FDA Reports Five Deaths Linked with Gastric Balloon Obesity Treatment

On August 10, 2017, the FDA released an update alerting health care providers to concerning developments with gastric balloons, which are used to help treat obesity. From 2016 to the date of the update, the FDA had received five reports of deaths linked to these balloons. All patient deaths occurred within a month or less of the patient’s receipt of the balloon.

The FDA also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.

The FDA has not identified the cause of these reported deaths, and so far is not blaming the products or the associated procedures. It is, however, warning healthcare providers to closely monitor patients treated with these devices for complications, and to report any adverse events to the FDA’s MedWatch system.

Reports of Patient Deaths and Serious Complications after Balloon Placement

There are many different brands of gastric balloons. The ones involved in the deaths reported to the FDA include:

• Orbera Instragastric Balloon System, manufactured by Apollo Endo Surgery (involved in four of the five initial reports and one of the additional reports); and
• ReShape Integrated Dual Balloon System, manufactured by ReShape Medical, Inc. (involved in one of the five initial reports and one of the additional reports).

In three of the five initial reports, the patients died within one to three days after balloon placement. In the other two, they died within a month or less. In the two additional reports, one death involving the Orbera balloon system was associated with complications from gastric perforation, and the other involving the ReShape balloon system was associated with complications from esophageal perforation.

The FDA sent a letter to physicians warning them of these issues, and both companies have revised their product labeling to alert doctors and patients to these risks. The FDA is also monitoring ongoing post-approval studies on the products to gather more information “to help assess the continued safety and effectiveness of these approved medical devices.”

Balloons Also Linked to Spontaneous Over-Inflation and Pancreatitis

An intragastric balloon is a saline-filled silicone balloon that doctors place in the stomach to help limit how much the patient eats. It helps people to feel fuller faster, and is a treatment option for those who are significantly overweight or obese, and haven’t been able to lose weight through other methods.

The balloons are inserted through the mouth and into the stomach through an endoscope tube. Once the balloon is in place, saline is injected through the tube to fill up the balloon. The balloons are meant to remain in place temporarily and are usually removed after six months or less.

There are risks associated with the procedure, including abdominal pain, nausea, swelling, and vomiting. The FDA also warned in February 2017 that the products may be associated with acute pancreatitis and spontaneous over-inflating. The FDA received “several dozen adverse event reports” concerning over-inflation with both the Orbera and the ReShape balloon systems. Spontaneous over-inflation of the balloon can occur within 9 days of implantation and may require removal of the balloon.

Acute pancreatitis is another side effect that has been reported with these types of balloons. Reports indicate that pancreatitis can occur as soon as three days after implantation. The manufacturers had not warned about either of these potential complications.