Did you have a gastric balloon weight loss procedure???
The Food and Drug Administration (FDA) issued a safety alert concerning gastric balloon systems after there were five "unanticipated deaths" from 2016 to the present that occurred in patients who had liquid-filled intragastric balloon systems inserted.
Gastric balloon procedures are considered "minimally invasive" FDA approved procedures that are used for treating obesity because the device is inserted through the mouth and requires no surgical incision. But of course, it's still invasive. All the reported deaths occurred within a month of the procedure but apparently, many other people suffered serious complications from these devices.
Overview: Gastric Balloon Deaths Lead to FDA Warning
Gastric balloons, also called intragastric balloons or weight loss balloons, were approved by the FDA in 2015. There are currently two gastric balloons on the market: the Orbera Intragastric Balloon System by Apollo Endo Surgery, approved in August 2015 and the ReShape Integrated Dual Balloon System made by ReShape Medical, approved in July 2015.
Four of the reported deaths were of patients who had the Orbera weight loss balloon implanted and the fifth death was a patient who had the ReShape gastric balloon. All of the deaths took place within a month of when the gastric balloons were implanted. Three of the deaths took place within one to three days of implantation.
The FDA says that it does not yet know if the deaths were caused by the devices themselves or were caused by the insertion procedure when the intragastric balloons were implanted.
There were two additional deaths reported during the same time period that the federal agency says may also be linked to gastric balloon complications. One death was caused by a gastric perforation in a patient that had the Orbera Intragastric Balloon System, and the other death was caused by esophageal perforation in a patient who had the ReShape Integrated Dual Balloon System implanted.
How Gastric Balloons Work
Intragastric balloons are one of the many gastric procedures that exist to treat obesity. In some cases, patients with type-2 diabetes were able to reverse their disease after a gastric procedure, but only immediately after the procedures. Studies of patients several years after surgery found most diabetics were no longer, diabetes free. Many gastric procedures, such as a gastric bypass, are considered invasive surgical procedures and are not done as often as before because of the high complication and death rate in follow up studies.
Intragastric balloons are implanted without the need for a surgical incision therefore were sold as a "non surgical procedure". They were implanted via a scope down the esophagus through the mouth. Once in the stomach, they are filled with fluid and are left in the stomach for 6 months.
The Orbera gastric balloon system uses one balloon. The ReShape system uses two.
Through this procedure, patients typically lose a third of their weight in 6 months.
Gastric Balloon Side Effects & Complications
Gastric balloon systems were advertised as having fewer risks than traditional bariatric surgery but this may be misleading as the balloons can cause several nasty complications and in fact, the FDA recently issued a warning because five deaths were connected to the gastric balloon.
The FDA first issued a safety report in February 2017 concerning gastric balloons after receiving "multiple reports" of two different serious complications linked to the weight loss procedure:
1. Spontaneous over-inflation: The federal agency said that several dozen patients have suffered from over-inflation problems, leading them to need to have the device to be removed prematurely. Symptoms of over-inflation include: abdominal pain, swelling/distention of the abdomen, breathing difficulty, and vomiting. In some cases, over-inflation has occurred nine days after the procedure. This complication occurred mostly in patients with the Orbera weight loss balloon system, but it has also occurred in patients with the ReShape system. At the time this alert was posted, the FDA said that over-inflation was not listed on the current warning label for the devices and that ER personnel and other healthcare professionals may not be aware of the problem.
2. Acute Pancreatitis: Both the Orbera and ReShape weight loss balloons have been linked to acute pancreatitis. The FDA says that this side effect has been caused by "the compression of gastrointestinal structures created by the implanted balloon(s)." In all of the patients who suffered from acute pancreatitis, the devices had to be removed prematurely, and in a handful of cases, the patients had to be hospitalized. This gastric balloon side effect occurred in some patients within days of having the device implanted. Symptoms include: severe abdominal and back pain. Acute pancreatitis is also not listed as a possible complication of gastric balloon devices, which means medical professionals may not be aware of it, leading to inappropriate or delayed treatment.
Gastric Balloon Class Action Lawsuit
If you or a loved one has suffered from complications following a gastric balloon procedure, you may be entitled to compensation. Learn more by filling out the form on this page or calling 1-(855)-JONES-LAW (1-855-566-3752) for a free case evaluation.