The global medical device consultant Emergo Australia has issued a health warning alert about its EndoBarrier duodenal-jejunal bypass liner, in consultation with the Therapeutic Goods Association (TGA) of Australian government’s Health Department.

In a clinical trial being carried out in the US, the device caused an increase in the incidence of liver abscess. The trial had to be terminated prematurely as the incidence of liver abscess crossed the threshold levels of 2 per cent among participants.

Endobarrier therapy is used in treating certain cases of obesity and obesity related type 2 diabetes. Implanted in the small intestine, it serves as a physical barrier between the intestine wall and food, delaying digestion and changing metabolic activity, according to the TGA.

The ENDO Trial Investigational Device Exemption study reported seven cases of hepatic abscess. The results showed a 3.5 per cent incidence, crossing the safety threshold of 2 per cent by a long margin. The occurrence was reported between 40 – 424 days after implant. Most of the patients showed elevated C-reactive protein and white blood cells, fever and abdominal pain in the upper-right quadrant.

Certain types of endobarrier therapy have long been used successfully in treating diabetes type 2, with patients losing weight and showing improved blood-sugar levels. However, there has been a global increase in incidence rate of liver abscess from the use of the device from 0.49 per cent in 2013 to 0.94 per cent in 2015, according to the TGA.

Early symptoms and signs of liver abscess have been described by the TGA to avoid complications. Pain or chills in the upper-right abdomen, fever, and a general feeling of being unwell, must be discussed on priority with a health professional.

“Early detection can reduce the severity and likelihood of subsequent issues associated with liver abscesses,” says the TGA web alert.

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