Deaths Linked to Weight-Loss Stomach Balloons

Aurora Colorado. John Moore

Gastric balloons are among many different devices on the market to treat severe obesity.

Five unexpected deaths have occurred in patients with liquid-filled intragastric balloon systems used to treat obesity, according to the Food and Drug Administration.

One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery. The balloons are left in the stomach for up to six months with the idea being they leave less room for food.

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 other two deaths occurred within a month or less of having the procedure. Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.

In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.

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.

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

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%.

The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.

CEO Todd Newton says, "Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously".

"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation.

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