People are dying after getting these weight-loss implants

  • People are dying after getting these weight-loss implants

People are dying after getting these weight-loss implants

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

In a report, the U.S. Food and Drug Administration (FDA) is warning health care providers about the liquid-filled balloon weight loss system created to fight obesity, announcing that since 2016, there have been five people dead after using it.

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 balloons are put inside patients' stomachs and inflated to help people feel full and eat less.

An obesity treatment that involves placing balloons inside the patient's stomach may have resulted in five deaths since 2016, the U.S. Food and Drug Administration said in a new warning. In three cases, the person died one to three days afterward.

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 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 other two died within a month.

Four of the cases involve Apollo Endo Surgery's Orbera Intragastric Balloon System while one involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. The other is a dual balloon system made by ReShape.

Apollo Endo-Surgery said in a press conference they are responsible for one death in the United States, one in Great Britain, one in Mexico, and two in Brazil.

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.

Last year America expended $2.5 billion on commercial weight-loss balloons.

Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.