Safety Alert for Microwave Thermotherapy Systems for Benign Prostatic Hyperplasia composed of Retinal Temperature Sensors and Urethral Catheters: (1) Prostatron, (2) Targis, (3) UroWave

Safety alert

185

2000-10-27

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The mentioned equipment can cause serious thermal lesions and related complications, when used in the treatment of benign prostatic hyperplasia (bph). the fda claims to have received 16 reports of thermal injuries. 10 of the 16 lesions resulted in fistula formation, and 6 of the 16 lesions resulted in significant clinical damage to the tissue of the penis or urethra. the fda adds that, these types of injuries may not be apparent immediately and may appear in hours, or days. complications of the lesions described above required colostomies, partial amputation of the penis and / or other therapeutic interventions. the fda states that several factors contribute to the injury, including: (1) inadequate placement or undetected migration of the catheter or rectal temperature sensors; (2) the inability of the physician to remain with the patient throughout the treatment period; (3) non-interruption of treatment when the patient complains of severe pain; (4) excessive sedation of the patient, which may compromise the patient's ability to communicate pain; (5) treatment of patients who underwent previous radiation therapy in the pelvic area; (6) treatising of patients whose prostate sizes are outside the labeled parameters; and (7) leakage in the balloons used to retain the urethral catheter or rectal sensor in the correct anatomical position.

The FDA recommends the following: (1) When a patient is being considered for microwave therapy for BPH, be sure to comply with the indications for use of the equipment, which include criteria for possible prostate sizes. Make sure that the patient has not previously undergone radiation therapy in the pelvic area. The label on each equipment mentions specific patient populations for which the safety and efficacy of the treatment have been tested and are either approved or are unknown and not approved for use because of lack of studies. (2) Ensure that the patient understands the risks and benefits mentioned on the equipment label, the duration of the procedure, the normal level of pain or discomfort, the importance of informing the physician about any unusual pain, such as operating any stop button emergency and the need to remain as still as possible. (3) Follow the operating instructions of the equipment carefully. Continuously supervise the entire procedure. Check for leaks in the urethral catheter retention flasks and the rectal temperature probe. Confirm catheter and rectal temperature sensor placement using direct visualization or ultrasound imaging prior to initiation of treatment and at other appropriate times. (4) Do not overeat the patient. (5) Carefully monitor the patient and equipment throughout the treatment. Manually discontinue treatment if the patient complains of excessive pain or if something unusual occurs. For more information, contact your local representative or directly with Laura Alonge, Office of Surveillance and Biometrics (HFZ-510), by mailing to 1350 Piccard Drive, Rockville, MD 20850, by phone1 (301) 594-0650 , by fax 1 (301) 594-2968, or by e-mail at phann@cdrh.fda.gov.