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techkenyot.com August 23, 2017


FDA safety alert: Five deaths after intragastric balloon insertions

11 August 2017, 05:39 | Silvia Roy

FDA Warns of Gastric Balloon Deaths

Obesity

The FDA says it can't confirm the devices are responsible for the deaths.

Gastric balloons are among the varied devices on the market to treat severe obesity.

In three of the cases the FDA said it does not yet know the root cause or incidence rate of patient death, nor can it "definitively attribute the deaths to the devices or the insertion procedures for these devices".

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The five people died within a month or less of having the balloons inserted.

Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program.

Deaths in all five patients occurred within one month of balloon placement with three occurring as early as 1-3 days after placement. The remaining two deaths could be related to "potential complications associated with balloon treatment", - one was a stomach perforation and the other was a perforation in the esophagus, according to the FDA.

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Apollo Endo-Surgery said, per NBC News, that worldwide sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include US patients. "Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms", added CMO Dr. Christopher Gostout.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity.

APEN shares closed down -23.3% at $4.34 apiece yesterday.

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