Parker Waichman LLP is investigating potential lawsuits on behalf of individuals who suffered adverse events related to fluid-filled intragastric balloons, such as the Orbera Balloon System manufactured by Apollo Endo-Surgery and the ReShape Balloon System manufactured by ReShape Medical Inc. These balloons are placed in the stomach to treat obesity.
The U.S. Food and Drug Administration (FDA) has warned that some patients have reported over-inflation and acute pancreatitis with these obesity balloon systems. The cause of these adverse events is unknown, the FDA wrote in a letter to health care providers. If you or someone you know experienced acute pancreatitis or over-inflation with an intragastric obesity balloon treatment, please contact one of our experienced medical device injury attorneys today.
Key Points of FDA Obesity Balloon Alert
- The Orbera and ReShape intragastric balloon systems are recently approved devices used to treat obesity.
- Patients with the Orbera, ReShape obesity balloons reported two types of adverse events: Over-inflation of the fluid-filled balloons and acute pancreatitis. These adverse events are not listed on the warning label.
- The FDA is advising health care providers to be aware of these adverse events and their symptoms. Keep in mind that a patient implanted with the Orbera and ReShape balloon system may develop symptoms shortly after placement and for the duration of their treatment.
- The FDA is working with device makers to investigate the issue.
FDA Warns of Adverse Events with Orbera, ReShape Balloon Systems
Intragastric balloon systems are designed to treat obesity by taking up space in a patient’s stomach. In 2015, the FDA approved the ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System; these systems use two balloons and one balloon, respectively. In both the ReShape and Orbera systems, the balloons are fluid-filled and are intended to treat obesity in combination with diet and exercise.
Doctors use a minimally invasive endoscopic procedure to place the balloons into the stomach through the mouth while the patient is mildly sedated. Fluid is added to the balloons once they are placed in the stomach. The ReShape balloons are filled with saline and blue dye, while the Orbera is only filled with saline. With ReShape, there will be blue dye in the patient’s urine if the balloon breaks. The balloons may remain in place for up to six months.
The Orbera was approved in August 2015. The device is intended for adult patients diagnosed with obesity who are not able to lose weight through diet and exercise. Specifically, is it cleared for patients with a Body Mass Index (BMI) of 30-40 kg/m2.
The ReShape, approved by the FDA in July 2015, is also intended for adult patients diagnosed with obesity and who have a BMI of 30-40 kg/m2. Additionally, these patients must also have a health condition related to obesity, such as diabetes, high blood pressure, or high cholesterol.
In a February 9, 2017 letter to health care providers, the FDA warned of potential risks associated with fluid-filled intragastric balloons. The agency indicated that it received reports of two types of adverse events related to the obesity balloons: Over-inflation and acute pancreatitis. With over-inflation, also known as spontaneous hyperinflation, the balloons reportedly over-inflated with more fluid or air. Over-inflation prompted patients to undergo premature device removal. Acute pancreatitis also causes balloon systems to be removed prematurely.
The cause of these adverse events is unknown, regulators indicated.
According to the FDA letter, several dozen reports of over-inflation have been submitted to the agency. Most of these complaints involved the Orbera Balloon System, but over-inflation was reported with the ReShape Balloon System as well. If the fluid-filled obesity balloon system over-inflates, patients may experience symptoms such as intense abdominal pain, abdominal swelling (abdominal distention) that may or may not cause discomfort, difficulty breathing, and vomiting. Treatment may require premature balloon removal. The FDA indicates that over-inflation may occur as early as nine days after the system is initially placed.
Regulators also note that the current labeling on fluid-filled obesity balloons does not warn about the risk of spontaneous over-inflation. As such, doctors and other health care professionals may not realize that a patient’s symptoms are caused by over-inflation.
The FDA indicated it also received reports of acute pancreatitis with both the ReShape and the Orbera systems. These adverse events occur when the balloon systems compress the gastrointestinal structures. In all patients who reported acute pancreatitis with fluid-filled balloon systems, the device was removed prematurely. Four patients required hospitalization. Acute pancreatitis was associated with symptoms of severe abdominal pain and back pain. Patients with fluid-filled intragastric balloons may experience acute pancreatitis as early as three days after the system is placed, the FDA notes. As with over-inflation, acute pancreatitis is not disclosed on the product warning label. "This could lead to unsuitable or delayed treatment for pancreatitis in patients with balloons who may have acute abdominal pain," the FDA warns.
The agency advises health care providers to be aware of these symptoms and consider that patients with fluid-filled intragastric balloons may experience adverse events related to over-inflation or acute pancreatitis. "Consider spontaneous over-inflation and/or pancreatitis in the differential diagnosis of patients presenting with the symptoms noted in this communication," the FDA indicated. "If abnormalities are found, perform any confirmatory diagnostic studies. If the device is removed, follow the manufacturer’s instructions for device returns or evaluations," the FDA added.
"We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices," according to the FDA.
Regulators are continuing to investigate fluid-filled intragastric balloons and reports of acute pancreatitis and over-inflation. To have a better understanding of these adverse events, the agency is working with ReShape Medical Inc. and Apollo Endo-Surgery.
Other Adverse Events, Complications with Obesity Balloons
According to the Orbera labeling information, possible adverse events are related to risks associated with the endoscopic procedure. Possible complications include intestinal obstruction, obstruction-related death, esophageal obstruction, gastric outlet obstruction, injury to the digestive tract, insufficient or no weight loss, gastric discomfort (nausea and vomiting after the initial procedure), abdominal pain or heaviness, gastroesophageal reflux, impaired digestion, blockage of food entering the stomach, growth of bacteria in the fluid, injury to digestive tract lining, death due to gastric or esophageal perforation, and balloon deflation.
According to ReShape labeling information, potential risks may include ulceration, perforation, significant gastric bleeding, need for blood transfusions, emergency endoscopic therapeutic intervention, abdominal pain, abdominal spasms, nausea, vomiting, bloating, belching, heartburn, dysphagia, dehydration, and sore throat. The system may need to be removed if these reactions are severe.
Intestinal obstruction is a complication that may occur if the balloon partially deflates or leaks. If this occurs, the deflated balloon may move from the stomach into the small intestine and subsequently lead to intestinal blockage; death from intestinal obstruction may occur.
Filing an Obesity Balloon Injury Lawsuit
If you or someone you know suffered adverse events such as over-inflation or acute pancreatitis with the Orbera Balloon System or the ReShape Balloon System, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing an obesity balloon injury lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).