Kathlyn Stone is an associate editor with HealthNewsReview.org. She tweets as @KatKStone.
When they were first approved in the summer of 2015, two new gastric balloon devices–the Orbera and ReShape–received widespread news coverage. Sources in news stories welcomed them with “enthusiasm” as a “new opportunity” for people wanting to shed pounds, with one doctor even envisioning them for someone “with an upcoming wedding, or women looking to shed baby weight.”
Both devices involve placing one (Orbera) or two (ReShape) gastric balloons in the stomach through the mouth, using an endoscopic procedure. When in place, the balloons are filled with saline so they expand and take up space in the stomach. In a trial involving 255 patients, individuals receiving the Orbrera device “lost an average of 21.8 pounds (10.2% of their body weight) after the device had been in place for six months,” according to the FDA.
Fast forward to this summer, though, and the news coverage shifted from excited to ominous, with reports that at least 5 people have died while using the balloon systems:
These news outlets likely all caught wind of the problem via an FDA alert on the deaths sent in early August. The agency said that the manufacturers–Apollo Endosurgery (Orbera) and ReShape Medical Inc.–reported five “unanticipated deaths” in patients within a month after the device had been implanted. In a companion news release posted on the same day, Apollo provided brief case studies on each of the deaths.
The FDA said it had previously updated physicians in February 2017, advising them to closely monitor patients receiving the implant for potential risks of acute pancreatitis and spontaneous over-inflation. The agency said the cause or incidence rate of patient deaths remains unknown and that they’ve been unable to “definitively attribute the deaths to the devices or the insertion procedures for these devices.”
The FDA also says it is investigating two additional deaths attributed to the devices that were reported through its Adverse Event Reporting System (FAERS). This is the voluntary harms collection site used by physicians, other clinical staff, patients and family members to report adverse events from a medical intervention directly to the FDA, rather than through the manufacturer.
In their reports on these deaths, none of the sampling of news stories we read addressed the bigger problem of weak medical device safety regulations. Nor did the stories make it clear that we have no way of knowing how many people have actually died as a result of these devices.
By checking the FDA MAUDE database last week, we found 6 deaths linked to the Orbera and 3 related to ReShape, though these are unconfirmed reports filed voluntarily by health professions or family members.
The public is likely not getting a realistic snapshot of what’s happening with the devices, according to Joseph Ross, MD, associate professor of medicine at Yale School of Medicine’s Center for Outcomes Research and Evaluation.
“The events reported to the FDA are likely only the tip of the iceberg,” Ross said, referring to the reporting of adverse events in general and not specifically to the balloon deaths, in an email. “AE (adverse event) reporting is voluntary among physicians and patients, mandatory among industry. But that means that AEs that occur, and which industry is not made aware of, are rarely reported to FDA.”
Jeanne Lenzer, an investigative journalist and associate editor for The BMJ, shares Ross’s lack of confidence in adverse event reporting (AER).
“There’s no way we can be certain of the number of deaths; this is true for virtually all devices,” she wrote in an email. “The last review by the Government Accountability Office of the percentage of device serious AEs reported was that only 1% of AEs are reported to the FDA’s database and the more serious the AE the less likely it was to be reported.”
The under-reporting of medical device adverse events is part of a much larger problem relating to medical device safety regulations, going back to the initial approval, said Michael Carome, MD, director of Public Citizen’s health research group.
“The pre-market studies for devices are minimal,” he said. The studies are often based on “small, not controlled, much less rigorous trials than clinical trials for drugs.” Some devices are allowed to enter the marketplace through just a pre-market notification process whereby the company isn’t required to provide data from human testing, they only need to demonstrate equivalency to another device on the market, Carome said.
In this case, the Obrera trial on which the approval was based enrolled just 255 patients. As we’ve noted previously, a study this size may conceal problems that occur when a device or drug is approved for wider use.
As a result, what’s known about the safety of medical devices relies heavily on post-market surveillance, Carome said, a process which often results in under-reporting, and that’s putting patients at risk.
Perhaps because AEs are known to be under-reported, the FDA alert on the devices specifically encourages physicians to promptly report complications:
RECOMMENDATION: FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
“Many physicians may not know what’s to be reported. They may conclude it’s [an AE] unrelated and decide not to report,” says Carome.
Several weeks after the news came out about patient deaths connected to the Orbera device–and U.S. regulators issued an alert–Apollo Endosurgery announced market expansion.
Apollo received CE Mark approval to sell the product in Europe and to extend the treatment period of the device from 6 to 12 months. (FDA’s approval allows the device to be worn for 6 months.) The CE marking, or “Conformité Européene,” means a product is approved for use in the European Union.
According to a company news release, “The approval enables Apollo to market and sell the ORBERA365 Weight Loss Balloon in European Union and the European Economic Area member countries. The Company expects ORBERA365 to be commercially available starting in the fourth quarter of 2017.”
So even as U.S. regulators are aware of at least nine reported deaths, Apollo is expanding its global market with a device approved for use twice as long as the one approved by the FDA.
The topic of harms is one of HealthNewsReview.org’s 10 criteria for rating health news stories and news releases. When we’ve reviewed articles and releases on gastric balloons for weight loss (including the Obalon, which was not part of the FDA’s August alert), we’ve noticed harms are often inadequately covered:
People weighing their treatment options for obesity or any other condition should be wary of any claims that a new device “appears safe” or is a “hot new procedure,” as People.com claimed two years ago. The reality is we often have no idea how safe a new device is–and the downsides may not surface until years later.
[Editor’s note: It’s important for reporters to understand how adverse event reporting works, what the gaps are, and how the system is failing patients. Please see our primer on medical device safety with tips to help reporters improve their reporting on medical devices.]
A PR firm representing Apollo Endosurgery contacted HealthNewsReview.org on September 28, 2017, wishing to add some details about the five deaths Apollo reported to the FDA in relation to the Orbera and ReShape gastric balloon devices.
As carefully stated in the HealthNewsReview.org article, the cause of these deaths and their relation to the device remains unclear: “The agency [FDA] said the cause or incidence rate of patient deaths remains unknown and that they’ve been unable to ‘definitively attribute the deaths to the devices or the insertion procedures for these devices.’”
In addition to linking to the FDA’s alert on the gastric balloons our story links to Apollo’s own news release issued on the same day the alert was published.
Here is the additional information Apollo wishes to share with readers:
Here is more detail on the reported cases…of the reported deaths noted in the FDA letter, 2 involved patients who had received the Orbera balloon in Brazil, one in Great Britain, and one in the United States. These four incidents occurred in 2016 and were reported to the FDA in 2016. The one case occurring in 2017 involved a patient from the United States who had received the Orbera balloon in Mexico.
1. For the first patient in Brazil, the cause of death was reported to be a heart attack. An autopsy was performed but the final report was not provided to us. There was no evidence provided of a device‐related malfunction or causation in this case.
2. For the second patient in Brazil, the hospital reported that a non‐device related gastric perforation occurred, causing complication and eventual death.
3. For the patient in Great Britain, the cause of death is unknown, though the death occurred after a second consecutive balloon was placed.
4. For the patient receiving their balloon in the United States, the cause of death is also unknown, but the physician reported that cause of death was not device‐related.
5. Lastly, for the patient who received the Orbera in Mexico earlier this year, the cause of death is also unknown, but the patient was found to have had cardiac complications due to a cardiac abnormality noted as a left bundle branch block.
In each of these cases, Apollo was not aware of any evidence that suggest a device malfunction or failure.”