FDA updates gastric balloon warning after 5 deaths

Five Die While Using Obesity Devices, FDA Says

All 5 patients died within 1 month of receiving the weight-loss balloon.

The FDA's announcement does not mean that the weight loss balloons caused the patients' deaths, but they are looking into two more deaths and advising doctors to closely monitor their patients using these devices.

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.

The FDA said the reports it received since 2016 indicate that the patients died within a month of implantation, with three as soon as three days later.

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.

Gastric balloons are among many different devices on the market to treat severe obesity. It has not received any product liability claims in connection with the five deaths.

It's still unclear whether there's a definitive link between the devices and the deaths.

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. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so".

"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. What are the potential side effects of intragastric balloons?

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.

APEN shares closed down -23.3% at $4.34 apiece yesterday.



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