Obesity Balloon Lawsuit

Five Deaths Reported After Intragastric Balloon Surgery

The FDA warned in August 2017 that at least five people had died following intragastric balloon surgery. An obesity balloon maker named in the agency’s letter to clinicians said it had received no product liability claims in connection with the fatalities. Our law firm is pursuing Obesity Balloon lawsuits for people who were injured or  who died following obesity balloon surgery. Contact us for a free legal consultation.

Intragastric Balloon System Problems
Four of five deaths involved the Orbera intragastric balloon system made by Apollo Endosurgery Inc of Austin, Texas. One death involved the ReShape integrated dual balloon system made by ReShape Medical Inc. of San Clemente, California. Both are used to treat obesity. Each patient died within a month after receiving an intragastric balloon, the FDA reported. Three deaths occurred within three days of balloon placement.  All five deaths occurred since January 2016.

FDA officials reported, “[W]e do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or insertion procedures for these devices.”

Two additional deaths may be related to complications from intragastric balloon treatment, FDA officials said. In one of those deaths, a gastric perforation occurred with the Orbera system. In the other death, an esophageal perforation occurred with the ReShape system. Both systems received FDA clearance via the agency’s controversial 510(k) process in 2015. That streamlined clearance process has long been questioned by critics of the agency and its close relations with medical device makers.

Apollo Endosurgery Defends Obesity Balloon
Apollo Endosurgery officials said their company self-reported the deaths to the FDA and that the death rate among patients who have received the Orbera system since August 2015 is less than 0.01%. The company also noted that its product is the only intragastric balloon that meets the American Society of Gastrointestinal Endoscopy’s standards for treating obesity.

Obesity Balloon Side Effects
The most recent FDA alert follows a February 2017 advisory informing clinicians of adverse events associated with liquid-filled intragastric balloons used for obesity treatment. Dozens of reports the agency received were of balloon over-inflation that caused symptoms including intense abdominal pain, abdominal distension, difficulty breathing, and vomiting. Most of those reports involved the Orbera system.

Acute Pancreatitis
More reports involving both obesity balloon brands said several patients developed acute pancreatitis as the implanted balloon compressed gastrointestinal structures. Symptoms included severe abdominal and back pain. The FDA said it is working with both balloon makers to uncover causes of the deaths, related pancreatitis cases, and balloon overinflation.

Obesity Balloon Lawsuit
If you were injured following obesity balloon surgery, or someone you love died or suffered injury following obesity balloon surgery, contact an experienced medical device attorney for a free, no-obligation, legal consultation. We have, for many years, been recognized as legal leaders in the field of medical device litigation for plaintiffs. Contact us now by phone or email. We work on a contingency fee basis, which means our clients pay us nothing unless we win their case in court or settle it.

RELATED

Share