FDA NewsPerspective

FDA issues alert after deaths associated with intragastric balloons

The FDA issued an alert for health care providers Monday following five additional deaths in patients with two liquid-filled intragastric balloon systems used to treat obesity, according to a press release from the agency.

Since 2016, 12 patient deaths worldwide have been reported to the FDA involving the Orbera intragastric balloon system (Apollo Endosurgery) and the ReShape integrated dual balloon system (ReShape Medical). The FDA approved labeling changes in May to reflect information about deaths possibly associated with the devices.

“We have been carefully tracking adverse events, including a total of 12 deaths over the past 2 years, that have been reported in patients with two balloon devices used to treat obesity,” William Maisel, MD, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release. “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.”

In addition to death, the FDA continues to monitor complications related to the placement and use of these devices, including perforation of the stomach wall or esophagus, acute pancreatitis and the balloon filling with air and enlarging spontaneous hyperinflation.

The FDA said it continues to work with the device manufacturers to better understand these issues. The agency advised health care providers to closely monitor patients who have intragastric balloons for complications. Health care providers should also explain symptoms to patients that could be signs of serious or even life-threatening problems and advise patients what to do if these symptoms happen.

In August, 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 and one involved a patient treated with the ReShape integrated dual balloon system. All deaths occurred within 1 month of balloon placement, and three occurred within 1 to 3 days.

In a press release issued in August, Apollo Endosurgery 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 to March 2017, the company said 21 reported deaths have occurred in patients undergoing treatment with the device, and the incidence rate remains below 0.01%.

In February, the American Society for Metabolic and Bariatric Surgery added the intragastric balloon to its list of approved devices and procedures, after an extensive review and safety analysis, the organization announced in a press release. – by Regina Schaffer

The FDA issued an alert for health care providers Monday following five additional deaths in patients with two liquid-filled intragastric balloon systems used to treat obesity, according to a press release from the agency.

Since 2016, 12 patient deaths worldwide have been reported to the FDA involving the Orbera intragastric balloon system (Apollo Endosurgery) and the ReShape integrated dual balloon system (ReShape Medical). The FDA approved labeling changes in May to reflect information about deaths possibly associated with the devices.

“We have been carefully tracking adverse events, including a total of 12 deaths over the past 2 years, that have been reported in patients with two balloon devices used to treat obesity,” William Maisel, MD, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release. “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.”

In addition to death, the FDA continues to monitor complications related to the placement and use of these devices, including perforation of the stomach wall or esophagus, acute pancreatitis and the balloon filling with air and enlarging spontaneous hyperinflation.

The FDA said it continues to work with the device manufacturers to better understand these issues. The agency advised health care providers to closely monitor patients who have intragastric balloons for complications. Health care providers should also explain symptoms to patients that could be signs of serious or even life-threatening problems and advise patients what to do if these symptoms happen.

In August, 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 and one involved a patient treated with the ReShape integrated dual balloon system. All deaths occurred within 1 month of balloon placement, and three occurred within 1 to 3 days.

In a press release issued in August, Apollo Endosurgery 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 to March 2017, the company said 21 reported deaths have occurred in patients undergoing treatment with the device, and the incidence rate remains below 0.01%.

In February, the American Society for Metabolic and Bariatric Surgery added the intragastric balloon to its list of approved devices and procedures, after an extensive review and safety analysis, the organization announced in a press release. – by Regina Schaffer

    Perspective

    We were all concerned about the recent report that there may have been up to five deaths in patients who had had intragastric weight-loss balloons in place. My understanding is that these deaths are not clearly related to the balloons. One patient had a balloon and had an accident. Another had what clearly looks like an unrelated complication. We need more information. Thousands of patients have used the balloons, particularly in Europe, before they were FDA-approved in the United States, and there hadn’t been a signal. While it needs exploration, let’s wait for the details to see if these were really related to the presence of the balloon.

    • Sarah E. Streett, MD
    • Clinical Associate Professor Stanford Medicine

    Disclosures: Streett reports no relevant financial disclosures.