In the summer of 2016, desperate to lose weight, 48-year-old Laurie Bell Parker took money out of her 401(k) and spent $6,200 on a weight-loss procedure.
A liquid-filled balloon called Orbera, her doctor told her, would make her want to eat less. Approved in the US in 2015 for people with a body mass index (BMI) of 30 to 40, Orbera is one of several brands of silicone weight-loss balloons that are inserted into the stomach via an endoscopic procedure, then filled with saline.
They’re supposed to be left in place for six months, with the goal of helping people feel fuller while eating smaller servings of food and “re-learning” how to eat more healthfully. They’re usually not covered by health insurance because insurers say they haven’t been proven to be very effective compared to more invasive, surgical procedures. If insurance doesn’t cover the balloon, that means the patient pays the doctor in cash.
But three weeks after having the balloon placed, and unable to keep any food, fluids, or medication down, Parker was admitted to the ICU and treated for severe dehydration, critically low potassium levels, and kidney failure that resulted from excessive vomiting. (Orbera’s directions for use say that vomiting could result from the balloon irritating the lining of the stomach or blocking the outlet of the stomach; 76 percent of the 160 people in Orbera’s clinical trial experienced vomiting and 5 percent had to have the balloon removed early because of severe nausea, vomiting, reflux, or pain.)
“The nausea and vomiting was constant,” says Bell, a business analyst who lives near Memphis, Tennessee. “I was sick the entire time—after the insertion procedure, before I even got home, I was sick. It just got worse.”
Steve Bugeja, 38, of Melbourne, Australia, had an Orbera inserted in October 2017—and also required hospitalization for dehydration and severe pain. “I was almost willing to do just about anything to achieve my goal,” he says of the procedure.
Jordi de Cima, 36, a TV producer and sound engineer in Arizona, opted to get an Orbera in 2016, and while he didn’t suffer any severe complications and lost 15 pounds right off the bat, he ended up gaining that back, plus another 15 pounds, while the balloon was in.
“It didn’t work at all,” he says.
On private Facebook groups, other online patient sites, and especially on MAUDE—the FDA’s anonymous database of adverse events connected to medical devices—it’s clear that there are many other people with similar unhappy stories related primarily to the Orbera Intragastric Balloon System, made by Apollo Endosurgery and, to a lesser extent, a similar product, the ReShape Integrated Dual Balloon System manufactured by ReShape Lifesciences.
The Orbera and ReShape balloons are often marketed as reversible, non-surgical weight-loss procedures. On its homepage, Orbera claims the average person loses “3x more weight than with exercise and diet alone.” ReShape, meanwhile, claims “patients have lost up to 81 pounds in just six months with the FDA-approved weight loss balloon.”
But since the devices hit the market in 2015, the FDA has issued three safety alert letters to healthcare providers, most recently on June 4. At least 12 deaths have been connected to the devices worldwide, seven of them in the US, the latest alert said; five more deaths than were previously known. Nine of the patients had Orbera devices, and three had ReShape.
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Experts Tonic spoke to said it’s almost guaranteed that some complications resulting in serious injury—and some deaths—are going unreported, since only device makers are required to report problems; doctors and patients aren’t required to report them to the FDA or to device makers. FDA spokesperson Deborah Kotz confirmed that underreporting is possible, and that the agency doesn’t know how many balloons have been implanted in people.
What is known is serious enough that the devices should be withdrawn, say researchers Chinara M. Tate and Allan Geliebter, of Mt. Sinai St Luke’s Health System and Touro College in New York. They co-published a paper in the December 2017 issue of the journal Advances in Therapy that reviewed the safety problems associated with the devices.
“Given the potential for severe adverse effects, including fatalities, and an efficacy below that available from pharmacological treatment, it is our recommendation that the FDA reconsider its approval and move to withdraw ORBERA and ReShape from the market,” their paper concluded.
When asked at what point the FDA might recall the devices, Kotz explained that they don’t have a set point of deaths or injuries that would need to be reached for that to happen, but that they are monitoring the reports related to the balloons. The June 4 safety alert required new labeling for the devices regarding possible adverse events, and the risks on their labels now include perforation of the stomach and esophagus, and death. These labels are for physicians, not patients, so it’s on doctors to relay these changes—and the fact that there have been multiple FDA safety alerts—to people interested in getting a balloon.
In a statement to Tonic, a spokesperson for ReShape LifeSciences said the company’s “highest priority is patient safety” and that it “will continue to work with the FDA to mitigate patient risk and optimize outcomes of the ReShape Balloon,” adding that “anyone with concerns about an existing ReShape Balloon or considering a ReShape Balloon should consult with a physician or contact our customer service department to learn about the potential risks associated with the use of intragastric balloons.”
In an additional statement on its website, ReShape says: “We reported to FDA that, in total, ReShape Lifesciences received three reports of death since the commercial launch of the ReShape Balloon™ in August 2015. These three deaths occurred out of more than 5,000 balloons implanted around the world, including those in our clinical trial (265) and those sold commercially. The occurrence rate, expressed as a percentage of all the ReShape Balloons implanted through April 30, 2018, is 0.06 percent.”
A spokesperson for Apollo Endosurgery said in a statement to Tonic that the company “always puts patient safety first,” adding that “ORBERA is recognized as the leading intra-gastric balloon and is the most widely reported on balloon in peer review literature because physicians are excited about the positive impact it can have on patients. ORBERA has a strong safety profile, with a global mortality rate of less than 0.01 percent (less than 1 percent of 1 percent), and more than 295,000 ORBERA balloons have been distributed worldwide. ORBERA has been researched in more than 230 studies and continues to be endorsed by experts.”
However, the spokesperson declined to say how many balloons had been placed out of the total distributed, and declined to answer questions about Orbera’s listed US mortality rate of 0.036 percent, which is higher than its global mortality rate. Their data for national and global mortality rates has not been published nor peer-reviewed, so it’s also unclear how they calculated the numbers, or how they decided if a death was device-related.
By comparison, according to a systematic review that has been published and peer-reviewed, a similar (but more invasive) procedure known as gastric banding appears to have a mortality rate of about 0.2 percent within two years of surgery.
Parker estimates that she’s spent about $11,000 from the cost of the balloon, lost wages, and her co-pay for her emergency hospital care. She said she wasn’t explicitly told about the possible risks by her doctor, but rather risks were mentioned in fine print. Frustrated by her doctor’s response—she says she was promised a refund she never got—and censored on weight-loss support groups when she shared her experience, she recently started her own Facebook group to find others who’d had similar experiences. The group now has more than 500 members.
“My doctor told my husband he had never heard of anyone having the balloon removed early, that I had to be the first,” she says. “I just knew there had to be someone else out there.”
On MAUDE, where detailed but anonymous injury and death reports are public, the most serious cases typically involve gastric erosion and perforation (the device weakening the stomach lining and tearing it open), or pancreatitis (the device can put harmful pressure on the pancreas and other nearby organs).
That safety problems—including deaths—are surfacing after the devices were approved is not surprising to investigative journalist Jeanne Lenzer, who recently published a book, The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It.
That’s because the FDA laws that regulate medical devices are more lax than the laws that regulate drugs, Lenzer says. It's relatively easy for many devices to get cleared for use before their safety—or effectiveness—has been established. (Some manufacturers will conduct trials even when they aren’t required to do so, but the quality of those studies often isn’t great; more on that below.) When problems do surface, weak enforcement laws mean industry has the upper hand. Doctors often get blamed for issues instead of the device manufacturers, Lenzer says.
“There can be thousands and thousands of deaths and [device makers] will say, ‘Oh it didn’t have anything to do with our device,’” she says. “It’s outrageous that we allow industry to be the arbiter of whether a device caused a death or serious injury...It’s a serious problem and the MAUDE database only has a tiny percentage of the harms.”
When something goes wrong, the problem can spiral far beyond the initial device malfunction, Parker explains. In her case, when she got to the ICU, no one at the hospital was willing to remove the device, even though it was the one thing that would make her better.
“They wouldn’t touch it, and my doctor couldn’t practice at that hospital,” she explained. “So they were just trying to get my [electrolyte] levels up so they could release me and I could have it removed. I lost trust, and having to go under again to have it removed, I was really scared. I was at their mercy.”
Bugeja’s experience was similar, but not as severe. After being hospitalized for dehydration, he decided to keep the balloon in and slowly adapted to it. He still has it in, and will get it removed soon. He’s lost a few pounds. Yet, he says, “if someone had informed me of the full side effects and how little effect it would have on my weight loss, I would have definitely not wasted my money.”
Whether or not the devices actually help the majority of people keep weight off in the long run is an unanswered question. Most of the research so far only measures short-term weight loss (less than a year), and the balloons have primarily been tested against weight loss and diet programs, instead of a sham procedure or medical treatments. This lack of research is common for medical devices, Lenzer notes, since the FDA has a lower clinical trial standard for medical devices, compared to drugs, to show they work.
The lack of benefit is a primary concern of Mitchell Roslin’s, a bariatric surgeon and self-described “skeptic” of the balloons. He says safety problems are to be expected with all devices inserted into the body, but, in this case, the lack of effectiveness makes that risk not worth it.
“The idea you’re going to put a balloon in to cure someone’s obesity—and they’re going to learn how to eat and lose weight, we’ve done that experiment 99 times,” says Roslin, who runs the bariatric surgery department at Lenox Hill Hospital and Northern Westchester Hospital in New York. “We’ve done it with liquid diets, and with other devices like the Lap-Band. We know people are going to regain their weight and yo-yo back up.” (The Lap-Band, a type of gastric banding, has been the target of federal fraud investigations and was purchased by Apollo Endosurgery in 2013, along with Orbera.)
Tate and Geliebter, the researchers, say the short-term data certainly points to the devices being slightly less effective than weight loss drugs, which carry fewer risks, which is one reason they think the devices should be recalled.
“My studies show that over time, there’s a reduced advantage to having a balloon...you adapt,” Geliebter says.
This was the case for de Cima, who had an uneventful experience with his balloon—except that he ended up gaining weight.
“I didn’t have any complications. But if someone asked me, I would say ‘don’t waste your money and think about another alternative.’”
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