The FDA has approved new labeling for Orbera and ReShape intragastric balloon systems after possible deaths have been reported. These balloons are weight-loss systems used to treat obesity. They are placed in the patient’s stomach, and when used with diet and exercise, can help a patient lose weight.
The FDA recommends health care providers “instruct patients regarding symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation” and that physicians “Monitor patients closely during the entire term of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis and spontaneous hyperinflation . . . .”
This is a follow up to a February 9, 2017, FDA letter to healthcare providers. The FDA had received multiple reports regarding two different types of adverse events associated with liquid-filled intragastric balloons. The first type of adverse event involved the balloon over-inflating with air or liquid (spontaneous hyperinflation) in patients’ stomachs. This caused premature device removal. The second type of adverse event was acute pancreatitis, which has also resulted in the need for premature device removal.
These products were approved by the FDA via the premarket approval process (PMA). This is the toughest approval process for medical devices by the FDA, and only for those devices that are deemed the riskiest. These Class III devices are considered high risk.
Devices that go through the PMA process can be more difficult to sue if a patient is injured. This is due to a law that states that because the FDA has approved these medical devices through the PMA process, those who are injured may not be able to sue in court.
However, there are exceptions. One example is the Essure litigation, that the attorneys at KBA are currently handling. Essure went through the PMA process, however, lawsuits are pending against the manufacturer, Bayer. While this may be a tough battle for those who have been injured, since many victims have no recourse against medical device companies due to the PMA preemption law, this is still worth investigating if you or a loved one has been injured. If you believe you or someone you know has been hurt due to an intragastric balloon system, please Contact Us today.
Justin Browne, Esq.