Gastric balloons are among the varied devices on the market to treat severe obesity.
The FDA issued an update to alert healthcare providers of 5 deaths that occurred since 2016 in patients with liquid-filled stomach balloons. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way. Of these, three occurred between one and three days after balloon placement. "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".
Of these fatal cases, four involve the Orbera Intragastric Balloon System produced by Apollo Endo Surgery.
Apollo Endosurgery (NASDAQ:APEN) says its ORBERA device has proven to be safe over the years in clinical trials and since its approval by the FDA in August 2015. The other is a dual balloon system made by ReShape. The use of the balloon is complemented with counseling and nutritional support or advice.
"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program", the agency said.
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In the product's package insert, there have been 21 deaths in ORBERA patients in the period from January 1, 2006 through March 31, 2017, out of more than 277K devices distributed during the same period, an incident rate below 0.01%.
Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients.
Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon.
"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement.
The agency is investigating two more deaths that may be linked to the so-called gastric balloons, including one patient who had a ReShape product implanted.