BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4192557 · Received October 22, 2014

    Report

    Report Number
    2951250-2014-00452
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    August 9, 2013
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    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 FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE# MW5037300) IN UNITED STATES ON (B)(6)-2014 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BACK PAIN AND PELVIC PAIN. CONSUMER REPORTED THAT ABOUT 11 MONTHS BEFORE THE TIME OF REPORT ((B)(6)-2013) SHE HAD A BIRTH CONTROL PROCEDURE (ESSURE). DOCTOR INFORMED HER THAT THE PROCEDURE WOULD BE SIMPLE WITH MINIMAL SIDE EFFECTS AND SHE DECIDED TO HAVE THE PROCEDURE DONE. UNFORTUNATELY, FOR 11 MONTH SHE HAS HAD BACK AND PELVIC PAIN WHICH CONTINUES TO PLAQUE HER. HER DOCTORS HAVE MADE VARYING EFFORTS TO HELP HER, YET SHE STILL HAS NO IDEA WHAT THE PROBLEM OR A DIAGNOSIS IS OR WHY SHE IS HAVING PAIN. CONSUMER INFORMED THAT AFTER THE PROCEDURE WAS COMPLETED, ALMOST IMMEDIATELY, SHE EXPERIENCED LOWER BACK PAIN. CONSUMER CONTACTED NURSES VIA PHONE WHO ASSURED HER THAT THE PAIN WOULD SUBSIDE, BUT IT ONLY GOT WORSE. AFTER 2 MONTHS, THE BACK AND PELVIC PAIN BECAME SO EXTREME THAT SHE MISSED WORK DAYS AND TOOK PAIN MEDICATION DAILY. IN 2013, SHE VISITED OBSTETRICIAN/GYNECOLOGIST DOCTOR; HE SUGGESTED REMOVING THE COILS (ESSURE) DEVICE AND SHE AGREED. IN (B)(6)-2014, PHYSICIAN PERFORMED HER LAPAROSCOPIC SURGERY TO REMOVE THE DEVICE. ACCORDING TO CONSUMER THE SURGERY ALSO INCLUDED REMOVING HER FALLOPIAN TUBES. AFTER WEEKS OF RECOVERY AND TIME OFF WORK SHE CONTINUED TO EXPERIENCE PELVIC AND BACK PAIN. DOCTOR TOLD HER THIS WAS NORMAL. AFTER 3 WEEKS OF CONTINUED PAIN, SHE CONTACTED DOCTOR WHO RELEASED HER TO WORK WITHOUT ADDRESSING HER PAIN ISSUES. SHE RECEIVED NO PAIN MANAGEMENT TREATMENT. SHE COMMUNICATED HER SYMPTOMS WITH SEVERAL DOCTORS, INCLUDING HER PRIMARY CARE PHYSICIAN, ON MANY OCCASIONS VIA E-MAIL, PHONE AND DOCTOR VISITS. CONSUMER DID PHYSICAL THERAPY, MASSAGE THERAPY, CHIROPRACTIC CARE, EPSON SALT BATHS, HEATING PADS AT WORK/HOME FOR SEVERAL MONTHS, BUT HER PAIN CONTINUED. IN ADDITION SHE REPORTED THAT, AS A PATIENT, SHE IS CONCERNED ABOUT HER HEALTH. SHE TRIES TO BE PROACTIVE IN HER HEALTH AND STATES THAT SHE WAS HEALTHY BEFORE THIS PROCESS BEGAN 11 MONTHS AGO. SHE TRIED TO FOLLOW THE DOCTORS' ORDERS. WHILE SHE RECOGNIZED THERE ARE NO GUARANTEES WITH MEDICAL PROCEDURES, HER CONCERNS ARE LISTED BELOW: SHE DOES NOT BELIEVE HER DOCTORS AND MEDICAL STAFF HAVE COMMUNICATED WITH OTHERS EFFECTIVELY. SHE HAS RECEIVED CONFLICTING ADVICE OR NO ANSWERS TO HER REQUEST. HER BACK AND SURROUNDING AREAS HAVE NOT RECEIVED A FULL EXAMINATION OR TEST BEFORE OR AFTER THE SURGERIES SHE HAS RECEIVED. SHE HAS NOT RECEIVED PAIN MANAGEMENT TREATMENT. SHE DOES NOT HAVE A DIAGNOSES OR REASON FOR THE CHRONIC PAIN. HER MOBILITY AND QUALITY OF LIFE ARE AFFECTED BY THIS CHRONIC PAIN. SHE HAS NO REAL UNDERSTANDING OF WHAT OR WHY THIS PROBLEM PERSISTS. SHE CONTINUE TO TAKE TESTS, DOES EVASIVE PROCEDURES, SPEND MONEY, AND MISS WORK TIME TO ADDRESS THIS ISSUE. THE CONSUMER DID NOT PROVIDE CONTACT INFORMATION, THEREFORE FURTHER INFORMATION CANNOT BE REQUESTED. FOLLOW-UP RECEIVED ON 07-OCT-2014. PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (REQUEST FOR CONFIRMATION OF QUALITY). (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. THE REPORTED ADVERSE EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE (B)(6) 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 BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED AND SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BACK PAIN AND PELVIC PAIN. THE EVENTS ARE SERIOUS DUE MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE THE CONSUMER INFORMED THAT SHE WAS SUFFERING FROM BACK AND PELVIC PAIN FOR 11 MONTHS. SHE ALSO STATED AFTER THE INSERTION PROCEDURE WAS COMPLETED, ALMOST IMMEDIATELY, SHE EXPERIENCED LOWER BACK PAIN. AFTER 2 MONTHS, THE PAIN BECAME SO EXTREME THAT SHE MISSED WORK DAYS AND TOOK PAIN MEDICATION DAILY. THE PAIN DID NOT SUBSIDE AND CONTINUED FOR 11 MONTHS. HER OBSTETRICIAN/GYNECOLOGIST DOCTOR SUGGESTED REMOVING THE COILS (ESSURE) DEVICE AND SHE AGREED. THEN, THE PHYSICIAN PERFORMED HER LAPAROSCOPIC SURGERY. ACCORDING TO CONSUMER THE SURGERY ALSO INCLUDED REMOVING HER FALLOPIAN TUBES. AFTER WEEKS OF RECOVERY AND TIME OFF WORK SHE CONTINUED TO EXPERIENCE PELVIC AND BACK PAIN (NEGATIVE DECHALLENGE). ALTHOUGH THE EVENTS HAD NOT IMPROVED AFTER THE MICRO-INSERTS REMOVAL, THE CAUSALITY WITH ESSURE CANNOT BE EXCLUDED, SINCE THE BACK AND PELVIC PAIN HAVE APPEARED AFTER THE DEVICE INSERTION. BESIDES, THE EVENTS LED TO A REQUIRED INTERVENTION, SO THE CASE IS REGARDED AS INCIDENT. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672881 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other