BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6335836 · Received February 16, 2017

    Report

    Report Number
    2951250-2017-00524
    Event Type
    Injury
    Date Received
    February 16, 2017
    Report Date
    February 11, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN / SEVERE PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922806) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DISCOMFORT ("SEVERE DISCOMFORT"), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FATIGUE ("CHRONIC FATIGUE") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DISCOMFORT, MENORRHAGIA, ABDOMINAL PAIN, FATIGUE AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DISCOMFORT, FATIGUE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICES IN EXPECTED POSITION IN THE FALLOPIAN TUBES BILATERALLY. DISTENTION OF THE ENDOMETRIAL CAVITY WITH CONTRAST MATERIAL PRODUCES NO EVIDENCE OF FREE SPILLAGE OF CONTRAST INTO THE PERITONEAL CAVITY.. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-FEB-2021: MR RECEIVED: LOT NUMBER WAS ADDED, REPORTER WAS ADDED, ESSURE REMOVAL DATE WERE UPDATED, LAB DATA WAS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-FEB-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REFERS TO A (B)(6) FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND BEGAN TO EXPERIENCE CHRONIC PELVIC PAIN / SEVERE PAIN. THREE YEARS AFTER INSERTION, SURGERY WAS PERFORMED TO REMOVE THE DEVICE. PELVIC PAIN, SERIOUS DUE TO MEDICAL SIGNIFICANCE, IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION OF ESSURE. PELVIC PAIN MAY OCCUR DURING THE USE OF ESSURE. BASED ON A COMPATIBLE TEMPORAL RELATIONSHIP, ON THE NATURE OF THE EVENT, AND ON THE LACK OF ALTERNATIVE EXPLANATIONS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED (RELATED). THIS CASE WAS REGARDED AS INCIDENT BECAUSE OF DEVICE REMOVAL. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. FURTHER INFORMATION IS EXPECTED ONLY THROUGH THE LITIGATION PROCESS.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / SEVERE PAIN") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED ESSURE FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), DISCOMFORT ("SEVERE DISCOMFORT"), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FATIGUE ("CHRONIC FATIGUE") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE IN (B)(6) 2015). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DISCOMFORT, MENORRHAGIA, ABDOMINAL PAIN, FATIGUE AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED PELVIC PAIN, DISCOMFORT, MENORRHAGIA, ABDOMINAL PAIN, FATIGUE AND ANXIETY TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ON AN UNKNOWN DATE: HYSTEROSALPINGOGRAM RESULT WAS COILS PROPERLY PLACED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REFERS TO A (B)(6) YEAR-OLD FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND BEGAN TO EXPERIENCE CHRONIC PELVIC PAIN / SEVERE PAIN. THREE YEARS AFTER INSERTION, SURGERY WAS PERFORMED TO REMOVE THE DEVICE. PELVIC PAIN, SERIOUS DUE TO MEDICAL SIGNIFICANCE, IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION OF ESSURE. PELVIC PAIN MAY OCCUR DURING THE USE OF ESSURE. BASED ON A COMPATIBLE TEMPORAL RELATIONSHIP, ON THE NATURE OF THE EVENT, AND ON THE LACK OF ALTERNATIVE EXPLANATIONS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED (RELATED). THIS CASE WAS REGARDED AS INCIDENT BECAUSE OF DEVICE REMOVAL. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS AWAITED. FURTHER INFORMATION IS EXPECTED ONLY THROUGH THE LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119395 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922806

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R