BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9072431 · Received September 16, 2019

    Report

    Report Number
    2951250-2019-06621
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    October 1, 2011
    Report Date
    July 8, 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 ('PHYSICAL PAIN / PELVIC PAIN') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852529) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROIDS, ADENOMYOSIS, POLYMENORRHOEA, UTERINE LEIOMYOMA, VAGINAL ITCHING, VAGINAL PAIN, BACTERIAL VAGINOSIS AND LYMPHADENOPATHY. SHE DENIES ANY ABDOMINAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), METRONIDAZOLE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BLADDER / URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION THE FALLOPIAN TUBES WERE BLOCKED. TUBAL OCCLUSION BILATERALLY STATUS POST ESSURE MICRO-INSERT PLACEMENT. PATHOLOGY TEST - ON (B)(6) 2017: MYOMETRIUM: SQUAMOUS METAPLASIA WITH MILD NONSPECIFIC REACTIVE/INFLAMMATORY CHANGES. BENIGN ENDOMETRIAL MUCOSA WITH GEOGRAPHIC AREAS OF MARKED ATTENUATION. FIBROIDS LEIOMYOMATA. UTERINE SEROSAL SURFACE: NO PATHOLOGIC DIACNOSIS. RIGHT AND LEFT FALLOPIAN TUBES: SEGMENTS OF FALLOPIAN TUBES; CONGESTION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN,PELVIC PAIN') IN A 28-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 UTERINE FIBROIDS, ADENOMYOSIS, POLYMENORRHOEA, UTERINE LEIOMYOMA, VAGINAL ITCHING, VAGINAL PAIN, BACTERIAL VAGINOSIS AND LYMPHADENOPATHY. SHE DENIES ANY ABDOMINAL PAIN. CONCOMITANT PRODUCTS INCLUDED METRONIDAZOLE AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION THE FALLOPIAN TUBES WERE BLOCKED. TUBAL OCCLUSION BILATERALLY STATUS POST ESSURE MICRO-INSERT PLACEMENT. PATHOLOGY TEST - ON (B)(6) 2017: MYOMETRIUM: SQUAMOUS METAPLASIA WITH MILD NONSPECIFIC REACTIVE/INFLAMMATORY CHANGES. BENIGN ENDOMETRIAL MUCOSA WITH GEOGRAPHIC AREAS OF MARKED ATTENUATION. FIBROIDS LEIOMYOMATA. UTERINE SEROSAL SURFACE: NO PATHOLOGIC DIACNOSIS. RIGHT AND LEFT FALLOPIAN TUBES: SEGMENTS OF FALLOPIAN TUBES; CONGESTION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-NOV-2019: PFS RECEIVED : FOLLOWING EVENT WAS ADDED : ABDOMINAL PAIN. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN / PELVIC PAIN') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852529) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROIDS, ADENOMYOSIS, POLYMENORRHOEA, UTERINE LEIOMYOMA, VAGINAL ITCHING, VAGINAL PAIN, BACTERIAL VAGINOSIS AND LYMPHADENOPATHY. SHE DENIES ANY ABDOMINAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), METRONIDAZOLE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BLADDER / URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION THE FALLOPIAN TUBES WERE BLOCKED. TUBAL OCCLUSION BILATERALLY STATUS POST ESSURE MICRO-INSERT PLACEMENT. PATHOLOGY TEST - ON (B)(6) 2017: MYOMETRIUM: SQUAMOUS METAPLASIA WITH MILD NONSPECIFIC REACTIVE/INFLAMMATORY CHANGES. BENIGN ENDOMETRIAL MUCOSA WITH GEOGRAPHIC AREAS OF MARKED ATTENUATION. FIBROIDS LEIOMYOMATA. UTERINE SEROSAL SURFACE: NO PATHOLOGIC DIACNOSIS. RIGHT AND LEFT FALLOPIAN TUBES: SEGMENTS OF FALLOPIAN TUBES; CONGESTION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PLAINTIFF FACT SHEET RECEIVED. OUTCOME OF THE EVENTS PERTAINING TO PAIN, BLEEDING AND BLADDER/URINARY PROBLEMS WAS UPDATED TO RECOVERED/RESOLVED. REPORTER INFORMATION 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 ('PHYSICAL PAIN') 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 UTERINE FIBROIDS, ADENOMYOSIS, POLYMENORRHOEA, UTERINE LEIOMYOMA, VAGINAL ITCHING, VAGINAL PAIN, BACTERIAL VAGINOSIS AND LYMPHADENOPATHY. SHE DENIES ANY ABDOMINAL PAIN. CONCOMITANT PRODUCTS INCLUDED METRONIDAZOLE AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, ANXIETY, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION. THE FALLOPIAN TUBES WERE BLOCKED. TUBAL OCCLUSION BILATERALLY STATUS POST ESSURE MICRO-INSERT PLACEMENT. PATHOLOGY TEST ON (B)(6) 2017: MYOMETRIUM: SQUAMOUS METAPLASIA WITH MILD NONSPECIFIC REACTIVE/INFLAMMATORY CHANGES. BENIGN ENDOMETRIAL MUCOSA WITH GEOGRAPHIC AREAS OF MARKED ATTENUATION. FIBROIDS LEIOMYOMATA. UTERINE SEROSAL SURFACE: NO PATHOLOGIC DIAGNOSIS. RIGHT AND LEFT FALLOPIAN TUBES: SEGMENTS OF FALLOPIAN TUBES; CONGESTION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED EVENTS "ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)" WERE ADDED. OUTCOME OF EVENT "PAIN" WAS UPDATED AS RECOVERING. CONCOMITANT DRUG, MEDICAL HISTORY AND LAB DATA WERE ADDED. REPORTER INFORMATION AND PATIENT AKA NAME WERE 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
    862987 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 852529 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| DEPO-PROVERA| DEPO-PROVERA| METRONIDAZOLE| METRONIDAZOLE| METRONIDAZOLE| METRONIDAZOLE| NSAIDS| NSAIDS| TYLENOL| TYLENOL| TYLENOL| TYLENOL [PARACETAMOL]