Back in August 2017, the Food and Drug Administration (FDA) released a report showing that five people had died in 2016 shortly after receiving gastric balloons manufactured by Apollo Endosurgery and ReShape Lifesciences. This week, the FDA released an update to that report indicating that, actually, the agency received 12 reports of people dying (seven of which occurred in the U.S.) in 2016 within weeks of receiving the liquid-filled weight-loss balloons.
Of the seven deaths that ocurred in the U.S., four occurred with the Orbera balloon and three involved the ReShape balloon. According to FDA reports for the deaths involving the Orbera balloons, one patient experienced a pulmonary embolism (a blood clot in the lungs) and sepsis (a severe, potentially-lethal response to infection), another developed sepsis following a gastric perforation, and another two reports indicate that patients experienced intestinal or gastric perforation with no mention of sepsis.
And, of those who received the ReShape balloon, "one was the result of sepsis secondary to an esophageal perforation," according to a statement from the company. "The second event occurred following device placement and involved severe vomiting during the 24-hour post-implant period. The third event was due to a pulmonary embolization secondary to a gastric perforation."
The update also clarified the circumstances of the five deaths included in the original report: Four of those patients died following a gastric perforation, while the fifth death is still being investigated and it's unclear whether any perforation occurred. Of the four deaths involving perforations, three patients received the Orbera Intragastric Balloon System from Apollo Endosurgery and one received the ReShape Integrated Dual Balloon System.
According to the update, the FDA has approved new packaging for the balloons involved and recommends doctors discuss the possibility of life-threatening complications associated with weight-loss balloons, including "balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation." Additionally, the FDA encourages doctors to closely monitor patients throughout their treatment for potential complications, which could also include spontaneous hyperinflation of the balloon and acute pancreatitis.
”These updates provide important enhancements to our existing labeling and support our continued emphasis on patient safety. Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events,” Christopher Gostout, M.D., chief medical officer at Apollo Endosurgery, said in a statement.
"We must reiterate that patient safety is our highest priority. We designed our intragastric dual balloon system with this mind, including providing our product in a sterile form and incorporating two balloons which is intended to provide protection from migration in the event of a deflation," Deborah L. Schmalz, vice president for regulatory affairs, clinical research, and compliance at ReShape said in a statement. "We will continue to work with the FDA to mitigate patient risk and optimize outcomes of the ReShape Balloon. Our customer service department has emailed updated [instructions for use] and patient information to all physician customers."
For more information about gastric balloons and the potential risks associated with them, read our original story below.
Original report, August 14, 2017:
In the few years they've been on the market in the U.S., weight-loss balloons have been making headlines as a cheaper, less intense alternative to invasive weight-loss surgeries. However, according to an FDA alert posted last week, the gastric balloons may come with unforeseen consequences: Five people died in 2016 within weeks of receiving their balloons.
"All five reports indicate that patient deaths occurred within a month or less of balloon placement," the FDA alert reads. "In three reports, death occurred as soon as one to three days after balloon placement." Of the five patients who died, four had received the Orbera balloon, which is manufactured by Apollo Endosurgery, and one had received Reshape Medical Inc.'s dual balloon system. A third type of balloon, the Obalon (which is filled with air), has also recently been approved by the FDA, but was not mentioned or linked to any deaths in the report.
Essentially, the balloons are inserted via the esophagus, placed in the stomach, and inflated with saline for six months, Amir A. Ghaferi, M.D., assistant professor of surgery at the University of Michigan, tells SELF. "They occupy space in the stomach and give a sensation of fullness, the idea being that patients will eat less [without altering] their anatomy in any permanent way." But, he says, the balloons are far from perfect. In addition to causing nausea as your stomach adjusts to having a foreign, inflatable thing inside, these balloons might come with even more serious side effects.
The new FDA alert comes just a few months after the agency advised health care providers to pay especially close attention to patients receiving the balloons. In that letter, sent in February of this year, the agency detailed two major complications connected to the balloons: over-inflation and acute pancreatitis, an infection in the pancreas. If the balloons become over-inflated, they can cause stomach pain and difficulty breathing, and may need to be surgically removed.
However, the FDA hasn't identified exactly what caused each death. And the agency can't say for certain whether or not the weight-loss balloons actually had anything to do with the deaths. So, for now, it's simply reminding everyone that serious complications are possible, and that doctors should monitor their patients closely after giving them the balloons.
"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously," Todd Newton, CEO of Apollo Endosurgery said in a statement. "The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity," he continued, suggesting that the company believes it's these other conditions that contributed to the deaths.
Dr. Ghaferi also points out that this is a relatively small number of cases compared to the hundreds of thousands of people who have gotten the balloons successfully worldwide. He also wonders whether the intense scrutiny the balloons have received is due, at least in part, to our society's bias against those seeking treatment for obesity. "Every time there is a treatment for obesity that's different from diet and exercise, people feel like it’s a cop-out, it's a shortcut," he says. "It’s not viewing obesity as the chronic disease that it is that requires treatment—sometimes invasive treatment."
Obviously, the balloons aren't the right choice for everyone. But people looking for any kind of treatment deserve access to safe, reliable options.
Correction: This article has been updated to clarify that Obalon was not mentioned in the recent FDA report.
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