A weight-loss procedure involving inserting a silicone balloon into the stomach has been associated with five deaths within the past year.
According to the FDA, Orbera Intragastric Balloon System and ReShape Integrated Dual Balloon System were linked to the five deaths.
In balloon surgery, the provider endoscopically inserts one or two deflated silicone balloons into the stomach. The balloons are then filled with a sterile saline solution to inflate them. The balloons are to remain in the stomach for no more than six months at which point they are deflated and removed.
Both insertion and removal of the balloons are outpatient procedures that take around a half hour.
The aim is to non-surgically reduce stomach capacity and help the patient feel full faster. Paired with a rigorous routine of counseling on lifestyle changes, this procedure can help patients cut down on portion size.
But four patients who tried Obera and one who used ReShape got results that were far from what they expected.
The FDA stated that it’s not yet clear how the weight loss procedures are connected to the deaths. But all instances occurred within a month of placing the balloon, indicating that there is some link.
Apollo Endo-Surgery, producer of the Obera system, states that incidence of death is still extremely low.
This doesn’t mean, however, that you should do nothing if someone in your family falls victim to a defective or dangerous medical device.
If a loved one has died and you suspect balloon surgery may have played a role, please contact the Harman Law Firm LLC for legal assistance.
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