Related: Obesity Balloon Lawsuit
FDA Issues Alert
The FDA issued a letter August 10, 2017 to an audience of surgeons, gastroenterologists, and other health care professionals. The agency said the deceased had all received “liquid-filled intragastric balloon systems to treat obesity.”
Deaths within a Month
The agency reported that five deaths occurred within a month or less of balloon placement. Death occurred in three cases within 1-3 days after a balloon was placed.
Orbera & ReShape Intragastric Balloon Systems
The agency said it also received two additional reports of balloon deaths in the same time frame. One was a gastric perforation with the Orbera Intragastric Balloon System and the other an esophageal perforation with the ReShape Integrated Dual Balloon System.
Four death reports involve the ReShape Integrated Dual Balloon System made by Apollo Endo Surgery; one involves the ReShape Integrated Dual Balloon System made by ReShape Medical, Inc.
Root Cause of Death Unknown
The FDA wrote in its August 2017 alert: “We do not know the root cause or incidence rate of patient death, no have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).
FDA Letter of Feb. 2017 Re: Intestinal Balloon Labeling
In Feb. 2017, FDA issued a previous letter to health care providers recommending close monitoring of obese patients treated with liquid-filled intragastric balloon systems. The FDA alerted providers to the potential risks of acute pancreatitis and spontaneous over-inflation. Both companies then revised their patient labeling to address these risks.
FDA continues to recommend health care providers closely monitor anyone implanted with an obesity balloon. It also urges professionals to promptly report any adverse events related to intragastric balloon systems through MedWatch., the FDA Safety Information and Adverse Event Reporting Program.
Law Firm Investigating Obesity Balloon Deaths
Matthews & Associates Law Firm is investigating obesity balloon death cases for potential litigation. Contact our law firm for a free legal consultation if you or someone you love was injured by an intestinal balloon used to treat obesity.