The FDA said the reports it received since 2016 indicate that the patients died within a month of implantation, with three as soon as three days later. Apollo's Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape's integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.
The FDA update comes six months after the agency issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape's devices. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
The company said the product can help overweight people lose more than three times the weight that diet and exercise alone can.
The process involves placing one or two uninflated balloons using an endoscope that goes through a patient's mouth into the stomach.
Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons.
'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'.
The company 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%", which is in line with what it reports in the directions for use of the device.
The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System.
They said that from January 2006 to March 2017, 21 patients using the Orbera device died.
"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously", said Apollo Endosurgery CEO Todd Newton in a statement.style="text-align: center;"