BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 4091999 · Received August 21, 2014

    Report

    Report Number
    2915056-2014-00009
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    January 1, 2010
    Report Date
    July 30, 2014
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INDUCTION OF CANCER IS A KNOWN EFFECT OF IONIZING RADIATION AND WHILE THE MANUFACTURER IS UNAWARE OF ANY PRIOR REPORTS OF PROSTATIC SQUAMOUS CELL CANCER AFTER BRACHYTHERAPY WITH IODINE-125 SEEDS SUCH AN OCCURRENCE IS CONSISTENT WITH THE POTENTIAL MEDICAL EFFECTS OF RADIOTHERAPY. HOWEVER, AS THE AUTHOR POINTS OUT, IT IS UNUSUAL FOR LOCALISED PROSTATE CANCER WITH HIGH RISK FEATURES TO BE TREATED WITH BRACHYTHERAPY AS MONOTHERAPY. IN FACT IT WOULD NOT BE IN KEEPING WITH GUIDELINES THAT WERE PUBLISHED BY IN SUBSEQUENT YEARS BY ESTRO, EAU, ABS, ASTRO OR AUA. SUCH PATIENTS WOULD NOWADAYS BE GIVEN BRACHYTHERAPY AS A BOOST TO A COURSE OF EXTERNAL BEAM RADIOTHERAPY AND PROBABLY ADJUVANT HORMONE THERAPY. IN VIEW OF "SEVERAL OT HER CHRONIC ILLNESSES" THE PATIENT HAD AN IMPLANT AND REMAINED BIOCHEMICALLY CONTROLLED AND SYMPTOM FREE FOR OVER 8 YEARS. THE AUTHORS ALSO NOTE THAT DUE TO HIS FAMILY HISTORY THIS PATIENT HAD A HIGH RISK OF DEVELOPING CANCER. A RECURRENCE OF THE PRIMARY ADENOCARCINOMA WOULD HAVE BEEN AN EXPECTED OUTCOME. IN SUCH A COMPLEX CASE, IT IS DIFFICULT TO DETERMINE IF THERE IS A CAUSAL LINK BETWEEN THE IMPLANT AND THE SUBSEQUENT INCIDENCE OF A PROSTATIC SQUAMOUS CELL CANCER.

    Description of Event or Problem · 1

    REPORT #2915056-2014-00009 IS A LITERATURE REPORT FROM (B)(6) THAT INVOLVES A 59 YEAR OLD MALE WHO EXPERIENCED SECONDARY SQUAMOUS CELL PROSTATE CANCER AFTER ADMINISTRATION OF IODINE (I-125) SEEDS FOR THE INDICATION OF PROSTATE CANCER. THE PT HAD A STRONG FAMILY HISTORY OF DIFFERENT CANCERS: HIS FATHER HAD DIED OF PC AT THE AGE OF 55 AND HIS BROTHER OF LUNG CANCER. ONE OF HIS SISTERS SUFFERED FROM BREAST CANCER AND HIS OTHER SISTER FROM GYNAECOLOGICAL CANCER. IN 1986 HE WAS EXAMINED FOR A URINARY TRACT INFECTION, AND A RELATIVE STRICTURE IN THE BULBOUS URETHRA WAS DIAGNOSED BUT LEFT UNTREATED. IN 1999 HE CONTACTED A UROLOGIST IN THE PRIVATE SECTOR; WITH A PROSTATESPECIFIC ANTIGEN (PSA) VALUE OF 5.8 MG/L/FREE PSA RATE 13%, PROSTATE BIOPSIES WERE TAKEN AND A HISTOLOGICAL DIAGNOSIS OF HYPERPLASIA WAS MADE. IN 12/2000, AT THE AGE OF 59 YEARS, HE WAS REFERRED TO THE UROLOGICAL OUTPATIENT CLINICS WITH MILD URINARY SYMPTOMS AND AN INCREASED PSA VALUE OF 6.0 MG/L/10%. HE HAD CHRONIC ILLNESSES INCLUDING TYPE 2 DIABETES, OBESITY (BODY MASS INDEX 35), HYPERTENSION AND CLAUDICATION. HE WAS A SMOKER. UPON TRANSRECTAL PALPATION THE RIGHT PROSTATE LOBE WAS FIRM. IN THE ULTRASOUND THE SIZE OF THE PROSTATE WAS 42 CM3. MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 1.5 EM LESION INSIDE THE PROSTATE WITH NO SIGNS OF CAPSULAR PENETRATION. URINARY FLOW WAS PERFECT; AT A VOLUME OF 316 ML, MAXIMAL FLOW (QMAX) WAS 24.8 ML/S, URINATION TIME (T) 21 SAND RESIDUAL URINE VOLUME 10 ML. NEW BIOPSIES REVEALED GRADE III GLEASON 7 (4 + 3) PROSTATE ADENOCARCINOMA. FOUR OUT OF SIX BIOPSIES SHOWED ADENOCARCINOMA AND -THE OVERALL LENGTH OF THE CARCINOMA FOCI WAS 1.3 EM. LOW-DOSE I-125 PROSTATE BRACHYTHERAPY WAS ADMINISTERED IN 01/2001. EIGHTY SEEDS WERE INSERTED WITHOUT DIFFICULTY AND THE PATIENT RECEIVED A TOTAL DOSE OF 140 GY IN THE PROSTATE. THE PATIENT RECOVERED WITH MILD URINARY TRACT SYMPTOMS. HE REMAINED POTENT. THE PSA WAS 0.9 MG/L AFTER 2 YEARS AND FURTHER FOLLOWUP WAS SCHEDULED TO THE HEALTHCARE CENTRE ACCORDING TO LOCAL PRACTICE. IN 12/2008, 8 YEARS AFTER BRACHYTHERAPY, THE PATIENT WAS REFERRED TO A UROLOGIST OWING TO DYSURIA. URINE ANALYSIS WAS CLEAN, PSA WAS 1.46 MG/L AND CREATININE 69 MMOL/L. THE URINE FLOW WAS ACCEPTABLE, VOIDED VOLUME 206 ML, T 20 S, QMAX 16.7 ML/S AND RESIDUAL VOLUME 68 ML. NO FURTHER EXAMINATIONS WERE CARRIED OUT. ONE YEAR LATER, IN 01/2010, HE WAS REFERRED AGAIN, WITH HAEMATURIA, POLLACISURIA AND SEVERE PAIN IN THE PENIS. THIS TIME THE URINE FLOW WAS WEAK, QMAX WAS ONLY 6.7 ML/S AND RESIDUAL VOLUME WAS 244 ML. ON CYSTOSCOPY A TIGHT STRICTURE AT THE LEVEL OF THE BULBOUS URETHRA WAS DIAGNOSED. AN OPTICAL URETHROTOMY WAS PERFORMED TO THE BULBOUS STRICTURE. AFTER THE STRICTURE, THE PROSTATIC URETHRA WAS COMPLETELY FILLED WITH A TUMOUR MASS AND NO WAY INTO THE BLADDER COULD BE FOUND. URETHROGRAPHY SHOWED A TINY FLOW OF CONTRAST FLUID ENTERING THE BLADDER. A GUIDEWIRE WAS SUCCESSFULLY INSERTED INTO THE BLADDER, A ROUTE WAY THROUGH THE PROSTATIC URETHRA WAS FOUND BY RESECTOSCOPY AND RESECTION OF THE PROSTATE COULD BE PERFORMED. TWENTY-TWO GRAMS OF PROSTATE TISSUE WAS RESECTED AND ALL THE CHIPS WERE FIXED AND ANALYSED. THE SLIDES SHOWED FIBROUS MODERATELY DIFFERENTIATED SQUAMOUS CELL CARCINOMA. MILD KERATINIZATION, NECROSIS, CALCIFICATION AND CHRONIC INFLAMMATION WERE ALSO SEEN, BUT NO GLANDULAR STRUCTURES. IMMUNE HISTOCHEMICAL STAINING SHOWED STRONG POSITIVITY FOR HIGH MOLECULAR WEIGHT CYTOKERATIN, BUT IMMUNO NEGATIVITY FOR PSA, CYTOKERATIN 20 AND CYTOKERATIN. CARCINOMA WAS PRESENT IN OVER 90% OF THE RESECTED TISSUE SAMPLES. NO METASTASES OR ENLARGED LYMPH NODES WERE SEEN ON ABDOMINAL COMPUTED TOMOGRAPHY. THE PATIENT WAS REFERRED TO AN ONCOLOGIST AND UNDERWENT EXTERNAL RADIATION THERAPY TO THE PROSTATE. THIS PATIENT HAD A HIGH-RISK PROSTATE CANCER AND THEREFORE WAS NOT A CANDIDATE FOR BRACHYTHERAPY AS MONOTHERAPY. DESPITE HIS YOUNG AGE HE HAD SEVERAL CHRONIC ILLNESSES, WHICH MIGHT HAVE FAVOURED THE CHOICE OF BRACHYTHERAPY. HOWEVER, HE SHOWED A GOOD RESPONSE TO THE TREATMENT OF PRIMARY PROSTATE CANCER FOR 10 YEARS. THE MEANING OF THE STRONG FAMILY BURDEN FOR DIFFERENT MALIGNANCIES REMAINS UN-KNOWN, AS DOES THE ANSWER TO WHETHER THE SQUAMOUS CELL CANCER WAS AN INDEPENDENT OR A SECONDARY EVENT. S. AALTOMAA, V. KARJA AND S. KAINULAINEN. SECONDARY SQUAMOUS CELL PROSTATE CANCER AFTER PROSTATE BRACHYTHERAPY TREATMENT. SCANDINAVIAN JOURNAL OF UROLOGY AND NEPHROLOGY, 2011; 45: 356-358.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504647 IODINE (I-125) SEEDS NONE KXK 6711

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other