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
The most common reoperations were band removal (41.8%), followed by band
"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
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.