BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8892546 · Received August 14, 2019

    Report

    Report Number
    2951250-2019-04785
    Event Type
    Injury
    Date Received
    August 14, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF SALPINGITIS ('LEFT SALPINGITIS') AND SYSTEMIC LUPUS ERYTHEMATOSUS ('LUPUS SLE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) 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 DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST, PARITY, POLYCYSTIC OVARIAN SYNDROME, ENDOMETRIOSIS, KNEE OPERATION, CERVICITIS, PARATUBAL CYST AND UTERINE PROLAPSE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: ORAL CONTRACEPTIVE NOS FROM 2000 TO 2011; FOR AN UNREPORTED INDICATION: LORTAB. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) FOR PAIN AS WELL AS ALPRAZOLAM (XANAX), GABAPENTIN SINCE 2013, HYDROCODONE BITARTRATE;PARACETAMOL (LORTAB) AND IBUPROFEN (MOTRIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: NOW ON HORMONE CREAM AND SHOTS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"), MIGRAINE ("MIGRAINES / HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MEMORY IMPAIRMENT ("MEMORY PROBLEM") AND CARDIOVASCULAR DISORDER ("CIRCULATION PROBLEM"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE SALPINGITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, DEVICE EXPULSION, MIGRAINE, VAGINAL DISCHARGE, FATIGUE, ABDOMINAL PAIN, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT AND CARDIOVASCULAR DISORDER OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSPAREUNIA AND ALOPECIA WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR SALPINGITIS WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CARDIOVASCULAR DISORDER, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SYSTEMIC LUPUS ERYTHEMATOSUS, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 3, RIGHT: 5. PREVIOUSLY REPORTED ESSURE INSERTION DATE : 01-SEP-2012. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE CONFIRMED VIA PATIENTS MEDICAL RECORD: PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENT WAS VIA PATIENTS MEDICAL RECORD: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-AUG-2019: QUALITY SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF SALPINGITIS ('LEFT SALPINGITIS') AND SYSTEMIC LUPUS ERYTHEMATOSUS ('LUPUS SLE') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) 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 DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST, PARITY, POLYCYSTIC OVARIAN SYNDROME, ENDOMETRIOSIS, KNEE OPERATION, CERVICITIS, PARATUBAL CYST AND UTERINE PROLAPSE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: ORAL CONTRACEPTIVE NOS FROM 2000 TO 2011; FOR AN UNREPORTED INDICATION: LORTAB. CONCURRENT CONDITIONS INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) FOR PAIN AS WELL AS ALPRAZOLAM (XANAX), GABAPENTIN SINCE 2013, HYDROCODONE BITARTRATE; PARACETAMOL (LORTAB) AND IBUPROFEN (MOTRIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: NOW ON HORMONE CREAM AND SHOTS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"), MIGRAINE ("MIGRAINES / HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MEMORY IMPAIRMENT ("MEMORY PROBLEM") AND CARDIOVASCULAR DISORDER ("CIRCULATION PROBLEM"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE SALPINGITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, DEVICE EXPULSION, MIGRAINE, VAGINAL DISCHARGE, FATIGUE, ABDOMINAL PAIN, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT AND CARDIOVASCULAR DISORDER OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSPAREUNIA AND ALOPECIA WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR SALPINGITIS WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CARDIOVASCULAR DISORDER, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SYSTEMIC LUPUS ERYTHEMATOSUS, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 3, RIGHT: 5. PREVIOUSLY REPORTED ESSURE INSERTION DATE: (B)(6) 2012. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE CONFIRMED VIA PATIENTS MEDICAL RECORD: PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENT WAS VIA PATIENTS MEDICAL RECORD: SALPINGITIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-AUG-2019: PFS AND MEDICAL RECORD RECEIVED: PREVIOUSLY REPORTED EVENT "INJURY" WAS UPDATED WITH ¿LEFT SALPINGITIS¿, NEW EVENTS- EXPULSION OF ESSURE DEVICE, LUPUS SLE, VAGINAL BLEEDING, MENORRHAGIA, MIGRAINE / HEADACHE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA, FATIGUE, VAGINAL DISCHARGE, HAIR LOSS, PELVIC PAIN, ABDOMINAL PAIN, HORMONAL CHANGES DESCRIBE: NOW ON HORMONE CREAM AND SHOTS, PATIENT DID NOT UNDERGO AN ESSURE CONFIRMATION TEST, MEMORY PROBLEM, CIRCULATION PROBLEM¿, LOT NUMBER , REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. MEDICAL HISTORICAL, HISTORICAL DRUG, LABORATORY DATA, CONCOMITANT DRUGS WERE ADDED. INCIDENT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686712 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R GABAPENTIN| GABAPENTIN| LORTAB [HYDROCODONE BITARTRATE,PARACETAMOL]| LORTAB [HYDROCODONE BITARTRATE,PARACETAMOL]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| TORADOL| TORADOL| XANAX| XANAX