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Four Orbera deaths are under investigation because doctors don’t know why the patients who received the weight loss balloon died.
The Orbera Intragastric Balloon System by Apollo Endosurgery was approved in August 2015 by the FDA. The FDA is unsure if the four deaths were due to the devices themselves or were caused by something going wrong when the balloons were inserted.
One other company, ReShape Medical, makes intragastric balloons known as the ReShape Integrated Dual Balloon System. One ReShape gastric balloon death has been recorded as well.
All of the ReShape and Orbera deaths occurred within a month of gastric balloon implantation. Three of the deaths happened within one to three days of device implantation.
Two other gastric balloon deaths have been reported with known causes. One was caused by a gastric perforation in a patient who had the Orbera balloon implanted. Still one other death was caused by esophageal perforation when a ReShape system was implanted.
What are Intragastric Balloons?
Meant to treat obesity, intragastric balloons offer an alternative to traditional gastric operations such as gastric bypass surgery or a lapband.
Intragastric balloons are placed in the stomach through the mouth, usually in pill form. Once inside the stomach, the balloon is filled with saline solution and left in the stomach for six months. The Orbera system consists of one balloon. The ReShape system uses two balloons.
ReShape and Orbera Deaths Show Balloons Have Risks
Even though these gastric balloon systems are marketed as having fewer risks than traditional bariatric surgery, they aren’t risk-free.
In February 2017, the FDA said they received “multiple reports” of at least two different, serious problems linked to intragastric balloons.
The FDA received reports from several dozen patients who complained of over-inflation issues. Abdominal pain, swelling or distention of the abdomen, vomiting, and breathing difficulty can be indications the balloon has over-inflated, which leads to the device’s early removal.
Over-inflation has been reported more often in Orbera patients, but some ReShape patients have experienced the problem, too. It is not known if Orbera deaths have been linked to over-inflation.
The FDA also has received reports of acute pancreatitis from patients of both the Orbera and Reshape weight loss balloons. The FDA explains this adverse effect is caused by “the compression of gastrointestinal structures created by the implanted balloon(s).”
All patients with acute pancreatitis have had to have their balloons removed early. Some patients became so ill they had to be hospitalized. Severe abdominal and back pain can be indications of pancreatitis. No warnings exist on current labels to indicate pancreatitis can be a side effect, which causes medical professionals to perhaps take longer to diagnose the problem.
ReShape and Orbera deaths continue to be investigated.
If you or someone you love has suffered adverse side effects from intragastric balloon systems, you could qualify for compensation through legal representation.
Join a Free Gastric Balloon Side Effects Class Action Investigation
If you or a loved one has suffered from complications following a gastric balloon procedure, you may be entitled to compensation.
Fill out the form on this page now or call 1-(855)-JONES-LAW (1-855-566-3752) for a FREE case evaluation. In general, gastric balloon lawsuits are filed individually by each plaintiff and are not class actions. After you fill out the form, the attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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