BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7082357 · Received December 5, 2017

    Report

    Report Number
    2951250-2017-09885
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    December 1, 2011
    Report Date
    October 5, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MIXED CONNECTIVE TISSUE DISEASE ("AUTOIMMUNE DISORDER ¿ MIXED CONNECTION TISSUE DISEASE") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIXED CONNECTIVE TISSUE DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), PELVIC ADHESIONS ("OTHER ¿ PELVIC ADHESIONS"), SUBCUTANEOUS HAEMATOMA ("S/P TLH DEVELOPED SMALL HEMATOMA IN RIGHT UPPER QUADRANT INCISION"), CERVICITIS ("CHRONIC CERVICITIS"), CERVICAL CYST ("NABOTHIAN CYSTS"), ENDOMETRIAL METAPLASIA ("IMMATURE SQUAMOUS METAPLASIA"), UTERINE ADHESIONS ("UTERINE FIBROUS ADHESIONS"), ADENOMYOSIS ("SUPERFICIAL AND DEEP ADENOMYOSIS") AND ADNEXA UTERI CYST ("BILATERAL FALLOPIAN PARATUBAL CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT, HYSTERECTOMY (PARTIAL), SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, MIXED CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, ANXIETY, HYPERSENSITIVITY, PELVIC ADHESIONS, SUBCUTANEOUS HAEMATOMA, CERVICITIS, CERVICAL CYST, UTERINE ADHESIONS, ADENOMYOSIS AND ADNEXA UTERI CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ADNEXA UTERI CYST, ANXIETY, CERVICAL CYST, CERVICITIS, ENDOMETRIAL METAPLASIA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MIXED CONNECTIVE TISSUE DISEASE, PELVIC ADHESIONS, PELVIC PAIN, SUBCUTANEOUS HAEMATOMA, SYSTEMIC LUPUS ERYTHEMATOSUS AND UTERINE ADHESIONS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ESSURE CONFIRMATION TEST YES TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- AUTOIMMUNE DISORDER ¿ MIXED CONNECTION TISSUE DISEASE, LUPUS, OTHER ¿ PELVIC ADHESIONS, S/P TLH DEVELOPED SMALL HEMATOMA IN RIGHT UPPER QUADRANT INCISION, CHRONIC CERVICITIS WITH NABOTHIAN CYSTS, IMMATURE SQUAMOUS METAPLASIA, UTERINE FIBROUS ADHESIONS, SUPERFICIAL AND DEEP ADENOMYOSIS, BILATERAL FALLOPIAN PARATUBAL CYSTS. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MIXED CONNECTIVE TISSUE DISEASE ("AUTOIMMUNE DISORDER ¿ MIXED CONNECTION TISSUE DISEASE") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIXED CONNECTIVE TISSUE DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), PELVIC ADHESIONS ("OTHER ¿ PELVIC ADHESIONS"), INCISION SITE HAEMATOMA ("S/P TLH DEVELOPED SMALL HEMATOMA IN RIGHT UPPER QUADRANT INCISION"), CERVICITIS ("CHRONIC CERVICITIS"), CERVICAL CYST ("NABOTHIAN CYSTS"), ENDOMETRIAL METAPLASIA ("IMMATURE SQUAMOUS METAPLASIA"), UTERINE ADHESIONS ("UTERINE FIBROUS ADHESIONS"), ADENOMYOSIS ("SUPERFICIAL AND DEEP ADENOMYOSIS") AND ADNEXA UTERI CYST ("BILATERAL FALLOPIAN PARATUBAL CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT, HYSTERECTOMY (PARTIAL), SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, MIXED CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, ANXIETY, HYPERSENSITIVITY, PELVIC ADHESIONS, INCISION SITE HAEMATOMA, CERVICITIS, CERVICAL CYST, UTERINE ADHESIONS, ADENOMYOSIS AND ADNEXA UTERI CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ADNEXA UTERI CYST, ANXIETY, CERVICAL CYST, CERVICITIS, ENDOMETRIAL METAPLASIA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INCISION SITE HAEMATOMA, MIXED CONNECTIVE TISSUE DISEASE, PELVIC ADHESIONS, PELVIC PAIN, SYSTEMIC LUPUS ERYTHEMATOSUS AND UTERINE ADHESIONS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ESSURE CONFIRMATION TEST YES TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PTC INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MIXED CONNECTIVE TISSUE DISEASE ("AUTOIMMUNE DISORDER ¿ MIXED CONNECTION TISSUE DISEASE") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED AXOTAL (ESGIC) SINCE 2014, DIAZEPAM SINCE 2013 AND PANTOPRAZOLE (PROTONIX) SINCE 2014. 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). IN 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: FACE RASH"). IN (B)(6) 2014, THE PATIENT EXPERIENCED INCISION SITE HAEMATOMA ("S/P TLH DEVELOPED SMALL HEMATOMA IN RIGHT UPPER QUADRANT INCISION"), CERVICITIS ("CHRONIC CERVICITIS"), CERVICAL CYST ("NABOTHIAN CYSTS"), ENDOMETRIAL METAPLASIA ("IMMATURE SQUAMOUS METAPLASIA"), UTERINE ADHESIONS ("UTERINE FIBROUS ADHESIONS"), ADENOMYOSIS ("SUPERFICIAL AND DEEP ADENOMYOSIS") AND ADNEXA UTERI CYST ("BILATERAL FALLOPIAN PARATUBAL CYSTS"). IN 2014, THE PATIENT EXPERIENCED MIXED CONNECTIVE TISSUE DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), PELVIC ADHESIONS ("OTHER ¿ PELVIC ADHESIONS") AND SCAR ("LOT OF SCAR TISSUE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT, HYSTERECTOMY (PARTIAL), SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, MIXED CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, ANXIETY, HYPERSENSITIVITY, PELVIC ADHESIONS, INCISION SITE HAEMATOMA, CERVICITIS, CERVICAL CYST, UTERINE ADHESIONS, ADENOMYOSIS, ADNEXA UTERI CYST, RASH AND SCAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ADNEXA UTERI CYST, ANXIETY, CERVICAL CYST, CERVICITIS, ENDOMETRIAL METAPLASIA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INCISION SITE HAEMATOMA, MIXED CONNECTIVE TISSUE DISEASE, PELVIC ADHESIONS, PELVIC PAIN, RASH, SCAR, SYSTEMIC LUPUS ERYTHEMATOSUS AND UTERINE ADHESIONS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2011: TOTAL BILATERAL OCCLUSION. ESSURE CONFIRMATION TEST YES TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2018: PLAINTIFF FACT SHEET WAS RECEIVED EVENTS ADDED FROM PFS- FACE RASH, SCAR TISSUE. EVENT ONSET DATE & CONCOMITANT DRUG WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, ANXIETY AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, HYPERSENSITIVITY AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864350 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910512

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R DIAZEPAM| ESGIC| PROTONIX