Safety Alert for MICROWAVE THERMOTHERAPY SYSTEMS FOR PROSTATE BENIGNINE HYPERPLASIA COMPOSITION OF RETERAL TEMPERATURE SENSORS AND URETHRAL CATHETERS: (1) PROSTATRON, (2) TARGIS, (3) UROWAVE

Safety alert

167

2000-10-27

Brazil

ANVISA

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

The equipment can cause serious thermal injuries and correlate complications when used in the treatment of benostine prostate hyperplasia (). fda declares to have received 16 thermal injury reports. 10 of 16 injuries resulted in fistula formation, and 6 of 16 injury results in significant clinical damage to penis or urethra. fda adds that these types of injury may not be apparent immediately and may appear on hours, or days. the complications of the injuries described, needed of colostomyas, partial amputation of penis and / or other therapeutic interventions. fda declares that various factors contribute to injury, including: (1) inadequate placement or an undue detected migration of the catheter or retained temperature sensors; (2) the physician's inability to remain with the patient during the treatment period; (3) non-interruption of treatment when patient claims of pain strong; (4) patient excessive sedation, which can commit the patient's capacity to communicate pain; (5) treatment of patients who were submitted to previous therapy with radiation in the pelvic area; (6) treatment of patients whose prostate sizes are outside labeled parameters; and (7) leakage in the balloons used to retract the urethral catheter or the retal sensor in the correct anatomical position.

The FDA RECOMMENDS THE FOLLOWING: (1) WHEN A PATIENT IS CONSIDERING FOR MICROWAVE THERAPY FOR HBP, MAKE SURE THAT HE FOLLOWS EQUIPMENT INDICATIONS, WHICH INCLUDE CRITERIA FOR POSSIBLE PROSTATE SIZES. MAKE SURE THAT THE PATIENT HAS NOT BEEN SUBMITTED PREVIOUSLY TO THERAPY IN THE PELVIC AREA. OF EACH EQUIPMENT MENTIONS SPECIFIC POPULATIONS OF PATIENTS FOR WHICH THE SAFETY AND EFFICIENCY OF THE TREATMENT ARE UNKNOWN. (2) WARRANT THAT THE PATIENT UNDERSTANDS THE RISKS AND BENEFITS MENTIONED FROM THE EQUIPMENT, THE DURATION OF THE PROCEDURE, THE NORMAL LEVEL OF PAIN OR DESCONFORT, THE IMPORTANCE OF INFORMING THE PHYSICIAN OF ANY INCOMUM PAIN, HOW TO OPERATE ANY EMERGENCY STOP BUTTON AND THE NEED TO REMAIN AS POSSIBLE. (3) FOLLOW THE EQUIPMENT OPERATING INSTRUCTIONS CAREFULLY. SUPERVISION CONTINUOUSLY ALL PROCEDURE. MAKE SURE THERE IS NO LEAKAGE IN THE RETRIEVAL BALLOONS OF THE URETHRAL CATHETER AND THE RIGHT TEMPERATURE PROBE. CONFIRM CATHETER POSITIONING AND RIGHT TEMPERATURE SENSOR USING DIRECT VIEWING OR ULTRASOM IMAGES BEFORE STARTING TREATMENT AND AT OTHER ADVANCED TIMES. (4) DO NOT STAY THE PATIENT TOO. (5) CAREFULLY MONITOR THE PATIENT AND EQUIPMENT DURING ALL TREATMENT. MANUALLY DISCONTINUED TREATMENT, IF PATIENT CLAIMS OF EXCESSIVE PAIN OR CASE, SOMETHING INCOMUM OCCURS. FOR FURTHER INFORMATION, CONTACT CARLOS FORNAZIER, E-MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR THROUGH PHONE / FAX 61-4481257. LAURA ALONGE, THE FDA SURVEILLANCE AND BIOMETRIC OFFICE (HFZ-510), IS ALSO EXPERT FOR MORE INFORMATION THROUGH CORRESPONDENCE TO 1350 PICCARD DRIVE, ROCKVILLE, MD 20850, IN THE UNITED STATES (BY PHONE 1 (301) 594-0650, BY FAX (301) 594-2968, OR BY E-MAIL PHANN@CDRH.FDA.GOV).