Five Deaths Tied to Obesity Treatments
This news may give you pause if you like to eat during the holiday season.
The U.S. Food and Drug Administration (FDA) reports there have been five deaths associated with a type of weight loss system used to treat obesity.
The medical device is called the Orbera Intragastric Balloon System made by Apollo Endosurgery of Austin, Texas.
Four reported deaths were associated with that device while another report involved a similar device, the ReShape Integrated Dual Balloon System, made by ReShape Medical Inc. of San Clemente, California.
The basic premise of the devices is the same.
One or two deflated balloons are placed in a person’s stomach with the help of an endoscope through the mouth. The intragastric balloon system then inflates the balloons with saline to approximately the size of a grapefruit so that the patient always feels full. The device is left in for six months.
The causes of death are not known at this time, said the FDA in a statement, but they occurred within a month of the device implant. In three of the cases, the patients died within days of receiving the balloon implants.
One theory is that the patients may have suffered intestinal obstruction or gastric esophageal perforation during the implanting procedure.
In 1992 another similar device for weight loss was withdrawn from the market fearing the balloon could rupture and block a patients’ arteries.
Patients who are ideal candidates for the ReShape and Orbera systems must have a body mass index between 30 and 40.
Apollo Endosurgery says about 220,000 patients have its balloon implanted with total sales in 2015 of $120 million.
The company told CBS it had not received any communication from doctors or hospitals that the deaths were blamed on the device. There is also no word whether or how the devices may have failed.
All five of the deaths occurred in 2016 and 2017.
With more than one-third of U.S. adults obese, Americans are desperate to try traditional diets and exercise.
In trials before the launch, patient lost about seven percent of their body weight over six months compared to 3.3 percent weight loss in patients without the balloon.
Problems with any medical device should be reported through MedWatch, the FDA complication reporting program.