The U.S. Food and Drug Administration revealed on Thursday that at least five people have died after they were fitted with liquid-filled intragastric balloon designed to help people lose weight.
5 Fatalities Related To Use Of Intragastric Balloon
The FDA said that it has not yet determined whether the weight loss devices or the surgery that implanted them is the cause of the deaths, but it had already issued an alert so doctors would closely monitor patients who have them.
"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program," FDA said.
In its statement released on Aug. 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon. Of these, three occurred between one and three days after balloon placement.
Of these fatal cases, four involve the Orbera Intragastric Balloon System produced by Apollo Endo Surgery. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.
The FDA said that they also received two other reports of fatal cases in the same period which were associated with potential complications linked to balloon treatment. One involves Orbera Intragastric Balloon System, and the other involves ReShape Integrated Dual Balloon System.
Adverse Events Associated With Intragastric Balloon
An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. Use of the device may have unwanted side effects. The company warned of serious adverse events linked to use of the products, which include cardiac arrest, ulcerations/erosions, esophageal perforation, balloon deflation/migration, and death.
Device For Treating Severe Obesity
Obesity is linked to a range of health conditions including diabetes. Gastric balloons is one of the many devices available in the market for treating severe obesity. It works for weight loss by filling the stomach, surgically reducing the stomach's volume, or closing off a part of the stomach to reduce the amount of food a person eats.
Diet and engaging in physical exercise are considered as among the safest ways to reduce weight but these do not always work for some people who need to shed unhealthy pounds. Surgical procedures to shrink the size of the stomach is one of the popular options for weight loss.