BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8860556 · Received August 5, 2019

    Report

    Report Number
    2951250-2019-04399
    Event Type
    Injury
    Date Received
    August 5, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFECTION ('INFECTION: PELVIC') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INDUCED ABORTION IN 2005, BLEEDING GENITAL, BACK PAIN, LEFT LOWER QUADRANT PAIN (BLQ PAIN, LLQ GREATER THAN RLQ,), ABDOMINAL BLOATING, FATIGUE, CHILLS, ATRIAL PRESSURE INCREASED (WORSENED LAP), VAGINAL ODOR, HEAVY PERIODS, BURNING SENSATION (EXPERIENCING BURNING IN LLQ WITH LBP), BACTERIAL VAGINOSIS, DYSMENORRHEA, PELVIC INFLAMMATORY DISEASE, AMENORRHEA, RETROVERTED UTERUS AND OBESITY. NEGATIVE IMAGING STUDIES. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 2010 TO ON (B)(6) 2014 FOR CONTRACEPTION AS WELL AS ETHINYLESTRADIOL; ETONOGESTREL (NUVARING) FROM 2006 TO 2009. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY PROBLEM OR CHANGES"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("ALLERGIC OR HYPERSENSITIVITY REACTION CHRONIC INTENSE PELVIC"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFECTION AND PELVIC PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, NAUSEA, ANXIETY, DEPRESSION, VAGINAL DISCHARGE, WEIGHT INCREASED, BLADDER DISORDER, DYSMENORRHOEA AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, NAUSEA, PELVIC INFECTION, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 234 LBS. PREVIOUSLY REPORTED INSERTION DATE WAS ON (B)(6) 2013. NUMBER OF VISIBLE COILS SEEN FROM RIGHT OSTIUM: 1, NUMBER OF VISIBLE COILS SEEN FOR LEFT OSTIUM: 6. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 78.9 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. BOTH UTERINE TUBES OCCLUDED IN A PATIENT STATUS POST ESSURE PROCEDURE. PATHOLOGY TEST: ON (B)(6) 2014: AN ESSURE COIL IS IDENTIFIED WITHIN THE RIGHT CORNU. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-DEC-2019: PLAINTIFF FACT SHEET RECEIVED, CONCOMITANT MEDICATION INFORMATION, EVENT ABNORMAL BLEEDING (GENERAL) ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 INFECTION ('INFECTION: PELVIC') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INDUCED ABORTION IN 2005, BLEEDING GENITAL, BACK PAIN, LEFT LOWER QUADRANT PAIN (BLQ PAIN, LLQ GREATER THAN RLQ,), ABDOMINAL BLOATING, FATIGUE, CHILLS, ATRIAL PRESSURE (WORSENED LAP), VAGINAL ODOR, HEAVY PERIODS, BURNING SENSATION (EXPERIENCING BURNING IN LLQ WITH LBP), BACTERIAL VAGINOSIS, DYSMENORRHEA, PELVIC INFLAMMATORY DISEASE, AMENORRHEA AND RETROVERTED UTERUS. NEGATIVE IMAGING STUDIES. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FOR CONTRACEPTION AS WELL AS ETHINYLESTRADIOL;ETONOGESTREL (NUVARING). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("ALLERGIC OR HYPERSENSITIVITY REACTION ¿ CHRONIC INTENSE PELVIC"), NAUSEA ("NAUSEA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ DEPRESSION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND URINARY TRACT DISORDER ("URINARY PROBLEM OR CHANGES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFECTION AND PELVIC PAIN HAD RESOLVED AND THE NAUSEA, ANXIETY, DEPRESSION, VAGINAL DISCHARGE, WEIGHT INCREASED, BLADDER DISORDER, DYSMENORRHOEA AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, NAUSEA, PELVIC INFECTION, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: (B)(6). PREVIOUSLY REPORTED INSERTION DATE WAS (B)(6) 2013. NUMBER OF VISIBLE COILS SEEN FROM RIGHT OSTIUM: 1, NUMBER OF VISIBLE COILS SEEN FOR LEFT OSTIUM: 6. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. BOTH UTERINE TUBES OCCLUDED IN A PATIENT STATUS POST ESSURE PROCEDURE. PATHOLOGY TEST - ON (B)(6) 2014: AN ESSURE COIL IS IDENTIFIED WITHIN THE RIGHT CORNU.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED FROM PATIENT¿S MEDICAL RECORD :PELVIC PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUL-2019: PFS AND MR RECEIVED: EVENT ¿INJURY TO HERSELF¿ IS REPLACED BY ¿ALLERGIC OR HYPERSENSITIVITY REACTION ¿ CHRONIC INTENSE PELVIC¿. NEW EVENTS- PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY; VAGINAL DISCHARGE, WEIGHT GAIN, BLADDER PROBLEMS OR CHANGES, URINARY PROBLEM OR CHANGES¿, CONCOMITANT DRUG, MEDICAL HISTORY, LAB DATA, REPORTER, PATIENT DEMOGRAPHIC ADDED. OUTCOME OF EVENTS ¿INFECTION: PELVIC, ALLERGIC OR HYPERSENSITIVITY REACTION ¿ CHRONIC INTENSE PELVIC¿ UPDATED TO ¿RECOVERED / RESOLVED¿ NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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
    653285 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R MIRENA| MIRENA| NUVARING| NUVARING