Dozens of people were seriously injured when their ReShape or Orbera weight-loss stomach balloons filled up with too much fluid or compressed internal organs and caused pancreatitis.
Need a Texas Gastric Balloon Injury Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with pancreatitis or needed surgery, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: 5 Deaths Linked to Stomach Balloons
August 2017 — The FDA is warning that 5 people died after receiving the ReShape or Orbera stomach balloons. All of the patients died within 1 month, and 3 of them died within 1-3 days of balloon placement. The FDA is also investigating 2 more people who died after their Orbera or ReShape stomach balloon perforated their esophagus or stomach. Click here to read more.
What is a Stomach Balloon?
Intragastric Non-Surgical Weight-Loss Balloon Systems, also known as “stomach balloons,” are medical devices that treat obesity. A silicone balloon is placed in the stomach through the mouth using an endoscope and filled with salt-water (saline) to the size of a grapefruit.
How Do Stomach Balloons Work?
Stomach balloons take up space in the stomach when they are filled with fluid. This makes a person feel full and reduces the amount of food they can eat. The balloon must be removed after 6 months.
Orbera Balloon System
The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery Inc. and it was approved by the FDA in August 2015. The system consists of one balloon made of silicone that is filled with 400 to 700 cc of saline.
ReShape Balloon System
The ReShape Integrated Dual Balloon System is manufactured by ReShape Medical Inc. and it was approved by the FDA in July 2015. It has two attached balloons that are filled with 2 cups of salt-water (saline) and a blue dye (methylene blue). If the balloon pops, the patient’s urine turns blue.
FDA Warns of Gastric Balloon Side Effects
In February 2017, the FDA warned doctors about “several dozen” reports of people who were injured by pancreatitis or spontaneous hyperinflation of Orbera or ReShape gastric balloons.
Potential Risks of Fluid-Filled Gastric Balloons
- Balloon Over-Inflation: Dozens of people were injured by stomach balloons that spontaneously filled up with too much fluid — mostly involving Orbera, but also ReShape — as soon as 9 days after implantation.
- Acute Pancreatitis: Stomach balloons may compress internal organs or put pressure on the pancreas. Four patients were hospitalized, but several more were injured. Pancreatitis occurred as soon as 3 days after implantation.
What is the Problem?
Pancreatitis and spontaneous over-inflation may require early removal of a gastric balloon. These side effects are not on the label for Orbera or ReShape, so doctors may not realize that a patient’s symptoms are caused by their weight-loss balloon. This could delay diagnosis until it becomes life-threatening, or misdiagnosis and improper treatment.
What is Acute Pancreatitis?
Acute pancreatitis is a sudden inflammation of the pancreas, which is a digestive gland located behind the stomach. The symptoms may include:
- Severe stomach pain
- Back pain
- Nausea, vomiting
Symptoms of Balloon Over-Inflation
A stomach balloon popping is extremely serious. The balloons are made of silicone and they do not “stretch” like a toy balloon, so they can break if they are over-filled. Even if the balloon does not pop, too much fluid in the balloon is dangerous and it often requires removal of the balloon. The symptoms may include:
- Intense abdominal pain
- Swelling of the abdomen
- Abdominal distention
- Difficulty breathing
Need a Gastric Balloon Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas gastric balloon lawyers for a free lawsuit review.