BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9179725 · Received October 11, 2019

    Report

    Report Number
    2951250-2019-09941
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    January 1, 2013
    Report Date
    October 24, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781437-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL (2015) AND SLEEVE GASTRECTOMY (2012). CURRENT WEIGHT 150 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HASHIMOTO'S THYROIDITIS, HOT FLASHES, NIGHT SWEATS, VAGINAL BURNING SENSATION AND FALLOPIAN TUBE CYST. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) FROM 2008 TO 2010 FOR CONTRACEPTION AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2017 TO (B)(6)2018, ESTRADIOL (ESTRACE)(B)(6)2016 TO 2017, ESTRADIOL SINCE (B)(6)2018, LEVOTHYROXINE SODIUM (SYNTHROID) FROM 2006 TO 2019, PROGESTERONE (PROMETRIUM) FROM (B)(6)2018 TO (B)(6)2018 AND THYROID (ARMOUR THYROID) SINCE 2006. ON (B)(6)2010, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL INFECTION ("VAGINITIS"), DERMATITIS ALLERGIC ("FOOD SENSITIVITY RASH/ ALLERGIC RASH"), ATROPHIC VULVOVAGINITIS ("VAGINAL ATROPHY") AND LICHEN SCLEROSUS ("LICHEN SCLEROSUS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL IMBALANCE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL INFECTION AND LICHEN SCLEROSUS HAD RESOLVED AND THE HORMONE LEVEL ABNORMAL, DERMATITIS ALLERGIC AND ATROPHIC VULVOVAGINITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ATROPHIC VULVOVAGINITIS, DERMATITIS ALLERGIC, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, LICHEN SCLEROSUS, MENORRHAGIA, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT COILS: 2 RIGHT COILS: 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2011: TOTAL BILATERAL OCCLUSION. LOT NUMBER REPORTED (781437 ) IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-2019: FU 4 AND PTC PROCESSED TOGETHER. UPDATE OF INFORMATION (BATCH IS NOT VALID) ON 8-OCT-2019: PFS RECEIVED. REPORTER INFORMATION UPDATED. NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781437) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL (2015) AND SLEEVE GASTRECTOMY (2012). CURRENT WEIGHT (B)(6). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HASHIMOTO'S THYROIDITIS, HOT FLASHES, NIGHT SWEATS, VAGINAL BURNING SENSATION AND FALLOPIAN TUBE CYST. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) FROM 2008 TO 2010 FOR CONTRACEPTION AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2017 TO (B)(6) 2018, ESTRADIOL (ESTRACE)(B)(6) 2016 TO 2017, ESTRADIOL SINCE (B)(6) 2018, LEVOTHYROXINE SODIUM (SYNTHROID) FROM 2006 TO 2019, PROGESTERONE (PROMETRIUM) FROM (B)(6) 2018 TO (B)(6) 2018 AND THYROID (ARMOUR THYROID) SINCE 2006. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL INFECTION ("VAGINITIS"), DERMATITIS ALLERGIC ("FOOD SENSITIVITY RASH"), ATROPHIC VULVOVAGINITIS ("VAGINAL ATROPHY") AND LICHEN SCLEROSUS ("LICHEN SCLEROSUS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL IMBALANCE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL INFECTION AND LICHEN SCLEROSUS HAD RESOLVED AND THE HORMONE LEVEL ABNORMAL, DERMATITIS ALLERGIC AND ATROPHIC VULVOVAGINITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ATROPHIC VULVOVAGINITIS, DERMATITIS ALLERGIC, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, LICHEN SCLEROSUS, MENORRHAGIA, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT COILS: 2 RIGHT COILS: 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2019: PFS AND MR RECEIVED. DATE OF EXPLANT ADDED. THIS CASE WAS UPGRADED FROM OTHER EVENT TO INCIDENT. LOT NUMBER ADDED. EVENT INJURY WAS UPDATED TO PAIN. FOLLOWING EVENTS WERE ADDED: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) HORMONAL IMBALANCE, FOOD SENSITIVITY RASH, VAGINAL ATROPHY, VAGINITIS, LICHEN SCLEROSIS AND DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG AND LAB DATA WERE ADDED. INCIDENT 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
    974387 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 781437-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R ARMOUR THYROID| ARMOUR THYROID| ESTRACE| ESTRACE| ESTRADIOL| ESTRADIOL| NUVARING| NUVARING| PROMETRIUM [PROGESTERONE]| PROMETRIUM [PROGESTERONE]| SYNTHROID| SYNTHROID| WELLBUTRIN| WELLBUTRIN