All surgeons, clinics and hospitals that offer Motiva Implants have recently received a Field Safety Notice (FSN) issued by Establishment Labs, the makers of Motiva Implants, to inform them of a change in the Directions For Use (DFU) of their implants that contain a micro-transponder.
It was recently noticed that the DFU booklet that is included in each box of Motiva Implants included an error. This error is associated with an incorrect indication about the maximum magnetic field the patient can undergo when scanned under an MRI. It was wrongly indicated that the patient could undergo a maximum of 7 Tesla when the correct indication is a maximum of 3 Tesla. Establishment Labs products have been tested to be MR Conditional to 1.5 and 3 Tesla MRls, which are the magnetic fields commonly available for MRls in Radiological centres around the world.
So what does this mean?
It is important to note that this FSN does not relate to a problem with the quality or safety of Motiva Implants. It is simply a notification of a change to the DFU. The DFU is a little booklet that is inside each box of Motiva Implants and usually goes straight in the bin. This is because every surgeon knows exactly how to use a breast implant.
Having said this, it is important that the information in the DFU is correct which is why we are making this amendment.
Should I be worried?
The quick answer to this is no.
The longer answer is also no but with an explanation as to why. The main reason is that the MRI scanners in the UK used for medical screening are either 1.5 or 3 Tesla scanners and Motiva implants are safe in these scanners.
There are several 7 Tesla scanners in the UK but there is little chance you will come across these as they are in research centres and even if they are available in Radiological Centres they are designed for scanning head and extremities and not the torso since they lack a body coil. So it is highly unlikely - if not impossible that a patient implanted with Motiva Implants® can undergo a scan over 3 Tesla, or in this case, a 7 Tesla scan. So there is no significant risk to patients.
What do I need to do?
You don't need to do anything. Please just take this FSN as notification that if you require an MRI of your body, you should make the radiographer aware that you have a medical device that contains a component that is not compatible with 7Tesla MRI scanners.
Please be assured of the safety and quality of your Motiva Implants.
If you have any other questions, you can access an FAQ here.