Five people have died after have anti-obesity devices surgically inserted into their stomachs, U.S. regulators have revealed. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak. Studies have suggested that fluid is superior to air for distending gastric balloons. Inflated balloons reduce the operative volume capacity of the stomach. The balloon is created to remain in place for several months. Of these, three occurred between one and three days after balloon placement.
The FDA said on Thursday that doctors should stay alerted when placing this expensive balloon system and to monitor the patient really close.
The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice.
All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers.
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. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System. The use of the balloon is complemented with counseling and nutritional support or advice.
According to NBC News, Apollo says it reported the deaths to the FDA itself.
Endoscopic placement of the balloon is temporary and reversible without surgical incisions.
The FDA update comes six months after the agency issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape's devices.
In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety".
The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting.