Friday, 18 August, 2017

Five people die after getting weight loss balloons to treat obesity

5 Die After Being Fitted With Balloons for Obesity FDA Says Five Die While Using Obesity Devices, FDA Says
Marlene Weaver | 12 August, 2017, 01:52

Five people have died after have anti-obesity devices surgically inserted into their stomachs, USA regulators have revealed. The balloon is created to stay in place for several months to help the patient lose weight.

The procedure involves a liquid-filled balloon placed in the stomach to make the patient feel more full and eat less.

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.

The alert from the FDA does not mean that the agency has definitively proven that the balloons caused the deaths, but that they are looking into it. One was a stomach perforation and the other was a perforation in the esophagus, according to the FDA.

Four of the cases involve Apollo Endo Surgery's Orbera Intragastric Balloon System while one involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. In three reports, the patients died in as little as one to three days later. The other is a dual balloon system made by ReShape.

Kim Kardashian Defends Putting Saint in a 'Dangerous' Position
Comments included, "he is so cute let's protect this handsome boy by making sure is rear facing", and, "Needs to be rear facing". Back in June, the reality TV star found herself at the center of controversy after posting a photo of her son Saint on Facebook.

The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices.

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 FDA's letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures. The exact causes in three of the deaths remained unknown.

The company has not received product-liability claims as a result of any of the deaths, it said.

The FDA update comes six months after the agency issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape's devices.

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