BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7441260 · Received April 18, 2018

    Report

    Report Number
    2951250-2018-01879
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    January 1, 2009
    Report Date
    July 13, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN PELVIC"), EMBEDDED DEVICE ("OUTER COIL WAS DEEPLY BURIED WITHIN THE CORNUAL MYOMETRIUM") AND DEVICE BREAKAGE ("THE INNER COIL VIAS REMOVED FROM THE BODY UNDER DIRECT VISUALIZATION /OUTER COIL WAS DEEPLY BURIED WITHIN THE CORNUAL MYOMETRIUM") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626905) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES NOS FOR BIRTH CONTROL AS WELL AS IBUPROFEN. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),), SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE DEVICES, BILATERAL "SALPINGECTOMY". ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED AND ALOPECIA WAS RESOLVING AND THE EMBEDDED DEVICE, DEVICE BREAKAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: EMBEDDED DEVICE, DEVICE BREAKAGE". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-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 PELVIC PAIN ("PAIN PELVIC") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626905) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES NOS FOR BIRTH CONTROL AS WELL AS IBUPROFEN. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED AND ALOPECIA WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED:EVENT ABNORMAL VAGINAL BLEEDING,MENORRHAGIA,ABDOMINAL PAIN,BACK PAIN.REPORTERS,CONCURRENT CONDITION AND LOT NUMBER 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN PELVIC"), EMBEDDED DEVICE ("OUTER COIL WAS DEEPLY BURIED WITHIN THE CORNUAL MYOMETRIUM") AND DEVICE BREAKAGE ("THE INNER COIL VIAS REMOVED FROM THE BODY UNDER DIRECT VISUALIZATION /OUTER COIL WAS DEEPLY BURIED WITHIN THE CORNUAL MYOMETRIUM") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626905) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES NOS FOR BIRTH CONTROL AS WELL AS IBUPROFEN. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),), SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE DEVICES, BILATERAL SALPINGECTOMIES) AND SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE DEVICES, BILATERAL SALPINGECTOMIES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED AND ALOPECIA WAS RESOLVING AND THE EMBEDDED DEVICE, DEVICE BREAKAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: EMBEDDED DEVICE, DEVICE BREAKAGE" MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "OUTER COIL WAS DEEPLY BURIED WITHIN THE CORNUAL MYOMETRIUM , THE INNER COIL VIAS REMOVED FROM THE BODY UNDER DIRECT VISUALIZATION /OUTER COIL WAS DEEPLY BURIED WITHIN THE CORNUAL MYOMETRIUM ", REPORTER ADDED FROM MEDICAL RECORD. 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 PELVIC") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES NOS FOR BIRTH CONTROL AS WELL AS IBUPROFEN. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, FATIGUE, HEADACHE, MIGRAINE, NAUSEA, PELVIC PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED: REPORTER INFORMATION, PATIENT DETAILS, LAB DATA, PRODUCT INFORMATION, CONCOMITANT DRUG WERE ADDED. THE PREVIOUSLY REPORTED EVENT "SEVERE PHYSICAL INJURIES" WAS REPLACED WITH MIGRAINES, HEADACHES, NAUSEA, NICKEL ALLERGY, PAIN PELVIC, FATIGUE, WEIGHT GAIN, WEIGHT LOSS, HAIR LOSS. ESSURE LEGAL MANUFACTURER HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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
    282952 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 626905

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN