BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7059433 · Received November 27, 2017

    Report

    Report Number
    2951250-2017-08968
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    June 1, 2012
    Report Date
    August 2, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDNOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED GERD, HIGH CHOLESTEROL AND THYROID DISORDER NOS. CONCOMITANT PRODUCTS INCLUDED BUPROPION (WELLBUTRIN), LEVOTHYROXINE, OMEPRAZOLE (PRILOSEC), SIMVASTATIN AND TOPIRAMATE (TOPAMAX). IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL, HEAVY BLEEDING, PROLONGED MENSES"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUATION"). IN 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), THE SECOND EPISODE OF MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND ABDOMINAL PAIN LOWER ("RLQ"). THE PATIENT WAS TREATED WITH PANADEINE CO (TYLENOL #3), IBUPROFEN (MOTRIN) AND SURGERY (UNDERGO A TOTAL HYSTERECTOMY WITH REMOVAL OF THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, URINARY TRACT INFECTION, THE LAST EPISODE OF MENORRHAGIA, HEADACHE, MIGRAINE, VAGINAL DISCHARGE, PELVIC PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF MENORRHAGIA TO BE RELATED TO ESSURE. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDNOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED GERD, HIGH CHOLESTEROL AND THYROID DISORDER NOS. CONCOMITANT PRODUCTS INCLUDED BUPROPION (WELLBUTRIN), LEVOTHYROXINE, OMEPRAZOLE (PRILOSEC), SIMVASTATIN AND TOPIRAMATE (TOPAMAX). IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL, HEAVY BLEEDING, PROLONGED MENSES"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUATION"). IN 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), THE SECOND EPISODE OF MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND ABDOMINAL PAIN LOWER ("RLQ/ CRAMPS"). THE PATIENT WAS TREATED WITH PANADEINE CO (TYLENOL #3), IBUPROFEN (MOTRIN) AND SURGERY (UNDERGO A TOTAL HYSTERECTOMY WITH REMOVAL OF THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, URINARY TRACT INFECTION, THE LAST EPISODE OF MENORRHAGIA, HEADACHE, MIGRAINE, VAGINAL DISCHARGE AND PELVIC PAIN OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF MENORRHAGIA TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: PLAINTIFF FACT SHEET RECEIVED, AKA ADDED, DEMOGRAPHIC ADDED, EVENT ADDED ARE AS FOLLOWS- UTI, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, MIGRAINE, VAGINAL DISCHARGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, DEVICE MONITORING PROCEDURE NOT PERFORMED. EVENTS ONSET DATE AND OUTCOME ADDED CONCOMITANT DRUG AND TREATMENT DRUG 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 ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL, HEAVY BLEEDING, PROLONGED MENSES"), DYSMENORRHOEA ("PAINFUL MENSTRUATION") AND DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT UNDERWENT A TOTAL HYSTERECTOMY WITH REMOVAL OF THE ESSURE (B)(6) 2012 (DISCREPANCY WITH INSERTION DATE). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA 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
    839573 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R LEVOTHYROXINE| PRILOSEC| SIMVASTATIN| TOPAMAX| WELLBUTRIN