BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6278852 · Received January 26, 2017

    Report

    Report Number
    2951250-2017-00299
    Event Type
    Injury
    Date Received
    January 26, 2017
    Report Date
    May 5, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("BLEEDING") IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2013, 122 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN"). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH ORAL CONTRACEPTIVE NOS AND SURGERY (NOVASURE IN (B)(6) 2014). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE AND PELVIC PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR GENITAL HAEMORRHAGE AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: NOVASURE WAS DONE IN (B)(6) 2014, IT DID NOT GET BETTER. PATIENT WAS KEPT ON BIRTH CONTROL PILLS TO HELP WITH THE BLEEDING, WITH NOT TOO MUCH RELIEF. HER PATIENT IS REQUESTING REMOVAL OF ESSURE. DIAGNOSTIC RESULTS: ON (B)(6) 2014, MEDICAL CONSULTATION, NOVASURE WAS DONE 1 MONTH LATER. 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. 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 KNOWN POSSIBLE UNDESIRABLE EVENTS AND 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: REPORTER DID NOT RESPOND TO FINAL FOLLOW-UP ATTEMPT. NO FURTHER INFORMATION COULD BE OBTAINED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS PHYSICIAN REPORT REFERS TO A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BLEEDING (INTERPRETED AS GENITAL BLEEDING) AND PAIN (INTERPRETED AS PELVIC PAIN) SINCE ESSURE INSERTION. MANAGEMENT OF BLEEDING WITH ENDOMETRIAL ABLATION AND ORAL CONTRACEPTIVES REMAINED UNSUCCESSFUL, THE PATIENT NOW WISHED REMOVAL OF ESSURE. GENITAL BLEEDING WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION OF ESSURE. CONSIDERING THAT THE USE OF ESSURE MAY CAUSE GENITAL BLEEDING AND PAIN, AND IN VIEW OF THE THERAPY-REFRACTORY COURSE OF THE EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED (RELATED). THE CASE WAS CLASSIFIED AS INCIDENT DUE TO THE REQUIRED INTERVENTION. A PRODUCT TECHNICAL ANALYSIS RESULTED IN AN UNCONFIRMED BUT PLAUSIBLE PRODUCT QUALITY DEFECT AND A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION COULD NOT BE OBTAINED.

    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. 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 KNOWN POSSIBLE UNDESIRABLE EVENTS AND 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS PHYSICIAN REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BLEEDING (INTERPRETED AS GENITAL BLEEDING) AND PAIN (INTERPRETED AS PELVIC PAIN) SINCE ESSURE INSERTION. MANAGEMENT OF BLEEDING WITH ENDOMETRIAL ABLATION AND ORAL CONTRACEPTIVES REMAINED UNSUCCESSFUL, THE PATIENT NOW WISHED REMOVAL OF ESSURE. GENITAL BLEEDING WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION OF ESSURE. CONSIDERING THAT THE USE OF ESSURE MAY CAUSE GENITAL BLEEDING AND PAIN, AND IN VIEW OF THE THERAPY-REFRACTORY COURSE OF THE EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED (RELATED). THE CASE WAS CLASSIFIED AS INCIDENT DUE TO THE REQUIRED INTERVENTION. A PRODUCT TECHNICAL ANALYSIS RESULTED IN AN UNCONFIRMED BUT PLAUSIBLE PRODUCT QUALITY DEFECT AND A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION FROM THE REPORTER IS AWAITED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("BLEEDING") IN A (B)(6) FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT STARTED ESSURE. IN 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH ORAL CONTRACEPTIVE NOS AND SURGERY (NOVASURE IN (B)(6) 2014). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE AND PELVIC PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR GENITAL HAEMORRHAGE AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: NOVASURE WAS DONE IN (B)(6) 2014, IT DID NOT GET BETTER. PATIENT WAS KEPT ON BIRTH CONTROL PILLS TO HELP WITH THE BLEEDING, WITH NOT TOO MUCH RELIEF. HER PATIENT IS REQUESTING REMOVAL OF ESSURE. DIAGNOSTIC RESULTS: (B)(6) 2014, MEDICAL CONSULTATION, NOVASURE WAS DONE 1 MONTH LATER. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS PHYSICIAN REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BLEEDING (INTERPRETED AS GENITAL BLEEDING) AND PAIN (INTERPRETED AS PELVIC PAIN) SINCE ESSURE INSERTION. MANAGEMENT OF BLEEDING WITH ENDOMETRIAL ABLATION AND ORAL CONTRACEPTIVES REMAINED UNSUCCESSFUL, THE PATIENT NOW WISHED REMOVAL OF ESSURE. GENITAL BLEEDING WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION OF ESSURE. CONSIDERING THAT THE USE OF ESSURE MAY CAUSE GENITAL BLEEDING AND PAIN, AND IN VIEW OF THE THERAPY-REFRACTORY COURSE OF THE EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED (RELATED). THE CASE WAS CLASSIFIED AS INCIDENT DUE TO THE REQUIRED INTERVENTION. A PRODUCT TECHNICAL ANALYSIS AND FOLLOW-UP INFORMATION ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62449 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R