ReShape and Orbera intragastric balloons, which are commonly used during certain types of weight loss surgery, may increase the risk of pancreatitis and over-inflation, according to federal regulators.
The FDA issued a letter to health care providers on February 9, indicating that adverse event reports have been received involving problems with the fluid-filled intragastric balloons. The letter calls for doctors to closely monitor patients with the balloons inside of them, and to report any adverse events to help the FDA better understand the problem.
Intragastric balloon systems are used to promote weight loss, by taking up space inside the stomach, resulting in less room in the stomach for food. There are currently fluid-filled intragastric balloons on the market in the U.S.: the ReShape Integrated Dual Balloon System by ReShape Medical Inc., and the Orbera Intragastric Balloon System by Apollo Endo-Surgery. Both were approved in 2015.
According to the FDA warning, the agency has received two different types of adverse event reports linked to the weight-loss balloons, including reports of overinflation and acute pancreatitis.
The agency reports that it has received several dozen adverse event reports on overinflation problems, where the balloons undergo spontaneous hyperinflation with either air or fluid. The FDA has not yet determined what is causing the overinflation incidents, which can happen as soon as nine days after the initial surgery.
Most of the overinflation reports have occurred involving the Orbera system, but there have been reports involving the ReShape as well, according to the FDA. Symptoms can include intense abdominal pain, swelling of the abdomen, breathing problems and vomiting. There are no warning labels on the products indicating this as a risk and health care professionals may not identify the symptoms as a problem with the balloons.
The FDA has also received a number of acute pancreatitis reports that developed in a number of patients, which the agency blames on the “compression of gastrointestinal structures created by the implanted ballon(s).” Four patients have been hospitalized and all cases have required revision surgery to remove the balloons.
Symptoms of acute pancreatitis can involve severe abdominal pain and back pain, and acute pancreatitis can occur as soon as three days after the devices are implanted.
Both brands are involved in the incidents, and neither carries label warnings about the risks of acute pancreatitis, meaning health care professionals may again be unaware of the risks or what is causing their patients to suffer acute pancreatitis.
The FDA is advising health care providers to recognize the symptoms of potential problems in patients with the weight loss balloons and to report any adverse events to the FDA’s MedWatch adverse event reporting program. The agency is continuing to investigate the problem with the manufacturer’s assistance, the warning indicates.