Five People Die After Using Weight Loss Balloons for Obesity

"The FDA's letter to Health Care Providers does not indicate that the patient deaths were related to the ORBERA device or the insertion procedures". Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. Neither the devices nor the insertion procedures (eg, gastric and esophageal perforation, intestinal obstruction) have been directly attributed to the patient deaths. The balloon is created to remain in place for several months.

In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said.

The U.S. Food and Drug Administration (FDA) released a report that since 2016, five people died after using liquid-filled balloon weight loss system meant to treat obesity.

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The FDA has also received two other reports of deaths since 2016 related to potential balloon treatment problems: one case where a person got stomach hole, with the Orbera Intragastric Balloon System, and one who got an esophagus hole, with the ReShape Integrated Dual Balloon System. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety. Patients with questions about this FDA update should contact their physicians directly". "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".

"The FDA's letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions".

Ayodhya dispute: Apex court begins hearing pleas against HC verdict
In a surprise, earlier this year the SC said that matter of the disputed land is sensitive and should be settled out of court. The Supreme Court suspended the High Court's verdict in 2011, but has yet to begin hearing appeals by the parties involved.

The process involves placing one or two uninflated balloons using an endoscope that goes through a patient's mouth into the stomach.

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

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