Published: Sun, August 13, 2017
Health Care | By Jeffery Armstrong

People are dying after getting these weight-loss implants

People are dying after getting these weight-loss implants

Five not-related people died of the same cause: an obesity system for individuals who have tried diets and exercises without any results, but the same enterprise did not make all of those balloons.

Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak.[1] Studies have suggested that fluid is superior to air for distending gastric balloons.[2] Inflated balloons reduce the operative volume capacity of the stomach. The balloon is created to stay in place for several months to help the patient lose weight.

Each of the five dead died within a month or less of receiving the balloon treatment.

The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths. The FDA is also looking into two additional deaths that could possibly be related to "complications associated with the balloon treatment"-one from each company". One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.

The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process. One involved the ReShape Integrated Dual Balloon System by ReShape Medical.

Image credit Dr Dirk
Image credit Dr Dirk

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.

In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.

Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems. "There is no responsibility that we take more seriously than patient safety", ReShape says in a statement.

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