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12 August 2017, 03:29 | Randall Craig
Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons
"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.
The FDA said that five deaths have been linked to intragastric balloons albeit it remains unclear if the fatalities were caused by the device itself or the surgery.
Five people have died unexpectedly shortly after being treated with a weight loss balloon devices. The balloon is created to stay in place for several months to help the patient lose weight. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.
The procedure involves a liquid-filled balloon placed in the stomach to make the patient feel more full and eat less. The company also notes that some people - it does not say how many - died while using the device.
FDA updates gastric balloon warning after 5 deaths
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring. It is meant to gather information about anything that happens while someone is using a device or drug, or soon after, so that investigators can determine cause and effect.
'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'.
In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.
Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.
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