Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Ebony Scott
August 11, 2017

In three of the cases the FDA said it does not yet know the root cause or incidence rate of patient death, nor can it "definitively attribute the deaths to the devices or the insertion procedures for these devices".

The FDA updated its warning on liquid-filled intragastric balloons used to treat obesity after receiving five new reports of patient deaths.

Five people have died after have anti-obesity devices surgically inserted into their stomachs, U.S. regulators have revealed.

Four of the patients were implanted with Apollo Endosurgery's Orbera balloon, while the fifth was implanted with ReShape Medical's Integrated Dual Balloon System.

The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.

The FDA is working with both companies and will track potential problems.

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"The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc.to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation", the agency said.

According to Apollo Endo-Surgery, there has been one additional death of a person who received its device.

The other two deaths occurred within a month or less of having the procedure.

The liquid-filled intragastric balloon systems have been used as a treatment for obesity, said the FDA alert issued on Thursday. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017.

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

'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. "Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms", added CMO Dr. Christopher Gostout.

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