BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10325102 · Received July 27, 2020

    Report

    Report Number
    2951250-2020-12250
    Event Type
    Injury
    Date Received
    July 27, 2020
    Report Date
    May 3, 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 MENSTRUATION IRREGULAR ('IMPLANTED (B)(6) IRREGULAR PERIODS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LEIOMYOMA NOS, ADENOMYOSIS, CERVICITIS, NEOPLASM MALIGNANT, CYST, MENORRHAGIA, UTERINE PROLAPSE, MENORRHAGIA AND INTERMENSTRUAL BLEEDING. IN 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ADNEXA UTERI PAIN ("HORRIBLE PAIN WHERE MY OVARIES"), ARTHRALGIA ("YES MINE (HIP) HURTS TO BUT MAINLY WHEN I SLEEP BUT ITS HURTS SO BAD WHEN I GET UP SOMETIMES") AND ABDOMINAL DISTENSION ("BELLY LOOKS LIKE I'M ABOUT SEVEN MONTHS PREGNENT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINING WEIGHT LIKE CRAZY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY; BILATERAL SALPINGO-OOPHORECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MENSTRUATION IRREGULAR, WEIGHT INCREASED, ADNEXA UTERI PAIN, ARTHRALGIA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADNEXA UTERI PAIN, ARTHRALGIA, MENSTRUATION IRREGULAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PER MR : (B)(6) 2014. ENDOMETRIAL ABLATION- (B)(6) 2014. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- WEIGHT GAIN, IRREGULAR PERIODS, HIP PAIN, OVARIAN PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-APR-2021: MEDICAL RECORD RECEIVED : LOT NUMBER WAS ADDED, REPORTER INFORMATION, MEDICAL HISTORY AND REMOVAL DATE WERE 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENSTRUATION IRREGULAR ('IMPLANTED 6/14 IRREGULAR PERIODS') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ADNEXA UTERI PAIN ("HORRIBLE PAIN WHERE MY OVARIES"), ARTHRALGIA ("YES MINE (HIP) HURTS TO BUT MAINLY WHEN I SLEEP BUT ITS HURTS SO BAD WHEN I GET UP SOMETIMES") AND ABDOMINAL DISTENSION ("BELLY LOOKS LIKE I'M ABOUT SEVEN MONTHS PREGNANT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINING WEIGHT LIKE CRAZY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENSTRUATION IRREGULAR, WEIGHT INCREASED, ADNEXA UTERI PAIN, ARTHRALGIA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADNEXA UTERI PAIN, ARTHRALGIA, MENSTRUATION IRREGULAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- WEIGHT GAIN, IRREGULAR PERIODS, HIP PAIN, OVARIAN PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 MENSTRUATION IRREGULAR ('IMPLANTED (B)(6) IRREGULAR PERIODS') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ADNEXA UTERI PAIN ("HORRIBLE PAIN WHERE MY OVARIES"), ARTHRALGIA ("YES MINE (HIP) HURTS TO BUT MAINLY WHEN I SLEEP BUT ITS HURTS SO BAD WHEN I GET UP SOMETIMES") AND ABDOMINAL DISTENSION ("BELLY LOOKS LIKE I'M ABOUT SEVEN MONTHS PREGNANT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINING WEIGHT LIKE CRAZY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENSTRUATION IRREGULAR, WEIGHT INCREASED, ADNEXA UTERI PAIN, ARTHRALGIA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADNEXA UTERI PAIN, ARTHRALGIA, MENSTRUATION IRREGULAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- WEIGHT GAIN, IRREGULAR PERIODS, HIP PAIN, OVARIAN PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. REPORTER INFORMATION ADDED. REMOVAL SURGERY ADDED FOR EVENT MENSTRUATION IRREGULAR. CASE BECAME SERIOUS-INCIDENT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793804 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 821581 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R