FDA Investigating 5 Deaths Following Obesity Procedure
Aug 13 2017
Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full.
According to the U.S. Food and Drug Administration (FDA), five people have died since 2016 after using intragastric balloons, which are liquid-filled balloons used for obesity treatments. In the procedures, patients are mildly sedated as a deflated balloon made of silicone is inserted through the throat and into the stomach, after which it's filled with saline to take up space in the stomach.
The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight. Of these, three occurred between one and three days after balloon placement.
"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.
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. The use of the balloon is complemented with counseling and nutritional support or advice.
In a statement in response to the FDA letter, Apollo Endosurgery said the company self-reported the deaths of five patients from four countries who have received the Orbera intragastric balloon since the FDA approved the device in August 2015.
Apollo Endo-Surgery said in a press conference they are responsible for one death in the U.S., one in Great Britain, one in Mexico, and two in Brazil.
An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States.
Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon.
The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.