BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7449166 · Received April 20, 2018

    Report

    Report Number
    2951250-2018-01901
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    January 1, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / HEAVY AND CLOATING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE 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 "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TUBAL LIGATION, MENORRHAGIA, OVARIAN CYST (RIGHT) AND LAPAROSCOPIC UTERINE NERVE ABLATION. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, POLYMENORRHEA, MORBID OBESITY, NONSMOKER, OBESITY, HYPERTENSION, ANXIETY ATTACK AND CHEST PAIN. CONCOMITANT PRODUCTS INCLUDED VICODIN (NORCO). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND RASH ("RASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), URINARY TRACT INFECTION ("UTI"), TOOTH LOSS ("DENTAL PROBLEMS / LOST TEETH"), CONSTIPATION ("CONSTIPATION"), CYSTITIS ("BLADDER INFECTIONS") AND VAGINAL INFECTION ("VAGINAL INFECTION") WITH VAGINAL DISCHARGE. THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) & PROXIMAL PARTIAL SALPINGECTOMY), SURGERY (UNILATERAL SALPINGECTOMY/HYSTERCTOMY/DILATATION AND CURETTAGE) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, HEADACHE, TOOTH LOSS, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, NAUSEA, FATIGUE, CONSTIPATION, ALOPECIA, CYSTITIS AND VAGINAL INFECTION HAD RESOLVED AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, CONSTIPATION, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, TOOTH LOSS, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.9 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAY-2018: PFS RECEIVED, REPORTER ADDED PATIENT CONCOMITANT CODNTION ADDED, EVENTS ADDED AS :- HORMONAL CHANGES, ABNORMAL BLEEDING (GENERAL),ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL)TYPE: UTI, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), RASHES OR SKIN CONDITIONS, MIGRAINES / HEADACHES, NAUSEA, DENTAL PROBLEMS, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE, FATIGUE,WEIGHT GAIN, CONSTIPATION, HAIR LOSS, FATIGUE, BLADDER INFECTION, VAGINAL INFECTION 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / HEAVY AND CLOATING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE 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 "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TUBAL LIGATION, MENORRHAGIA, OVARIAN CYST (RIGHT) AND LAPAROSCOPIC UTERINE NERVE ABLATION. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, POLYMENORRHEA, MORBID OBESITY, NONSMOKER, MORBID OBESITY, HYPERTENSION, ANXIETY ATTACK AND CHEST PAIN. CONCOMITANT PRODUCTS INCLUDED VICODIN (NORCO). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND RASH ("RASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), URINARY TRACT INFECTION ("UTI"), TOOTH LOSS ("DENTAL PROBLEMS / LOST TEETH"), CONSTIPATION ("CONSTIPATION"), CYSTITIS ("BLADDER INFECTIONS") AND VAGINAL INFECTION ("VAGINAL INFECTION") WITH VAGINAL DISCHARGE. THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) & PROXIMAL PARTIAL SALPINGECTOMY), SURGERY (UNILATERAL SALPINGECTOMY/HYSTERCTOMY/DILATATION AND CURETTAGE) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, HEADACHE, TOOTH LOSS, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, NAUSEA, FATIGUE, CONSTIPATION, ALOPECIA, CYSTITIS AND VAGINAL INFECTION HAD RESOLVED AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, CONSTIPATION, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, TOOTH LOSS, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.9 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TUBAL LIGATION, MENORRHAGIA AND OVARIAN CYST (RIGHT). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY/HYSTERCTOMY/DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA TO BE RELATED TO ESSURE. ON (B)(6) 2018: THE CASE WAS UPGRADE IN THE INCIDENT CATEGORY. THE REPORTER INFORMATION WAS UPDATED. THIS CASE CONCERNS ADULT PATIENT. HER HISTORICAL CONDITION WAS ADDED. ESSURE INSERTION AND REMOVAL DATE WAS UPDATED. ESSURE INDICATION WAS ADDED. EVENTS: DYSMENORRHEA (CRAMPING) AND SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST WAS ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER (B)(4) AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY¿. 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
    291882 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R NORCO| NORCO