BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12621679 · Received October 13, 2021

    Report

    Report Number
    2951250-2021-03360
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    April 1, 2013
    Report Date
    October 15, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('LOWER BACK PAIN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36525) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEART DISEASE CONGENITAL, PAP SMEAR ABNORMAL, MULTIGRAVIDA AND PARITY 4. CURRENT WEIGHT 160 LBS. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN), ETHINYLESTRADIOL;LEVONORGESTREL (NORDETTE), HYDROCODONE AND IBUPROFEN. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), NAUSEA ("NAUSEA,,"), FATIGUE ("FATIGUE,") AND ABDOMINAL PAIN ("PAIN ABDOMEN"). IN JANUARY 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN FEBRUARY 2013, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: TEM120RARY BLURRED VISION"). IN APRIL 2013, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POLYMENORRHOEA ("HORMONAL CHANGES DESCRIBE: MENSTRUAL CYCLE IS OFF") AND VULVOVAGINAL PAIN ("VAGINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("INTENSE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE BACK PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ALOPECIA, DYSMENORRHOEA, POLYMENORRHOEA, MIGRAINE, HEADACHE, NAUSEA, VISION BLURRED, FATIGUE, WEIGHT INCREASED, VULVOVAGINAL PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, POLYMENORRHOEA, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25 KG/SQM. SMEAR CERVIX - ON (B)(6) 2020: NORMAL PAP SMEAR. ULTRASOUND PELVIS - ON (B)(6) 2013: ADMINISTERED A PELVIC ULTRASOUND WAS PERFORMED. UT M 78X60X56MM. ENDO M 5.1MM. BILATERAL ESSURE COILS ARE IN PLACE. BILATERAL ADNEXA APPEAR WNL. NO ADN MASSES/ FF SEEN. FLUP AS INDICATED. ASSESSMENT: LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION - FLU FOR COLPO; CONTRACEPTIVE SURVEILLANCE - ESSURE IN NORMAL LOCATION. ULTRASOUND SCAN VAGINA - IN (B)(6) 2014: TOTAL BILATERAL OCCLUSION. LOT NUMBER: A36525. MANUFACTURING DATE: 2012-08. EXPIRATION DATE: 2015-08-31. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-OCT-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('LOWER BACK PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36525) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEART DISEASE CONGENITAL, PAP SMEAR ABNORMAL, MULTIGRAVIDA AND PARITY 4. CURRENT WEIGHT (B)(6) LBS. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN), ETHINYLESTRADIOL;LEVONORGESTREL (NORDETTE), HYDROCODONE AND IBUPROFEN. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), NAUSEA ("NAUSEA,,"), FATIGUE ("FATIGUE,") AND ABDOMINAL PAIN ("PAIN ABDOMEN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: TEMPORARY BLURRED VISION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POLYMENORRHOEA ("HORMONAL CHANGES DESCRIBE: MENSTRUAL CYCLE IS OFF") AND VULVOVAGINAL PAIN ("VAGINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("INTENSE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE BACK PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ALOPECIA, DYSMENORRHOEA, POLYMENORRHOEA, MIGRAINE, HEADACHE, NAUSEA, VISION BLURRED, FATIGUE, WEIGHT INCREASED, VULVOVAGINAL PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, POLYMENORRHOEA, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25 KG/SQM. SMEAR CERVIX - ON (B)(6) 2020: NORMAL PAP SMEAR. ULTRASOUND PELVIS - ON (B)(6) 2013: ADMINISTERED A PELVIC ULTRASOUND WAS PERFORMED. UT M 78X60X56MM. ENDO M 5.1MM. BILATERAL ESSURE COILS ARE IN PLACE. BILATERAL ADNEXA APPEAR WNL. NO ADN MASSES/ FF SEEN. FLUP AS INDICATED. ASSESSMENT LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION FLU FOR COLPO. CONTRACEPTIVE SURVEILLANCE ESSURE IN NORMAL LOCATION. ULTRASOUND SCAN VAGINA IN (B)(6) 2014: TOTAL BILATERAL OCCLUSION. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: MEDICAL RECORD RECEIVED. CASE BECAME SERIOUS INCIDENT. REPORTER, LAB DATA AND ESSURE REMOVAL DETAILS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518822 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A36525 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R HYDROCODONE| HYDROCODONE| IBUPROFEN| IBUPROFEN| NORDETTE| NORDETTE| YASMIN| YASMIN