BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12195835 · Received July 20, 2021

    Report

    Report Number
    2951250-2021-02922
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    September 1, 2015
    Report Date
    July 23, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER VIA A LAWYER AND DESCRIBES THE OCCURRENCE OF MULTIPLE EPISODES OF PELVIC PAIN ('PELVIC PAIN / SEVERE ABDOMINAL PELVIC PAINS ON THE SIDES OF THE BODY TOWARDS THE FALLOPIAN TUBES', 'SEVERE PELVIC PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B02267) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENARCHE (AT 12 YEARS-OLD) IN 2004, PARITY 4 (VAGINAL DELIVERIES) AND MULTI GRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL SYNDROME. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (MEDROXIPROGESTERONA) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("SHE FEELS PAIN DURING ESSURE PLACEMENT"). IN (B)(6) 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN ON THE LEFT SIDE"), FATIGUE ("FATIGUE"), ALOPECIA ("EXCESSIVE HAIR LOSS"), MIGRAINE ("SEVERE MIGRAINE") AND THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2020, THE PATIENT EXPERIENCED VARICOSE VEINS PELVIC ("PELVIC VARICOSE VEINS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CHEST PAIN ("CHEST PAIN"). IN (B)(6) 2020, THE PATIENT EXPERIENCED SCAR INFLAMMATION ("SCAR INFLAMMATION"). ON (B)(6) 2020, THE PATIENT EXPERIENCED THE SECOND EPISODE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND THE SECOND EPISODE OF DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREMENSTRUAL SYNDROME ("MILD PREMENSTRUAL SYNDROME") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH BROMOPRIDE (BROMOPRIDA), CEFAZOLIN (CEFAZOLINA), DIAZEPAM (DIAZEPAN), DICLOFENAC POTASSIUM (LFM DICLOFENACO DE POTASSIO), DIMETICONE (LUFTAL), HYOSCINE BUTYLBROMIDE (HIOSCINA), IBUPROFEN (IBUPROFENO), KETOPROFEN (CETOPROFENO), METAMIZOLE SODIUM (DIPIRONA), MORPHINE (MORFINA), SIMETICONE (SIMETICONA) AND SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGRECTOMY ON (B)(6) 2020). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PROCEDURAL PAIN, ABDOMINAL PAIN, CHEST PAIN, FATIGUE, ALOPECIA, MIGRAINE, SCAR INFLAMMATION, PREMENSTRUAL SYNDROME, VARICOSE VEINS PELVIC, NAUSEA, THE LAST EPISODE OF PELVIC PAIN AND THE LAST EPISODE OF DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CHEST PAIN, FATIGUE, MIGRAINE, NAUSEA, PREMENSTRUAL SYNDROME, PROCEDURAL PAIN, SCAR INFLAMMATION, VARICOSE VEINS PELVIC, THE FIRST EPISODE OF DYSPAREUNIA, THE FIRST EPISODE OF PELVIC PAIN, THE SECOND EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE PLACEMENT WAS PERFORMED WITHOUT COMPLICATION, 1 COIL IN THE RIGHT TUBE AND 4 COILS IN THE LEFT TUBE . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD HEAVY METAL TEST - ON (B)(6) 2020: LOWER THAN 2.00 MCG/L (PEOPLE NOT EXPOSED LOWER THAN 2.00 MCG/L). HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2015: NEGATIVE; ON (B)(6) 2020: NEGATIVE. PATHOLOGY TEST - ON (B)(6) 2020: MATERIAL: LEFT AND RIGHT TUBES; MACROSCOPIC: LEFT FALLOPIAN TUBE MEASURING 3.7X0.7 CM WITH SMOOTH AND SHINY SEROSA. THE SECTIONS SHOW VIRTUAL LIGHT, RIGHT UTERINE TUBE MEASURING 4.0X0.6 CM WITH SMOOTH AND SHINY SEROSA. AT CUTS IT DISPLAYS VIRTUAL LIGHT. CONCLUSION BOTH TUBES WITHOUT SIGNIFICANT ALTERATIONS. RED BLOOD CELL ANALYSIS - ON (B)(6) 2020: RESULTS UNREMARKABLE. SMEAR TEST - ON (B)(6) 2020: SMEAR CERVIX NORMAL. ULTRASOUND ABDOMEN - ON (B)(6) 2020: HEPATIC FATTY INFILTRATION. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: ESSURE WAS NORMOPOSITIONED; ON (B)(6) 2020: SHOW ESSURE WAS NORMOPOSITIONED AND PELVIC VARICOSE VEINS. URINE ANALYSIS - ON (B)(6) 2020: NORMAL. WHITE BLOOD CELL ANALYSIS - ON (B)(6) 2020: RESULTS UNREMARKABLE. LOT NUMBER:B02267 MANUFACTURING DATE: 2013-02 EXPIRATION DATE:2016-02. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUL-2021: QUALITY SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MULTIPLE EPISODES OF PELVIC PAIN ('PELVIC PAIN / SEVERE ABDOMINAL PELVIC PAINS ON THE SIDES OF THE BODY TOWARDS THE FALLOPIAN TUBES', 'SEVERE PELVIC PAIN') IN A (B)(6) -YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B02267) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENARCHE (AT (B)(6) YEARS-OLD) IN 2004, PARITY 4 (VAGINAL DELIVERIES) AND MULTI GRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL SYNDROME. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (MEDROXIPROGESTERONA) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("SHE FEELS PAIN DURING ESSURE PLACEMENT"). IN (B)(6) 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN ON THE LEFT SIDE"), FATIGUE ("FATIGUE"), ALOPECIA ("EXCESSIVE HAIR LOSS"), MIGRAINE ("SEVERE MIGRAINE") AND THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2020, THE PATIENT EXPERIENCED VARICOSE VEINS PELVIC ("PELVIC VARICOSE VEINS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CHEST PAIN ("CHEST PAIN"). IN (B)(6) 2020, THE PATIENT EXPERIENCED SCAR INFLAMMATION ("SCAR INFLAMMATION"). ON (B)(6) 2020, THE PATIENT EXPERIENCED THE SECOND EPISODE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND THE SECOND EPISODE OF DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREMENSTRUAL SYNDROME ("MILD PREMENSTRUAL SYNDROME") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH BROMOPRIDE (BROMOPRIDA), CEFAZOLIN (CEFAZOLINA), DIAZEPAM (DIAZEPAN), DICLOFENAC POTASSIUM (LFM DICLOFENACO DE POTASSIO), DIMETICONE (LUFTAL), HYOSCINE BUTYLBROMIDE (HIOSCINA), IBUPROFEN (IBUPROFENO), KETOPROFEN (CETOPROFENO), METAMIZOLE SODIUM (DIPIRONA), MORPHINE (MORFINA), SIMETICONE (SIMETICONA) AND SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGRECTOMY ON (B)(6) 2020). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PROCEDURAL PAIN, ABDOMINAL PAIN, CHEST PAIN, FATIGUE, ALOPECIA, MIGRAINE, SCAR INFLAMMATION, PREMENSTRUAL SYNDROME, VARICOSE VEINS PELVIC, NAUSEA, THE LAST EPISODE OF PELVIC PAIN AND THE LAST EPISODE OF DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, CHEST PAIN, FATIGUE, MIGRAINE, NAUSEA, PREMENSTRUAL SYNDROME, PROCEDURAL PAIN, SCAR INFLAMMATION, VARICOSE VEINS PELVIC, THE FIRST EPISODE OF DYSPAREUNIA, THE FIRST EPISODE OF PELVIC PAIN, THE SECOND EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE PLACEMENT WAS PERFORMED WITHOUT COMPLICATION, 1 COIL IN THE RIGHT TUBE AND 4 COILS IN THE LEFT TUBE . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD HEAVY METAL TEST - ON (B)(6) 2020: LOWER THAN 2.00 MCG/L (PEOPLE NOT EXPOSED LOWER THAN 2.00 MCG/L). HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2015: NEGATIVE; ON (B)(6) 2020: NEGATIVE. PATHOLOGY TEST - ON (B)(6) 2020: MATERIAL: LEFT AND RIGHT TUBES; MACROSCOPIC: LEFT FALLOPIAN TUBE MEASURING 3.7X0.7 CM WITH SMOOTH AND SHINY SEROSA. THE SECTIONS SHOW VIRTUAL LIGHT, RIGHT UTERINE TUBE MEASURING 4.0X0.6 CM WITH SMOOTH AND SHINY SEROSA. AT CUTS IT DISPLAYS VIRTUAL LIGHT. CONCLUSION BOTH TUBES WITHOUT SIGNIFICANT ALTERATIONS. RED BLOOD CELL ANALYSIS - ON (B)(6) 2020: RESULTS UNREMARKABLE. SMEAR TEST - ON (B)(6) 2020: SMEAR CERVIX NORMAL. ULTRASOUND ABDOMEN - ON (B)(6) 2020: HEPATIC FATTY INFILTRATION. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: ESSURE WAS NORMOPOSITIONED; ON (B)(6) 2020: SHOW ESSURE WAS NORMOPOSITIONED AND PELVIC VARICOSE VEINS. URINE ANALYSIS - ON (B)(6) 2020: NORMAL. WHITE BLOOD CELL ANALYSIS - ON (B)(6) 2020: RESULTS UNREMARKABLE. WE RECEIVED A LOT NUMBER IN THIS CASE. 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
    1094721 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B02267 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]