BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9303596 · Received November 11, 2019

    Report

    Report Number
    2951250-2019-11352
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    April 1, 2016
    Report Date
    December 6, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: HASHIMOTO'S DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901328) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FATIGUE, ANEMIA, ASTHMA, HYPERPROLACTINEMIA, HYPOTHYROIDISM, EMOTIONAL INSTABILITY, OVARIAN CYST, ENDOMETRIOSIS EXTERNA, PILONIDAL CYST, BLOOD PRESSURE HIGH, URINARY TRACT INFECTION, DIABETES, MALIGNANT NEOPLASM OF CERVIX UTERI, HYPOTHYROIDISM, HOT FLASHES, PROLACTIN LEVELS DECREASED, VITAMIN D DEFICIENCY, CONSTIPATION, MOOD SWINGS, MENOMETRORRHAGIA AND GRAND MULTIPARITY. CONCOMITANT PRODUCTS INCLUDED BUPIVACAINE, CABERGOLINE, CEFAZOLIN, CHOLECALCIFEROL (VITAMIN D3), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), ERGOCALCIFEROL (VITAMIN D2), ETHINYLESTRADIOL; FERROUS FUMARATE; NORETHISTERONE ACETATE (LO LOESTRIN FE), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROMORPHONE, IRON, LEVONORGESTREL (MIRENA), LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), MOMETASONE FUROATE (ASMANEX) AND SALBUTAMOL (VENTOLINE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / HEAVY BLEEDING"). IN 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND INFLAMMATION ("GENERAL INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE AUTOIMMUNE THYROIDITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, ALOPECIA AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE THYROIDITIS, FATIGUE, INFLAMMATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THREE 3 COILS WERE VISIBLE ON THE PATIENT'S LEFT SIDE AND FOUR 4 COILS WERE VISIBLE ON THE PATIENT'S RIGHT SIDE. ESSURE INSERTION DATE PROVIDED IN PFS: (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: MENORRHAGIA, ANEMIA, PELVIC PAIN. LOT NUMBER: 901328, MANUFACTURING DATE: 2011-09, EXPIRATION DATE: 2014-09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER, LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ CHRONIC'), AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: HASHIMOTO'S DISEASE') AND GENITAL HAEMORRHAGE ('ABNO GEN BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901328) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FATIGUE, ANEMIA, ASTHMA, HYPERPROLACTINEMIA, HYPOTHYROIDISM, EMOTIONAL INSTABILITY, OVARIAN CYST, ENDOMETRIOSIS EXTERNA, PILONIDAL CYST, BLOOD PRESSURE HIGH, URINARY TRACT INFECTION, DIABETES, MALIGNANT NEOPLASM OF CERVIX UTERI, HYPOTHYROIDISM, HOT FLASHES, PROLACTIN LEVELS DECREASED, VITAMIN D DEFICIENCY, CONSTIPATION, MOOD SWINGS, MENOMETRORRHAGIA AND GRAND MULTIPARITY. CONCOMITANT PRODUCTS INCLUDED BUPIVACAINE, CABERGOLINE, CEFAZOLIN, COLECALCIFEROL (VITAMIN D3), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), ERGOCALCIFEROL (VITAMIN D2), ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LO LOESTRIN FE), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROMORPHONE, IRON, LEVONORGESTREL (MIRENA), LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), MOMETASONE FUROATE (ASMANEX) AND SALBUTAMOL (VENTOLINE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / HEAVY BLEEDING"). IN 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), INFLAMMATION ("GENERAL INFLAMMATION") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE AUTOIMMUNE THYROIDITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, ALOPECIA, INFLAMMATION AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE THYROIDITIS, FATIGUE, GENITAL HAEMORRHAGE, INFLAMMATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THREE 3 COILS WERE VISIBLE ON THE PATIENT'S LEFT SIDE AND FOUR 4 COILS WERE VISIBLE ON THE PATIENT'S RIGHT SIDE. ESSURE INSERTION DATE PROVIDED IN PFS : (B)(6) 2012 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2016: NOT REPORTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: MENORRHAGIA, ANEMIA, PELVIC PAIN LOT NUMBER: 901328, MANUFACTURING DATE: 2011-09, EXPIRATION DATE: 2014-09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER, LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2019: PFS RECEIVED: EVENT ABNO GEN BLEED ADDED. SUSPECT DRUG START DATE UPDATED. WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 PELVIC PAIN ('PELVIC PAIN') AND AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: HASHIMOTO'S DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901328) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FATIGUE, ANEMIA, ASTHMA, HYPERPROLACTINEMIA, HYPOTHYROIDISM, EMOTIONAL INSTABILITY, OVARIAN CYST, ENDOMETRIOSIS EXTERNA, PILONIDAL CYST, BLOOD PRESSURE HIGH, URINARY TRACT INFECTION, DIABETES, MALIGNANT NEOPLASM OF CERVIX UTERI, HYPOTHYROIDISM, HOT FLASHES, PROLACTIN LEVELS DECREASED, VITAMIN D DEFICIENCY, CONSTIPATION, MOOD SWINGS, MENOMETRORRHAGIA AND GRAND MULTIPARITY. CONCOMITANT PRODUCTS INCLUDED BUPIVACAINE, CABERGOLINE, CEFAZOLIN, CHOLECALCIFEROL (VITAMIN D3), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), ERGOCALCIFEROL (VITAMIN D2), ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LO LOESTRIN FE), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROMORPHONE, IRON, LEVONORGESTREL (MIRENA), LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), MOMETASONE FUROATE (ASMANEX) AND SALBUTAMOL (VENTOLIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / HEAVY BLEEDING"). IN 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND INFLAMMATION ("GENERAL INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE AUTOIMMUNE THYROIDITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, ALOPECIA AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE THYROIDITIS, FATIGUE, INFLAMMATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THREE 3 COILS WERE VISIBLE ON THE PATIENT'S LEFT SIDE AND FOUR 4 COILS WERE VISIBLE ON THE PATIENT'S RIGHT SIDE. ESSURE INSERTION DATE PROVIDED IN PFS : (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: MENORRHAGIA, ANEMIA, PELVIC PAIN. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER, LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY TO HERSELF" UPDATED TO "PELVIC PAIN", EVENTS- "ABNORMAL BLEEDING VAGINAL, MENORRHAGIA, AUTOIMMUNE DISORDER TYPE OF DISORDER: HASHIMOTO'S DISEASE, FATIGUE, HAIR LOSS, GENERAL INFLAMMATION", REPORTER, MEDICAL HISTORY, LAB DATA, LOT NUMBER, PATIENT DEMOGRAPHIC ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102050 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 901328 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R ASMANEX| ASMANEX| ASMANEX| BUPIVACAINE| BUPIVACAINE| BUPIVACAINE| CABERGOLINE| CABERGOLINE| CABERGOLINE| CEFAZOLIN| CEFAZOLIN| CEFAZOLIN| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| HYDROMORPHONE| HYDROMORPHONE| HYDROMORPHONE| IRON| IRON| IRON| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LO LOESTRIN FE| LO LOESTRIN FE| LO LOESTRIN FE| MIRENA| MIRENA| MIRENA| SYNTHROID| SYNTHROID| SYNTHROID| VENTOLINE [SALBUTAMOL]| VENTOLINE [SALBUTAMOL]| VENTOLINE [SALBUTAMOL]| VITAMIN D2| VITAMIN D2| VITAMIN D2| VITAMIN D3| VITAMIN D3| VITAMIN D3| YAZ| YAZ| YAZ