FDA safety alert: Five deaths after intragastric balloon insertions

The FDA issued a safety alert warning health care providers that since 2016, five patients who were treated with liquid-filled intragastric balloons for obesity died unexpectedly.

Four of these reported deaths involved patients treated with the Orbera Intragastric Balloon System (Apollo Endosurgery) and one involved a patient treated with the ReShape Integrated Dual Balloon System (ReShape Medical).

All deaths occurred within 1 month of balloon placement, and three occurred within 1 to 3 days.

“At this time, we do not know the root cause of incidence rate of patient death, 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 wrote.

The agency added that it has also received two reports of death related to possible complications associated with the balloons occurring in the same time period, one of which was a gastric perforation associated with the Orbera balloon, and the other an esophageal perforation associated with the ReShape balloon.

The FDA said it will work with the manufacturers to better understand this issue and continue to obtain data on the safety and effectiveness of these devices in FDA-mandated post-approval studies. In addition, it will continue monitoring the possible complications of acute pancreatitis and spontaneous overinflation, which the agency reported in a previous safety communication in February. Since then, “both companies have revised their product labeling to address these risks,” the agency noted.

Apollo Endosurgery issued a press release to clarify that there have been five reported deaths of patients treated with the Orbera balloon in four different countries since the device was approved, which the company reported to the FDA as part of its global product surveillance program. The company noted that the FDA’s safety communication did not indicate that the deaths were related to the device or the procedure, nor did the attending physicians or hospitals where the deaths occurred.

Further, the company said it has not received any product-liability claims related to these cases. Of the 277,000 Obera balloons distributed from 2006 through March 2017, they said that 21 reported deaths have occurred in patients undergoing treatment with the device, and the incidence rate remains below .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,” Todd Newton, CEO of Apollo, said in the press release. “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 FDA’s letter reinforces the fact that complications and adverse events can occur within patients having obesity-related comorbid conditions,” Christopher Gostout, MD, chief medical officer of Apollo, added. “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.”

ReShape Medical has not responded to our request for comment. – by Adam Leitenberger

Reference:

FDA. UPDATE: Potential risks with liquid-filled intragastric balloons – Letter to Health Care Providers. Accessed August 10, 2017. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm570707.htm

Disclosures: Newton and Gostout are employed by Apollo Endosurgery.

Editor's note: This article was updated on August 11 with comments from the manufacturer.