The U.S. Food and Drug Administration (FDA) released a report that since 2016, five peopledied after using liquid-filled balloon weight loss system meant to treat obesity. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak. Studies have suggested that fluid is superior to air for distending gastric balloons. Inflated balloons reduce the operative volume capacity of the stomach. Of these, three occurred between one and three days after balloon placement.
The FDA said the deaths occurred from some time in 2016 to the present and have issued the warning as a precautionary measure, as the regulatory body has yet to directly link the intragastric balloons to the cause of death.
Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery. The FDA is also looking into two additional deaths that could possibly be related to "complications associated with the balloon treatment"-one from each company". Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery. It's still unclear whether there's a definitive link between the devices and the deaths.
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'The FDA's letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures.
Apollo Endo-Surgery said, per NBC News, that global 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 USA patients. The agency recommends that doctors closely monitor patients who are using these devices.
Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients.
The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.
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