FDA Warns of Prostate Procedure

A therapy that shrinks enlarged prostates by microwaving the gland can cause a rare but serious injury, occasionally burning men’s tissue enough to require a colostomy or other surgery, the Food and Drug Administration warned doctors Friday.

Microwave therapy for enlarged prostates is a highly effective outpatient treatment to relieve urinary symptoms, and some doctors consider it safer than traditional prostate surgery. About 25,000 men have undergone the treatment since the FDA approved the first prostate-heating machine in 1996.

But the FDA has learned of 16 men who were injured when the microwave temperatures got too high or the microwaves beamed onto the wrong spot. In six cases, burns damaged the penis or urethra. Ten other men developed fistulas, abnormal channels that can form in such spots as the colon or the urinary tract when tissue dies.

Some men required colostomies, partial penile amputation or other treatment, the FDA said in a warning e-mailed to health workers.

The warning shouldn’t frighten men, cautioned David Daly of the FDA’s medical device surveillance office. The risk is very rare, and the FDA calls microwave therapy overall safe and effective, but it issued the warning so doctors can take fairly easy steps to prevent burns.