Updated to include response from Apollo Endosurgery
The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS).
The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated dual balloon system up to 12 since 2016, the agency said.
The federal watchdog said that it continues to monitor complications related to the placement and use of the devices, which include perforation of the stomach wall or esophagus, inflammation of the pancreas and the balloon filling with air and enlarging.
The FDA said it is continuing to work with the device makers as it tries to better understand the issues, and advised healthcare providers to closely monitor patients with intragastric balloons for complications and inform them of signs of serious or life-threatening problems and what to do if they occur.
“We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients with two balloon devices used to treat obesity. The FDA continues to work with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices, and to ensure the product labeling adequately addresses these risks. While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” FDA Center for Devices and Radiological Health Office of Device Evaluation director Dr. William Maisel said in a prepared statement.
The notice comes shortly after the FDA approved labeling changes which reflected information about deaths possibly associated with the device, the agency said.
In a statement released today, ReShape that one of the deaths reported since August 2017 involved a patient implanted with its balloon,
“The patient death was due to a pulmonary embolization secondary to a surgical repair of a gastric perforation,” the company said. “ReShape has received no product liability-related claims in connection with this 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,” chairman & CEO Dan Gladney said in prepared remarks. “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.”
“Unfortunately, all health care procedures have a certain amount of associated risk, especially when they are dealing with a patient population that often has many associated difficult medical conditions,” added Dr. Scott Shikora of Boston’s Brigham & Women’s Hospital. “It is important to note that FDA’s recommendation to providers remains the same: Intragastric balloon patients should be closely monitored during the entire term of their treatment.”
Apollo Endosurgery also released a statement in response to the FDA notice, indicating that four patients who had received the Orbera device have died since the FDA released its “Updated Letter to Healthcare Providers” last August.
Apollo indicated that updated US physician training, alongside labeling updates, has been approved by the FDA, including more detailed descriptions of the symptomology of persistent intolerance, methods of assessing patients and updated recommendations for the management of symptoms and removal of the device
“These updates provide important enhancements to our existing labeling and support our continued emphasis on patient safety. Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events,” Apollo Endosurgery chief medical officer Dr. Christopher Gostout said in a press release.
Alongside the update, Apollo also released results from a meta-analysis of intragstric balloons, including its Orbera, touting superior weight loss with the liquid-filled device as compared to gas-filled balloons.
The analysis examined 21 randomized clinical trials with 877 patients and found that fluid-filled balloons resulted in 60% more total body weight loss at six months compared with gas-filled balloons. The company touted that the Orbera had the highest average weight loss of the balloons in the analysis.
“Gastric emptying is the key to how Orbera helps patients lose weight. When a patient has an Orbera balloon in their stomach it acts like a valve that slowly allows food they eat to pass through their stomach. Without a balloon a normal meal will typically pass through a patients stomach in 20-30 minutes. Now with an Orbera balloon in their stomach, we have data that a large portion of that meal would still be in their stomach 2 hours after eating. This delayed emptying helps patients feel full, helps them learn proper portion control and most importantly helps them lose a clinically significant amount of weight,” Dr. Gostout said in a prepared statement.
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