Will Urolift MRI restrictions cause any problems

Men's health
1

I just found out today by reading Urolift FAQs, that Urolift is "MRI conditional".  Here is a Quote from the Urolift FAQs:

"Non-clinical testing has demonstrated that the UroLift Implant is MR Conditional. A patient with this device can be safely scanned in an MR system immediately after placement meeting the following conditions:

Static magnetic field of 3.0 Tesla or less

Maximum spatial field gradient of 1,500 Gauss/cm (15 T/m) (extrapolated)

Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of continuous scanning (i.e., per pulse sequence) (First Level Controlled Operating Mode)

Under the scan conditions defined above, the UroLift Implant is expected to produce a maximum temperature rise of 2.4°C after 15 minutes of continuous scanning (i.e., per pulse sequence)

In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the UroLift Implant when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.

The safety of the delivery system has not been evaluated in the MR environment, and therefore, the delivery system should not be used within the MR environment.

Patient implant cards are provided to inform the patient that the UroLift implant is MR Conditional and can safely be scanned only under specific MR conditions."

These are my concerns:

1. The limit for MRI strength with Urolift is 3 Tesla or less.  I was under the impression that 3 Tesla is the strongest MRI available as of this time Sept 2018. Does anyone know if this is true ?

2.  I am also under the impression that an MRI of at least 3 Tesla must be used for MRI diagnosis of prostate cancer and MRI guided cancer biopsy.  Does anyone know if this is true ?

3. If more powerful MRI machines become available in the future would you not be able to use them with Urolift implants ?

4.  "The image artifact caused by the device extends approximately 15 mm from the UroLift Implant". This seems to imply a distortion in the MRI image up to 15 mm or  0.59 inches around the Urolift implant (metal clips ?).  In diameter that would be 30 mm or 1.18 inches.  The distortion area seems large to me.  What problems will this cause with the MRI images ?  

5. Are these MRI limitations why Dr Karamanian in Houston, Tx. does not want to perform FLA on patients with Urolift ? 

Thomas

2

What you have here is true.  It is on the back of my card.  I had 2 MRI 's last year with no problem.  I have ask Dr. K. about the Uroiift procedure.  He told me  in his e-mail that he has had not had the opportunity to work on anyone that have had a Urolift.  But he told me that he would be will to try.  Take care  Ken 

3

Sorry.  He is willing to try  Ken

4

Yes it musses up the MRI 16mm around each metal clip.  But MRIs are dubious, if they say all clear you are good like a low PSA, if they say Liekhart scale 4 out of 5 like mine it can be nothing (mine was nothing).  Here's another thing to worry about, if they do TRUS or Trans perineal biopsy using fired sharpened hollow 2mm needles and one goes through one of the urolift's sutures, do the inner and outer tabs later drift free ?

5

I have not heard of any imaging MRI that is stronger then 3T. Usually one worries about clips that are magnetic, because those can be ripped out due to strong magnetic field (safety issue). Image distortion is secondary, clips create blank/blurred space around metal object due to eddy currents that are created from MRI scanning, but doctors can work around it.

6

I have been refused a 3T scan, but a 2T is ok