The FDA said that it has not yet determined whether the weight loss devices or the surgery that implanted them is the cause of the deaths, but it had already issued an alert so doctors would closely monitor patients who have them.
Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program.
Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due. The balloons are left in the stomach for up to six months with the idea being they leave less room for food. And in three of those reports, death occurred as soon as one to three days after the balloon was placed, the agency notes. The enterprise 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%", exactly what's specified in the directions of use of the gastric balloon.
The FDA is also investigating two other deaths, one from each company, due to "potential complications associated with balloon treatment.".
Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert. The other is a dual balloon system made by ReShape.
The agency, however, cautioned that it has yet to determine whether the devices or the way in which they were placed in the stomachs directly caused those deaths. The use of the balloon is complemented with counseling and nutritional support or advice.
A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve US patients.
The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding. "There is no responsibility that we take more seriously than patient safety", ReShape says in a statement.
The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting.