UPDATED August 15, 2017, with comment from ReShape Medical.
The FDA yesterday updated its warning of the risks associated with fluid-filled intragastric balloons after receiving new reports of the deaths of patients implanted with the devices.
Intragastric balloons, made by Apollo Endosurgery (NSDQ:APEN) and ReShape Medical, are used to treat obesity. Placed in the stomach orally in a minimally invasive endoscopic procedure, they’re designed to be filled with fluid and stay in the stomach for six months. 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.
Earlier this year the federal safety watchdog warned of the risk of two types of adverse event associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal.
Yesterday the FDA said it received five reports of “unanticipated” deaths since 2016 in patients treated with the balloons, four with Apollo’s Orbera and another with ReShape’s dual-balloon system; in a press release, Apollo said there have been five deaths of Orbera patients since the agency approved the device in August 2015.
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. The root causes for the deaths are unknown, the agency said, “nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”
The FDA also said another two patients died from complications from balloon implantation: a gastric perforation in an Orbera patient and an esophageal perforation in a ReShape patient.
Apollo said it reported all five deaths of Orbera patients in the U.s., Mexico, Brazil and Great Britain to the FDA and has had no indication that any were related to the device or its insertion procedure. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.
“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. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of Orbera and we will continue to do so,” CEO Todd Newton said in prepared remarks.
“The FDA’s letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms,” added CMO Dr. Christopher Gostout.
APEN shares closed down -23.3% at $4.34 apiece yesterday.
“There is no responsibility that we take more seriously than patient safety. ReShape is committed to supporting the continued safe and effective use of the dual balloon and is proactively communicating with physicians about this FDA update. Patients with questions about this FDA update should contact their physicians directly,” that company wrote in an email to CNN.