Study: Poor Results From Lap-Band Surgery
Researchers Say Weight Loss From Lap-Band Is Relatively Low; Critics Say Study Has Flaws
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Weight Loss Surgery continued...
Among the findings:
- The death rate from the operation itself was zero, although 3.7% of patients died during the study period from unrelated causes.
- 39% had major complications such as erosion of the band, in which it erodes into the stomach and typically requires removal.
- About 50% required band removal and nearly 60% needed additional procedures.
- Average excess weight loss overall was 42.8% of excess weight after 12 years, but 48% among those who still had their band at the end of follow-up. Greater than 50% is considered a good result, experts say. Overall, 60.3% of patients were satisfied.
- About 6% of patients had type 2 diabetes before band insertion while 14% had diabetes 12 years after their procedure.
Himpens reports consultant work for Ethicon Endosurgery, which makes another gastric band, Realize, and for Covidien, a health care products company.
In an email, Cathy Taylor, a spokeswoman for Allergan, the maker of Lap-Band, says: "While Allergan encourages and is committed to the ongoing publication of important, balanced and robust scientific information to advance the practice of medicine, we are disappointed to see the publication of an ill-construed, single-center clinical assessment that does not meet the high clinical standards one should expect from peer-reviewed data, and is not reflective of today's clinical standards."
Among the flaws of the study, she says, are the incompleteness of patient follow-up. Bands have improved, she says, as have surgical techniques.
''The erosion rate is uniquely high," she says, ''strongly suggesting technical errors." She cites other research finding rates of 1.4% to 15%.
Other Views on Weight Loss Surgery
The study results are a mix of good and bad news, according to Bruce Wolfe, MD, president of the American Society for Metabolic & Bariatric Surgery and professor of surgery at Oregon Health & Science University in Portland.
He reviewed the study for WebMD but was not involved in it. Some limitations are inherent, he says, such as the older bands used at the study start.
''There is some shorter-term data which indicates the complications Himpens reports as troublesome -- mostly erosion -- have been reduced with the improved band technique," Wolfe tells WebMD. He reports consultant work in the past for Allergan.
Even so, he calls the finding of 39% with band erosion "a concerning number."
In a critique published along with the study, Clifford W. Deveney, MD, a professor of surgery at Oregon Health & Science University who practices with Wolfe, writes: "These data do not shed a favorable light on the use of laparoscopic adjustable gastric banding."
Weight loss after banding, he tells WebMD, typically takes five years to achieve the maximum, in his experience. "With gastric bypass, most of the loss is in the first one and a half years," he says. That procedure involves reducing the stomach pouch size and typically involves bypassing part of the small intestine.
Wolfe says the study should inspire those considering the gastric banding procedure to ask the doctor who is offering it about complication rates, average weight loss, and other outcomes.