This post was authored by Sai Gandhe and Giovanni Ciavarra, PhD. Sai is a summer intern at Innovative Science Solutions and a senior at Case Western Reserve University studying systems biology and business management.
Obesity has been associated with numerous health problems such as increased risk for heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems (among others). Treating obesity in a manner that is safe and effective has been a major challenge, but there are some options, including dietary modification and exercise, prescription medicines, and bariatric surgery. Due to an increasing demand for non-surgical fat loss technologies, many individuals have chosen these Intragastric Balloon Systems to reap instant results.
In 2015, the U.S. Food and Drug Administration (FDA) approved two Liquid Filled Intragastric Balloon Systems in the U.S. for the treatment of Obesity. The two products are: 1) ReShape Integrated Dual Balloon System (ReShape Medical Inc.) which uses two intragastric balloons, and 2) Orbera Intragastric Balloon System (Apollo Endo-Surgery) which uses one intragastric balloon. Notably, both products are intragastric balloon systems which are indicated for use in conjunction with diet and exercise for maximum efficacy.
How Intragastric Balloons Work
Intragastric balloons are regulated as medical devices and designed to help obese patients lose weight by limiting how much a person can physically eat. Essentially, they occupy space in the stomach and thus make the patient feel full faster. In general, candidates for these products are adults with a Body Mass Index (BMI) of ≥30 and willing to participate in a medically supervised program and has not undergone any previous stomach or esophageal surgery.
FDA Reports a Surge in Reported Deaths
Since 2016, the FDA has received reports of a total of 12 deaths that occurred in patients with liquid-filled intragastric balloon systems worldwide. Seven of the deaths occurred in the U.S. (four with the Orbera Intragastric Balloon System, and three with the ReShape Integrated Dual Balloon System). Orbera claims that the current (as of June 2018) U.S. mortality rate is 0.036% (i.e. less than 4 deaths per 10,000 patients), but it has increased slightly from the 2017 rate of 0.01%. ReShape has indicated that “These three deaths occurred out of more than 5000 balloons implanted around the world, including those in our clinical trial (265) and those sold commercially.”
The FDA recently (June 2018) issued a safety alert to healthcare providers and this has shined a bright light on the notion that 5 people died after receiving the ReShape or Orbera stomach balloons within 1 month since their previous update in August 2017.
In the August 10, 2017 update, the FDA noted: “At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”
While there remain many unanswered questions, intragastric balloon devices are certainly on the radar of plaintiff’s attorneys. In addition to the deaths, their websites allege these devices are associated with a variety of adverse events and/or complications, including:
- Spontaneous Hyperinflation
- Acute Pancreatitis
- Gastric/Esophageal Perforation
Litigation on the Horizon?
While any safety issues related to these devices remain to be fully understood, plaintiff’s attorneys have been aggressively advertising to recruit patients (or their family members) that have been injured after having an intragastric balloon inserted.
Notably, some experts, such as Stanford bariatric surgeon John Morton, has noted that the technique involved with inserting these devices is very important and may be a reason for some of the noted failures. In a LA Times article, Dr. Morton indicated that: “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.”
In addition to surgical skill, the underlying science and company data will surely come into play in any future actions. ISS is continuing to monitor this issue and the science related to intragastric balloons.
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