Consumers and health professionals are advised that Emergo Australia, in consultation with the TGA, has issued a hazard alert regarding its EndoBarrier gastrointestinal liner with delivery system.
Emergo Australia is also undertaking a recall for product correction to update the Instructions for Use (IFU) for this device.
EndoBarrier gastrointestinal liner with delivery 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 that part of the intestine wall, which delays digestion and affects the body's metabolic functions.
It has been identified that the IFU needed to be updated to adequately mitigate the risks of newly identified, and in some cases serious, complications. The IFU has been updated to ensure that the device is only used in patients with:
- type 2 diabetes with body mass index (BMI) of 30 or greater
- BMI of 30 or greater with one or more co-morbidities
- BMI of 35 or greater.
The IFU has also been updated to state that this device should not be used in pregnant women.
As with all implant procedures, serious injury and, in worst case scenarios, death can occur during implant or removal of an EndoBarrier gastrointestinal liner. There is also a range of adverse events that can occur during the treatment period in which an EndoBarrier gastrointestinal liner remains in the patient (details of the specific adverse events are available in the Information for health professionals section below).
Information for consumers
Emergo Australia has written to health professionals who have implanted EndoBarrier gastrointestinal liners providing further information about this issue, including advice regarding patients who have already received one of these devices.
EndoBarrier gastrointestinal liners are not suitable for use in all people and there are a range of adverse events that can occur during implantation or removal of the device, as well as during the treatment period in which the device remains in the patient.
If you have received an EndoBarrier gastrointestinal liner, you should talk to your health professional to see if the changes made to the IFU are relevant to you.
If you have any gastrointestinal symptoms, such as abdominal pain or changes in bowel habit, you should talk to your health professional.
Information for all health professionals
Emergo Australia has written to surgeons who have implanted EndoBarrier gastrointestinal liners providing further information about this issue, including advice regarding patients who have already received one of these devices.
Patient who have an EndoBarrier gastrointestinal liner should be referred to the implanting surgeon if:
- you think it may be contrary to the updated IFU
- you suspect that they are experiencing complications associated with this device (see Information for surgeons below for a full list of potential complications during the treatment period)
- they have any questions or concerns about this issue.
Information for surgeons
If you intend to use EndoBarrier gastrointestinal liner with delivery system, refer to the updated IFU. In particular, note the current indications and contraindications for this device.
If you are treating a patient who has an EndoBarrier gastrointestinal liner, consider if the changes to the IFU affect their treatment or whether this device is still appropriate for them.
If a patient has been implanted with an EndoBarrier gastrointestinal liner contrary to the updated IFU, you are advised to monitor them closely for associated adverse events (see below for further details).
Any decision regarding whether or not to remove an EndoBarrier gastrointestinal liner earlier than planned should be based on the patient's individual circumstances and in context of the information in the updated IFU.
The updated IFU, with the added potential complications relating to implantation and/or removal of the device, are as follows:
- GI tract laceration
- oropharyngeal perforation
- oesophageal perforation
- gastric perforation
- bowel perforation
- bleeding - in rare cases, significant bleeding that may result in surgery and/or transfusion
- aspiration
- infection with or without fever
- adverse events associated with endoscopic procedures (such as, sore throat or deep vein thrombosis)
- prolonged procedure time
- headache.
Additional potential complications during implantation include:
- reaction to antibiotic use
- anchor across pylorus (misplacement)
- dizziness.
Additional potential complications during removal include:
- adynamic ileus
- infection with and without fever
- hepatic abscess
- pancreatitis (with or without bile duct blockage)
- biliary disease/cholelithiasis
- inability to remove the duodenal-jejunal bypass (DJB) liner endoscopically, resulting in surgical removal
- alopecia
- abdominal pain
- pain - flank/back
- GORD
- hypoglycaemia
- hyperglycaemia
- concurrent illness
- diarrhoea
- constipation
- serum chemistry changes
- vitamin and mineral deficiency
- GI liner migration/rotation
- nausea/vomiting
- weakness.
The updated IFU also lists the following potential complications during the treatment period:
- small bowel/DJB liner obstruction
- DJB liner migration or rotation
- bezoar
- erosion
- bleeding - in rare cases, significant bleeding that may result in surgery and/or transfusion
- vitamin and mineral deficiency
- dehydration - in rare cases leading to compromised renal function
- constipation
- bloating
- diarrhoea
- infection with or without fever
- hepatic abscess
- pancreatitis (with or without bile duct blockage)
- gastroenteritis
- hypoglycaemia
- hyperglycaemia
- flatulence
- GORD
- oesophagitis
- pseudopolyps
- nausea/vomiting
- GI pain/cramping
- peptic ulcer disease
- duodenitis
- gastric or bowel perforation
- local inflammatory tissue reaction
- flank/back pain
- alopecia
- intestinal intessuseption
- headache
- biliary disease/cholelithiasis
- hypotension
- hypertension
- serum chemistry changes
- adhesions
- abdominal pain
- concurrent illness
- weakness (due to diet)
- patient intolerance.
If you have any questions or concerns about this issue, contact Emergo Australia by phone on 02 9006 1662 or email AUSvigilance@emergogroup.com.
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.