BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7470083 · Received April 27, 2018

    Report

    Report Number
    2951250-2018-01972
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    February 26, 2015
    Report Date
    August 2, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (TERMINATION)") AND BREAST CONSERVING SURGERY ("PARTIAL MASTECTOMY (RIGHT BREAST)") IN A 47-YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 3) WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BREAST MASS IN 2016, MULTIPAROUS, D & C, BREAST CONSERVING SURGERY, PERMANENT CARDIAC PACEMAKER INSERTION AND GRAVIDA II. CONCURRENT CONDITIONS INCLUDED SYNCOPE VASOVAGAL SINCE 1986, LIGHTHEADEDNESS, UTERINE ADENOMYOMA AND CONGENITAL HEART BLOCK SINCE 1986. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, 1 YEAR AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN") AND PAIN IN EXTREMITY ("LEG PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED OVARIAN CYST ("RIGHT OVARIAN CYST") AND LIBIDO DECREASED ("DECREASED LIBIDO"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("UTI"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), URTICARIA ("HIVES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), BALANCE DISORDER ("LOSS OF BALANCE"), GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX") AND BREAST CONSERVING SURGERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), EXCEDRIN, SURGERY (FRACTIONAL DILATATION AND CURETTAGE) AND SURGERY (FRACTIONAL DILATATION AND CURETTAGE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, ALOPECIA, URINARY TRACT INFECTION, ANXIETY, MIGRAINE, HEADACHE, URTICARIA, NAUSEA, TOOTH DISORDER, BALANCE DISORDER, LIBIDO DECREASED, PAIN IN EXTREMITY AND GASTROOESOPHAGEAL REFLUX DISEASE HAD NOT RESOLVED, THE OVARIAN CYST HAD RESOLVED AND THE BREAST CONSERVING SURGERY OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, BALANCE DISORDER, BREAST CONSERVING SURGERY, DYSMENORRHOEA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN CYST, PAIN IN EXTREMITY, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT WAS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FULL OCCLUSION OF FALLOPIAN TUBES ULTRASOUND ABDOMEN - ON (B)(6) 2016: RIGHT OVARIAN CYST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUN-2018: PFS RECEIVED, REPORTER ADDED, HISTORICAL CONDITION ADDED, EVENT ADDED AS:- PARTIAL MASTECTOMY. 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

    ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (TERMINATION)") AND BREAST CONSERVING SURGERY ("PARTIAL MASTECTOMY (RIGHT BREAST)") IN A 47-YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 3) WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BREAST MASS IN 2016, MULTIPAROUS, D & C, BREAST CONSERVING SURGERY, PERMANENT CARDIAC PACEMAKER INSERTION AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED SYNCOPE VASOVAGAL SINCE 1986, LIGHTHEADEDNESS, UTERINE ADENOMYOMA AND CONGENITAL HEART BLOCK SINCE 1986. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, 1 YEAR AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN MARCH 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN") AND PAIN IN EXTREMITY ("LEG PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED OVARIAN CYST ("RIGHT OVARIAN CYST") AND LIBIDO DECREASED ("DECREASED LIBIDO"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST CONSERVING SURGERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("UTI"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), URTICARIA ("HIVES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), BALANCE DISORDER ("LOSS OF BALANCE") AND GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), EXCEDRIN, SURGERY (FRACTIONAL DILATATION AND CURETTAGE) AND SURGERY (FRACTIONAL DILATATION AND CURETTAGE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, ALOPECIA, URINARY TRACT INFECTION, ANXIETY, MIGRAINE, HEADACHE, URTICARIA, NAUSEA, TOOTH DISORDER, BALANCE DISORDER, LIBIDO DECREASED, PAIN IN EXTREMITY AND GASTROOESOPHAGEAL REFLUX DISEASE HAD NOT RESOLVED, THE BREAST CONSERVING SURGERY OUTCOME WAS UNKNOWN AND THE OVARIAN CYST HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, BALANCE DISORDER, BREAST CONSERVING SURGERY, DYSMENORRHOEA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN CYST, PAIN IN EXTREMITY, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT WAS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FULL OCCLUSION OF FALLOPIAN TUBES ULTRASOUND ABDOMEN - ON (B)(6) 2016: RIGHT OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAIN 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (TERMINATION)") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BREAST MASS IN 2016, MULTIPAROUS, D & C, BREAST CONSERVING SURGERY AND PERMANENT CARDIAC PACEMAKER INSERTION. CONCURRENT CONDITIONS INCLUDED SYNCOPE VASOVAGAL SINCE 1986, LIGHTHEADEDNESS, UTERINE ADENOMYOMA AND CONGENITAL HEART BLOCK SINCE 1986. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, 1 YEAR AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN") AND PAIN IN EXTREMITY ("LEG PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED OVARIAN CYST ("RIGHT OVARIAN CYST") AND LIBIDO DECREASED ("DECREASED LIBIDO"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("UTI"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), URTICARIA ("HIVES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), BALANCE DISORDER ("LOSS OF BALANCE") AND GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), EXCEDRIN, SURGERY (FRACTIONAL DILATATION AND CURETTAGE) AND SURGERY (FRACTIONAL DILATATION AND CURETTAGE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, ALOPECIA, URINARY TRACT INFECTION, ANXIETY, MIGRAINE, HEADACHE, URTICARIA, NAUSEA, TOOTH DISORDER, BALANCE DISORDER, LIBIDO DECREASED, PAIN IN EXTREMITY AND GASTROOESOPHAGEAL REFLUX DISEASE HAD NOT RESOLVED AND THE OVARIAN CYST HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, BALANCE DISORDER, DYSMENORRHOEA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN CYST, PAIN IN EXTREMITY, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT WAS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FULL OCCLUSION OF FALLOPIAN TUBES. ULTRASOUND ABDOMEN - ON (B)(6) 2016: RIGHT OVARIAN CYST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED - NEW EVENT "ABNORMAL BLEEDING (VAGINAL), UTI, PREGNANCY (TERMINATION), DEVICE INEFFECTIVE, ANXIETY, MIGRAINES, HEADACHES, HIVES, NAUSEA, DENTAL PROBLEMS, LOSS OF BALANCE, RIGHT OVARIAN CYST, DECREASED LIBIDO, LEG PAIN, ACID REFLUX" WERE ADDED. LOT NUMBER WAS ADDED. NEW REPORTER WERE ADDED. HISTORICAL CONDITIONS AND CONCOMITANT DISEASES AND PRODUCT WERE ADDED. INCIDENT CATEGORY WAS UPDATED FROM OTHER TO INCIDENT. ON 28-FEB-2018: FU 2 AND FU 3 PROCEED TOGETHER. MEDICAL RECORD RECEIVED - NEW REPORTER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313179 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952109

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R DEPO-PROVERA| ORAL CONTRACEPTIVE NOS