BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3960359 · Received July 17, 2014

    Report

    Report Number
    2951250-2014-00281
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    October 14, 2024
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY CAUSALITY COMMENT: THIS CASE REPORT DERIVED FROM MEDICAL LITERATURE, ARTICLE ENTITLED "ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT", REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. THE EVENT WAS CONSIDERED AS RELATED TO ESSURE BY THE REPORTER. THE EVENT IS SERIOUS DUE MEDICAL IMPORTANCE, LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION AND REGARDED AS INCIDENT, SINCE DEVICE REMOVAL BY LAPAROSCOPY WAS PERFORMED. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, THE PATIENT EXPERIENCED PAIN IMMEDIATELY AFTER PLACEMENT, INCREASED WITH TIME AND DID NOT DISAPPEAR USING STANDARD ANALGESIC DRUGS. THEN, AS THE EVENT PERSISTED, THE DEVICE WAS REMOVED BY LAPAROSCOPY. THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. CONSIDERING THIS POSITIVE TEMPORAL RELATIONSHIP AND DECHALLENGE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. ADDITIONALLY NON-SERIOUS EVENT MILD PROCEDURAL PAIN WAS REPORTED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: J OBSTET GYNAECOL; AUTHOR: CASTELO-BRANCO C; ARJONA BERRAL JE, RODRIGUEZ JIMENEZ B, VELASCO SANCHEZ E,ET AL; TITLE: ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT; VOLUME: XX YEAR: 2014 PAGES: 1-2.

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(4) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (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: THE REPORTED EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NEITHER A TECHNICAL BATCH EVALUATION NOR A BATCH SIGNAL CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. DUE TO LACK OF SAMPLE RETURN AND ANY VALID BATCH INFORMATION THE (B)(4) WAS UNABLE TO CONFIRM ANY QUALITY DEFECT AND THEREFORE CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. (B)(4). COMPANY CAUSALITY COMMENT: THIS CASE REPORT DERIVED FROM MEDICAL LITERATURE, ARTICLE ENTITLED "ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT", REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. THE EVENT WAS CONSIDERED AS RELATED TO ESSURE BY THE REPORTER. THE EVENT IS SERIOUS DUE MEDICAL IMPORTANCE, LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION AND REGARDED AS INCIDENT, SINCE DEVICE REMOVAL BY LAPAROSCOPY WAS PERFORMED. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, THE PATIENT EXPERIENCED PAIN IMMEDIATELY AFTER PLACEMENT, INCREASED WITH TIME AND DID NOT DISAPPEAR USING STANDARD ANALGESIC DRUGS. THEN, AS THE EVENT PERSISTED, THE DEVICE WAS REMOVED BY LAPAROSCOPY. THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. CONSIDERING THIS POSITIVE TEMPORAL RELATIONSHIP AND DECHALLENGE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. ADDITIONALLY NON-SERIOUS EVENT MILD PROCEDURAL PAIN WAS REPORTED. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS CASE REPORT FROM (B)(6) WAS DERIVED FROM MEDICAL LITERATURE ON 17-JUN-2014, ARTICLE ENTITLED "ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT". IT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE MICRO-INSERTS) INSERTED FOR HYSTEROSCOPIC STERILISATION AND EXPERIENCED MILD PROCEDURAL PAIN AND CHRONIC PELVIC PAIN. CASE REPORT: (B)(6) FEMALE PATIENT (CASE 1 FROM TABLE L) HAD STERILIZATION. THE SURGEON DESCRIBED THE PROCEDURE AS SATISFACTORY DEVICE PLACEMENT WITH 2 COILS IN RIGHT TUBE AND 3 COILS IN LEFT TUBE. PATIENT EXPERIENCED PROCEDURAL MILD VIA PAIN ASSESSMENT TOLERANCE. X-RAY WAS DONE AS A CONTROL TEST. CHRONIC PELVIC PAIN THAT STARTED IMMEDIATELY AFTER PLACEMENT INCREASED WITH TIME AND DID MICRO-INSERT REMOVAL. THE DEVICE WAS REMOVED BY LAPAROSCOPY, TIME BETWEEN MICRO-INSERT PLACEMENT AND REMOVAL WAS 22 MONTHS. THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. AUTHOR'S COMMENTS: THE PRESENT, VERY LARGE SAMPLE DEMONSTRATES THAT CHRONIC PELVIC PAIN IS A VERY RARE COMPLICATION WITH THE ESSURE SYSTEM. INDEED SIX OF THE SEVEN WOMEN REPORTED THAT THE ONSET OF SYMPTOMS STARTED IMMEDIATELY AFTER THE PROCEDURE AND DID NOT IMPROVE WITH THE INTAKE OF STANDARD ANALGESICS. IN THREE OF THESE PATIENTS, THE SURGEON DESCRIBED THE DEVICE PLACEMENT AS DIFFICULT, REQUIRING A HYSTEROSALPINGOGRAPHY AS A CONTROL TEST, SHOWING DEVICE OCCLUSION AS WELL AS DEVICE DISPOSAL. THIS FACT IS NOTEWORTHY, SINCE PELVIC PAIN MAY BE RELATED TO MALPOSITIONING OF A MICROINSERT. THREE OF THE SEVEN CASES DESCRIBED THE PAIN DURING THE PROCEDURE AS HIGH, WITH THIS PERCENTAGE BEING GREATER THAN THAT OBSERVED IN THE WHOLE COHORT. SERIES IS THE LARGEST TO DATE EVALUATING THE FEASIBILITY, SAFETY AND EFFECTIVENESS OF ESSURE HYSTEROSCOPIC STERILISATION, WITH THE INCIDENCE OF CHRONIC PP OBSERVED BEING EXTREMELY LOW. AUTHOR IDENTIFIED ALL WOMEN UNDERGOING THE PROCEDURE DURING THE STUDY PERIOD. THE CAUSES THAT MIGHT EXPLAIN CHRONIC PP IN WOMEN WITH ESSURE REMAIN UNKNOWN AND, CONSEQUENTLY, FURTHER STUDIES ARE WARRANTED. PUBLICATION ABSTRACT: THE AIM OF THIS STUDY WAS TO ASSESS THE INCIDENCE OF CHRONIC PELVIC PAIN IN WOMEN AFTER PLACEMENT OF ESSURE MICROINSERTS. THIS WAS A CASE SERIES STUDY AT THE HYSTEROSCOPY UNIT IN A TEACHING HOSPITAL. AUTHOR INCLUDED 4,274 PATIENTS UNDERGOING PERMANENT STERILIZATION WITH ESSURE MICROINSERTS FROM JANUARY 2005 TO DECEMBER 2011. ESSURE DEVICES WERE REMOVED IN ALL PATIENTS REPORTING PELVIC PAIN AFTER INSERTION. ALL DATA WERE COLLECTED FROM THE HYSTEROSCOPY UNIT DATABASE WITH LATER REVIEW OF MEDICAL RECORDS IN CASES OF CHRONIC PELVIC PAIN AND A TELEPHONE SURVEY AFTER MICROINSERT REMOVAL. MAIN OUTCOME MEASURES WERE: GRADE OF PROCEDURE DIFFICULTY PERCEIVED BY THE SURGEON; TOLERANCE DESCRIBED BY THE PATIENT AFTER PLACEMENT; THE NEED FOR ANALGESICS DURING OR IMMEDIATELY AFTER THE PROCEDURE; SIDE-EFFECTS; AVERAGE TIME BETWEEN DEVICE PLACEMENT AND THE ONSET OF SYMPTOMS; TIME BETWEEN DEVICE PLACEMENT AND REMOVAL; TECHNIQUE FOR DEVICE REMOVAL AND ANY SYMPTOMS THEREAFTER. A TOTAL OF SEVEN WOMEN (0.16%) PRESENTED WITH CHRONIC PELVIC PAIN REQUIRING MICROINSERT REMOVAL, WITH FOUR CLASSIFYING THE PAIN PERCEIVED DURING THE PROCEDURE AS MEDIUM HIGH. SIX PATIENTS DID NOT REQUIRE ANALGESICS AFTER THE PROCEDURE AND A VASOVAGAL SYNDROME REQUIRING ENDOVENOUS ANALGESIA AND MONITORING OCCURRED IN ONLY ONE CASE. SIX WOMEN REPORTED PAIN IMMEDIATELY AFTER THE PROCEDURE, WITH A MEAN TIME BETWEEN PLACEMENT AND REMOVAL OF 29.4 MONTHS. IN ALL CASES, THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. AUTHOR CONCLUDED THAT THE DEVELOPMENT OF CHRONIC PELVIC PAIN IS VERY UNCOMMON AFTER PLACEMENT OF ESSURE MICROINSERTS. REMOVAL OF THESE DEVICES USUALLY IMPROVES THE PAIN. OTHER CASES FROM THIS ARTICLE: 2014-092125, 2014-092126, 2014-092127, 2014-092128, 2014-092129, 2014-092130.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420465 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051
    420617 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Other| R