In an “unanticipated” series of tragedies, the U.S. Food and Drug Administration (FDA) confirmed Thursday that a balloon weight loss system designed to treat obesity has killed 5 of its patients.
The deaths occurred from 2016 to present. Four of the 5 patients were using ORBERA® Intragastric Balloon Systems, a brand manufactured by Apollo Endosurgery, while the fifth had used ReShape Medical Inc.’s Integrated Dual Balloon System. Both released onto the market in 2015, these are 2 of 3 FDA-approved liquid-filled gastric balloon devices in the U.S.
According to a safety warning, in 2 cases, the patients died within a month or less of the balloon’s insertion. The other 3 patients were killed within 3 days.
“At this time, we do not know the root cause or 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,” the FDA alert reads.
A relatively new weight-loss treatment, gastric (or intragastric) balloons were thought to be a safe and effective treatment in the short run. So what went wrong?
What Is a Gastric Balloon?
For those struggling with obesity, non-surgical methods are often the preferred form of treatment. That’s where the gastric balloon, a temporary, short-term alternative, comes in.
The painless, 15-minute process involves inserting 1 or 2 uninflated silicon balloons into the stomach via the patient’s mouth using an endoscope, then filling the balloons with saline. This reduces space in the stomach, simulating a feeling of fullness and encouraging the patient to eat smaller portions. During treatment, according to manufacturers, the patient can expect to lose 20 to 30 percent of their excess weight and may even benefit from decreased risk of diabetes or cardiac health issues.
However, the balloons are not without a few drawbacks. The balloon must be deflated and removed after 6 months; past this point, the risks of balloon deflation, perforation, or leakage are higher. Other side effects may include:
- Gastric discomfort
- Nausea
- Vomiting
- Acid reflux
- Stomach cramps
In February 2017 – apparently well after the FDA was first informed of the alleged balloon-related deaths – the agency warned doctors that closer monitoring of liquid-filled intragastric balloons was needed. The only potential problems the FDA cited, however, were acute pancreatitis and spontaneous over-inflation.
“Both companies have revised their product labeling to address these risks,” the FDA stated. But until now, nobody got the memo about potential death.
Another FDA Slip
In its safety announcement, the FDA also indicated its intent to investigate 2 additional deaths related to Apollo Endosurgery and ReShape Medical, linked to “potential complications associated with balloon treatment.” These involved gastric and esophageal perforations, respectively.
But as is customary with FDA investigations, these post-approval reviews are clearly too little, too late. Earlier this year, a report found that as many as a third of drugs present safety risks after FDA approval, and the problem is similar with medical devices: under pressure from Big Pharma, the FDA has a history of cutting corners to get products to market faster.
Despite the supposed benefits that have made gastric balloons so popular, there simply isn’t enough long-term data to assure patients of the device’s safety and efficacy. Sadly, 5 of these patients unknowingly risked their lives, and an estimated 5,000 more balloons have been implanted. The sooner FDA officials reopen their investigations of gastric balloon treatment, the fewer lives there may be in danger.
“The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation,” said the agency, calling on healthcare providers to keep a close eye on their patients. In the meantime, the FDA suggested, “patients should speak to their doctors to determine which obesity treatment option is best for them.”
