FDA is still keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity as at least a dozen patients have died in the past two years after receiving one of the devices. The agency first alerted physicians about deaths possibly associated with the devices last year after five patient deaths had been reported.
FDA has also approved labeling changes to reflect this information. The agency said it also continues to monitor complications related to the placement and use of these devices, including perforation of the stomach wall or esophagus, inflammation of the pancreas, and the balloon filling with air and enlarging (spontaneous hyperinflation).
The devices on FDA's radar include the Orbera Intragastric Balloon System made by Austin, TX-based Apollo Endosurgery, and the ReShape Integrated Dual Balloon System made by San Clemente, CA-based ReShape Lifesciences. Both balloon systems were among a rash of devices FDA approved in 2015 aimed at tackling the obesity epidemic.
The monitoring does not appear to include the Obalon system made by San Diego, CA-based Obalon Therapeutics. That device, approved in 2016, uses gas instead of liquid to inflate the balloon.
ReShape said there has been one reported death following the implantation of its device since August 2017 FDA letter. That patient died from a pulmonary embolization secondary to a surgical repair of a gastric perforation, the company said, and there have been no product liability-related claims in connection with that case.
"Patient safety is our highest priority at ReShape Lifesciences, and safety was the main driver behind the unique dual balloon design of our ReShape Balloon," said Dan Gladney, CEO and chairman of ReShape Lifesciences. "We worked closely with FDA to review and enhance our Instructions for Use (IFU), patient information and physician training materials and we will continue to work with the FDA to mitigate patient risk and optimize outcomes so that we can continue to safely and effectively change lives with our obesity solutions."
Last year after FDA first posted a letter about the possible connection between the Orbera and the ReShape balloons and patient deaths, Apollo Endosurgery CEO Todd Newton defended the Orbera system during a conference call with investors.
At that time, Newton said a total of 21 patients had died while the Orbera balloon was in their stomach between January 2006 and March 31, 2017, which includes clinical trial patients. During this same period, he said more than 277,000 Orbera balloons were distributed, making the mortality rate less than 0.01%.
"It is incomplete to talk about a numerator in isolation and lose track, or fail to discuss, the denominator," Newton said. "The very low mortality rate associated with Orbera actually gives an exceedingly strong testimony of the product's safety profile."
On Monday, in response to FDA's latest letter regarding these devices, Apollo said the updated labeling reports a U.S. mortality rate in Orbera patients of 0.036%, which the company said is less than four deaths per 10,000 patients.
Apollo also pointed out that the mortality rate of the device is in line with that of a colonoscopy, which is the most common gastrointestinal procedure performed.
FDA said it is working with Apollo and ReShape to better understand these issues. In the meantime, the agency urged doctors to closely monitor patients who have intragastric balloons for complications, and also recommended that patients be educated about symptoms that could be signs of serious or life-threatening problems.
Apollo said FDA has also approved the company's revised U.S. physician training, which provides additional guidance on how to manage Orbera patients experiencing symptoms that suggest the patient is not tolerating the device well.
"While infrequent in occurrence, these patients can develop an intolerance to the balloon potentially caused by a greater than anticipated delay in gastric emptying with gastric distention and retention of food and fluid," Apollo said. "These patients may be at greater risk for both perforation and aspiration at the time of balloon removal."