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.
In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. The balloons are left in the stomach for up to six months with the idea being they leave less room for food. Three patients died 1 to 3 days afterward.
"At this time, we do not know the root cause or incidence per rate of patient death", the FDA said, adding that it is working with the companies that manufacture the devices.
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It is unclear whether the devices or the surgeries used to implant them caused the deaths, officials said.
Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.
Apollo Endosurgery uses one balloon, while ReShape Medical uses two. The agency recommends that doctors closely monitor patients who are using these devices.
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Cuban officials have pledged to investigate the incidents as well and take appropriate action, the officials told the Post . It comes a day after the U.S. said its diplomats in Havana were experiencing odd physical symptoms.
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.
A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve USA patients.
Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon.
Endoscopic placement of the balloon is temporary and reversible without surgical incisions.
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Price said the administration has the resources it needs to combat the epidemic without formally invoking the emergency powers. The current United States addiction epidemic cuts across class boundaries, with many middle class people among those affected.
The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting.