Earlier this month, the U.S. Food and Drug Administration announced that since last year, five patients have unexpectedly died after having gastric balloon weight loss devices inserted in their stomachs. The liquid-filled intragastric balloon systems are inserted through an endoscopic procedure and used to treat obesity by creating a feeling of fullness in the patient and preventing the urge to overeat. Four of the deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endosurgery and approved by the FDA in August 2015. Another death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc. and approved in July 2015.
Gastric balloons are inserted through the mouth while the patient is under mild sedation. It is considered a minimally invasive endoscopic procedure and typically takes less than 30 minutes to implant. Once inserted into the patient’s stomach, the balloon is inflated with a sterile solution, causing the patient to feel satiated and less hungry. The balloon devices are designed to be implanted in the stomach for six months. Patients typically experience a five to ten percent weight loss.
The FDA’s alert to health care providers states that all five incidents of death occurred within a month or less of the balloon implantation. In three of the reports, death occurred as soon as one to three days after balloon placement. The FDA does not know the root cause or incidence rate of patient death and have not been able to definitively attribute the deaths to the devices or the insertion procedures. The FDA also disclosed that it has received reports of two other deaths possibly caused by complications from gastric balloons. One patient who had received the Orbera balloon device suffered a gastric perforation; the other patient suffered an esophageal perforation after receiving the ReShape balloon device.
This news comes on the heels of a February 2017 letter from the FDA warning health care providers about the potential risks of the instragastric balloons, which include acute pancreatitis and spontaneous over-inflation of the devices. Since the FDA’s warning, both Apollo Endosurgery and ReShape Medical Inc. included those risks in their product labels. The FDA has issued a recommendation that health care providers continue to monitor their patients for complications and report any adverse affects to the agency. The FDA states it will keep the public apprised of any new information, as the post-approval studies for these devices continue.
The Future of Gastric Balloon Litigation: How Can the Experts Weigh in?
Any time a product, particularly a medical device, is potentially linked to a death, the obvious question remains: Who should be held responsible? While representatives for ReShape Medical Inc. have not commented, Apollo Endosurgery released a statement indicating that the company reported all incidents to the FDA and that they have “received no product liability-related claims in connection with these five cases.” However, that does not mean that litigation is not on the horizon.
As with any case involving a medical device defect, a products liability complaint, alleging defective design or inadequate warnings of the devices, may be filed against the manufacturers of the gastric balloons in question. Typically, medical device experts would be utilized to attest to the condition of the gastric balloons and its effects on the patients. A medical device specialist can ascertain whether the product was inadequately designed, or whether a particular device was defective. Failure to warn experts can also been useful in establishing whether the manufacturers’ warning labels, which had been recently altered after the February 2017 FDA letter, were adequate in disclosing all of the risks associated with gastric balloon implantation.
The viability of a products liability cause of action, however, cannot be precisely predicted at this time, largely due to the unanswered questions regarding the balloon’s effect on the patient’s death. The cause of death of the first of the five patients was reported to be a heart attack (though the final autopsy report was not provided to the company). Apollo Endosurgery states that, “There was no evidence provided of a device‐related malfunction or causation in this case.” Likewise, the second reported patient death was due to a “non-device related gastric perforation,” according to the company. The causes of death for two other patients remain unknown. While another patient died in Mexico from a heart abnormality, it is unclear what role, if any, the gastric balloon played. If and when more patients suffer complications from these devices, the element of causation will become clearer.
However, it may be discovered that the causes of death have more to do with the implantation procedure, rather than the product itself. Stanford bariatric surgeon John Morton, who is also the former president of the American Society for Metabolic and Bariatic Surgery, has implanted ReShape devices in approximately 70 patients, and has yet to experience complications. As Morton explains, “I can only speculate this is likely to do with technique…There’s skill involved in the placement of these balloons. Who places them makes a difference. If you’re an experienced endoscopist and surgeon, you recognize the signs of perforation, which is important because they’re treatable.”
Interestingly, a study published by the American Medical Association’s medical journal, JAMA Internal Medicine, found that between 1992 and 2014, Gastroenterologists experienced the greatest spike in payment amount for medical malpractice settlements. While there is no link between such payment increases and gastric balloons, it is important to note the current climate of medical malpractice litigation in this medical specialty. A slew of medical experts specializing in gastroenterology and gastric surgical procedures would be needed to establish the standard of care and whether the defendant surgeons deviated from said standard during the implantation procedure.
Morton notes that about 5,000 gastric balloons have been implanted in patients within the United States, while the American Society for Metabolic and Bariatric Surgery says the facilities that are accredited to perform these types of procedures have implanted about 1,000 of the devices. The organization reported that no they have not seen any deaths associated with these procedures. On the international level, according to Apollo’s website, more than 220,000 patients worldwide have had a gastric balloon implanted. As the number of patients continues to grow and gastric balloon devices gain popularity, it may become easier to identify the cause of any medical complications or adverse effects.
While still in its infancy, the issues plaguing gastric balloon devices should be under close watch for any further developments.