The recent FDA alert about deaths related to the intragastric balloons for weight loss has triggered concern and questions, both from those with the devices in place and those considering the procedure.
EndocrineWeb gathered details about the devices, information from the U.S. Food and Drug Administration (FDA) and the two companies involved, and informed opinion from a physician expert. Here, what to know now.
Three balloon systems are FDA-approved for weight loss in the U.S. Obalon, approved in 2016, is not involved in the recent alert. The other two are the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System. Both were approved in 2015 for use along with diet and exercise for those whose body mass index (BMI) is 30 or higher and who have been unable to shed weight through lifestyle changes alone.1
The two systems are approved for six months at the most and are then deflated and removed. With the balloon system in place, patients feel full faster, eat less and lose weight.
The FDA, which monitors medical devices, issued the alert Aug. 10 to healthcare providers, informing them that it had received five reports of death occurring from 2016 to the present in those with the two systems in place. Four reports involved Orbera and the fifth involved ReShape. All deaths occurred within a month or less of the placement, the FDA says. In three, it occurred as soon as one to three days after the procedure.1
The FDA says it does not know the cause nor can they attribute the fatalities to the devices or the insertion procedure.
In addition, the FDA received two more death reports related to complications linked with the balloon, including gastric or esophageal perforation.
The newest alert follows a letter sent to healthcare providers in February, warning them of two other potential risks—overinflation of the balloon and acute pancreatitis (inflammation of the pancreas). Overinflation can cause pain in the abdomen, swelling, and vomiting. Pancreatitis can be deadly.
As the FDA continues to work with the companies to understand the causes of the deaths, it expects to get more information from ongoing post-approval studies of the devices.
The FDA advice? It recommends health care providers ''closely monitor patients treated with these devices for complications" and that they report any problems to the FDA.1
However, the FDA alert does not specify what ''close monitoring'' should include.
And that will vary from person to person, says Caroline Apovian, MD, professor of medicine and pediatrics at the Boston University School of Medicine, director of the Center for Nutrition and Weight Management at Boston Medical Center, and a member of the Endocrine Web editorial board.
While there are no official guidelines on such monitoring, she says it would be reasonable for patients who have gotten the devices to be monitored once a week for the first month, then monthly for the next five months. That monitoring should be done by the obesity medicine specialist caring for the patient, she says.
Before deciding on the device, the patient should receive extensive counseling, she says. After the device is removed, the patient needs information on how to maintain the loss, Dr. Apovian says.
Before deciding on the procedure, a multidisciplinary team should all confer on whether a person is a good candidate for the system, Dr. Apovian says. That team, at the least, should include an obesity medicine specialist, a dietitian, a surgeon and a psychologist, she says. "We make the decision together on whether someone is a candidate."
Soon after the alert, the American Society for Gastrointestinal Endoscopy and the Association for Bariatric Endoscopy issued a joint statement. It urges caution in any weight loss treatment decision. "Any weight loss procedure must be evaluated for its risks as well as benefits," it reads in part.
In an evaluation of both the Orbera and ReShape system, the associations estimate that the death rate is about 1 in 10,000 people. 2
In a statement, ReShape Medical says they take patient responsibility seriously and continue to talk with doctors about the FDA update. 3
Apollo Endosurgery, which provides the Orbera system, conducted a conference call for investors and others Aug. 11. During it, CEO Todd Newton noted that the cause of death for one of the patients was a heart attack and that in others the cause was not certain or was unknown. In all of the five cases, he says, "we are not aware of any evidence that suggest (sic) a device malfunction or failure."
More than 277,000 Orbera balloons have been distributed worldwide in over 60 countries, according to company information from Apollo. ReShape did not provide numbers.4