All 5 patients died within 1 month of receiving the weight-loss balloon.
FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.
In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution.
The balloons are put inside patients' stomachs and inflated to help people feel full and eat less. "In three reports, death occurred as soon as one to three days after balloon placement", said the FDA.
"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 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". Four of those deaths involved the Orbera Intragastric Balloon System, and one involved the ReShape Integrated Dual Balloon System, the FDA says.
The other two deaths occurred within a month or less of having the procedure. The other is a dual balloon system made by ReShape.
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Still, the company said it has not received product-liability claims in connection to those five cases, and it has not received information from physicians and hospitals indicating that its Orbera device had caused those deaths.
CEO Todd Newton says, "Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously".
Endoscopic placement of the balloon is temporary and reversible without surgical incisions.
Apollo Endosurgery also said that 21 deaths have been reported in the last 11 years, from January 2006 to last March, out of more than 277,000 Orbera balloons distributed during that time period.
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.
The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting.