Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Francis Osborne
August 13, 2017

The FDA is investigating after five people have died since 2016 following an anti-obesity procedure involving silicone balloons, the Washington Post reports.

It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device.

In an alert issued Thursday, the FDA said four reports involved 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. One involved the ReShape Integrated Dual Balloon System by ReShape Medical.

Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products.

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.

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Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons.

RECOMMENDATION: 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. Since issuing this letter, both companies have revised their product labeling to address these risks.

Now there are three FDA approved balloons in the USA. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk. This can be done in an outpatient setting under sedation. They aim to reduce how much a person can eat by filling the stomach, closing off part of the stomach or even surgically reducing stomach volume. Less intake of food will result in weight loss.

Apollo Endosurgery uses one balloon, while ReShape Medical uses two.

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.

Other reports by TheDailyFarc

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