The Risks of Intragastric Devices

Responding to several patient deaths, the Food and Drug Administration (FDA) recently issued an updated alert about the risks associated with liquid-filled intragastric balloon devices. These increasingly popular devices, inserted via endoscopy, allow patients to receive treatment for obesity without an incision. However, the FDA has received multiple reports of patient complications and has, in turn, provided recommendations for healthcare providers offering the devices to patients.

Physicians should be aware of these adverse event reports, along with the FDA’s recommendations for mitigating the potential risks. In summary, the FDA has noted four complications with these devices:

• Over-inflation of the balloon with air or water
• Acute pancreatitis
• Gastric perforation
• Esophageal perforation

To date, these issues have arisen with two FDA-approved intragastric balloon systems: the Orbera® Intragastric Balloon System and the ReShape® Integrated Dual Balloon System.

The root cause and incidence of these issues is not known, but the FDA has suggested that providers closely monitor patients receiving these devices. Practitioners can access the FDA’s original alert here, and an update here.

Curi’s Risk Management Department also recommends practitioners take the following steps when offering these devices to patients:

• Review possible risks: Practitioners should ensure that patients are aware of possible complications and know which symptoms are not considered normal following the insertion of an intragastric device. Providers should also advise patients to notify the practice immediately if they experience any problems or complications. Physicians should let patients know that they are closely monitoring the situation.
• Use procedure-specific consent forms for all intragastric procedures: Providers should check the device manufacturers’ websites for recommendations on how to explain risks and complications. For example, the Orbera® website lists potential risks, such as gastric perforation, which can be included on consent forms.
• Monitor patients closely: All of the recent deaths related to intragastric balloon devices occurred within the first month post-insertion, and a majority within three days. As such, physicians should closely monitor their patients for symptoms related to the above complications post-placement and for the duration of treatment.
• Document all patient conversations: Documentation should include the patient’s understanding of the risks associated with these devices, as well as the educational information provided prior to treatment.
• Develop a staff plan: Physicians should consult with medical staff to determine if any patients warrant follow-up appointments or calls to better monitor their condition. Staff should be aware of any concerning symptoms based on the FDA’s warnings and alert to patients calling to report complications, ask questions, or express concerns.

For further guidance, Curi members are encouraged to contact our Risk Management Department at 800.662.7917.