BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8779440 · Received July 11, 2019

    Report

    Report Number
    2951250-2019-03670
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    September 12, 2014
    Report Date
    July 15, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN.') AND SYSTEMIC LUPUS ERYTHEMATOSUS ('AUTOIMMUNE DISORDER TYPE OFDISORDER: LUPUS') IN A 48-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 726762-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NONINFECTIOUS MYELITIS, OSTEOPENIA, THYROID NODULE, HYPOTHYROIDISM, DVT, GERD, IRRITABLE BOWEL SYNDROME, POLYCYSTIC OVARY, MENSES IRREGULAR, VAGINITIS AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED BIOTIN, CALCIUM, CYANOCOBALAMIN (B 12), CYCLOBENZAPRINE, DOCOSAHEXAENOIC ACID (DHA), FISH OIL, FOLIC ACID, HYDROXYCHLOROQUINE, LEVOTHYROXINE SODIUM (SYNTHROID), METHOTREXATE AND OMEPRAZOLE (PROTONIX). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2010, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SYSTEMIC LUPUS ERYTHEMATOSUS AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, PELVIC PAIN AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 15-DEC-2010: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JUL-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN.') AND SYSTEMIC LUPUS ERYTHEMATOSUS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 726762) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INFLAMMATION LOCALISED, OSTEOPENIA, THYROID NODULE, HYPOTHYROIDISM, DVT, GERD, IRRITABLE BOWEL SYNDROME, POLYCYSTIC OVARY, MENSES IRREGULAR, VAGINITIS AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED BIOTIN, CALCIUM, CYANOCOBALAMIN (B 12), CYCLOBENZAPRINE, DOCOSAHEXAENOIC ACID (DHA), FISH OIL, FOLIC ACID, HYDROXYCHLOROQUINE, LEVOTHYROXINE SODIUM (SYNTHROID), METHOTREXATE AND OMEPRAZOLE (PROTONIX). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SYSTEMIC LUPUS ERYTHEMATOSUS AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, PELVIC PAIN AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2019: PFS AND MR RECEIVED: EVENT ¿INJURY NOS¿ IS REPLACED WITH PELVIC PAIN. CASE BECOME INCIDENT. AKA NAME ADDED, REPORTER ADDED, LOT NUMBER ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE REMOVAL DATE ADDED, PRODUCT INDICATION UPDATED. EVENTS ADDED- LUPUS, DYSMENORRHEA (CRAMPING), PELVIC PAIN. EVENTS ONSET DATE, EVENTS SEVERITY , CONCOMITANT DRUG, MEDICAL HISTORY AND LAB DATA ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575845 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 726762-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R B 12| B 12| BIOTIN| BIOTIN| CALCIUM| CALCIUM| CYCLOBENZAPRINE| CYCLOBENZAPRINE| DHA| DHA| FISH OIL| FISH OIL| FOLIC ACID| FOLIC ACID| HYDROXYCHLOROQUINE| HYDROXYCHLOROQUINE| METHOTREXATE| METHOTREXATE| PROTONIX [OMEPRAZOLE]| PROTONIX [OMEPRAZOLE]| SYNTHROID| SYNTHROID| B 12| BIOTIN| CALCIUM| CYCLOBENZAPRINE| DHA| FISH OIL| FOLIC ACID| HYDROXYCHLOROQUINE| METHOTREXATE| PROTONIX (OMEPRAZOLE)| SYNTHROID