BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 20880846 · Received December 9, 2024

    Report

    Report Number
    2951250-2024-00792
    Event Type
    Injury
    Date Received
    December 9, 2024
    Report Date
    May 27, 2026
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4). UTERUS PERFORATED [PERFORATION OF UTERUS]. EXTREMELY HEAVY MENSTRUAL CYCLES [BLEEDING MENSTRUAL HEAVY]. MY HEMOGLOBIN DROPPED [HEMOGLOBIN DECREASED]. Y HEMOGLOBIN AND RED BLOOD CELLS DROPPED CRITICALLY LOW [RED BLOOD CELL COUNT. DECREASED]. MY BLOOD VOLUME DROPPED SO LOW [VOLUME BLOOD DECREASED]. BREAST TISSUE PAINFUL [PAINFUL BREASTS]. LUMPY BREAST [LUMPY BREASTS]. WBC LOW [WHITE BLOOD CELL COUNT LOW]. IRON LOW [IRON LOW]. IRON SATURATION LOW [IRON SATURATION DECREASED] PALTELATE HIGH [PLATELET COUNT INCREASED] RDW [RDW INCREASED] HEMATOCRIT LOW [HEMATOCRIT DECREASED] MCV DECREASED [MEAN CELL VOLUME DECREASED]. MCH DECREASED [MCH DECREASED]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("UTERUS PERFORATED") AND HEAVY MENSTRUAL BLEEDING ("EXTREMELY HEAVY MENSTRUAL CYCLES") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D06930) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, HERNIA REPAIR, CHOLECYSTECTOMY AND CESAREAN SECTION. IN 2010, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BREAST PAIN ("BREAST TISSUE PAINFUL") AND BREAST MASS ("LUMPY BREAST") AND WAS FOUND TO HAVE HAEMOGLOBIN DECREASED ("MY HEMOGLOBIN DROPPED"), RED BLOOD CELL COUNT DECREASED ("Y HEMOGLOBIN AND RED BLOOD CELLS DROPPED CRITICALLY LOW"), VOLUME BLOOD DECREASED ("MY BLOOD VOLUME DROPPED SO LOW"), WHITE BLOOD CELL COUNT DECREASED ("WBC LOW"), BLOOD IRON DECREASED ("IRON LOW"), TRANSFERRIN SATURATION DECREASED ("IRON SATURATION LOW"), PLATELET COUNT INCREASED ("PALTELATE HIGH"), RED CELL DISTRIBUTION WIDTH INCREASED ("RDW"), HAEMATOCRIT DECREASED ("HEMATOCRIT LOW"), MEAN CELL VOLUME DECREASED ("MCV DECREASED") AND MEAN CELL HAEMOGLOBIN DECREASED ("MCH DECREASED"). THE PATIENT WAS TREATED WITH IRON (FERROUS SULFATE) AND MEDROXYPROGESTERONE (MEDROXYPROGESTERONE ACETATE) AS WELL AS SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, HAEMOGLOBIN DECREASED, RED BLOOD CELL COUNT DECREASED, UTERINE PERFORATION, VOLUME BLOOD DECREASED, BREAST PAIN, BREAST MASS, WHITE BLOOD CELL COUNT DECREASED, BLOOD IRON DECREASED, TRANSFERRIN SATURATION DECREASED, PLATELET COUNT INCREASED, RED CELL DISTRIBUTION WIDTH INCREASED, HAEMATOCRIT DECREASED, MEAN CELL VOLUME DECREASED OR MEAN CELL HAEMOGLOBIN DECREASED. THE REPORTER COMMENTED: IN 2010, I HAD THE ESSURE PROCEDURE PERFORMED. TO DATE I AM STILL HAVING MAJOR COMPLICATIONS. EXTREMELY HEAVY MENSTRUAL CYCLES TO THE POINT THAT MY HEMOGLOBIN AND RED BLOOD CELLS DROPPED CRITICALLY LOW AGAIN THIS YEAR. I WAS IN NEED OF A BLOOD TRANSFUSION, BUT OPTED FOR IRON INFUSION TREATMENTS. MY DOCTOR WANTED TO PERFORM A HYSTERECTOMY ON ME, BUT I'M AFRAID AS HE RECENTLY ATTEMPTED AN ABLATION TO HELP WITH THE HEAVY MENSTRUAL BUT MY UTERUS PERFORATED. DURING MY MENSTRUAL CYCLE I HAVE TO WEAR THE MOST ABSORBENT TAMPON, PAD, DEPEND AND TWO PAIR OF PANTS. I HAVE SOILED THROUGH MY CLOTHES COUNTLESS TIMES AT WORK LEADING TO VERY EMBARRASSING MOMENTS. YOUR COMPANY COMPENSATED WOMEN THAT HAVE HAD THIS PROCEDURE DONE. I ASKED MY DOCTOR TO REMOVE THIS ESSURE AND HE SAID THAT HE COULDN'T, BUT WOULD HAVE TO PERFORM A HYSTERECTOMY. I DESERVE TO BE COMPENSATED FOR EVERYTHING I HAVE BEEN THROUGH BEHIND THIS PROCEDURE. I HAVE PHOTOS AND DOCUMENTATION I CAN PROVIDE. I WOULD LIKE TO FILE A CLAIM WITH YOUR COMPANY. THANKS FOR YOUR TIME! NO OTHER INFORMATION PROVIDED DISCREPANCY NOTED IN ESSURE INSERTION DATE (B)(6) 2015 & 2010. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD IRON ( 50- 112 MCG/DL)] (DATE UNKNOWN): 24. [BLOOD METHAEMOGLOBIN ( 12- 15.2 G/DL)] (DATES UNKNOWN): DROPPED CRITICALLY LOW AND 6.8 [HAEMATOCRIT ( 36- 46 %)] (DATE UNKNOWN): 23. [MEAN CELL HAEMOGLOBIN ( 23- 27 PG)] (DATE UNKNOWN): 18. [MEAN CELL VOLUME ( 82- 97 FL)] (DATE UNKNOWN): 61.5. [PLATELET COUNT] (DATE UNKNOWN): 761. [RED BLOOD CELL COUNT] (DATE UNKNOWN): DROPPED CRITICALLY LOW. [RED CELL DISTRIBUTION WIDTH ( 12.3- 17 %)] (DATE UNKNOWN): 24.1. [SERUM FERRITIN ( 13- 150 NG/ML)] (DATE UNKNOWN): 5 [SMEAR CERVIX] (DATE UNKNOWN): NORMAL [TRANSFERRIN SATURATION ( 15- 55 %)] (DATE UNKNOWN): 7 [ULTRASOUND SCAN VAGINA] (DATE UNKNOWN): UTERUS: VISUALIZED, UTERUS POSITION: ANTEVERTED UTERUS LENGTH: 128 MM UTERUS WIDTH: 112 MM [WHITE BLOOD CELL COUNT ( 3.6- 1.5 THOUSAND PER MICROLITRE)] (DATE UNKNOWN): 3.5 BATCH NO (B)(4). PRODUCTION DATE~2014-08-29 EXPIRATION DATE 2017-08-28. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 11-DEC-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). UTERUS PERFORATED [PERFORATION OF UTERUS], EXTREMELY HEAVY MENSTRUAL CYCLES [BLEEDING MENSTRUAL HEAVY], MY HEMOGLOBIN DROPPED [HEMOGLOBIN DECREASED], Y HEMOGLOBIN AND RED BLOOD CELLS DROPPED CRITICALLY LOW [RED BLOOD CELL COUNT DECREASED], MY BLOOD VOLUME DROPPED SO LOW [VOLUME BLOOD DECREASED], BREAST TISSUE PAINFUL [PAINFUL BREASTS], LUMPY BREAST [LUMPY BREASTS], WBC LOW [WHITE BLOOD CELL COUNT LOW], IRON LOW [IRON LOW], IRON SATURATION LOW [IRON SATURATION DECREASED], PALTELATE HIGH [PLATELET COUNT INCREASED], RDW [RDW INCREASED], HEMATOCRIT LOW [HEMATOCRIT DECREASED], MCV DECREASED [MEAN CELL VOLUME DECREASED], MCH DECREASED [MCH DECREASED]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("UTERUS PERFORATED") AND HEAVY MENSTRUAL BLEEDING ("EXTREMELY HEAVY MENSTRUAL CYCLES") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: D06930) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, HERNIA REPAIR, CHOLECYSTECTOMY AND CESAREAN SECTION. IN 2010, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BREAST PAIN ("BREAST TISSUE PAINFUL") AND BREAST MASS ("LUMPY BREAST") AND WAS FOUND TO HAVE HAEMOGLOBIN DECREASED ("MY HEMOGLOBIN DROPPED"), RED BLOOD CELL COUNT DECREASED ("Y HEMOGLOBIN AND RED BLOOD CELLS DROPPED CRITICALLY LOW"), VOLUME BLOOD DECREASED ("MY BLOOD VOLUME DROPPED SO LOW"), WHITE BLOOD CELL COUNT DECREASED ("WBC LOW"), BLOOD IRON DECREASED ("IRON LOW"), TRANSFERRIN SATURATION DECREASED ("IRON SATURATION LOW"), PLATELET COUNT INCREASED ("PALTELATE HIGH"), RED CELL DISTRIBUTION WIDTH INCREASED ("RDW"), HAEMATOCRIT DECREASED ("HEMATOCRIT LOW"), MEAN CELL VOLUME DECREASED ("MCV DECREASED") AND MEAN CELL HAEMOGLOBIN DECREASED ("MCH DECREASED"). THE PATIENT WAS TREATED WITH IRON (FERROUS SULFATE) AND MEDROXYPROGESTERONE (MEDROXYPROGESTERONE ACETATE) AS WELL AS SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, HAEMOGLOBIN DECREASED, RED BLOOD CELL COUNT DECREASED, UTERINE PERFORATION, VOLUME BLOOD DECREASED, BREAST PAIN, BREAST MASS, WHITE BLOOD CELL COUNT DECREASED, BLOOD IRON DECREASED, TRANSFERRIN SATURATION DECREASED, PLATELET COUNT INCREASED, RED CELL DISTRIBUTION WIDTH INCREASED, HAEMATOCRIT DECREASED, MEAN CELL VOLUME DECREASED OR MEAN CELL HAEMOGLOBIN DECREASED. THE REPORTER COMMENTED: IN 2010, I HAD THE ESSURE PROCEDURE PERFORMED. TO DATE I AM STILL HAVING MAJOR COMPLICATIONS. EXTREMELY HEAVY MENSTRUAL CYCLES TO THE POINT THAT MY HEMOGLOBIN AND RED BLOOD CELLS DROPPED CRITICALLY LOW AGAIN THIS YEAR. I WAS IN NEED OF A BLOOD TRANSFUSION, BUT OPTED FOR IRON INFUSION TREATMENTS. MY DOCTOR WANTED TO PERFORM A HYSTERECTOMY ON ME, BUT I'M AFRAID AS HE RECENTLY ATTEMPTED AN ABLATION TO HELP WITH THE HEAVY MENSTRUAL BUT MY UTERUS PERFORATED. DURING MY MENSTRUAL CYCLE I HAVE TO WEAR THE MOST ABSORBENT TAMPON, PAD, DEPEND AND TWO PAIR OF PANTS. I HAVE SOILED THROUGH MY CLOTHES COUNTLESS TIMES AT WORK LEADING TO VERY EMBARRASSING MOMENTS. YOUR COMPANY COMPENSATED WOMEN THAT HAVE HAD THIS PROCEDURE DONE. I ASKED MY DOCTOR TO REMOVE THIS ESSURE AND HE SAID THAT HE COULDN'T BUT WOULD HAVE TO PERFORM A HYSTERECTOMY. I DESERVE TO BE COMPENSATED FOR EVERYTHING I HAVE BEEN THROUGH BEHIND THIS PROCEDURE. I HAVE PHOTOS AND DOCUMENTATION I CAN PROVIDE. I WOULD LIKE TO FILE A CLAIM WITH YOUR COMPANY. THANKS FOR YOUR TIME! NO OTHER INFORMATION PROVIDED. DISCREPANCY NOTED IN ESSURE INSERTION DATE ON (B)(6) 2015 & 2010. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD IRON (50- 112 MCG/DL)] (DATE UNKNOWN): 24. [BLOOD METHAEMOGLOBIN (12- 15.2 G/DL)] (DATES UNKNOWN): DROPPED CRITICALLY LOW AND 6.8. [HAEMATOCRIT (36- 46 %)] (DATE UNKNOWN): 23. [MEAN CELL HAEMOGLOBIN (23- 27 PG)] (DATE UNKNOWN): 18. [MEAN CELL VOLUME (82- 97 FL)] (DATE UNKNOWN): 61.5. [PLATELET COUNT] (DATE UNKNOWN): 761. [RED BLOOD CELL COUNT] (DATE UNKNOWN): DROPPED CRITICALLY LOW. [RED CELL DISTRIBUTION WIDTH (12.3- 17 %)] (DATE UNKNOWN): 24.1. [SERUM FERRITIN (13- 150 NG/ML)] (DATE UNKNOWN): 5. [SMEAR CERVIX] (DATE UNKNOWN): NORMAL. [TRANSFERRIN SATURATION (15- 55 %)] (DATE UNKNOWN): 7. [ULTRASOUND SCAN VAGINA] (DATE UNKNOWN): UTERUS: VISUALIZED, UTERUS POSITION: ANTEVERTED. UTERUS LENGTH: 128 MM. UTERUS WIDTH: 112 MM. [WHITE BLOOD CELL COUNT (3.6- 1.5 THOUSAND PER MICROLITRE)] (DATE UNKNOWN): 3.5. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 27-NOV-2024: PROCESSED WITH INITIAL. 27-NOV-2024: PROCESSED WITH INITIAL. 27-NOV-2024: PROCESSED WITH INITIAL. 03-DEC-2024: PROCESSED WITH INITIAL. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608971 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 D06930 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1