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US issues health warning on radiological BPH (benign prostatic hyerplasia) treatment

This article was originally published in Clinica

Executive Summary

Microwave energy used to treat benign prostatic hyerplasia (BPH) could cause unexpected injury to patients, the US FDA has warned. The agency's Center for Devices and Radiological Health (CDRH) said in a letter to physicians that it has received reports of 16 thermal injuries linked to microwave thermotherapy systems. Of these, 10 resulted in fistula formation and six resulted in clinically significant tissue damage to the penis or urethra. The injuries, which may not be apparent for hours or even days, required colostomies, partial amputation of the penis and other therapeutic interventions.

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