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Consumers and health professionals are advised that Emergo Australia, in consultation with the TGA, has issued a hazard alert regarding its EndoBarrier duodenal-jejunal bypass liner.
The EndoBarrier duodenal-jejunal bypass liner system is used for the treatment of obesity and obesity-related type 2 diabetes in patients who meet certain criteria. It is placed in the small intestine and acts as a physical barrier between food and the intestine wall, which delays digestion and affects the body's metabolic functions.
An increase in the incidence of liver abscesses has been observed in a clinical trial involving the EndoBarrier duodenal-jejunal bypass liner system being conducted in the United States. The trial has been terminated before completion because the incidence rate of liver abscesses among trial participants exceeded the safety threshold of 2% for the clinical trial.
The global incidence rate of liver abscesses associated with the use of EndoBarrier duodenal-jejunal bypass liner system has increased from 0.49% two years ago to 0.94% now.
Information for consumers
If you or someone you care for has an EndoBarrier duodenal-jejunal bypass liner implanted, you should discuss the early signs and symptoms of liver abscess, such as generally feeling unwell, fever, chills and/or pain in the upper-right abdomen, with your health professional.
Early detection can reduce the severity and likelihood of subsequent issues associated with liver abscesses.
Please note that liver abscesses can also occur several months after your EndoBarrier duodenal-jejunal bypass liner is removed.
If you suspect that you are experiencing signs or symptoms associated with a liver abscess, or if you have any questions or concerns about this issue, contact your health professional immediately for advice and treatment.
Information for all health professionals
If you are treating a patient with an implanted EndoBarrier duodenal-jejunal bypass liner, ensure they are aware of this issue and educate them regarding the early signs and symptoms of hepatic abscess.
Please note, hepatic abscesses can also occur several months after the EndoBarrier duodenal-jejunal bypass liner is removed.
If you suspect that the patient is experiencing any complications associated with the EndoBarrier duodenal-jejunal bypass liner system, or if they have any further questions or concerns about the above issue, refer them to their surgeon or the hospital where the device was implanted.
Information for surgeons
If you have implanted a patient with an EndoBarrier duodenal-jejunal bypass liner, discuss with them the early signs and symptoms associated with hepatic abscesses and advise them to contact you immediately if any are suspected.
Inform patients that hepatic abscesses can occur several months after their EndoBarrier duodenal-jejunal bypass liner is removed.
Continue to regularly monitor patients and ensure that they adhere to the maximum implant duration of 12 months, as set out in the Instructions for Use for this device.
If you have further questions or concerns about this issue, contact Emergo Australia by phone on 02 9006 1662 or email AUSvigilance@emergogroup.com.
Additional information
Seven cases of hepatic abscess were observed in the ENDO Trial Investigational Device Exemption study in the United States before the decision to stop the trial. The incidence rate was approximately 3.5%, which exceeded the established safety threshold of 2%.
Hepatic abscess occurred as early as 40 days and as late as 424 days post-implant, with a mean of 235 days. The majority post-explantation hepatic abscess cases occurred less than 30 days after removal.
Most commonly, patients present with upper-right quadrant abdominal pain, fever, and elevated white blood cells and C-reactive protein. Diagnosis is made either via ultrasound or by CT scan.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.