their coverage of the gastric band device."

In an invited commentary, Jon Gould, MD, from the Medical College of Wisconsin in Milwaukee, notes that there has been a "precipitous decline" in the use of gastric banding in the United States in the last 5 years, to the point that "we may be close to saying goodbye" to the procedure.

Although acknowledging the "outstanding analysis" in this study, he disagreed that payers should reconsider their coverage of gastric banding. Many patients "do well for a long period" after the procedure, he wrote. Patients still need options, because no single bariatric procedure is appropriate for all patients.

"Do not throw the baby out with the bathwater is an idiomatic expression and a concept used to suggest an avoidable error in which something good is eliminated when trying to get rid of something bad. Let us not do that here," he urged.

The study was funded by the Robert Wood Johnson Foundation, the US Department of Veterans Affairs, the National Institute on Aging, and the National Institute of Diabetes and Digestive and Kidney Diseases. One coauthor has a financial interest in ArborMetrix, Inc, which had no role in this analysis. The other authors and Dr Gould have disclosed no relevant financial relationships.

JAMA Surg. Published online May 17, 2017. Article abstract, Commentary extract

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