BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6864836 · Received September 14, 2017

    Report

    Report Number
    2951250-2017-03669
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    April 1, 2012
    Report Date
    December 17, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ALLERGY FROM 2010 TO 2011, RESPIRATORY DISTRESS FROM 2011 TO 2012, ASTHMA, HEART DISORDER, GERD, DEPRESSION, UTERINE LEIOMYOMA, TONSILLECTOMY, CYST OF OVARY, NULLI GRAVIDA, AUGMENTATION MAMMOPLASTY, TONSILLECTOMY AND ADENOIDECTOMY. *DENIES TOBACCO USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUTICASONE FROM 2010 TO 2011. FAMILY HISTORY INCLUDED CANCER (*MOTHER), HYPERTENSION (*GRANDFATHER), HEART DISEASE, UNSPECIFIED (*GRANDFATHER) AND PANCREATIC CANCER (*MOTHER). CONCOMITANT PRODUCTS INCLUDED CITALOPRAM FROM 2012 TO 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN JULY 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN APRIL 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACK PAIN ("BACK PAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"), 1 YEAR 9 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE; LOCATION OF DEVICE: LEFT AND RIGHT CORNU") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, BACK PAIN AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-NOV-2018: PFS RECEIVED - NEW EVENT "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), MALPOSITION OF ESSURE DEVICE;LOCATION OF DEVICE: LEFT AND RIGHT CORNU, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT GAIN, ABNORMAL BLEEDING (GENERAL), ENDOMETRIOSIS" WERE ADDED. LOT NUMBER WAS ADDED. LAB DATA WAS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"), UTERINE LEIOMYOMA ("UTERINE FIBROID") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSFUNCTIONAL UTERINE BLEEDING, PELVIC PAIN AND UTERINE LEIOMYOMA 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
    644926 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 802745

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R CITALOPRAM| CITALOPRAM