The Food and Drug Administration (FDA) reports that since 2016, five people have died after starting a weight-loss treatment that involves a liquid-filled balloon inside the stomach. All five fatalities occurred within a month following the implantation of the device, and three occurred within just three days. It’s possible this approach to weight loss presents a grave danger.
“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),” said the agency in a safety alert.
Four of the deaths are associated with the Orbera Intragastric Balloon System, and one is associated with the ReShape Integrated Dual Balloon System, said the FDA. Moreover, the agency is investigating two more deaths, one from each company, that might be related to complications of the treatment; namely, a stomach perforation and an esophageal perforation.
Both the Orbera and ReShape systems are approved for patients who have a body mass index between 30 and 40. Doctors consider the balloons a less invasive alternative to bariatric surgery for patients unable to tolerate a permanent surgical change of their gastrointestinal tract.
In the procedure, one or two uninflated balloons are inserted using an endoscope that goes from the patient’s mouth to the stomach. Afterward, the balloons are inflated with a saline solution, and they remain in place for six months. They work by taking up space in the stomach, which produces a feeling of fullness and leads to a 5 to 10 percent loss of total body weight.
The new safety alert comes after the FDA issued an advisory in February urging doctors to monitor patients for spontaneous over-inflation and acute pancreatitis. The agency had received reports of incidences of both problems, which necessitated the need for early removal of the devices.
“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,” said the agency.
According to many natural health advocates and practitioners, surgery is a poor solution for obesity, a condition that often stems from a faulty diet and lack of exercise. Research has found a patient’s risk of death within 30 days of gastric bypass surgery is 1 in 50. While gastric banding is considered less risky, many who undergo this procedure experience major complications years later. Now, with reports of deaths from the gastric balloons, it appears all the surgical options may pose serious threats to health.
Obesity drugs aren’t a good alternative to surgery. Weight-loss drugs come with an array of side effects such as a fast heart rate, insomnia, dizziness, nervousness and high blood pressure. Moreover, several drugs were removed from the market years ago because they were linked to stroke.
By Mary West
http://www.liveinthenow.com/article/fda-five-deaths-linked-to-weight-loss-balloon-treatment
