BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7269239 · Received February 14, 2018

    Report

    Report Number
    2951250-2018-00645
    Event Type
    Injury
    Date Received
    February 14, 2018
    Report Date
    September 11, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FAD, REFERENCE NUMBER: MW5074612) ON 30-NOV-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 10-SEP-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C35240) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST- NO". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MINI PILL BIRTH CONTROL FROM (B)(6) 2013 TO (B)(6) 2013. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2010. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("LOSING HAIR/ HAIR LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE/FATIGUE"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND VULVOVAGINAL DRYNESS ("HORMONAL CHANGES - DESCRIBES: VAGINAL DRYNESS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), BONE PAIN ("BONE PAIN"), ARTHRALGIA ("JOINT PAIN") AND PAIN ("BONE AND BODY HURT FROM MY KNEES TO MY RIB CASGE AND IT WAS DEEP PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - BILATERAL REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PAIN, ALOPECIA, FATIGUE, MOOD SWINGS AND DYSPAREUNIA HAD RESOLVED AND THE ABDOMINAL PAIN, BONE PAIN, ARTHRALGIA, VULVOVAGINAL DRYNESS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, ARTHRALGIA, BONE PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MOOD SWINGS, PAIN, PELVIC PAIN, VAGINAL HAEMORRHAGE, VULVOVAGINAL DRYNESS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5074561) ON 05-FEB-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("IT HAS PERFORATED MY UTERUS"), DIABETES MELLITUS ("DIABETES") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED TRULICITY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DIABETES MELLITUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIES ("PCOS"), HYPERTENSION ("HIGH BLOOD PRESSURE") AND PELVIC PAIN ("CHRONIC PELVIC PAIN"). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DIABETES MELLITUS, AUTOIMMUNE DISORDER, POLYCYSTIC OVARIES, HYPERTENSION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AUTOIMMUNE DISORDER, DIABETES MELLITUS, HYPERTENSION, PELVIC PAIN AND POLYCYSTIC OVARIES WITH ESSURE. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE HAS CAUSED A LOT OF HEALTH ISSUES SINCE INSERTION. CONSUMER MENTIONED A SERIOUS INJURY (REQUIRED INTERVENTION) BUT DID NOT SPECIFY IT TO ONE OF THE EVENTS. 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
    112432 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ORAL BLOOD GLUCOSE LOWERING DRUGS| ORAL BLOOD GLUCOSE LOWERING DRUGS| ORAL BLOOD GLUCOSE LOWERING DRUGS