BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12244754 · Received July 29, 2021

    Report

    Report Number
    2951250-2021-02949
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    May 1, 2016
    Report Date
    August 6, 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('CONSTANT LOWER BACK PAIN FIR OVER 5 YEARS THAT HAS SPREAD TO MY NECK') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREMATURE MENOPAUSE ("MENOPAUSE AT 42"), AMNESIA ("MEMORY LOSS"), ABDOMINAL PAIN ("CONSTANT PAIN IN LOWER BACK, ABDOMEN, NECK"), NECK PAIN ("CONSTANT PAIN IN LOWER BACK, ABDOMEN, NECK"), LOSS OF LIBIDO ("LOSS OF SEX DRIVE,MY SEX DRIVE IS ZERO"), MIGRAINE ("MIGRAINE"), GLUCOSE TOLERANCE IMPAIRED ("PREDIABETES"), SLEEP TALKING ("SCREAMING WHILE SLEEPING") AND NEURALGIA ("BURNING OF NERVES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE, SEMAGLUTIDE (OZEMPIC) AND SURGERY (ESSURE REMOVAL SCHEDULED ON (B)(6) 2021). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN, PREMATURE MENOPAUSE, AMNESIA AND NECK PAIN HAD NOT RESOLVED AND THE ABDOMINAL PAIN, LOSS OF LIBIDO, MIGRAINE, GLUCOSE TOLERANCE IMPAIRED, WEIGHT INCREASED, SLEEP TALKING AND NEURALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, BACK PAIN, GLUCOSE TOLERANCE IMPAIRED, LOSS OF LIBIDO, MIGRAINE, NECK PAIN, NEURALGIA, PREMATURE MENOPAUSE, SLEEP TALKING AND WEIGHT INCREASED TO BE RELATED TO ESSURE. LOT NUMBER: 822375. MANUFACTURE DATE: 2011-01. EXPIRATION DATE: 2014-01. 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 6-AUG-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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('CONSTANT LOWER BACK PAIN FIR OVER 5 YEARS THAT HAS SPREAD TO MY NECK') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREMATURE MENOPAUSE ("MENOPAUSE AT 42"), AMNESIA ("MEMORY LOSS"), ABDOMINAL PAIN ("CONSTANT PAIN IN LOWER BACK, ABDOMEN, NECK"), NECK PAIN ("CONSTANT PAIN IN LOWER BACK, ABDOMEN, NECK"), LOSS OF LIBIDO ("LOSS OF SEX DRIVE,MY SEX DRIVE IS ZERO"), MIGRAINE ("MIGRAINE"), GLUCOSE TOLERANCE IMPAIRED ("PREDIABETES"), SLEEP TALKING ("SCREAMING WHILE SLEEPING") AND NEURALGIA ("BURNING OF NERVES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE, SEMAGLUTIDE (OZEMPIC) AND SURGERY (ESSURE REMOVAL SCHEDULED ON (B)(6) 2021). AT THE TIME OF THE REPORT, THE BACK PAIN, PREMATURE MENOPAUSE, AMNESIA AND NECK PAIN HAD NOT RESOLVED AND THE ABDOMINAL PAIN, LOSS OF LIBIDO, MIGRAINE, GLUCOSE TOLERANCE IMPAIRED, WEIGHT INCREASED, SLEEP TALKING AND NEURALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, BACK PAIN, GLUCOSE TOLERANCE IMPAIRED, LOSS OF LIBIDO, MIGRAINE, NECK PAIN, NEURALGIA, PREMATURE MENOPAUSE, SLEEP TALKING AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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
    1146616 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822375 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R