This Weight-Loss “Solution” Caused Five Deaths

in #health7 years ago

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.

 

Weight Loss Surgery and Pills Are Poor Solutions for Obesity

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 


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