FDA Investigating 5 Deaths Following Obesity Procedure

13 August, 2017, 01:10 | Author: Clint Gray
  • Five Die While Using Obesity Devices, FDA Says

Five people have died after have anti-obesity devices surgically inserted into their stomachs, United States regulators have revealed.

Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due. The balloon is created to stay in place for several months to help the patient lose weight.

Four deaths occurred among patients implanted with the Apollo Endo Surgery's Orbera Intragastric Balloon System, and one involved ReShape Medical's ReShape Integrated Dual Balloon System.

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"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the USA clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. In three reports, the patients died in as little as one to three days later.

"At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices", the U.S. Food and Drug Administration said on Thursday.

The FDA is also investigating two other deaths, one from each company, due to "potential complications associated with balloon treatment.". However, the FDA says it hasn't determined if the deaths were, in fact, caused by the silicone balloons or the procedure to insert them. Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery.

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

According to NBC News, Apollo says it reported the deaths to the FDA itself.

The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding. "Patients must be monitored closely during the entire term of treatment to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms". "There is no responsibility that we take more seriously than patient safety", ReShape says in a statement.

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