BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055223 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-06960
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    January 1, 2015
    Report Date
    October 21, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF DEVICE ¿ PROTRUDING FROM FALLOPIAN TUBE") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN/PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY PREVENTION: MIRENA FROM 2008 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED SCIATICA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ MENORRHAGIA"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN") AND PELVIC PAIN ("PAIN (PELVIS)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HOWEVER, REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF HER UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED (B)(6) 2015:PATHOLOGY REPORT PATHOLOGICAL DIAGNOSES: ENDOMETRIUM ¿ DISORDERED PROLIFERATIVE ENDOMETRIUM, FOCAL SIMPLE HYPERPLASIA, NO COMPLEX HYPERPLASIA OR CARCINOMA, MYOMETRIUM ¿ ADENOMYOSIS, FOCAL, SMALL SUBMUCOSAL LEIOMYOMA, CERVIX/ENDOCERVIX ¿ CHRONIC CERVICITIS/ENDOCERVICITIS, RIGHT FALLOPIAN TUBE ¿ GROSSLY UNREMARKABLE, LEFT FALLOPIAN TUBE ¿ GROSSLY UNREMARKABLE. 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF DEVICE ¿ PROTRUDING FROM FALLOPIAN TUBE") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED SCIATICA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ MENORRHAGIA"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN") AND PELVIC PAIN ("PAIN (PELVIS)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HOWEVER, REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF HER UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED (B)(6) 2015:PATHOLOGY REPORT PATHOLOGICAL DIAGNOSES: ENDOMETRIUM: DISORDERED PROLIFERATIVE ENDOMETRIUM. FOCAL SIMPLE HYPERPLASIA. NO COMPLEX HYPERPLASIA OR CARCINOMA. MYOMETRIUM: ADENOMYOSIS, FOCAL. SMALL SUBMUCOSAL LEIOMYOMA CERVIX/ENDOCERVIX: CHRONIC CERVICITIS/ENDOCERVICITIS. RIGHT FALLOPIAN TUBE: GROSSLY UNREMARKABLE. LEFT FALLOPIAN TUBE: GROSSLY UNREMARKABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2018: PLAINTIFF FACT SHEET & MEDICAL RECORD RECEIVED. EVENTS ABNORMAL BLEEDING VAGINAL,MIGRATION OF DEVICE, PELVIC PAIN ARE ADDED. LOT NUMBER ADDED. LAB DATA UPDATED. CONCOMITANT, HISTORICAL CONDITIONS & DRUGS ARE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF DEVICE ¿ PROTRUDING FROM FALLOPIAN TUBE') AND ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY PREVENTION: MIRENA FROM 2008 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED SCIATICA. CONCOMITANT PRODUCTS INCLUDED GABAPENTIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ MENORRHAGIA"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN"), PELVIC PAIN ("PAIN (PELVIS)") AND INFLAMMATION ("SHE ALWAYS FELT LIKE SHE HAD ESSURE CHRONIC INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE, ALLERGY TO METALS AND INFLAMMATION OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, INFLAMMATION, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HOWEVER, REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF HER UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. DIAGNOSTIC RESULTS: (B)(6) 2015: PATHOLOGY REPORT PATHOLOGICAL DIAGNOSES: ENDOMETRIUM ¿ DISORDERED PROLIFERATIVE ENDOMETRIUM. FOCAL SIMPLE HYPERPLASIA. NO COMPLEX HYPERPLASIA OR CARCINOMA. MYOMETRIUM ¿ ADENOMYOSIS, FOCAL. SMALL SUBMUCOSAL LEIOMYOMA. CERVIX/ENDOCERVIX ¿ CHRONIC CERVICITIS/ENDOCERVICITIS. RIGHT FALLOPIAN TUBE ¿ GROSSLY UNREMARKABLE. LEFT FALLOPIAN TUBE ¿ GROSSLY UNREMARKABLE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA ; INFLAMMATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: SOCIAL MEDIA RECEIVED EVENTS "SHE ALWAYS FELT LIKE SHE HAD ESSURE CHRONIC INFLAMMATION" WAS ADDED. REPORTER INFORMATION WAS ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HOWEVER, REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF HER UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. 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
    834789 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910515

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R GABAPENTIN