The U.S. Food and Drug Administration issued a warning about a popular type of gastric balloon meant to help with weight loss because five patients have died. The FDA issued its warning on Aug. 10. All five of the deaths occurred from 2016 until the safety alert was issued and involved two out of the three gastric balloons that are filled with liquid and have received FDA approval for the treatment of obesity. Four of the patients who died received the ORBERA® Intragastric Balloon Systems while the remaining patient received the Integrated Dual Balloon System. When patients are seriously injured or killed because of defective medical devices, a personal injury lawyer might help the victims or their families.
How Gastric Balloons Work
Liquid-filled gastric balloons are inserted into the stomach of patients by doctors using endoscopes. The balloons are made out of silicon. After they are placed, they are then filled with a saline solution. Patients can expect to lose as much as 30 percent of their excess weight when they have the balloons. The balloons help the patients to feel full and to eat smaller portions, leading to weight loss. Because of the risk of perforations, the balloons must be removed within six months of their insertion.
Deaths and the FDA Warning
Three out of the five patients died less than three days after having the balloons inserted. The remaining two patients died in less than a month. The FDA reports that it is unclear what caused the deaths and whether they were related to the balloons or to the insertions.
Problems With FDA Warnings
These deaths demonstrate problems with the FDA and its warnings. The FDA receives significant pressure from manufacturers to speed up its approval process to get products to the market. This may lead to unsafe products receiving FDA approval and being sold. Often, FDA alerts come in reaction to consumer injuries and deaths after a product have already been approved.
In the case of the gastric balloons, the FDA was notified about some of the deaths before it issued an earlier safety alert to doctors. However, this earlier alert, which was issued in Feb. 2017, only informed doctors of the risks of spontaneous over-inflations and acute pancreatitis. The alert in February made no mention of the patient deaths. A personal injury lawyer may investigate products to show that they are defective.