Health Care

FDA: Five deaths reported while using weight loss balloon treatment

FDA: Five deaths reported while using weight loss balloon treatment

Yesterday the FDA said it received five reports of "unanticipated" deaths since 2016 in patients treated with the balloons, four with Apollo's Orbera and another with ReShape's dual-balloon system; in a press release, Apollo said there have been five deaths of Orbera patients since the agency approved the device in August 2015.

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. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the USA clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. In February 2017, the agency sent out a letter to health care providers recommending close monitoring of patients using the balloon device to treat obesity for the potential risks of acute pancreatitis and spontaneous over-inflation.

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. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System. It has not received any product liability claims in connection with the five deaths.

'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'.

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"In three reports, death occurred as soon as one to three days after balloon placement".

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'.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.