BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10052339 · Received May 13, 2020

    Report

    Report Number
    2951250-2020-07268
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    January 1, 2013
    Report Date
    June 4, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) 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 "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD PRESSURE HIGH. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD FROM 2009 TO 2013 AND DEPO SHOT. CONCURRENT CONDITIONS INCLUDED CHEST PAIN, FATIGUE AND CHEST TIGHTNESS. CONCOMITANT PRODUCTS INCLUDED LISINOPRIL SINCE 2011, NSAIDS AND PARACETAMOL (ACETAMINOPHEN) SINCE 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING)"), 4 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE ("UTERINE HEMORRHAGING"), BACK PAIN ("LOWER BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, WEIGHT INCREASED, ALOPECIA, DYSMENORRHOEA, BACK PAIN, ABDOMINAL PAIN, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, UTERINE HAEMORRHAGE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION:- (B)(6) 2012 . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. NEW EVENTS: BLADDER INFECTION, UTI, VAGINAL INFECTION, VAGINAL DISCHARGE WERE ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 PELVIC PAIN ('SEVERE PELVIC PAIN') AND UTERINE HAEMORRHAGE ('UTERINE HEMORRHAGING') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) 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 "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD PRESSURE HIGH. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD FROM 2009 TO 2013 AND DEPO SHOT. CONCURRENT CONDITIONS INCLUDED CHEST PAIN, FATIGUE AND CHEST TIGHTNESS. CONCOMITANT PRODUCTS INCLUDED LISINOPRIL SINCE 2011, NSAIDS AND PARACETAMOL (ACETAMINOPHEN) SINCE 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING)"), 4 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, WEIGHT INCREASED, ALOPECIA, DYSMENORRHOEA, BACK PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION: (B)(6) 2012 AND (B)(6) 2012. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2020: PFS RECEIVED REMOVAL DETAILS WAS ADDED. REPORTER INFORMATION WAS ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514190 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940970 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| LISINOPRIL| LISINOPRIL| NSAIDS| NSAIDS| ACETAMINOPHEN| LISINOPRIL| NSAIDS