BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6944342 · Received October 12, 2017

    Report

    Report Number
    2951250-2017-04590
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    January 1, 2012
    Report Date
    January 21, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ABDOMINOPLASTY, AUGMENTATION MAMMOPLASTY AND CHOLECYSTECTOMY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PELVIC PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL PERIODS/DYSMENORRHOEA -CRAMPING."). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"), MENORRHAGIA ("ABNORMAL BLEEDING-MENORRHAGIA/HEAVY PERIODS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, FATIGUE AND PELVIC PAIN HAD RESOLVED AND THE ABDOMINAL DISTENSION, DEPRESSION, MIGRAINE, HEADACHE, ALLERGY TO METALS, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OR ABOUT (B)(6) OR (B)(6), PLAINTIFF UNDERWENT THE ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGECTOMY - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS AND MEDICAL RECORD RECEIVED: REPORTER INFORMATION, PATIENT DETAILS, OTHER RELEVANT HISTORY, LAB DATA, PRODUCT INFORMATION, CONCOMITANT DRUGS AND EVENTS: ABNORMAL BLEEDING (VAGINAL), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, MIGRAINES, HEADACHES, NICKEL ALLERGY, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT GAIN, PELVIC PAIN WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND UTERINE HAEMORRHAGE ("HEMATOMETRA") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINOPLASTY, AUGMENTATION MAMMOPLASTY AND CHOLECYSTECTOMY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PELVIC PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL PERIODS/DYSMENORRHOEA -CRAMPING."). IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING-MENORRHAGIA/HEAVY PERIODS") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, FATIGUE AND PELVIC PAIN HAD RESOLVED AND THE ABDOMINAL DISTENSION, DEPRESSION, MIGRAINE, HEADACHE, ALLERGY TO METALS, DYSPAREUNIA, WEIGHT INCREASED AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OR ABOUT 2011 OR 2012, PLAINTIFF UNDERWENT THE ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGECTOMY - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. REPORTERS INFORMATION UPDATED. EVENT:HEMATOMETRA WAS 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ABDOMINOPLASTY, AUGMENTATION MAMMOPLASTY AND CHOLECYSTECTOMY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PELVIC PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL PERIODS/DYSMENORRHOEA -CRAMPING."). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"), MENORRHAGIA ("ABNORMAL BLEEDING-MENORRHAGIA/HEAVY PERIODS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMSCONDITION: DEPRESSION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, FATIGUE AND PELVIC PAIN HAD RESOLVED AND THE ABDOMINAL DISTENSION, DEPRESSION, MIGRAINE, HEADACHE, ALLERGY TO METALS, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OR ABOUT 2011 OR 2012, PLAINTIFF UNDERWENT THE ESSURE PROCEDURE . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGECTOMY - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), DYSMENORRHOEA ("PAINFUL PERIODS") AND MENORRHAGIA ("HEAVY PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A SURGICAL REMOVAL OF THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL DISTENSION, DYSMENORRHOEA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OR ABOUT 2011 OR 2012, PLAINTIFF UNDERWENT THE ESSURE PROCEDURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724915 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 863581

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R DEPO PROVERA| DEPO PROVERA| DEPO PROVERA