BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18362057 · Received December 20, 2023

    Report

    Report Number
    2951250-2023-03588
    Event Type
    Injury
    Date Received
    December 20, 2023
    Report Date
    February 7, 2024
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A 40 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF RENAL COLIC IN 2014, LYMPHADENOPATHY CERVICAL IN 2012, SUPRAPUBIC PAIN, GASTRITIS AND HYPERCHOLESTEROLEMIA IN 2011, UTI FROM 2010 TO 2014 AND COPD. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: IUD NOS AND ORAL CONTRACEPTIVE NOS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS METRONIDAZOLE FOR BACTERIAL VAGINOSIS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 42 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL DISCOMFORT ("ABDOMINAL DISCOMFORT"). IN (B)(6) 2016 SHE EXPERIENCED VULVOVAGINAL CANDIDIASIS ("PERITONEAL IRRITATION"). ON (B)(6) 2016 SHE EXPERIENCED PARAESTHESIA ("PARESTHESIA IN THE HAND") AND NECK PAIN ("NECK PAIN"). ON (B)(6) 2016 SHE EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON (B)(6) 2016 SHE EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2017 SHE EXPERIENCED DYSPEPSIA ("DYSPEPSIA"). ON (B)(6) 2017 SHE EXPERIENCED CHEST PAIN ("CHEST PAIN"). ON (B)(6) 2017 SHE EXPERIENCED GASTRITIS ("GASTRITIS PROBABLE NEW H. PYLORI INFECTION"). ON (B)(6) 2017 SHE EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON (B)(6) 2017 SHE EXPERIENCED HERNIA ("HERNIAS IN C4-C5 AND L4-L5 "). ON (B)(6) 2018 SHE EXPERIENCED PYELONEPHRITIS ("PYELONEPHRITIS"). ON (B)(6) 2018 SHE EXPERIENCED ABDOMINAL PAIN UPPER ("EPIGASTRIC PAIN"). ON (B)(6) 2018 SHE EXPERIENCED CHILLS ("CHILLS"). ON (B)(6) 2019 SHE EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DIZZINESS ("DIZZINESS"). ON (B)(6) 2019 SHE EXPERIENCED FEELING COLD ("FEELING COLD") AND NIGHT SWEATS ("NIGHT SWEATING"). ON (B)(6) 2019 SHE EXPERIENCED HYPERKERATOSIS ("CALLUSES ON THE FEET"). ON (B)(6) 2019 SHE EXPERIENCED VAGINAL DISCHARGE ("MALODOROUS LEUCORRHEA OF 2 WEEKS DURATION") AND ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"). ON (B)(6) 2019 SHE EXPERIENCED NAUSEA ("NAUSEA") AND VOMITING ("VOMITING"). ON (B)(6) 2021 SHE EXPERIENCED UTERINE CERVICAL PAIN ("CERVICAL PAIN IN RELATION TO POSSIBLE DISC DISEASE"). ON (B)(6) 2021 SHE EXPERIENCED SCIATICA ("LUMBOSCIATALGIA"), RENAL PAIN ("PAIN IN THE RIGHT KIDNEY FOSSA") AND PAIN IN EXTREMITY ("PAIN IN LEFT LEG"). ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENITAL BLEEDING LASTING A MONTH"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC REACTION"), ARTHRITIS ("ANKLE ARTHRITIS"), BACK PAIN ("LOWER BACK PAIN"), AEROPHAGIA ("AEROPHAGIA"), MASTITIS ("LEFT MASTITIS"), HAEMORRHOIDS ("HEMORRHOIDS") AND LYMPHADENOPATHY ("CERVICAL ADENOPATHY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, INTERMENSTRUAL BLEEDING, HYPERSENSITIVITY, ARTHRITIS, BACK PAIN, AEROPHAGIA, HAEMORRHOIDS, PARAESTHESIA, NECK PAIN, ABDOMINAL DISCOMFORT, VULVOVAGINAL CANDIDIASIS, URINARY TRACT INFECTION, ALOPECIA, DYSPEPSIA, LYMPHADENOPATHY, CHEST PAIN, GASTRITIS, BACTERIAL VAGINOSIS, HERNIA, PYELONEPHRITIS, ABDOMINAL PAIN UPPER, CHILLS, DYSMENORRHOEA, DIZZINESS, FEELING COLD, NIGHT SWEATS, HYPERKERATOSIS, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, NAUSEA, VOMITING, UTERINE CERVICAL PAIN, SCIATICA, RENAL PAIN AND PAIN IN EXTREMITY WERE RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, AEROPHAGIA, ALOPECIA, ARTHRITIS, BACK PAIN, BACTERIAL VAGINOSIS, CHEST PAIN, CHILLS, DIZZINESS, DYSMENORRHOEA, DYSPEPSIA, FEELING COLD, GASTRITIS, GENITAL HAEMORRHAGE, HAEMORRHOIDS, HERNIA, HYPERKERATOSIS, HYPERSENSITIVITY, INTERMENSTRUAL BLEEDING, LYMPHADENOPATHY, MASTITIS, NAUSEA, NECK PAIN, NIGHT SWEATS, PAIN IN EXTREMITY, PARAESTHESIA, PYELONEPHRITIS, RENAL PAIN, SCIATICA, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VOMITING AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALLERGY TEST] ON (B)(6) 2019: FACIAL FLUSHING DUE TO CORTICOSTEROIDS AND ALLERGIC CONTACT DERMATITIS TO SILVER NITRATE AND SODIUM TETRARACHLOROPALADATE [COMPUTERISED TOMOGRAM] ON (B)(6) 2014: INTRASOMATIC HERNIAS IN L1 AND L2 AND PROTRUSIONS BETWEEN L3 AND S1 WITHOUT SIGNIFICANT STENOSIS OVER THE CANAL; ON (B)(6) 2016: ESSURE NORMALLY INSERTED; ON (B)(6) 2016: ESSURE NORMALLY INSERTED QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 07-FEB-2024: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF RENAL COLIC IN 2014, LYMPHADENOPATHY CERVICAL IN 2012, SUPRAPUBIC PAIN, GASTRITIS AND HYPERCHOLESTEROLEMIA IN 2011, UTI FROM 2010 TO 2014 AND COPD. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: IUD NOS AND ORAL CONTRACEPTIVE NOS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS METRONIDAZOLE FOR BACTERIAL VAGINOSIS. ON (B)(6) 2016, 92 DAYS BEFORE ESSURE INSERTION, SHE EXPERIENCED MASTITIS ("LEFT MASTITIS"). ON (B)(6) 2016 SHE EXPERIENCED HAEMORRHOIDS ("HEMORRHOIDS"). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016 SHE EXPERIENCED ABDOMINAL DISCOMFORT ("ABDOMINAL DISCOMFORT"). IN (B)(6) 2016 SHE EXPERIENCED VULVOVAGINAL CANDIDIASIS ("PERITONEAL IRRITATION"). ON (B)(6) 2016 SHE EXPERIENCED PARAESTHESIA ("PARESTHESIA IN THE HAND") AND NECK PAIN ("NECK PAIN"). ON (B)(6) 2016 SHE EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON (B)(6) 2016 SHE EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2017 SHE EXPERIENCED DYSPEPSIA ("DYSPEPSIA"). ON (B)(6) 2017 SHE EXPERIENCED CHEST PAIN ("CHEST PAIN"). ON (B)(6) 2017 SHE EXPERIENCED GASTRITIS ("GASTRITIS PROBABLE NEW H. PYLORI INFECTION"). ON (B)(6) 2017 SHE EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON (B)(6) 2017 SHE EXPERIENCED HERNIA ("HERNIAS IN C4-C5 AND L4-L5 "). ON (B)(6) 2018 SHE EXPERIENCED PYELONEPHRITIS ("PYELONEPHRITIS"). ON (B)(6) 2018 SHE EXPERIENCED ABDOMINAL PAIN UPPER ("EPIGASTRIC PAIN"). ON (B)(6) 2018 SHE EXPERIENCED CHILLS ("CHILLS"). ON (B)(6) 2019 SHE EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DIZZINESS ("DIZZINESS"). ON (B)(6) 2019 SHE EXPERIENCED FEELING COLD ("FEELING COLD") AND NIGHT SWEATS ("NIGHT SWEATING"). ON (B)(6) 2019 SHE EXPERIENCED HYPERKERATOSIS ("CALLUSES ON THE FEET"). ON (B)(6) 2019 SHE EXPERIENCED VAGINAL DISCHARGE ("MALODOROUS LEUCORRHEA OF 2 WEEKS DURATION") AND ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"). ON (B)(6) 2019 SHE EXPERIENCED NAUSEA ("NAUSEA") AND VOMITING ("VOMITING"). ON (B)(6) 2021 SHE EXPERIENCED UTERINE CERVICAL PAIN ("CERVICAL PAIN IN RELATION TO POSSIBLE DISC DISEASE"). ON (B)(6) 2021 SHE EXPERIENCED SCIATICA ("LUMBOSCIATALGIA"), RENAL PAIN ("PAIN IN THE RIGHT KIDNEY FOSSA") AND PAIN IN EXTREMITY ("PAIN IN LEFT LEG"). AN UNKNOWN TIME LATER SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENITAL BLEEDING LASTING A MONTH"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC REACTION"), ARTHRITIS ("ANKLE ARTHRITIS"), BACK PAIN ("LOWER BACK PAIN"), AEROPHAGIA ("AEROPHAGIA") AND LYMPHADENOPATHY ("CERVICAL ADENOPATHY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, INTERMENSTRUAL BLEEDING, HYPERSENSITIVITY, ARTHRITIS, BACK PAIN, AEROPHAGIA, HAEMORRHOIDS, PARAESTHESIA, NECK PAIN, ABDOMINAL DISCOMFORT, VULVOVAGINAL CANDIDIASIS, URINARY TRACT INFECTION, ALOPECIA, DYSPEPSIA, LYMPHADENOPATHY, CHEST PAIN, GASTRITIS, BACTERIAL VAGINOSIS, HERNIA, PYELONEPHRITIS, ABDOMINAL PAIN UPPER, CHILLS, DYSMENORRHOEA, DIZZINESS, FEELING COLD, NIGHT SWEATS, HYPERKERATOSIS, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, NAUSEA, VOMITING, UTERINE CERVICAL PAIN, SCIATICA, RENAL PAIN AND PAIN IN EXTREMITY WERE RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, AEROPHAGIA, ALOPECIA, ARTHRITIS, BACK PAIN, BACTERIAL VAGINOSIS, CHEST PAIN, CHILLS, DIZZINESS, DYSMENORRHOEA, DYSPEPSIA, FEELING COLD, GASTRITIS, GENITAL HAEMORRHAGE, HAEMORRHOIDS, HERNIA, HYPERKERATOSIS, HYPERSENSITIVITY, INTERMENSTRUAL BLEEDING, LYMPHADENOPATHY, MASTITIS, NAUSEA, NECK PAIN, NIGHT SWEATS, PAIN IN EXTREMITY, PARAESTHESIA, PYELONEPHRITIS, RENAL PAIN, SCIATICA, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VOMITING AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALLERGY TEST] ON (B)(6) 2019: FACIAL FLUSHING DUE TO CORTICOSTEROIDS AND ALLERGIC CONTACT DERMATITIS TO SILVER NITRATE AND SODIUM TETRARACHLOROPALADATE [COMPUTERISED TOMOGRAM] ON (B)(6) 2014: INTRASOMATIC HERNIAS IN L1 AND L2 AND PROTRUSIONS BETWEEN L3 AND S1 WITHOUT SIGNIFICANT STENOSIS OVER THE CANAL; ON (B)(6) 2016: ESSURE NORMALLY INSERTED; ON (B)(6) 2016: ESSURE NORMALLY INSERTED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205467 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention METRONIDAZOLE| METRONIDAZOLE