The FDA has determined that intragastric cylinders against obesity could lead to the death of patients

The FDA has determined that intragastric cylinders against obesity could lead to the death of patients

Management under the control over products and medicines reports of death of five people after they were installed intragastric balloons for the fight against excess weight.

Not sure whether to blame the device for the death of people, but the administration is asking doctors to closely monitor patients who are installing these tanks.

The FDA has determined that intragastric cylinders against obesity could lead to the death of patients

«All five reports indicate that the death occurred within one month or less after placing of cylinders,» — said in a statement, the Management.

«In three cases, death occurred 1-3 days after surgery. Currently, we don’t know the root cause of the death of patients.»

Intragastric cylinders represent balloonsfilled with salt water that is placed into the stomach. Filling a space, they reduce the amount of food consumed, and thus promote weight loss. One of the manufacturers of these cylinders is the company Apollo Endo-Surger.
Their device Orbera received approval from the management in August 2015. The company reported that since they received reports about five cases of death of patients in four different countries after the installation of the cylinders.

«Although the cause of death has not been established in all cases, our company has not received any reports from doctors or hospitals that the death was caused by a device Orbera. Global experience of use of the Orbera shows serious side effects such as erosion, perforation of the esophagus, heart complications, cardiac arrest and death, but in clinical studies the USA was similar was not» — says the statement on the website of Appolo.

Management is also exploring other deaths: «We have received two more reports of death during the same period of time, associated with possible complications after the installation of the cylinders».

 

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