Five Die While Using Obesity Devices, FDA Says

Posted August 13, 2017

The weight loss system, which the FDA first issued a safety warning for in February, involves the inflation of balloons in patients' stomachs via a micro-catheter.

The U.S. Food and Drug Administration has received reports of five deaths associated with liquid-filled intragastric balloon systems used to treat obesity. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit. The balloon is created to remain in place for several months.

In its statement released on August 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon. Three people died just one to three days later.

"At this time, we do not know the root cause or incidence per rate of patient death", the FDA said, adding that it is working with the companies that manufacture the devices.

All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers. The FDA says it can't confirm the devices are responsible for the deaths. One involved the ReShape Integrated Dual Balloon System by ReShape Medical. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.

"All five reports indicate that patient deaths occurred within a month or less of balloon placement", the FDA said in a statement cited by NBC. The use of the balloon is complemented with counseling and nutritional support or advice.

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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%.

"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.

Endoscopic placement of the balloon is temporary and reversible without surgical incisions.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems. The agency recommends that doctors closely monitor patients who are using these devices.

The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting.