Risks of the MRgFUS Procedure

Infrequent and general complications that have been reported following ExAblate® MRgFUS treatments are described below.

Short term risks - Day of treatment up to 2-weeks post-treatment

General risks include position-related pain due to the position you must maintain during the entire treatment process; this can appear up to 1-3 days after treatment and should resolve quickly. This can be minimized by careful positioning at the start of the procedure to support the rest of the body in a comfortable position during the treatment.

If there is improper acoustic coupling (i.e., the interface between the body and the transducer gel pad has gaps), then there is a possibility of skin burn. These events are acute, occurring on the day of treatment with red skin patches or even 2nd-3rd degree burns. This risk is minimized by ensuring the skin around the area of the treatment is free of any hair and cleaned with alcohol prior to treatment. In addition, these events may be further minimized by communication with your doctor when you first feel skin pain. Mild to moderate skin burns should heal and fade within 7-14 days.

You may experience a blood clot during the procedure because of the prolonged stationary position required for treatment, and you may have complications related to the clot if it is not treated quickly. Venous clots can travel to other part of the body and cause heart, brain, or lung damage.

You may experience a fever within a few days after the procedure if a large amount of tissue has been ablated. If your temperature goes above 101°F for 24 hours, you should call your physician.

You may see blood in your urine or have a bladder or kidney infection because of the catheter used to drain your bladder during the procedure, but it should resolve completely. If you get a urinary tract infection, you may need antibiotics.

You may have bruising in the area of the intravenous catheter following the procedure, similar to that experienced after blood draws. This should resolve within a week.

You may feel tired for several days after the procedure because of the exertion to remain still for so long.

Long term risks - Longer than 2-weeks post-treatment

Overall, ExAblate® MRgFUS is a reasonably safe procedure with minimal risk. Infrequent complications that have been reported following ExAblate® treatment include the possibility of scar formation after skin burn and possible numbness. If a nerve was damaged (unintended), there may be muscle weakness, numbness, or sensory loss that may resolve after several months, or it may be non-reversible.

If you experience a blood clot after the procedure that is not treated emergently, you may have long term complications related to it if it does not resolve quickly. You could have muscle, heart, brain, or lung damage.

Specific risks

Learn more about other risks specifically associated with treatment for uterine fibroids, bone metastasis and osteoid osteoma.