Information for patients
If you are a patient reading this and have a concern about an MRI scan you are scheduled to attend, we strongly recommend you contact the site where your scan is due to take place, you may also wish to refer to our ‘Information for Patients’ section. Please note local variations to the policies detailed on this website may apply, therefore please contact the hospital where your appointment is scheduled for clarification.
Disclaimer (MUST READ)
The MRI safety information contained within this webpage is intended for use by staff from NHS Greater Glasgow and Clyde (GGC) and associated health boards, namely: NHS Ayrshire and Arran, NHS Borders, NHS Dumfries & Galloway, NHS Forth Valley, NHS Golden Jubilee, and NHS Lanarkshire. Only staff from these health boards are approved to use this information and local variations to the policies detailed may apply. Non-approved users i.e. patients and staff from health boards other than those listed above, or staff from private medical organisations use this information at their own risk. We, NHS GGC, accept no responsibility for patient injury or adverse outcomes that may occur as a consequence of the information contained herein. If you have any questions regarding this disclaimer, please contact the NHS GGC MRI physics team on: ggc.MRSafetyExpert@nhs.scot.
NHS GGC MRI safety policy for patients with Gastric bands
Must read: What this policy does not cover / notable exceptions
This policy does not cover patients with Gastric Electrical stimulation (gastric pacemaker) devices such as the Enterra device some of which are known to be MR Unsafe. Note that these devices are not common and are typically used to treat Gastroparesis where patients will typically experience symptoms such as vomiting and nausea. If you are in doubt as to whether the patient has a gastric band or a gastric stimulation device then you must take further steps to confirm the specific device the patient has. The patient themselves or existing patient records and/or images may be able to assist you in confirming the type of the device a patient has. Similarly, devices for Gastero-oesophageal reflux disorder (GORD/GERD) such as the LINX device are also not covered by this policy. Device and model specific conditions must be reviewed.
Must read: What the policy covers
This policy covers considerations for 1.5T and 3T MRI in patients with gastric bands.
Must read: The MR safety policy
A patient implanted with a gastric band in Scotland may safely undergo 1.5T or 3T MRI. If the device was implanted elsewhere in the UK after 2012, then the patient may safely undergo 1.5T and 3T MRI. If the device was implanted outside of the locations and dates described above, then the make and model of the device must be established in order to determine the MRI safety status of the device. With regard to two gastric band devices of concern (Allergan/Endoart Medical Technologies, Easyband device and Cavu Medical’s, Attune device), implanted as part of clinical trials, see the additional information section below.
Risk assessment: A risk assessment underpinning this policy can be found here: GenericRiskAssessmentForm_gastric_bands
Additional background information and discussion
The overwhelming majority of Gastric Band devices are MR Conditional with conditions that are fairly typical and straightforward to satisfy. Two devices of concern are Allergan/Endoart Medical Technologies, Easyband device and Cavu Medical’s, Attune device.
The Easyband was installed as part of a multi-nation clinical trial in Europe including England, The Netherlands, Belgium and Italy. We believe hundreds (not thousands) of patients had these devices implanted. The MR Conditions can be found on page 5 of the attachment below. Of note is that the conditions preclude the use of the body transmit coil (or transmission over the area of the device with a local body transmit coil) i.e. only head or upper or lower limb imaging is permitted when local T/R coils can be used. Information regarding the clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT00948246.
Easyband IFU including MRI conditions
Cavu Medical’s Attune device was implanted as part of an Australian Clinical Trial. We do not have any information on the MRI safety status of this device at this time. However, based on the information at this website (https://clinicaltrials.gov/ct2/show/NCT01422941), we believe only 40 patients had these devices implanted, at a couple of sites in Australia between Oct 2010 and July 2011.
Please note: a gastric sleeve (or a sleeve gastrectomy) involves a portion of the stomach being removed. The only implant from a gastric sleeve are staples, which are covered in a separate policy (Staples).