BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6103097 · Received November 15, 2016

    Report

    Report Number
    2951250-2016-02490
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    December 9, 2016
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC RECEIVED ON 17-NOV-2016: (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. DEVICE SIMILAR INCIDENT LISTING THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 18-NOV-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: PELVIC PAIN: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1815 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT WAS RECEIVED VIA REGULATORY AUTHORITY AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD PELVIC PAIN. SHE WAS PENDING FOR A HYSTERECTOMY. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. SINCE THE CONSUMER MENTIONED SHE WAS PENDING FOR A HYSTERECTOMY AND NO FURTHER INFORMATION WILL BE AVAILABLE, THIS CASE WAS REGARDED AS INCIDENT IN A CONSERVATIVE APPROACH (SURGICAL INTERVENTION WILL LIKELY BE REQUIRED). THIS IS ALSO IN LINE WITH THE HEALTH AUTHORITY´S ASSESSMENT. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION WILL BE AVAILABLE AS NO CONTACT DATA WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (B)(6) (CASE# (B)(4)) IN (B)(6) ON 21-OCT-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN 2011. JUST ONE YEAR AFTER ESSURE INSERTION, THE CONSUMER STARTED TO DEVELOP HEALTH PROBLEM. SHE REPORTED IT HAD NOTHING TO DO WITH THE FACT THAT SHE WOULD HAVE NO MORE CHILDREN BECAUSE THIS CHOICE WAS MADE FOR A LONG TIME. SHE DEVELOPED DEPRESSION WHICH LASTED 3 YEARS, WITHOUT REAL CAUSE AND ACCUMULATION OF HEALTH PROBLEMS FOR 5 YEARS. SHE WAS ALWAYS TIRED BUT DID NOT KNOW WHY, SHE HAD MIGRAINES, EXPERIENCED WEIGHT GAIN OF 12 KG WHICH SHE COULD NOT LOSE. NEITHER HER GENERAL PRACTITIONER NOR HER PSYCHOLOGIST UNDERSTOOD WHY SHE EXPERIENCED THESE EVENTS AS THEY WERE NOT LISTED IN ADVERSE EVENTS OF ANTIDEPRESSANT DRUGS THAT SHE TOOK FOR 3 YEARS. SHE ALSO EXPERIENCED CONTINUOUS LOW ABDOMINAL PAIN AND PAIN IN OVARIES. CLINICAL CONSEQUENCES WERE THE FOLLOWING: DEPRESSION, SIGNIFICANT DAILY FATIGUE, FREQUENT HEADACHES, PELVIC PAIN, INEXPLICABLE CONSEQUENT WEIGHT GAIN, ACUTE EPISODES OF LUMBAR PAIN REQUIRING INFILTRATIONS, SLIGHT LOSS OF SENSE OF SMELL, PAIN EXTENDED FROM SHOULDER TO ELBOW LIKE NERVE INFLAMMATION, LUMP UNDER THE FOOT, PSYCHOLOGICAL FRAGILITY, REPEATED URINARY INFECTIONS, RESTLESS LEGS. PRE-MENOPAUSE STARTED WHEN THE CONSUMER WAS (B)(6). THE CONSUMER UNDERWENT LUMBER MRI, BLOOD SAMPLES ++, 2D X-RAY OF ESSURE INSERTS AND FOOT ULTRASOUND. ALLERGY TESTS FOR HEAVY METALS WERE PERFORMED. THE CONSUMER WAS PENDING FOR THE RESULTS. PLAIN ABDOMEN X-RAY WAS TO BE PERFORMED QUICKLY. THE CONSUMER WAS PENDING FOR HYSTERECTOMY. NO FURTHER INFORMATION WILL BE AVAILABLE AS NO CONTACT DATA WAS PROVIDED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT WAS RECEIVED VIA REGULATORY AUTHORITY AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD PELVIC PAIN. SHE WAS PENDING FOR A HYSTERECTOMY. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. SINCE THE CONSUMER MENTIONED SHE WAS PENDING FOR A HYSTERECTOMY AND NO FURTHER INFORMATION WILL BE AVAILABLE, THIS CASE WAS REGARDED AS INCIDENT IN A CONSERVATIVE APPROACH (SURGICAL INTERVENTION WILL LIKELY BE REQUIRED). THIS IS ALSO IN LINE WITH THE HEALTH AUTHORITY'S ASSESSMENT. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. NO FURTHER INFORMATION WILL BE AVAILABLE AS NO CONTACT DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753604 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R