Five people have died unexpectedly shortly after being treated with a weight loss balloon devices.
The Orbera balloon, approved in August 2015, is filled with saline and inserted in an obese patient's stomach to help them with portion control. The balloon is created to stay in place for several months to help the patient lose weight.
"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 agency said. The FDA is also looking into two additional deaths that could possibly be related to "complications associated with the balloon treatment"-one from each company".
It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System. However, the FDA says it hasn't determined if the deaths were, in fact, caused by the silicone balloons or the procedure to insert them. Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System.
According to NBC News, Apollo says it reported the deaths to the FDA itself. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.
A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve US patients.
Last year America expended $2.5 billion on commercial weight-loss balloons.