The Effect of the Moon

Lap-Band: The Difference Between Efficacy and Effectiveness

Apollo Endosurgery is selling off the Lap-Band just five years after they bought it. This news is the latest chapter in a long story of what might have been. In 2013, Apollo bought this device from Allergan for $75 million in cash up front. Stock and contingencies meant that the price could have gone as high as $110 million.

Yesterday, the company sold it to ReShape Life Sciences for $10 million in cash, plus the rights to ReShape’s gastric balloon. Apollo plans to discontinue the ReShape balloon after they take it over. Apollo already has a gastric balloon – the Orbera device.

More Efficacy Than Real-World Effectiveness

This transaction marks the latest development in downward spiral down for the Lap-Band. A decade ago, implanting a Lap-Band was the most common bariatric surgery in the U.S. But since then, its popularity has faded so fast that it accounts for less than three percent of all bariatric procedures.

The simple reason is the perception that real-world, long-term outcomes with the band are poor, compared to a bypass or a sleeve operation. This 2011 paper in the Archives of Surgery presents some of the typically negative views:

Because nearly 1 out of 3 patients experienced band erosion, and nearly 50% of the patients required removal of their bands (contributing to a reoperation rate of 60%), LAGB appears to result in relatively poor long-term outcomes.

Professor John Dixon conducted randomized clinical trials on the Lap-Band. Here and here are prime examples of his fine work. Dixon offers a different view of the Lap-Band:

The band was a great idea. In the trained hands, it worked and continues to work very well. Appropriately trained follow-up is the key and a purely surgical model of care was NEVER going to be appropriate.

The Gap

This gap shows us why efficacy and effectiveness are very different. Researchers define efficacy as the delivery of expected results under ideal, controlled conditions. By contrast, effectiveness is a measure of real-world outcomes.

In the case of Lap-Band, the difference likely has something to do with follow-up. In clinical trials, patients received careful follow-up. But under real-world conditions, such meticulous follow-up was less common. The result? Higher complications in the long term.

Whether this outcome was inevitable is something people can debate for years to come. However, none of that will change the fact that the Lap-Band is decidedly out of favor.

Click here for more on sale of the Lap-Band by Apollo.

The Effect of the Moon, painting by Eugene Boudin / WikiArt

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December 20, 2018

One Response to “Lap-Band: The Difference Between Efficacy and Effectiveness”

  1. December 20, 2018 at 2:42 pm, Allen Browne said:

    John Dixon ( as usual) hits it on the head – “The band was a great idea. In the trained hands, it worked and continues to work very well. Appropriately trained follow-up is the key and a purely surgical model of care was NEVER going to be appropriate.” Having surgeons manage lap-band patients is a little like having surgeons manage patients with diabetes after placement of an insulin pump. The “trained hands” John is referring to is a multidisciplinary weight management program with someone able to do band adjustments. The AGB remains a valuable weight loss device for some patients and has substantial advantages over weight loss surgery – cost, safety, adjustability, reversibility.