FDA Warns of Health Risks with Stomach Balloons to Treat ObesityFeb 14, 2017
The U.S. Food and Drug Administration (FDA) has issued a warning to health care providers about reports of two different problems with fluid-filled balloons placed in the stomach to treat obesity. Neither complication is listed as a potential problem on the device's labeling, Law360 reports.
The FDA warning involves products from ReShape Medical Inc. and Apollo Endosurgery Inc. The FDA has recently received several dozen reports of two types of adverse events linked to these balloons: the balloon spontaneously overinflates with air or more fluid, and the patient develops acute pancreatitis. In both instances, the balloon must be removed prematurely.
The device-injury attorneys at Parker Waichman LLP monitor the latest research on medical devices and can answer questions from individuals who have suffered health consequences from a stomach balloon.
FDA Safety Alert to Health Care Providers
In the FDA's February 9th letter to health care providers, Dr. William Maisel, deputy director for science, Center for Devices and Radiological Health, wrote that the FDA wanted to ensure that health care providers were aware of these potential complications in patients treated with the stomach balloons. The "root cause" of these complications is not known, Maisel wrote.
The FDA notes that patients may develop balloon-related symptoms or other abnormalities following balloon placement and throughout the duration of the treatment. If the balloon is removed, the doctor should follow the manufacturer's instructions for device returns or evaluation.
Balloon Devices to Help with Weight Loss
In July 2015, the FDA approved a temporary, implanted balloon device to treat obesity. The balloon works by taking up space in the stomach, making the person to feel full. At the time of the approval, the FDA explained that people would typically use the balloon for no longer than six months. Under the FDA approval, use of the balloon is limited to patients with one or more obesity-related conditions including high blood pressure, high cholesterol, and diabetes. The balloon is intended for people who have been unsuccessful in losing weight through diet and exercise, the FDA said.
The balloon is placed in the stomach through the mouth during an outpatient procedure that typically takes less than 30 minutes. The patient is under mild sedation. Once the balloon is in place, it is inflated with a sterile solution.
The balloon does not change the stomach's natural anatomy, the FDA said. The patient must follow a medically supervised diet and exercise plan, to help with weight loss while the balloon is in place and to maintain weight loss after the device is removed.
Adverse Events with ReShape and Orbera Balloons
Most of the adverse events reports have involved Apollo's Orbera balloon system, which uses one balloon filled with saline. The ReShape system uses two balloons system filled with saline and blue dye. Both systems can be placed in the stomach for up to six months, according to the FDA.
Symptoms of balloon overinflation include intense abdominal pain, vomiting, swelling of the abdomen, and difficulty breathing. Thus far, reports of overinflation have been limited to the Orbera system. The FDA said the balloon could overinflate as soon as nine days after being implanted.
Another set of reports involves both the Orbera and ReShape balloons. Several patients developed acute pancreatitis—inflammation of the pancreas—because the balloon compressed their gastrointestinal systems, the FDA said. "All of these cases required premature device removal, and four of the patients required hospitalization," the FDA said.
Symptoms of acute pancreatitis in those with an inflated stomach balloon included severe abdominal and back pain. Patients can develop pancreatitis in as little as three days after the balloon is implanted, according to the FDA.
Pancreatitis can cause serious health complications including infection, kidney failure, breathing problems, malnutrition, diabetes, pseudocysts (fluid and debris collects in cystlike pockets in the pancreas), and pancreatic cancer. Long-standing inflammation of the pancreas caused by chronic pancreatitis is a risk factor for pancreatic cancer.
Chronic pancreatitis can damage the insulin-producing cells in the pancreas, leading to diabetes, which affects the way the body uses blood sugar. If blood sugar is not properly controlled, it can result in serious even life-threatening complications including cardiovascular disease, kidney damage, nerve damage (neuropathy), eye damage, and amputations.
Legal Help for Health Complications from a Stomach Balloon
If you or someone you know has suffered pancreatitis or other adverse health consequences after insertion of a ReShape or Apollo stomach balloon, the attorneys at Parker Waichman LLP can provide a free, no obligation case evaluation. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).