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News From the Food and Drug Administration
December 6, 2000

Microwave Therapy Warning

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JAMA. 2000;284(21):2711. doi:10.1001/jama.284.21.2711

The FDA warns physicians that treatment of benign prostatic hyperplasia (BPH) with microwave energy has been associated with serious thermal injuries and related complications. Ten of the 16 injuries reported in the last 4 years resulted in fistula formation and six in clinically significant tissue damage to the penis and urethra. The injuries have required colostomies, partial amputation of the penis, and other therapeutic interventions.

The agency has identified the following factors that may have contributed to the reported injuries: incorrect placement or undetected migration of the treatment catheter or the rectal temperature sensors; failure of the physician to remain with the patient throughout the treatment; failure to pause treatment when the patient is communicating serious pain; oversedation of the patient that compromised his ability to communicate pain; treatment of patients who have undergone prior radiation therapy to the pelvic area; treatment of patients whose prostate sizes are outside the ranges specified in the labeling; and water or air leakage from the balloons that retain the urethral catheter and the rectal temperature sensor, respectively, in the correct anatomical position.