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Complications from overinflation and acute pancreatitis can create problems for obesity patients treated with intragastric balloons, according to a statement from the Food and Drug Administration. In a letter to health care providers published on February 9, 2017, the FDA warned of the two specific issues that have been the subject of multiple adverse event reports.
“We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices,” the letter said.
Most of the overinflation reports involved the Orbera Intragastric Balloon System (Apollo Endosurgery) that uses a single balloon, although some reports involved the ReShape Integrated Dual Balloon System (ReShape Medical) that uses two balloons. Neither product mentions overinflation risk in its labeling. “At this moment there is not enough information to determine what is causing the balloon to overinflate,” according to the FDA letter.
A separate set of adverse event reports noted the development of acute pancreatitis caused when the balloons compressed other gastrointestinal structures. Both the Orbera and ReShape products were associated with pancreatitis, although neither lists pancreatitis as a potential complication on their labels. Pancreatitis was reported as early as 3 days after implantation, and symptoms included severe back and abdominal pain.
The FDA letter recommends that health care providers consider overinflation and pancreatitis in their differential diagnoses of obesity patients with intragastric balloons who present with the symptoms described, and to report any type of serious adverse events associated with intragastric balloons to the FDA through the MedWatch program. For more information about reporting adverse events to the FDA, visit the MedWatch site.
Complications from overinflation and acute pancreatitis can create problems for obesity patients treated with intragastric balloons, according to a statement from the Food and Drug Administration. In a letter to health care providers published on February 9, 2017, the FDA warned of the two specific issues that have been the subject of multiple adverse event reports.
“We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices,” the letter said.
Most of the overinflation reports involved the Orbera Intragastric Balloon System (Apollo Endosurgery) that uses a single balloon, although some reports involved the ReShape Integrated Dual Balloon System (ReShape Medical) that uses two balloons. Neither product mentions overinflation risk in its labeling. “At this moment there is not enough information to determine what is causing the balloon to overinflate,” according to the FDA letter.
A separate set of adverse event reports noted the development of acute pancreatitis caused when the balloons compressed other gastrointestinal structures. Both the Orbera and ReShape products were associated with pancreatitis, although neither lists pancreatitis as a potential complication on their labels. Pancreatitis was reported as early as 3 days after implantation, and symptoms included severe back and abdominal pain.
The FDA letter recommends that health care providers consider overinflation and pancreatitis in their differential diagnoses of obesity patients with intragastric balloons who present with the symptoms described, and to report any type of serious adverse events associated with intragastric balloons to the FDA through the MedWatch program. For more information about reporting adverse events to the FDA, visit the MedWatch site.
Complications from overinflation and acute pancreatitis can create problems for obesity patients treated with intragastric balloons, according to a statement from the Food and Drug Administration. In a letter to health care providers published on February 9, 2017, the FDA warned of the two specific issues that have been the subject of multiple adverse event reports.
“We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices,” the letter said.
Most of the overinflation reports involved the Orbera Intragastric Balloon System (Apollo Endosurgery) that uses a single balloon, although some reports involved the ReShape Integrated Dual Balloon System (ReShape Medical) that uses two balloons. Neither product mentions overinflation risk in its labeling. “At this moment there is not enough information to determine what is causing the balloon to overinflate,” according to the FDA letter.
A separate set of adverse event reports noted the development of acute pancreatitis caused when the balloons compressed other gastrointestinal structures. Both the Orbera and ReShape products were associated with pancreatitis, although neither lists pancreatitis as a potential complication on their labels. Pancreatitis was reported as early as 3 days after implantation, and symptoms included severe back and abdominal pain.
The FDA letter recommends that health care providers consider overinflation and pancreatitis in their differential diagnoses of obesity patients with intragastric balloons who present with the symptoms described, and to report any type of serious adverse events associated with intragastric balloons to the FDA through the MedWatch program. For more information about reporting adverse events to the FDA, visit the MedWatch site.