NOT AVAILABLE TO PT

Description of Event or Problem

PT WAS INSERTED WITH CESIUM IMPLANTS IN PROSTATE DUE TO THE FACT THAT PT HAD BEEN DIAGNOSED WITH PROSTATE CANCER AND HAD DECIDED TO GO THE RADIOACTIVE SEED ROUTE IN ORDER TO ERADICATE THE LOCALIZED CANCER. SYMPTOMS AND DISCOMFORT SINCE THE IMPLANT OF SEVENTY-TWO SEEDS HAVE BEEN NORMAL ACCORDING TO UROLOGIST AND RADIOLOGIST. HOWEVER, FOLLOWING CARDIOLOGIST ADVICE PT NOW NEEDS TO LET THE FDA BE AWARE THAT TEN MOS LATER CARDIOLOGIST OBSERVED, DURING AN ANGIOGRAM CONDUCTED AT HOSP THREE -3- OF THE SEEDS INSIDE ONE OF PT'S LUNGS. PT CONTACTED UROLOGIST AND WAS TOLD THAT THE SEEDS WOULD NOT CREATE A HEALTH PROBLEM AND ALTHOUGH IT WAS UNUSUAL TO HAVE SEEDS TRAVEL TO OTHER INTERNAL ORGANS, THERE WERE OTHER SIMILAR CASES ON RECORD WITH NO SIDE EFFECTS WHATSOEVER. IN DR'S REPORT, HE STATES: "I NOTICED THREE VERY RADIOGRAPHICALLY DARK, LINEAR DENSITIES OF APPROX 4MM IN LENGTH AND APPROX 1/2 TO 3/4 O A MM IN THICKNESS. ONE OF THESE DID NOT MOVE WITH THE CARDIAC CYCLE. THE TWO INFERIOR ONES MOVED WITH THE CARDIAC CYCLE. THESE WERE IDENTICAL IN APPEARANCE TO THE CESIUM IMPLANTS THAT WERE IN THE PROSTATE BED THAT WAS FLUOROSCOPED DURING MY INJECTION OF THE RIGHT FEMORAL ARTERIAL SHEATH. I SUSPECT THESE ARE MIGRATED CESIUM IMPLANTS. THE PT WAS INFORMED OF THESE AND IT WAS RECOMMENDED THAT HE CALL HIS RADIATION ONCOLOGIST TO SEE IF ANY FOLLOW UP WAS INDICATED FOR THIS. NONE OF THESE APPEARED TO BE INTRACORONARY. TWO MAY BE IN PULMONARY LOCATIONS, VERY CLOSE TO THE CARDIAC LOCATION." PT IS PARTICULARLY CONCERNED WITH THE FACT THAT THEY ARE AMBULATORY AND MAY TRAVEL TO AREAS THAT CAN BE AFFECTED BY THEIR PRESENCE OR THAT THEY MAY BECOME AN OBSTRUCTION TO A VITAL PART OF PT'S BODY.