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New Study Highlights Serious Concerns About Gastric Band Safety

Surgeons are performing fewer gastric band surgeries, in large part because patients often suffer complications that require additional procedures. In fact, a recent study found that 1 in 5 patients needed additional surgeries within about 5 years of receiving a gastric band.

The U.S. Food and Drug Administration (FDA) approved laparoscopic gastric bands in 2001. Since then, approximately 96,000 devices have been placed each year. While gastric band surgery was initially the most popular weight-loss procedure, it has fallen out of favor with doctors, in large part due to concerns about the safety of the medical product.

Gastric band complications can occur when the medical device erodes into the stomach or causes obstruction by slipping down. In addition, the device can fail to generate sufficient weight loss. Any of the above situations can require additional surgery. Prior studies found reoperation rates range from 4% to 6%.

The latest study, which represents the first long-term nationwide examination of gastric band-related reoperations, raises serious safety concerns. The researchers reviewed 25,042 cases of Medicare beneficiaries who underwent gastric band placement between 2006 and 2013 and identified gastric band–related reoperations, including device removal, replacement, or revision to a different procedure (such as sleeve gastrectomy or gastric bypass).

Nearly 20% of the patients required a subsequent surgery. In total, 4,636 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%).

"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," wrote lead author Andrew Ibrahim, MD, from the University of Michigan in Ann Arbor, and colleagues.

The study findings are particularly concerning given that the FDA recently expanded the indication for gastric banding. The device may now be implanted in patients with a body mass index above 30 kg/m2, which makes approximately 19 million Americans eligible for gastric band surgery.

Given the likelihood of reoperation and the decision of many doctors to no longer offer lap bands, patients should be wary if offered one. As with any medical procedure, it is important to understand both the risks and benefits.

Contact a San Diego product liability attorney at the Law Offices of Robert Vaage if you or someone you love has suffered serious harm due to a dangerous or defective medical device.