At least 5 patients who underwent procedures with liquid-filled weight-loss balloons have died unexpectedly since 2016, according to an FDA Safety Alert issued Thursday.
Free Confidential Lawsuit Evaluation: If you or a loved one had complications after weight-loss balloon surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
August 10, 2017 – All 5 deaths occurred within 1 month or less of weight-loss balloon placement, FDA said. In 3 cases, death occurred as soon as 1 to 3 days after patients received the device.
All but one of the deaths have been linked to Apollo Endosurgery’s Orbera Intragastric Balloon System, and the other occurred in a patient implanted with the ReShape Integrated Dual Balloon System, according to the Safety Alert.
It is still unclear as to what caused the deaths, and what part the weight-loss balloons or their insertion procedures may have played in the event.
In addition to the 5 deaths, FDA is aware of at least 2 other fatalities associated with complications of intragastric balloon treatment. These events included 1 gastric perforation with the Orbera Intragastric Balloon System and 1 esophageal perforation with the ReShape Integrated Dual Balloon System, the agency said.
FDA in February 2017 sent a letter to healthcare providers concerning risks associated with weight-loss balloons made by ReShape Medical and Apollo Endosurgery. The agency’s letter came in response to dozens of reports of acute pancreatitis and over-inflation associated with the devices.
Since the letter was issued, both manufacturers have revised their product labeling to address these risks. Additionally, the agency has ordered that post-approval studies be conducted on the results of intragastric balloon operations, which will help assess the safety and effectiveness of gastric balloons.
Do I Have an Intragastric Balloon Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in weight loss balloon lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you had problems following a procedure with intragastric balloons, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.