BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6731979 · Received July 21, 2017

    Report

    Report Number
    2951250-2017-02621
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    January 1, 2013
    Report Date
    July 18, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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"), PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN") AND ADNEXA UTERI PAIN ("PAIN OVER OVARIES/ OVER OVARIES/ABDOMINAL AREA(MILD TO SEVERE CRAMPING)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 IN 2006, MIGRAINE HEADACHE, PPD SKIN TEST POSITIVE, ORAL SURGERY, MENARCHE, C-SECTION IN 2006, CHORIOAMNIONITIS, POLYHYDRAMNIOS, BLEEDING GENITAL, SPOTTING VAGINAL, OVARIAN CYST, CHOLELITHIASIS, CHRONIC CHOLECYSTITIS, CHRONIC TONSILLITIS, CHOLECYSTECTOMY, TONSILLECTOMY, BIPOLAR DISORDER, NOSE BLEEDS, HOARSENESS, SORE THROAT, PALPITATION, CONSTIPATION, DEPRESSION, HEADACHE, WHEEZING, DYSPNEA AND BLEEDING BREAKTHROUGH. SOCIAL HISTORY: DENIED ALCOHOL, TOBACCO. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IN 2006, LOESTRIN 24, WELLBUTRIN, ZOLOFT AND CYMBALTA. FAMILY HISTORY INCLUDED BREAST CANCER (PATERNAL GRANDMOTHER DIAGNOSED IN HER 50'S,), HYPERTENSION (OTHER GRANDMOTHER), DIABETES MELLITUS INSULIN-DEPENDENT (FATHER), PROSTATE CANCER (FATHER), SKIN CANCER (FATHER) AND ASTHMA (ONE OF HER CHILDREN). CONCOMITANT PRODUCTS INCLUDED ESTRADIOL AND IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC TYPE REACTIONS/ NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL; GREEN DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/ GREEN DISCHARGE/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL; GREEN DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS"), VAGINAL INFECTION ("VAGINAL INFECTION"), CYSTITIS ("BLADDER INFECTION"), FUNGAL INFECTION ("YEAST INFECTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), INFECTION ("MULTIPLE INFECTIONS"), ABDOMINAL PAIN ("PAIN OVER ABDOMINAL AREA / OVER OVARIES/ABDOMINAL AREA(MILD TO SEVERE CRAMPING)"), ADNEXA UTERI PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FOOT FRACTURE ("BROKEN FOOT"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (SHE UNDERWENT TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ALLERGY TO METALS, URINARY TRACT INFECTION, VAGINAL INFECTION, CYSTITIS, FUNGAL INFECTION, DYSMENORRHOEA, ADNEXA UTERI PAIN AND FOOT FRACTURE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED, FEMALE SEXUAL DYSFUNCTION, INFECTION AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALLERGY TO METALS, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, FOOT FRACTURE, FUNGAL INFECTION, INFECTION, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. ULTRASOUND ABDOMEN - ON (B)(6) 2007: IMPRESSION: GALLSTONES.; ON (B)(6) 2007: IMPRESSION: REVEALED GALLSTONES ULTRASOUND PELVIS - ON (B)(6) 2007: IMPRESSION: LEFT OVARIAN CYST; ON (B)(6) 2010: THE IUD WAS SEEN TO BE APPROPRIATELY POSITIONED; ON (B)(6) 2012: IUD WAS SEEN TO BE IN THE APPROPRIATE POSITION IN 2012: ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. (B)(6) 2007: RADIOLOGY REPORT - IMPRESSION: SHADOWING WITHIN THE ENDOMETRIUM COMPATIBLE WITH AN IUD, 2.2 CM LEFT OVARIAN CYST. (B)(6) 2007: ULTRASOUND - IMPRESSION: THERE WAS TINY SIMPLE APPEARING CYST. THE IUD WAS VISUALIZED AND APPEARS TO BE IN PLACE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JAN-2018: NEW EVENTS ADDED: MIGRATION OF ESSURE DEVICE, VAGINAL DISCHARGE/ GREEN DISCHARGE/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL; GREEN DISCHARGE, BLADDER INFECTION, URINARY TRACT INFECTIONS, VAGINAL INFECTION, YEAST INFECTION, DYSMENORRHEA (CRAMPING), WEIGHT GAIN, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), PAIN OVER ABDOMINAL AREA / OVER OVARIES/ABDOMINAL AREA(MILD TO SEVERE CRAMPING), PAIN OVER OVARIES/ OVER OVARIES/ABDOMINAL AREA(MILD TO SEVERE CRAMPING), MULTIPLE INFECTIONS, BROKEN FOOT. LOT NO ADDED. PRODUCT START AND STOP DATE 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN") AND ADNEXA UTERI PAIN ("PAIN OVER OVARIES/ OVER OVARIES/ABDOMINAL AREA(MILD TO SEVERE CRAMPING)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 IN 2006, MIGRAINE HEADACHE, PPD SKIN TEST POSITIVE, ORAL SURGERY, MENARCHE, C-SECTION IN 2006, CHORIOAMNIONITIS, POLYHYDRAMNIOS, BLEEDING GENITAL, SPOTTING VAGINAL, OVARIAN CYST, CHOLELITHIASIS, CHRONIC CHOLECYSTITIS, CHRONIC TONSILLITIS, CHOLECYSTECTOMY, TONSILLECTOMY, BIPOLAR DISORDER, NOSE BLEEDS, HOARSENESS, SORE THROAT, PALPITATION, CONSTIPATION, DEPRESSION, HEADACHE, WHEEZING, DYSPNEA AND BLEEDING BREAKTHROUGH. SOCIAL HISTORY: DENIED ALCOHOL, TOBACCO. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IN 2006, LOESTRIN 24, WELLBUTRIN, ZOLOFT AND CYMBALTA. FAMILY HISTORY INCLUDED BREAST CANCER (PATERNAL GRANDMOTHER DIAGNOSED IN HER 50'S,), HYPERTENSION (OTHER GRANDMOTHER), DIABETES MELLITUS INSULIN-DEPENDENT (FATHER), PROSTATE CANCER (FATHER), SKIN CANCER (FATHER) AND ASTHMA (ONE OF HER CHILDREN). CONCOMITANT PRODUCTS INCLUDED ESTRADIOL AND IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ALLERGY TO METALS ("ALLERGIC TYPE REACTIONS/ NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL; GREEN DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE/ GREEN DISCHARGE/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL; GREEN DISCHARGE") AND INFECTION ("MULTIPLE INFECTIONS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS"), VAGINAL INFECTION ("VAGINAL INFECTION"), CYSTITIS ("BLADDER INFECTION"), FUNGAL INFECTION ("YEAST INFECTION"), ABDOMINAL PAIN ("PAIN OVER ABDOMINAL AREA / OVER OVARIES/ABDOMINAL AREA(MILD TO SEVERE CRAMPING)"), ADNEXA UTERI PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FOOT FRACTURE ("BROKEN FOOT"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) . ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ALLERGY TO METALS, URINARY TRACT INFECTION, VAGINAL INFECTION, CYSTITIS, FUNGAL INFECTION, DYSMENORRHOEA, ADNEXA UTERI PAIN AND FOOT FRACTURE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED, FEMALE SEXUAL DYSFUNCTION, INFECTION AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALLERGY TO METALS, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, FOOT FRACTURE, FUNGAL INFECTION, INFECTION, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. ULTRASOUND ABDOMEN - ON (B)(6) 2007: IMPRESSION: GALLSTONES.; ON (B)(6) 2007: IMPRESSION: REVEALED GALLSTONES ULTRASOUND PELVIS - ON (B)(6) 2007: IMPRESSION: LEFT OVARIAN CYST; ON (B)(6) 2010: THE IUD WAS SEEN TO BE APPROPRIATELY POSITIONED; ON (B)(6) 2012: IUD WAS SEEN TO BE IN THE APPROPRIATE POSITION IN 2012: ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. (B)(6) 2007: RADIOLOGY REPORT - IMPRESSION: SHADOWING WITHIN THE ENDOMETRIUM COMPATIBLE WITH AN IUD, 2.2 CM LEFT OVARIAN CYST. (B)(6) 2007: ULTRASOUND - IMPRESSION: THERE WAS TINY SIMPLE APPEARING CYST. THE IUD WAS VISUALIZED AND APPEARS TO BE IN PLACE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HYPERSENSITIVITY ("ALLERGIC TYPE REACTIONS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY ON (B)(6) 2015.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYPERSENSITIVITY AND PELVIC PAIN TO BE RELATED TO ESSURE. 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
    512190 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893029

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R ESTRADIOL| ESTRADIOL| IBUPROFEN| IBUPROFEN