Balloon obesity devices linked to 5 patient deaths, says FDA

Balloon obesity devices linked to 5 patient deaths, says FDA

Balloon obesity devices linked to 5 patient deaths, says FDA

Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.

Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products. In three cases, the person died within one to three days of treatment.

"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", the FDA writes, adding that it is looking into two other deaths.

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.

The agency, however, cautioned that it has yet to determine whether the devices or the way in which they were placed in the stomachs directly caused those deaths.

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The FDA is also investigating two other deaths, one from each company, due to "potential complications associated with balloon treatment.". Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation.

More than 180,000 of Apollo Endo-Surgery's Orbera balloons have been placed in patients since the product was approved by the FDA in 2015.

They said that from January 2006 to March 2017, 21 patients using the Orbera device died.

MORE: I Swallowed a Balloon For Weight Loss and Lost 40 Lbs.

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".

'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'.

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