BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7360451 · Received March 21, 2018

    Report

    Report Number
    2951250-2018-01221
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    September 4, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PENICILLIN. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED RASH WITH PENICILLIN. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING AND CERVICAL DYSPLASIA. CONCOMITANT PRODUCTS INCLUDED GLYCERYL TRINITRATE (TRANSDERM PATCH) FROM 2008 TO 2013 AND NORETHISTERONE (MINI-PILL) FROM 2008 TO 2013 FOR CONTRACEPTION AND BETA-LACTAMASE SENSITIVE PENICILLINS (PENICILLIN) FOR RASH. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("IRREGULAR AND EXCESSIVE VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), ABDOMINAL PAIN LOWER ("EXCESSIVE CRAMPING"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), AMENORRHOEA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: AMENORRHAGIA") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL DISTENSION HAD RESOLVED AND THE DYSPAREUNIA, ABDOMINAL PAIN LOWER AND AMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMENORRHOEA, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - IN 2013: TOTAL BILATERAL OCCLUSION ON (B)(6) 2016 SURGICAL PATHOLOGICAL REPORT SHOWS- DIAGNOSIS: UTERUS AND CERVIX, HYSTERECTOMY - BENIGN CERVIX, NEGATIVE FOR DYSPLASIA AND MALIGNANCY; TROPHIC ENDOMETRIUM, NEGATIVE FOR HYPERPLASIA AND MALIGNANCY,FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY S, RIGHT FALLOPIAN TUBE WITH BENIGN PARATUBAL CYSTS;COMPLETE CROSS SECTIONS OF BILATERAL FALLOPIAN TUBES ARE IDENTIFIED. GROSS DESCRIPTION: DIMENSION, AND AT THE PROXIMAL END IS A HELICAL METALLIC FRAGMENT LEFT FALLOPIAN TUBE: 3,5 X 0,6 CM DESCRIPTION: TAN-PINK FIMBRIATED, AND AT THE PROXIMAL END IS A HELICAL METALLIC FRAGMENT. REPRESENTATIVE SECTIONS ARE SUBMITTED IN 4 CASSETTE(S) FOR MICROSCOPIC EXAMINATION, BLOCK SUMMARY: A1- TRANSITION ZONE; A2- ENDOMYOMETRIUM AND SEROSA; A3- RIGHT TUBE; A4- LEFT TUBE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (MENORRHAGIA), AMENORRHAGIA, BLOATING. REPORTER INFORMATION, CONCOMITANT DISEASE & LAB DATA WERE 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("IRREGULAR AND EXCESSIVE VAGINAL BLEEDING") AND ABDOMINAL PAIN LOWER ("EXCESSIVE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE 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
    199421 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R MINI-PILL| PENICILLIN| TRANSDERM PATCH