BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4151220 · Received October 8, 2014

    Report

    Report Number
    2951250-2014-00416
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    January 1, 2009
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUPLICATED CASE IDENTIFIED ON 26-MAY-2016: THE INFORMATION FROM DUPLICATED CASE (B)(4) WAS TRANSFERRED TO THE PRESENT CASE. DURING 3.5 YEARS OF IMPLANTATION, PATIENT HAS SEVERE PAIN AND DISCOMFORT, ALONG WITH A SYSTEMIC ITCHY RASH. UPON INTERNAL REVIEW, INFORMATION RECEIVED ON 26-MAY-2016 WAS AMENDED. SINCE THE DUPLICATED CASE (B)(4) WAS CONSIDERED MEDICALLY CONFIRMED, THIS CASE WAS ALSO CONSIDERED. AFTER INTERNAL REVIEW ON 01-JUN-2016, INFORMATION RECEIVED ON 26-MAY-2016 WAS AMENDED. THIS CASE WAS NOT CONSIDERED MEDICALLY CONFIRMED. FOLLOW UP INFORMATION RECEIVED ON 01-JUN-2016 FROM CONSUMER VIA NEWS ARTICLE: SHE EXPERIENCED MAJOR PELVIC PAIN LIKE STABBING, ABDOMINAL PAIN, SHE WENT TO THE ER ON SEVERAL OCCASIONS FOR THAT NOT KNEW WHAT IT WAS; SHE STATED IT WAS LIKE BEING STABBED WITH A KNIFE. SHE ALSO EXPERIENCED BLEEDING RASHES ON HER HANDS, TORSO AND ANKLES FOR 3 AND HALF YEARS. WHEN DOCTORS COULDN'T PINPOINT THE CAUSE OF THE RASH, SHE CHANGED HER LIFESTYLE TO AVOID POTENTIAL FOOD AND METAL ALLERGENS, INCLUDING TAKING OFF HER WEDDING RING. SHE HAD THE BIRTH CONTROL IMPLANTS REMOVED IN 2013. SHE REPORTED THAT WITHIN 24 HOURS, THE RASH ON HER TORSO WAS GONE AND THE PELVIC PAIN DISAPPEARED. THE CONSUMER IS ONE OF THE WOMEN WHO ARE PART OF A CLASS-ACTION LAWSUIT THAT ALLEGES THE SPRING-LIKE DEVICE LED TO MAJOR COMPLICATIONS. CASE CONSIDERED POTENTIAL LEGAL CASE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABDOMINAL PAIN, MAJOR PELVIC PAIN LIKE STABBING AND RASH, LATER SHE DISCOVERED SHE WAS ALLERGIC TO NICKEL. SHE UNDERWENT BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS AND RECOVERED FROM HER SYMPTOMS. THIS CASE WAS CONSIDERED POTENTIAL LEGAL AFTER RECEIVING FOLLOW-UP INFORMATION. THESE EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND ARE LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. ALLERGIC REACTIONS TO ESSURE ARE MORE COMMONLY RELATED TO NICKEL SENSITIVITY AND ITS MANIFESTATIONS INCLUDE SKIN ITCHING, RASH, ECZEMATOUS DERMATITIS, AND HIVES THAT RESOLVE AFTER DEVICE REMOVAL. ALSO, DURING ESSURE THERAPY ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS PARTICULAR CASE, CONSIDERING THE POSITIVE TEMPORAL RELATIONSHIP AND AS THE PAIN AND RASH RECOVERED AFTER ESSURE REMOVAL A CAUSAL RELATION WITH THE SUSPECT INSERT CANNOT BE EXCLUDED AND DUE TO THE REQUIRED INTERVENTION, THIS CASE WAS REGARDED AS AN INCIDENT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONSIDERED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# (B)(6) ON (B)(6) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED IN 2009 FOR PERMANENT BIRTH CONTROL AND OVER THE COURSE OF THE FOLLOWING 3.5 YEARS EXPERIENCED ABDOMINAL PAIN AND DEVELOPED A VERY ITCHY RASH THAT SPREAD ALL OVER THE BODY. AFTER MUCH TESTING, MULTIPLE BIOPSIES AND CHEMICAL PATCH TESTING FOR ALLERGIES, IT WAS DETERMINED THAT SHE WAS HIGHLY ALLERGIC TO NICKEL. THE ESSURE COILS CONTAIN NICKEL. SHE WAS TREATED WITH CLOBESOL STEROID CREAM ALMOST THE ENTIRE 3 YEARS OF SYMPTOMS TO TRY TO CONTROL THE RASH. SHE HAD NEVER EXPERIENCED ANYTHING RELATED TO THAT PRIOR TO THE INSERTION OF THE ESSURE DEVICE. SHE UNDERWENT A BILATERAL SALPINGECTOMY AND ESSURE COILS WERE REMOVED. HER PAIN WAS GONE IMMEDIATELY AND HER SKIN BEGAN AN IMMEDIATE IMPROVEMENT. SYMPTOMS WENT AWAY FOLLOWING ESSURE SURGICAL REMOVAL. NO FOLLOW-UP FOR ADVERSE EVENTS IS FEASIBLE TO PROCEED. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(6) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. HOWEVER, THE REPORTED ADVERSE EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT WAS RECEIVED VIA REGULATORY AUTHORITY, AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABDOMINAL PAIN AND WAS ALLERGIC TO NICKEL. BOTH EVENTS ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. ALLERGIC REACTIONS TO ESSURE ARE MORE COMMONLY RELATED TO NICKEL SENSITIVITY AND ITS MANIFESTATIONS INCLUDE SKIN ITCHING, RASH, ECZEMATOUS DERMATITIS, AND HIVES THAT RESOLVE AFTER DEVICE REMOVAL. IN THIS PARTICULAR CASE, THE CONSUMER DEVELOPED ABDOMINAL PAIN AND AN ITCHY RASH AFTER ESSURE INSERTION; SHE WAS SUBMITTED TO BIOPSIES AND PATCH TESTING AND STATED THAT SHE WAS ALLERGIC TO NICKEL. THEN, SHE UNDERWENT BILATERAL SALPINGECTOMY AND ESSURE COILS WERE REMOVED, BOTH PAIN AND SKIN RASH RECOVERED AFTER THIS PROCEDURE. CONSIDERING THE POSITIVE TEMPORAL RELATIONSHIP, DECHALLENGE AND THE EVENTS NATURE THEY WERE CONSIDERED AS RELATED TO THE SUSPECT INSERT; AND DUE TO THE REQUIRED INTERVENTION, THIS CASE WAS REGARDED AS AN INCIDENT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED; NO BATCH NUMBER WAS REPORTED NEITHER A COMPLAINT SAMPLE PROVIDED FOR FURTHER TECHNICAL EVALUATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". MEDICAL PTC ASSESSMENT CONSIDERED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. NO FOLLOW-UP CAN BE PURSUED SINCE THIS IS A HEALTH AUTHORITY CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632468 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other