FDA Addresses Health Care Providers After Five Deaths From Weight Loss Balloon Treatment
Authorities recently reported about five deaths related to the use of obesity treatments. Their current letter to health care providers echoes a similar advisory that they sent out earlier in the year.
Five Deaths From Obesity Treatment
Last Aug. 10, the Food and Drugs Administration (FDA) issued an advisory to health care providers regarding five deaths that are evidently related to the use of Apollo Endo Surgery and ReShape Medical Inc. brands of liquid-filled intragastric balloon system.
The unexpected deaths were recorded among patients who were treated with the system from 2016 until present day. All five deaths were reported to have occurred in close proximity to the placement of the balloon, with three of the deaths occurring within one up to three days after balloon placement.
As of now, the agency remains unsure of whether the deaths are related to the use of the device or as a result of the insertion procedures of the device. The FDA is continuously working with the device manufacturers to investigate the five deaths.
Advisory To Health Care Providers
Because of the unfortunate incidences, the FDA issued a letter to health care providers, recommending closely monitoring patients with liquid-filled intragastric balloon systems for potential adverse effects such as pancreatitis and sudden overinflation.
Further, the FDA will be conducting post-approval studies to assess the effectiveness of the already-approved devices. For now, the agency advises prompt reporting of any adverse effects relating to the weight-loss treatment, as it will help better understand the risks of using such devices.
Both manufacturers have adjusted their labeling to include these risks.
In February of this year, the FDA also sent out an advisory to health care providers regarding the liquid-filled device. Back then, the advisory was sent out due to multiple reports of two specific adverse effects: spontaneous hyperinflation and pancreatitis, both resulting in the premature removal of the device.
Patients who reported such reactions experienced intense abdominal pain, abdomen swelling, vomiting, difficulty breathing, and back pain. As such, doctors were then advised to recognize that patients with the device are at risk of these adverse effects and other abnormalities and to consider these two possibilities when patients with the device report such symptoms.
The FDA-approved balloon system is being used to help treat obesity. The balloons are inserted into the stomach via the mouth using an endoscopic procedure. Once in the stomach, the balloons are filled with saline and stay in the organ for a maximum of six months.
Another kind of balloon system is inserted into the stomach by swallowing a catheter-attached capsule, which is then filled with air. To date, only the liquid-filled balloons have been reported to have adverse effects.
Any reports related to intragastric balloon systems may be sent to the FDA through MedWatch.