The FDA says it doesn't know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.
Gastric balloons are among many different devices on the market to treat severe obesity. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.
Earlier this year the federal safety watchdog warned of the risk of two types of adverse event associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal.
Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery.
At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.
"The FDA's letter to Health Care Providers does not indicate that the patient deaths were related to the ORBERA device or the insertion procedures".
The FDA said the deaths occurred from some time in 2016 to the present and have issued the warning as a precautionary measure, as the regulatory body has yet to directly link the intragastric balloons to the cause of death.
Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products.
The company said it "received no product liability-related claims in connection with these five cases" and noted that the incidence rate "remains less than 0.01%", which is in line with what it reports in the directions for use of the device.
In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity. "In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so".
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.