Risks of The Gastric Balloon

Alert for Fluid-Filled Intragastric Balloons by the FDA

 

The FDA has issued an alert to healthcare providers about potential adverse events linked to fluid-filled intragastric balloons for the treatment of obesity.

 

Intragastric balloon

 

The FDA has recently received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons:

  • The first type of adverse event involves over inflating with fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need of premature device removal.
  • The second type of adverse event is the development of acute pancreatitis, which has also resulted in premature removal.

The FDA recommends that providers closely monitor patients with these devices for the above adverse events.

Symptoms to look for in balloon over-inflation include:

  • Intense abdominal pain
  • Swelling of the abdomen (with or without discomfort)
  • Difficulty breathing
  • Vomiting

 

Balloon 3

The reports indicate that balloon over-inflation can occur as soon as nine days after implantation and as yet there isn’t enough information to determine what is causing the balloon to over-inflate.

 

Acute pancreatitis develop in patients’ due to the compression of gastrointestinal structures created by the inflated balloon.

Symptoms to look for with acute pancreatitis are:Balloon 4

  • Severe abdominal pain
  • Back pain

 

The reports indicate that acute pancreatitis can occur as soon as three days after implantation.

It is important that healthcare providers are aware of these adverse events to be able to identify the symptoms and treat the patient as soon as possible by removing the device.

 

The FDA is working closely with the manufacturers of the intragastric balloon to better understand these issues of acute pancreatitis and over-inflation in patients with fluid-filled intragastric balloons.

 

Advertisements

Fear of Cancer After A Sleeve Gastrectomy

The Truth About Reflux After The Sleeve Gastrectomy

 

In my humble opinion and observance of patients over a period of working in the field of bariatrics for 13 years; in the rush to seek a quick fix operation to experience rapid weight loss many people overlook the negative side effects of the procedures.

gastric sleeve

It is recognised that some of the main complications of the sleeve gastrectomy and the gastric bypass are leaks and internal hernias but since the rise of the sleeve gastrectomy procedure some studies are showing a post sleeve acid reflux rate of between 20-30%. The question and concern is, that this form of acid reflux can be the cause of oesophageal cancer. So could this mean that in the weight loss surgery world we are creating a whole generation of sleeve patients with a lifetime risk of cancer?

GERD

In a recent edition of the Bariatric News Dr Robert Rutledge who has pioneered the mini gastric bypass procedure explains that a primary cause of gastric cancer is commonly caused by the bacteria H. Pylori and that patients who were likely infected were at a higher long term risk of developing gastric cancer. He advised that if surgeons are worried about gastric cancer they should look for Heliobacter Pylori and treat it appropriately. In his opinion the sleeve is creating moderate to severe acid reflux with oesophagitis in a moderate to large percentage of patients. General surgeons know that this is a pre-cancerous and potential cause of oesophageal cancer.

 

 

At the moment the data is limited for the gastric sleeve but in 20 years’ time we could see acid reflux rates as high as 50% so the question is patients considering the gastric sleeve procedure should be concerned about long term oesophagitis which is an unequivocal precursor to cancer.