ReShape and Orbera stomach balloons for weight-loss have been linked to pancreatitis (pancreas inflammation) and spontaneously over-filling with fluid. Dozens of people have been injured — some in just a few days of receiving the implant.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting gastric balloon induced injury cases in all 50 states. If you or somebody you know has been diagnosed with side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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 Are Weight-Loss Balloons?
Intragastric weight-loss balloons, also known as “stomach balloons,” are non-surgical devices that treat obesity. The silicone balloons are inserted down the throat with endoscope. Once in the stomach, they are filled with air or salt-water (saline) to about the size of a grapefruit.
How Do They Work?
Gastric balloons physically fill up the stomach, making a person feel full and limiting the amount of food they can eat. Patients also have to exercise, follow a strict diet, and remove the balloon after 6 months.
Orbera Intragastric Balloon System
In August 2015, the FDA approved the Orbera Intragastric Balloon System made by the Texas-based medical device company Apollo Endosurgery Inc. The system is a single silicone balloon filled with 400-700 cc saline.
ReShape Dual Balloon System
In July 2015, the FDA approved the ReShape Integrated Dual Balloon System made by the California-based device company ReShape Medical Inc. The system is two silicone balloons attached to each other. The balloons are filled with saline and methylene blue, which is a dye that causes the patient’s urine to turn blue if the balloon pops.
FDA Warning for Stomach Balloon Side Effects
February 9, 2017 — The FDA is warning doctors to closely monitor patients for symptoms of pancreatitis and over-filled gastric balloons after dozens of serious injuries were linked to Orbera and Re-Shape.
- Spontaneous Hyperinflation: The FDA said “several dozen” people were injured when their gastric balloons filled up with too much fluid as soon as 9 days after implantation. The reports mostly involved Obera, but also ReShape.
- Acute Pancreatitis: Four people were hospitalized and several more were diagnosed with pancreatitis as soon as 3 days after implantation of Orbera or ReShape — possibly because balloons compressed the pancreas or other organs.
What is the Risk?
Acute pancreatitis and over-inflation of gastric balloons are very serious side effects that may require emergency removal of the balloon. Neither side effect is on the label for ReShape or Orberon, so doctors may not realize they are causing a patient’s symptoms. This could delay diagnosis and lead to life-threatening complications. It could also lead to misdiagnosis and inappropriate treatments.
Symptoms of Pancreatitis
Acute pancreatitis occurs when the pancreas (a digestive gland behind the stomach) suddenly becomes inflamed. This could cause the following symptoms:
- Severe stomach pain
- Back pain
- Nausea, vomiting
- Fever
- Rapid heartbeat
Symptoms of an Over-Filled Stomach Balloon
Gastric balloons are made of silicone, so they do not “stretch” like a toy balloon made of rubber. Too much fluid increases the risk of a stomach balloon popping. Even if it does not pop, an over-filled balloon is dangerous and it may need to be removed. The symptoms may include:
- Intense abdominal pain
- Swelling of the abdomen
- Abdominal distention
- Discomfort
- Difficulty breathing
- Vomiting
Do I have a Gastric Balloon Lawsuit?
The Schmidt Firm, PLLC is currently accepting gastric balloon induced injury cases in all 50 states. If you or somebody you know has been diagnosed with side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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