Tuesday, 24 October, 2017

5 deaths associated with gastric-bypass procedure spur FDA warning

Five Die While Using Obesity Devices, FDA Says Apollo responds to FDA letter, says morality rate in patients with Orbera less than 0.01%
Sammy Stanley | 13 August, 2017, 01:07

The FDA is investigating after five people have died since 2016 following an anti-obesity procedure involving silicone balloons, the Washington Post reports. The less space, the less food the stomach can contain and digest.

Five people have died after have anti-obesity devices surgically inserted into their stomachs, USA regulators have revealed. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

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

Not one of the five people lasted more than a month after introducing the balloon system into their bodies.

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 Food and Drug Administration sent a letter to doctors warning that devices produced by Apollo Endo-Surgery and ReShape have been linked to suspicious deaths.

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%. The agency said two more death reports it received happened within the same time frame and are potentially related to complications from the balloon treatment. Use of the device may have unwanted side effects.

The agency is also looking into a couple of additional deaths, one from each of the companies listed above, that may have been a result of complications from the treatment.

'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'.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. The size of the gastric medical object is too big and can't pass through the pylorus, the part of the stomach that connects to the small intestine. The capsule is attached to a catheter used to inflate the balloons with air.

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