BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8801213 · Received July 18, 2019

    Report

    Report Number
    2951250-2019-03981
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    January 1, 2014
    Report Date
    July 19, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LODGED IN UTERUS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B53035) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED IBUPROFEN. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DEGENERATIVE DISC DISEASE, INTERVERTEBRAL DISC BULGING, SPINAL STENOSIS, BIPOLAR DISORDER, POST-TRAUMATIC STRESS DISORDER, INSOMNIA, FOLLICULAR CYST OF OVARY AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2015, DROSPIRENONE;ETHINYLESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) FROM (B)(6) 2016 TO (B)(6) 2016 , ETHINYLESTRADIOL;NORGESTIMATE (PREVIFEM) FROM (B)(6) 2017 TO (B)(6) 2017 , MEDROXYPROGESTERONE ACETATE FROM (B)(6) 2016 TO (B)(6) 2016 AND MEGESTROL ACETATE FROM (B)(6) 2017 TO (B)(6) 2017. ON AN UNKNOWN DATE, THE PATIENT STARTED IBUPROFEN AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), LIBIDO DECREASED ("HORMONAL CHANGES DESCRIBE: REDUCED LIBIDO"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH ON STOMACH AND UNDER BREAST"), MIGRAINE ("MIGRAINES/HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN LOWER ("LOWER STOMACH PAIN"), BACK PAIN ("LOWER BACK PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH BUPROPION, LAMOTRIGINE, NAPROXEN SODIUM (NAPROXIN), TRAZODONE HYDROCHLORIDE (TRAZODON) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - LEFT OVARIES TO PREVENT MENOPAUSE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, HOT FLUSH, LIBIDO DECREASED, DEPRESSION, ANXIETY, MIGRAINE, ABDOMINAL PAIN LOWER AND BACK PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, DYSMENORRHOEA AND ABDOMINAL PAIN UPPER HAD RESOLVED AND THE DYSPAREUNIA AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, HOT FLUSH, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 268 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 200 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.1 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION ALL WAS GOOD. LOT NUMBER: B53035 MANUFACTURE DATE: 2013-07. EXPIRATION DATE: 2016-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LODGED IN UTERUS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B53035) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED IBUPROFEN. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DEGENERATIVE DISC DISEASE, INTERVERTEBRAL DISC BULGING, SPINAL STENOSIS, BIPOLAR DISORDER, POST-TRAUMATIC STRESS DISORDER, INSOMNIA, FOLLICULAR CYST OF OVARY AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2015, DROSPIRENONE;ETHINYLESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) FROM (B)(6) 2016 TO (B)(6) 2016, ETHINYLESTRADIOL;NORGESTIMATE (PREVIFEM) FROM (B)(6) 2017 TO (B)(6) 2017, MEDROXYPROGESTERONE ACETATE FROM (B)(6) 2016 TO (B)(6) 2016 AND MEGESTROL ACETATE FROM (B)(6) 2017. ON AN UNKNOWN DATE, THE PATIENT STARTED IBUPROFEN AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), LIBIDO DECREASED ("HORMONAL CHANGES DESCRIBE: REDUCED LIBIDO"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH ON STOMACH AND UNDER BREAST"), MIGRAINE ("MIGRAINES/HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN LOWER ("LOWER STOMACH PAIN"), BACK PAIN ("LOWER BACK PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH BUPROPION, LAMOTRIGINE, NAPROXEN SODIUM (NAPROXIN), TRAZODONE HYDROCHLORIDE (TRAZODONE) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - LEFT OVARIES TO PREVENT MENOPAUSE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, HOT FLUSH, LIBIDO DECREASED, DEPRESSION, ANXIETY, MIGRAINE, ABDOMINAL PAIN LOWER AND BACK PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, DYSMENORRHOEA AND ABDOMINAL PAIN UPPER HAD RESOLVED AND THE DYSPAREUNIA AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, HOT FLUSH, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.1 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION ALL WAS GOOD. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUL-2019: NEW PFS+MR RECEIVED. LOT NUMBER RECEIVED. EVENT INJURY WAS UPDATED AND NEW EVENTS: HORMONAL CHANGES DESCRIBE: HOT FLASHES; REDUCED LIBIDO, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION; ANXIETY, MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LODGED IN UTERUS, RASHES OR SKIN CONDITIONS TYPE: RASH ON STOMACH AND UNDER BREAST, MIGRAINES / HEADACHES, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN, LOWER STOMACH PAIN, LOWER BACK PAIN, STOMACH PAIN WERE ADDED. REMOVAL DETAILS ADDED. OUTCOME FOR EVENTS WERE ADDED. NEW REPORTERS AND PLAINTIFFS INFORMATION ADDED. CONCOMITANT CONDITIONS AND DRUGS WERE ADDED. LAB DATA 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
    595695 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B53035 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R DROSPIRENONE AND ETHINYL ESTRADIOL| DROSPIRENONE AND ETHINYL ESTRADIOL| MEDROXYPROGESTERONE ACETATE| MEDROXYPROGESTERONE ACETATE| MEGESTROL ACETATE| MEGESTROL ACETATE| PREVIFEM| PREVIFEM| WELLBUTRIN| WELLBUTRIN| DROSPIRENONE AND ETHINYL ESTRADIOL| MEDROXYPROGESTERONE ACETATE| MEGESTROL ACETATE| PREVIFEM| WELLBUTRIN