Apollo Endosurgery Inc. recently announced an update and clarifications to a letter sent by the U.S. Food and Drug Administration to health care providers about potential risks with liquid-filled intragastric balloons.
Apollo markets an intragastric balloon system called Orbera.
“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,” Apollo CEO Todd Newton said in a statement. “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.”
The company noted specific facts about Orbera, including that it is FDA-approved for safety. Apollo claims that, although there have been five patient deaths since 2015, there has been no indication that the deaths were caused by the balloons.
“The FDA’s letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions,” Dr. Christopher Gostout, chief medical officer of Apollo, said. “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.”