BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6854617 · Received September 11, 2017

    Report

    Report Number
    2951250-2017-03511
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    May 23, 2012
    Report Date
    September 10, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND THE SECOND EPISODE OF DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED POST-TRAUMATIC STRESS DISORDER, FATIGUE, ANXIETY, GAS, DEPRESSION AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED CEFALEXIN (KEFLEX), NORETHISTERONE (NORETHINDRONE) SINCE 2008 AND VALACICLOVIR HYDROCHLORIDE (VALTREX). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 29 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, THE FIRST EPISODE OF DYSMENORRHOEA ("MENSTRUAL PAIN") AND UTERINE PAIN ("UTERUS PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), UTERINE LEIOMYOMA ("UTERINE FIBROIDS") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016- TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND UTERINE PAIN OUTCOME WAS UNKNOWN, THE LAST EPISODE OF DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER AND UTERINE LEIOMYOMA HAD NOT RESOLVED, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, MENORRHAGIA, MENSTRUAL DISORDER, UTERINE LEIOMYOMA, UTERINE PAIN, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2016, PATIENT CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED- REPORTER INFORMATION, PATIENT DETAILS, OTHER RELEVANT HISTORY, PRODUCT INFORMATION, CONCOMITANT DRUGS, EVENTS- MIGRATION OF ESSURE DEVICE, ABDOMEN PAIN, MENSTRUAL PAIN, UTERUS PAIN, DEVICE MONITORING PROCEDURE NOT PERFORMED WERE ADDED. ON 1-MAR-2018: REPORTERS AND CONCOMITANT CONDITIONS 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), THE SECOND EPISODE OF DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN") AND GENITAL HAEMORRHAGE ("EXTREME BLEEDING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED POST-TRAUMATIC STRESS DISORDER, FATIGUE, ANXIETY, GAS, DEPRESSION AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED CEFALEXIN (KEFLEX), NORETHISTERONE (NORETHINDRONE) SINCE 2008 AND VALACICLOVIR HYDROCHLORIDE (VALTREX). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, THE FIRST EPISODE OF DYSMENORRHOEA ("MENSTRUAL PAIN") AND UTERINE PAIN ("UTERUS PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), ABDOMINAL PAIN ("ABDOMEN PAIN"), LETHARGY ("LETHARGIC") AND ALLERGY TO METALS ("ISSUE WITH METAL"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016- TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, UTERINE PAIN, LETHARGY AND ALLERGY TO METALS OUTCOME WAS UNKNOWN, THE LAST EPISODE OF DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER AND UTERINE LEIOMYOMA HAD NOT RESOLVED, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, LETHARGY, MENORRHAGIA, MENSTRUAL DISORDER, UTERINE LEIOMYOMA, UTERINE PAIN, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2016, PATIENT CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2018: SOCIAL MEDIA CASE - NEW EVENTS "EXTREME BLEEDING, LETHARGIC, ISSUE WITH METAL" WERE ADDED. NEW REPORTER WAS 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

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ UNABLE TO LOCATE ONE OF THE ESSURE INSERTS BECAUSE IT MIGRATED."), VULVOVAGINAL INJURY ("TORN VAGINAL ARTERY "), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN") AND GENITAL HAEMORRHAGE ("EXTREAME BLEEDING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED POST-TRAUMATIC STRESS DISORDER, FATIGUE, ANXIETY, GAS, DEPRESSION AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED CEFALEXIN (KEFLEX), NORETHISTERONE (NORETHINDRONE) SINCE 2008 AND VALACICLOVIR HYDROCHLORIDE (VALTREX). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND UTERINE PAIN ("UTERUS PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VULVOVAGINAL INJURY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), ABDOMINAL PAIN ("ABDOMEN PAIN"), LETHARGY ("LETHARGIC") AND ALLERGY TO METALS ("ISSUE WITH METAL"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016- TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (SURGERY TO CAUTERIZE THE TORN VAGINAL ARTERY) AND SURGERY ((B)(6) 2016- TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, VULVOVAGINAL INJURY, GENITAL HAEMORRHAGE, UTERINE PAIN, LETHARGY AND ALLERGY TO METALS OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER AND UTERINE LEIOMYOMA HAD NOT RESOLVED, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, LETHARGY, MENORRHAGIA, MENSTRUAL DISORDER, UTERINE LEIOMYOMA, UTERINE PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2016, PATIENT CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. THE REMAINING ESSURE IMPLANT IS STILL CAUSING PROBLEMS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENT ADDED: TORN VAGINAL ARTERY. PATIENT HAD ONLY ONE OF THE ESSURE IMPLANT WAS REMOVED. 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 DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL 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 DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), UTERINE LEIOMYOMA ("UTERINE FIBROIDS") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"). 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 DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER AND UTERINE LEIOMYOMA HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2016, PATIENT CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. 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
    635359 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R KEFLEX| KEFLEX| KEFLEX| NORETHINDRONE| NORETHINDRONE| NORETHINDRONE| NORETHINDRONE| NORETHINDRONE| NORETHINDRONE| VALTREX| VALTREX| VALTREX