BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6878479 · Received September 20, 2017

    Report

    Report Number
    2951250-2017-03823
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    February 1, 2011
    Report Date
    October 26, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTION") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEVICE ALLERGY AND DRUG ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING, HIVES, SWELLING NOS, ANGIOEDEMA, DRUG ALLERGY, UTERINE LEIOMYOMA AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN) AND PARACETAMOL (TYLENOL 8 HOUR). IN (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS- CONDITION:"). ON (B)(6)2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ROBOTIC HYSTERECTOMY( PARTIAL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, MENTAL DISORDER, DEPRESSION, ANXIETY AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, MENORRHAGIA, MENSTRUAL DISORDER, MENTAL DISORDER, PAIN IN EXTREMITY, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT TOOK LEAVE FROM (B)(6)2016 TO (B)(6)2016 FOR HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-OCT-2018: PFS RECEIVED: NEW EVENT DEPRESSION, MENTAL ANGUISH, LEG PAIN WERE ADDED. OUTCOME OF MENORRHAGIA AND VAGINAL BLEEDING UPDATED TO RECOVERED / RESOLVED. CONCOMITANT AND HISTORICAL MEDICATION WERE ADDED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTION") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEVICE ALLERGY AND DRUG ALLERGY. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING, HIVES, SWELLING NOS, ANGIOEDEMA, DRUG ALLERGY, UTERINE LEIOMYOMA AND UTERINE BLEEDING. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ROBOTIC HYSTERECTOMY WITH BILATERAL TUBAL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. EVENT ADDED AS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA). HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTION") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEVICE ALLERGY AND DRUG ALLERGY. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING, HIVES, SWELLING NOS, ANGIOEDEMA, DRUG ALLERGY, UTERINE LEIOMYOMA AND UTERINE BLEEDING. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS- CONDITION:"). IN FEBRUARY 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ROBOTIC HYSTERECTOMY( PARTIAL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON 31-OCT-2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE AND MENTAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, MENORRHAGIA, MENSTRUAL DISORDER, MENTAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 4-FEB-2012: ESSURE DEVICE WAS SUCCESSFUJLY OCCLUDED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: PATIENT WEIGHT AND NEW EVENT : MENTAL DISORDER ADDED. OUTCOME FOR THE EVENT PELVIC PAIN UPDATED TO RECOVERED / RESOLVED. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ROBOTIC HYSTERECTOMY WITH BILATERAL TUBAL REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM. ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659765 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R ACETAMINOPHEN| TYLENOL 8 HOUR