BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7000857 · Received November 3, 2017

    Report

    Report Number
    2951250-2017-06122
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    July 25, 2012
    Report Date
    August 10, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/ PROLONGED MENSTRUATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION DONE ON THE DAY OF INSERTION ((B)(6) 2012)". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 2 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - TOTAL LAPAROSCOPIC HYSTERECTOMY/BILATERAL SALPINGECTOMY) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MIGRAINE AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT ESSURE REMOVAL, HER UTERUS, CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PLAINTIFF'S SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: LOT NUMBER, REPORTER INFORMATION, PATIENT DETAILS, LAB DATA, PRODUCT INFORMATION, EVENTS- ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), MIGRAINES, HEADACHES WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, 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"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/ PROLONGED MENSTRUATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION DONE ON THE DAY OF INSERTION((B)(6) 2012)". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY, MIGRAINE, UTERINE DILATION AND CURETTAGE, MISCARRIAGE AND DYSFUNCTIONAL UTERINE BLEEDING. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 2 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - TOTAL LAPAROSCOPIC HYSTERECTOMY/BILATERAL SALPINGECTOMY) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MIGRAINE AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT ESSURE REMOVAL, HER UTERUS, CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PLAINTIFF'S SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES ON (B)(6) 2012, PROCEDURE : HYSTEROSALPINGOGRAPHY, IMPRESSION: SATISFACTORY CLOSURE OF THE RIGHT AND LEFT FALLOPIAN TUBES WITHOUT RETROPERITONEAL SPILL. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT, DX: (MICROSCOPIC): UTERUS AND CERVIX WITH BILATERAL FALLOPIAN TUBES, TOTALLY LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX- MILD CHRONIC ENDOCERVICITIS. ENDOMETRIUM - SECRETORY PHASE ENDOMETRIUM. MYOMETRIUM - NO SIGNIFICANT DIAGNOSTIC CHANGES. BILATERAL FALLOPIAN TUBES - NO SIGNIFICANT DIAGNOSTIC CHANGES. ON (B)(6) 2016, PROCEDURE(S): TOTAL LAPAROSCOPIC HYSTERECTOMY LAPAROSCOPIC SALPINGECTOMY. FINDINGS: THE PATIENT WAS NOTED TO HAVE ABOUT A 9 CM UTERUS. BOTH TUBES AND OVARIES WERE VISUALIZED AND NOTED TO BE NORMAL. THE ESSURE IMPLANTS WERE PALPABLE IN THE FALLOPIAN TUBES AT THE END OF THE PROCEDURE. NO OTHER PELVIC ABNORMALITIES WERE NOTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MIGRAINE, MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, MEDICAL DEVICE MONITORING ERROR. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT AT THE TIME OF REPORTING, 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL CRAMPING"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/ PROLONGED MENSTRUATION") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT ESSURE REMOVAL, HER UTERUS, CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PLAINTIFF'S SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. 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
    779182 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 880435

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R