BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9265502 · Received November 1, 2019

    Report

    Report Number
    2951250-2019-10994
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    February 1, 2010
    Report Date
    May 25, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT 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 CONJUNCTIVITIS, SCIATICA, COMPLICATION OF PREGNANCY, LIGAMENT PAIN, ABDOMINAL PAIN, BREAST PAIN, MASTITIS, MOLAR PREGNANCY, THROMBOCYTOPENIA AND D & C. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, SINUS CONGESTION, EAR PAIN, SORE THROAT, CHILLS, MALAISE, CONSTIPATION, TINEA PEDIS, HORDEOLUM, CERVICALGIA, DIZZINESS, HEMORRHOIDS, PARESTHESIA, CHEST PAIN, CARPAL TUNNEL SYNDROME, VULVOVAGINAL CANDIDA, UTI, DYSURIA, URGENCY URINATION, URINARY FREQUENCY, VITAMIN D DEFICIENCY AND VAGINITIS. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2010 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2010 FOR PELVIC PAIN FEMALE AS WELL AS ETHINYLESTRADIOL;ETYNODIOL DIACETATE (ZOVIA) FROM (B)(6)2009 TO (B)(6)2011. ON(B)(6)2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PELVIC PAIN/PAIN"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND ANXIETY ("MENTAL ANGUISH") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("BLEEDING: GEN. ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION"), FATIGUE ("FATIGUE,"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTIONS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL INFECTION, DEPRESSION, WEIGHT INCREASED, URINARY TRACT INFECTION, FATIGUE, VAGINAL HAEMORRHAGE, MIGRAINE, ANXIETY, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT RECEIVED TREATMENT FOR GEN. ABNORMAL BLEEDING, BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION, FATIGUE, WEIGHT GAIN, VAGINAL DISCHARGE. THE PATIENT HAS NOT PLANNED THE REMOVAL AS SHE IS UNABLE TO AFFORD SURGERY. CURRENT WEIGHT 139 LBS CURRENT WEIGHT LLBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 139 LBS. 5 COILS ON THE RIGHT, 5 COILS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6)2010: (AS PER PFS): ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. BILATERAL OCCLUSION. (AS PER MR): IMPRESSIONS: POST ESSURE PROCEDURE, ABLATION OF BOTH RIGHT AND LEFT TUBES, SPECIFICALLY NO FILLING OF TUBES, NO PERITONEAL SPILL. NORMAL UTERUS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PIF RECEIVED: BLADDER PROBLEMS, URINARY PROBLEMS , URINARY PROBLEMS , VAGINAL DISCHARGE AND REPORTER INFORMATION WERE UPDATED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('BLEEDING: GEN. ABNORMAL BLEEDING') IN AN ADULT 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 CONJUNCTIVITIS, SCIATICA, COMPLICATION OF PREGNANCY, LIGAMENT PAIN, ABDOMINAL PAIN, BREAST PAIN, MASTITIS, MOLAR PREGNANCY, THROMBOCYTOPENIA AND D & C. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, SINUS CONGESTION, EAR PAIN, SORE THROAT, CHILLS, MALAISE, CONSTIPATION, TINEA PEDIS, HORDEOLUM, CERVICALGIA, DIZZINESS, HEMORRHOIDS, PARESTHESIA, CHEST PAIN, CARPAL TUNNEL SYNDROME, VULVOVAGINAL CANDIDA, UTI, DYSURIA, URGENCY URINATION, URINARY FREQUENCY, VITAMIN D DEFICIENCY AND VAGINITIS. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2010 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2010. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PELVIC PAIN/PAIN"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION"), DEPRESSION ("PSYCH INJURY: DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION") AND FATIGUE ("FATIGUE,") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL INFECTION, DEPRESSION, WEIGHT INCREASED, URINARY TRACT INFECTION, FATIGUE, VAGINAL HAEMORRHAGE, MIGRAINE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT RECEIVED TREATMENT FOR GEN. ABNORMAL BLEEDING, BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION, FATIGUE, WEIGHT GAIN. THE PATIENT HAS NOT PLANNED THE REMOVAL AS SHE IS UNABLE TO AFFORD SURGERY. CURRENT WEIGHT LLBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT (B)(6). 5 COILS ON THE RIGHT, 5 COILS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2010: (AS PER PFS): ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. BILATERAL OCCLUSION. (AS PER MR): IMPRESSIONS: POST ESSURE PROCEDURE, ABLATION OF BOTH RIGHT AND LEFT TUBES, SPECIFICALLY NO FILLING OF TUBES, NO PERITONEAL SPILL. NORMAL UTERUS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), MIGRAINES / HEADACHES WERE ADDED. EVENT PSYCHOLOGICAL TRAUMA WAS REPLACED WITH THE EVENTS: DEPRESSION AND MENTAL ANGUISH. SURGERY ABLATION WAS ADDED TO THE EVENT: MENORRHAGIA AND CASE BECAME INCIDENT. CONCOMITANT CONDITIONS, HISTORICAL CONDITIONS AND CONCOMITANT DRUGS WERE ADDED. REPORTER'S INFORMATION AND LAB DATA WAS ADDED. 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
    1060072 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R ACETAMINOPHEN.| ACETAMINOPHEN.| NSAIDS.| NSAIDS.| ZOVIA.