BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5068544 · Received September 10, 2015

    Report

    Report Number
    2951250-2015-00760
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 28, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOW UP 03-MAY-2016: LEGAL CLAIM WAS RECEIVED. PLAINTIFF WAS IMPLANTED ON OR ABOUT (B)(6) 2009 WITH ESSURE. AS A RESULT OF ESSURE, PLAINTIFF SUFFERED FROM SEVERE PELVIC PAIN, ADENOMYOSIS, AND EXTREME MENSTRUAL CHANGES. ON OR ABOUT (B)(6) 2014, PLAINTIFF HAD TO HAVE A HYSTERECTOMY AS A RESULT OF ESSURE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND HAD EXCESSIVE BLEEDING, PELVIC INFLAMMATION, NICKEL TOXICITY, BACTERIAL LUNG INFECTION, HBP (HIGH BLOOD PRESSURE), ADENOMYOSIS, STABBING PAINS (PELVIC PAIN) AND SCAR TISSUE ATTACHING TO OTHER ORGANS. ESSURE IMPLANTS WERE REMOVED. AFTER THAT, STABBING PAIN WAS IMMEDIATELY GONE AND DID NOT NEED HIGH BLOOD PRESSURE MEDICINE ANYMORE. EXCESSIVE BLEEDING, PELVIC PAIN AND PELVIC INFLAMMATION ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, THE OTHER EVENTS ARE UNLISTED. ALTHOUGH THE CONSUMER WAS DIAGNOSED WITH ADENOMYOSIS THAT COULD EXPLAIN THE GENITAL BLEEDING AND ADHESIONS THAT COULD EXPLAIN THE PELVIC PAIN, SINCE ESSURE MAY CAUSE THESE EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. WHILE ESSURE IS STERILE IT MAY, DUE TO CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTION IN THE FIRST 4 WEEKS AFTER INSERTION. IN THIS CASE, NO INFORMATION SUGGESTING A CLOSE TEMPORAL RELATIONSHIP WITH THE INSERTION PROCEDURE WAS MENTIONED THEREFORE PELVIC INFLAMMATION WAS CONSIDERED UNRELATED TO ESSURE. CONSUMER UNDERWENT LYSIS OF ADHESIONS 9 YEARS PRIOR TO ESSURE INSERTION, THEREFORE EVENT SCAR TISSUE ATTACHING TO OTHER ORGANS WAS CONSIDERED UNRELATED TO ESSURE. IT IS UNLIKELY THAT THE AMOUNT OF NICKEL RELEASED FROM THE DEVICE WOULD BE SUFFICIENT TO CAUSE METAL POISONING. THEREFORE, EVENT NICKEL TOXICITY WAS ASSESSED AS UNRELATED TO ESSURE. GIVEN THE PATHOPHYSIOLOGY OF BACTERIAL LUNG INFECTION, HBP AND ADENOMYOSIS, AND ESSURE'S LOCAL EFFECT IN FALLOPIAN TUBES, THESE EVENTS WERE ASSESSED AS UNRELATED TO ESSURE. THIS CASE WAS UPGRADED TO INCIDENT UPON RECEIPT OF INFORMATION STATING THE CONSUMER UNDERWENT HYSTERECTOMY. TECHNICAL ANALYSIS CONCLUDED BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# MW5032832) IN UNITED STATES ON 13-JAN-2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXTREME BLOATING, ABDOMINAL PAIN THAT MAKES IT DIFFICULT TO WALK, SIDE WALL PAIN THAT MAKES IT DIFFICULT TO WALK, EXCESS SCAR TISSUE ATTACHING TO OTHER ORGANS, EXCESSIVE BLEEDING, NAUSEA, BOWEL ISSUES, PELVIC INFLAMMATION, NICKEL TOXICITY, TEETH ARE LOOSENING, EXTREME FATIGUE, DEPRESSION, MEMORY ISSUES, HIP AND THIGH NUMBNESS AND FLU-LIKE SYMPTOMS THAT DO NOT GO AWAY FOR A YEAR. NO INFORMATION GIVEN ON CONSUMER'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATION RECEIVED. IN 2009 THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. THE CONSUMER EXPERIENCED FLU-LIKE SYMPTOMS THAT DO NOT GO AWAY FOR A YEAR, EXTREME BLOATING, ABDOMINAL PAIN AND SIDE WALL PAIN THAT MAKES IT DIFFICULT TO WALK, EXCESS SCAR TISSUE ATTACHING TO OTHER ORGANS, EXCESSIVE BLEEDING, NAUSEA, BOWEL ISSUES, PELVIC INFLAMMATION, VITAMIN DEFICIENCIES DUE TO NICKEL TOXICITY, TEETH ARE LOOSENING, EXTREME FATIGUE, DEPRESSION, MEMORY ISSUES, HIP AND THIGH NUMBNESS, AND NICKEL TOXICITY. SHE STATES SHE WAS CLOSE TO LOSING ALL HER FEMALE ORGANS DUE TO ESSURE IMPLANT. ESSURE WAS ONGOING. NO OUTCOME WAS PROVIDED. NO CAUSALITY ASSESSMENT WAS GIVEN. CORRECTION ON 24-JAN-2014 FOLLOWING COMPANY INTERNAL CODING REVIEW. THE EVENT EXCESS SCAR TISSUE ATTACHING TO OTHER ORGANS CODED TO MEDDRA LLT SCAR WHICH LEADS TO PT SCAR, WAS RECODED TO MEDDRA LLT ADHESION WHICH LEADS TO PT ADHESION. FOLLOW-UP INFORMATION RECEIVED FROM CONSUMER ON 23-JAN-2014: THE CONSUMER'S BIRTH DATE WAS INFORMED. SHE WAS (B)(6) AT THE TIME OF EVENTS ONSET AND SHE WAS (B)(6). HER RELEVANT GYNECOLOGICAL HISTORY INCLUDED MODERATE DYSPLASIA IN HER TWENTIES AND HAD THE TIP OF HER CERVIX BURNED OUT. SHE ALSO HAD LYSIS OF ADHESIONS IN 2000 DUE TO ADHESIONS TO HER INTESTINE AND LEFT OVARY. SHE DID NOT HAVE ANY OTHER RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITION. THE PATIENT HAD ESSURE INSERTED IN (B)(6) 2009. SHE HAD DELIVERED THREE TO FIVE MONTHS BEFORE THE INSERTION. AFTER THE INSERTION PROCEDURE, SHE HAS PERFORMED SEXUAL ABSTINENCE AS BACK-UP CONTRACEPTIVE METHOD. THE HYSTEROSALPINGOGRAPHY WAS PERFORMED 90 DAYS AFTER THE INSERTION AND THE TUBES WERE COMPLETELY BLOCKED. IN ADDITION TO PREVIOUSLY REPORTED EVENTS, SHE HAS HAD RESPIRATORY ISSUES AND SHE HAD A BACTERIAL LUNG INFECTION THAT PUT HER IN THE HOSPITAL. SHE HAS ALSO DEVELOPED FIBROMYALGIA A FEW MONTHS AFTER THE IMPLANTATION. FIVE MONTHS BEFORE THIS REPORTING, SHE WAS DIAGNOSED WITH OSTEOPOROSIS. SHE HAS NOT SEEN HER DOCTOR CONCERNING THESE SYMPTOMS, BUT SHE WAS TAKING TRAMADOL AS NEEDED. ON (B)(6) 2013, AN ULTRASOUND TEST SHOWED EVIDENCE OF BILATERAL TUBAL LIGATION. ADDITIONALLY, SHE INFORMED THAT MOST OF SYMPTOMS SHE HAS REPORTED STARTED SOON AFTER THE ESSURE WAS INSERTED AND THAT SHE WAS NOT HOSPITALIZED (DISCREPANCY NOTED AS SHE REPORTED BEING IN HOSPITAL DUE TO BACTERIAL LUNG INFECTION). THE REMOVAL OF THE ESSURE DEVICES WAS NOT PLANNED. THE CONSUMER BELIEVED MANY OF THE REPORTED ISSUES WERE CAUSED BY THE ESSURE AND THE SCAR TISSUE SHE HAS HAD IN THE PAST WAS ALSO CONTRIBUTING TO THE ISSUES. HER PHYSICIAN'S CONTACT INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION RECEIVED ON 20-APR-2014 - PTC INVESTIGATION RESULT: PTC GLOBAL NUMBER: (B)(4). MEDICAL ASSESSMENT: THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THE EVENTS WERE REPORTED WITH AN OCCURRENCE OVER A PERIOD OF ABOUT 4,5 YEARS AND ARE OF BROAD NATURE. NO BATCH NUMBER WAS REPORTED. NO COMPLAINT SAMPLE WAS PROVIDED FOR TECHNICAL INVESTIGATION. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER OR SAMPLE. AT TIME OF THIS MEDICAL EVALUATION THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. FINAL ASSESSMENT: NO LOT NUMBER PROVIDED; THEREFORE, NO LOT HISTORY RECORD (LHR) REVIEW COULD BE DONE. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. FOLLOW UP 13-AUG-2015: THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING TAKING PLACE IN (B)(4) 2015 (CASE# (B)(4), AWARENESS DATE 13-AUG-2015). IT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE IN UNITED STATES WHO HAD ESSURE (FALLOPIAN TUBE INSERT) INSERTED. CONSUMER REPORTED THAT 5 YEARS AFTER IMPLANT, SHE BEGAN TO EXPERIENCE SEVERE, RANDOM STABBING PAINS SPECIFICALLY AT HER IMPLANT SITE. SHE BEGAN TO SWELL AT RANDOM, OFF AND ON, DAILY TO LOOK 6 MONTHS PREGNANT. SHE ONLY WEIGHED (B)(6). SHE BEGAN TO BLEED FOR 7-10 DAYS AT RANDOM, 2-3 TIMES A MONTH. HER GUESS WAS EARLY MENOPAUSE, SO SHE HAD TESTS DONE. SHE QUICKLY BECAME MORE ILL. THE PAIN OF THE IMPLANTS WAS NOW 24/7. SHE STARTED HAVING HEART PALPITATIONS, HBP (HIGH BLOOD PRESSURE) EVEN TRANSFERRED FROM URGENT CARE TO THE HOSPITAL FOR FEAR OF STROKE OR HEART ATTACK. SHE COULD NOT BEND, PUSH, KNEEL, VACUUM, BATHE HER CHILD OR BARELY WALK FROM STABBING PAIN. HER FIBRO WAS PERMANENTLY FLARED, LOWER BACK ISSUES GREW IN SEVERITY, HER TEETH LOOSENED WITHOUT AN OUNCE OF DECAY, INCREASED ISSUES WITH NERVES, MUSCLES AND TISSUE OCCURRED ALL AT THE SAME TIME. SHE REQUESTED TO BE REFERRED TO A GYNECOLOGIST WHO WOULD REMOVE THE IMPLANTS THROUGH A HYSTERECTOMY. SEVEN MONTHS AFTER SEEKING HELP, A NEW ULTRASOUND SHOWED HER UTERUS (WHERE THE ESSURE COILS HAPPEN TO TOUCH) DEVELOPED A DISEASE CALLED ADENOMYOSIS. A HYSTERECTOMY WITH LYSIS OF ADHESIONS WAS DONE. CORRECTION REGARDING FOLLOW-UP RECEIVED ON 13-AUG-2015: THE CONSUMER STATED THAT GAVE BIRTH AT (B)(6) TO A (B)(6) BABY. IT WAS SUGGEST A BIRTH CONTROL, AS, IF SHE HAD MORE CHILDREN THEY PROBABLY WOULD NOT SURVIVE. DUE TO THE REPORTED EVENTS SHE UNDERWENT BLOOD WORK AND ULTRASOUND WHICH SHOWED NOTHING TO CREATE THESE SYMPTOMS. SHE WAS GIVEN BIRTH CONTROL AT (B)(6), BUT IT DID NOTHING. ONCE HER ESSURE IMPLANTS WERE REMOVED, THE STABBING PAIN WAS IMMEDIATELY GONE, SHE LOST THE RANDOMLY PREGNANT LOOK, HER HEART FEELS NORMAL, AND SHE DOES NOT USE HBP (HIGH BLOOD PRESSURE) MEDICINE. SHE WAS ABLE TO GARDEN, VACUUM, AND HER IMMUNITY SYSTEM WAS STILL IMPROVING. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND HAD EXCESSIVE BLEEDING, PELVIC INFLAMMATION, NICKEL TOXICITY, BACTERIAL LUNG INFECTION, HBP (HIGH BLOOD PRESSURE), ADENOMYOSIS, STABBING PAINS (PELVIC PAIN) AND SCAR TISSUE ATTACHING TO OTHER ORGANS. ESSURE IMPLANTS WERE REMOVED. AFTER THAT, STABBING PAIN WAS IMMEDIATELY GONE AND DID NOT NEED HIGH BLOOD PRESSURE MEDICINE ANYMORE. EXCESSIVE BLEEDING, PELVIC PAIN AND PELVIC INFLAMMATION ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, THE OTHER EVENTS ARE UNLISTED. REGARDING GENITAL BLEEDING, IN THIS CASE THE CONSUMER WAS LATER DIAGNOSED WITH ADENOMYOSIS WHICH COULD HAVE CONTRIBUTED FOR THE BLEEDING. HOWEVER, GIVEN THE NATURE OF THIS EVENT CAUSALITY WITH ESSURE CANNOT BE TOTALLY EXCLUDED. REGARDING PELVIC PAIN, CONSUMER ALSO HAD ADHESIONS WHICH COULD HAVE CONTRIBUTED FOR THE OCCURRENCE OF THE PAIN, HOWEVER GIVEN THE NATURE OF THIS EVENT CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. WHILE ESSURE IS STERILE IT MAY, DUE TO CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTION IN THE FIRST 4 WEEKS AFTER INSERTION. IN THIS CASE, NO INFORMATION SUGGESTING A CLOSE TEMPORAL RELATIONSHIP WITH THE INSERTION PROCEDURE WAS MENTIONED THEREFORE PELVIC INFLAMMATION WAS CONSIDERED UNRELATED TO ESSURE. CONSUMER UNDERWENT LYSIS OF ADHESIONS 9 YEARS PRIOR TO ESSURE INSERTION, THEREFORE EVENT SCAR TISSUE ATTACHING TO OTHER ORGANS WAS CONSIDERED UNRELATED TO ESSURE. IT IS UNLIKELY THAT THE AMOUNT OF NICKEL RELEASED FROM THE DEVICE WOULD BE SUFFICIENT TO CAUSE METAL POISONING. THEREFORE, EVENT NICKEL TOXICITY WAS ASSESSED AS UNRELATED TO ESSURE. GIVEN THE PATHOPHYSIOLOGY OF BACTERIAL LUNG INFECTION, HBP AND ADENOMYOSIS, AND ESSURE'S LOCAL EFFECT IN FALLOPIAN TUBES, THESE EVENTS WERE ASSESSED AS UNRELATED TO ESSURE. THIS CASE WAS UPGRADED TO INCIDENT UPON RECEIPT OF INFORMATION STATING THE CONSUMER UNDERWENT HYSTERECTOMY. TECHNICAL ANALYSIS CONCLUDED BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598212 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 641436

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R CLOTRIMAZOLE| CLOTRIMAZOLE| CLOTRIMAZOLE| DICLOFENAC AL| DICLOFENAC AL| DICLOFENAC AL| DIFLUCAN| JOLIVETTE-28| JOLIVETTE-28| JOLIVETTE-28| JOLIVETTE-28| JOLIVETTE-28| NYSTATIN| PREDNISONE