According to the U.S. Food and Drug Administration (FDA), five people have died since 2016 after using intragastric balloons, which are liquid-filled balloons used for obesity treatments.
The intragastric balloon is placed inside the human’s stomach to create a sensation of fullness, forcing the individual to stop eating and making them feel less anxious. The less space, the less food the stomach can contain and digest.
The FDA said on Thursday that doctors should stay alerted when placing this expensive balloon system and to monitor the patient really close. They also confirmed this was the cause of the five deaths.
The liquid-filled intragastric balloons were made by different corporations
Five not-related people died of the same cause: an obesity system for individuals who have tried diets and exercises without any results, but the same enterprise did not make all of those balloons. Four of them, named Orbera Intragastric Balloon Systems, were manufactured by Apollo Endo Surgery, while the other one, named ReShape Integrated Dual Balloon System, was fabricated by ReShape Medical Inc. Both of these companies focus on less invasive therapies for obesity treatment.
Not one of the five people lasted more than a month after introducing the balloon system into their bodies. Three of them died within the first three days, the administration said. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation.
“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices,” the U.S. Food and Drug Administration said on Thursday.
The FDA is investigating both Apollo Endo-Surgery and ReShape Medical Inc.
The administration is already investigating both enterprises, Apollo Endo-Surgery and ReShape Medical Inc., to know what exactly could have caused the deaths.
The FDA is also investigating two other deaths, one from each company, due to “potential complications associated with balloon treatment.”. According to the corporation, one of those deaths was caused by a stomach perforation and the other one by an esophagus perforation.
“FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program,” the agency said.
Apollo Endo-Surgery said in a press conference they are responsible for one death in the US, one in Great Britain, one in Mexico, and two in Brazil. The enterprise said it “received no product liability-related claims in connection with these five cases,” and noted that the incidence rate “remains less than 0.01%,” exactly what’s specified in the directions of use of the gastric balloon. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.
Apollo company declared it had not received any communication from the official investigators indicating the deaths have been due to the Orbrera device. They assured the cause of these deaths still remains unknown.
“Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the U.S. clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death,” it says on its website.
The gastric balloon system occupies stomach’s volume, causing a loss of space for the food
The method is used by individuals who don’t want to undergo surgery. The ball is placed into the stomach when the patient is sedated. Once inside, the balloon is filled with saline and remains floating all over the organ. The size of the gastric medical object is too big and can’t pass through the pylorus, the part of the stomach that connects to the small intestine.
Other materials different from saline are used to fill the balloons. Some of them are made from silicone and hold dye – such as methylene blue – or some other radio-opaque material as a radiographic marker.
A typical stomach has a gastric volume of 900 ml, and the inflated balloon occupies a volume around 700 ml. Thus, the space for food is reduced, tending to a loss of weight. An appropriate diet is also prescribed for the patient. After a maximum of six months, the balloon device is removed.
Last year America expended $2.5 billion on commercial weight-loss balloons. This treatment is costly, and not everyone can afford it, so it’s usually chosen as an ultimate option. There are other solutions to lose weight successfully, like finding a group of friends or family to support each other when doing diet, stop consuming drinks with sugar and calories, and always exercising.