BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055639 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07430
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    August 1, 2010
    Report Date
    August 20, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/PAIN"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) HEAVY BLEEDING"), BARRETT'S OESOPHAGUS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BARRETT'S ESOPHAGUS") AND CHOLECYSTECTOMY ("SURGERY (OTHER) TYPE OF SURGERY: GALL BLADDER REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227411) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED EYE DISORDER AND PREGNANCY. CONCURRENT CONDITIONS INCLUDED ACID REFLUX (OESOPHAGEAL) SINCE 2010, HAEMORRHOIDS, SCIATICA, OVARIAN CYST, URINARY TRACT INFECTION, ENDOMETRIOSIS, FIBROMYALGIA, GASTROESOPHAGEAL REFLUX DISEASE AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED BUPROPION (WELLBUTRIN) FROM 2012 TO 2015, HYDROCORTISONE SINCE 2013, LIDOCAINE SINCE 2013, MELATONIN SINCE 2013, OMEPRAZOLE SINCE 2012, PANTOPRAZOLE SODIUM (SOMAC) SINCE 2012 AND PROCTOFOAM [HYDROCORTISONE ACETATE,PRAMOCAINE HYDROCHLORIDE]. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) HEAVIER THAN NORMAL BLEEDING DURING PERIOD WHICH ALSO OCCURED TWICE A MONTH AND LASED 3-10 DAY"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) HEAVIER THAN NORMAL BLEEDING DURING PERIOD WHICH ALSO OCCURED TWICE A MONTH AND LASED 3-10 DAY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) DURING PERIOD SEVERE STABBING PAIN"), FATIGUE ("FATIGUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE INCREASE IN AMOUNT AND CHANGE IN COLOR AND SMELL"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("KNEE PAIN") AND VAGINAL ODOUR ("VAGINAL DISCHARGE INCREASE IN AMOUNT AND CHANGE IN COLOR AND SMELL"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2010, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("HORMONAL CHANGES DESCRIBE: CHANGES IN PERIOD.") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: CHANGES IN PERIOD, MOOD SWINGS"). IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NAUSEA ("NAUSEA DURING PERIOD"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), FUNGAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS, HAD YEAST INFECTION BEFORE BUT INCREASED WITH ESSURE"), MIGRAINE ("MIGRAINES / HEADACHES I STARTED HAVING SEVERE MIGRAINE A COUPLE TIMES A MONTH") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION HAS WORSENED"). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) VAGINAL PAIN AND PELVIC PAIN") AND VULVOVAGINAL PAIN ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) VAGINAL PAIN AND PELVIC PAIN"). IN 2014, THE PATIENT UNDERWENT CHOLECYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: INCONTINENCE, LEAKING LOW URINE PRESSURE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES: BLADDER FELL") AND OLIGURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: INCONTINENCE, BLADDER FELL, LEAKING LOW URINE PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BARRETT'S OESOPHAGUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("MIGRAINES / HEADACHES STARTED HAVING SEVERE MIGRAINE A COUPLE TIMES A MONTH"), ALLERGY TO METALS ("NICKEL ALLERGY, HAD ISSUE WITH NICKEL AND JEWELLERY"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL PAIN UPPER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-STOMACH PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL(UTERUS AND CERVIX REMOVED)., BILATERAL SALPINGECTOMY.), ALTERNATIVE THERAPY (CHIROPRACTOR), ALTERNATIVE THERAPY (CHIROPRACTOR) AND ALTERNATIVE THERAPY (CHIROPRACTOR). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND FUNGAL INFECTION HAD RESOLVED, THE AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, MENORRHAGIA, URINARY INCONTINENCE, BLADDER DISORDER, OLIGURIA, DYSMENORRHOEA, DYSPAREUNIA, BARRETT'S OESOPHAGUS, MENSTRUAL DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, CHOLECYSTECTOMY, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, ARTHRALGIA, VULVOVAGINAL PAIN, ABDOMINAL PAIN UPPER AND VAGINAL ODOUR OUTCOME WAS UNKNOWN AND THE FATIGUE, ALOPECIA, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, BARRETT'S OESOPHAGUS, BLADDER DISORDER, CHOLECYSTECTOMY, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, OLIGURIA, PELVIC PAIN, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL ODOUR, VISUAL IMPAIRMENT, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.7 KG/SQM. HYSTEROSALPINGOGRAM - IN AUGUST 2010: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PFS AND MR RECEIVED. EVENTS PER PFS: ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER OR URINARY PROBLEMS OR CHANGES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BARRETT'S ESOPHAGUS, HAIR LOSS, HORMONAL CHANGES DESCRIBE: CHANGES IN PERIOD, MOOD SWINGS, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS, MIGRAINES / HEADACHES, NAUSEA, NICKEL ALLERGY, PAIN, SURGERY (OTHER) TYPE OF SURGERY: GALL BLADDER REMOVAL, VAGINAL DISCHARGE, VISION/EYE PROBLEMS TYPE: VISION HAS WORSENED, WEIGHT GAIN, PATIENT'S MEDICAL HISTORY WAS ADDED, OUTCOME OF THE EVENTS WERE UPDATED. 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

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/PAIN/ WASHINGTON OB/OYN ASSOCIATE DID MINE. SHE DID A WONDERFUL JOB AND NO COMPLICATIONS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) HEAVY BLEEDING"), BARRETT'S OESOPHAGUS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BARRETT'S ESOPHAGUS") AND CHOLECYSTECTOMY ("SURGERY (OTHER) TYPE OF SURGERY: GALL BLADDER REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227411) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED EYE DISORDER AND PREGNANCY. CONCURRENT CONDITIONS INCLUDED ACID REFLUX (OESOPHAGEAL) SINCE 2010, HAEMORRHOIDS, SCIATICA, OVARIAN CYST, URINARY TRACT INFECTION, ENDOMETRIOSIS, FIBROMYALGIA, GASTROESOPHAGEAL REFLUX DISEASE AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED BUPROPION (WELLBUTRIN) FROM 2012 TO 2015, HYDROCORTISONE SINCE 2013, LIDOCAINE SINCE 2013, MELATONIN SINCE 2013, OMEPRAZOLE SINCE 2012, PANTOPRAZOLE SODIUM (SOMAC) SINCE 2012 AND PRAMOCAINE HYDROCHLORIDE (PROCTOFOAM). IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) HEAVIER THAN NORMAL BLEEDING DURING PERIOD WHICH ALSO OCCURED TWICE A MONTH AND LASED 3-10 DAY"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) HEAVIER THAN NORMAL BLEEDING DURING PERIOD WHICH ALSO OCCURED TWICE A MONTH AND LASED 3-10 DAY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) DURING PERIOD SEVERE STABBING PAIN"), FATIGUE ("FATIGUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE INCREASE IN AMOUNT AND CHANGE IN COLOR AND SMELL"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("KNEE PAIN") AND VAGINAL ODOUR ("VAGINAL DISCHARGE INCREASE IN AMOUNT AND CHANGE IN COLOR AND SMELL"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2010, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("HORMONAL CHANGES DESCRIBE: CHANGES IN PERIOD.") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: CHANGES IN PERIOD, MOOD SWINGS"). IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NAUSEA ("NAUSEA DURING PERIOD"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS, HAD YEAST INFECTION BEFORE BUT INCREASED WITH ESSURE"), MIGRAINE ("MIGRAINES / HEADACHES I STARTED HAVING SEVERE MIGRAINE A COUPLE TIMES A MONTH") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION HAS WORSENED"). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) VAGINAL PAIN AND PELVIC PAIN") AND VULVOVAGINAL PAIN ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) VAGINAL PAIN AND PELVIC PAIN"). IN 2014, THE PATIENT UNDERWENT CHOLECYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: INCONTINENCE, LEAKING LOW URINE PRESSURE"), BLADDER PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES: BLADDER FELL") AND OLIGURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: INCONTINENCE, BLADDER FELL, LEAKING LOW URINE PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BARRETT'S OESOPHAGUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("MIGRAINES / HEADACHES STARTED HAVING SEVERE MIGRAINE A COUPLE TIMES A MONTH"), ALLERGY TO METALS ("NICKEL ALLERGY, HAD ISSUE WITH NICKEL AND JEWELLERY"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL PAIN UPPER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-STOMACH PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL(UTERUS AND CERVIX REMOVED)., BILATERAL SALPINGECTOMY.), ALTERNATIVE THERAPY (CHIROPRACTOR), ALTERNATIVE THERAPY (CHIROPRACTOR) AND ALTERNATIVE THERAPY (CHIROPRACTOR). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL MYCOTIC INFECTION HAD RESOLVED, THE AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, MENORRHAGIA, URINARY INCONTINENCE, BLADDER PROLAPSE, OLIGURIA, DYSMENORRHOEA, DYSPAREUNIA, BARRETT'S OESOPHAGUS, MENSTRUAL DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, CHOLECYSTECTOMY, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, ARTHRALGIA, VULVOVAGINAL PAIN, ABDOMINAL PAIN UPPER AND VAGINAL ODOUR OUTCOME WAS UNKNOWN AND THE FATIGUE, ALOPECIA, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, BARRETT'S OESOPHAGUS, BLADDER PROLAPSE, CHOLECYSTECTOMY, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, OLIGURIA, PELVIC PAIN, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL ODOUR, VISUAL IMPAIRMENT, VULVOVAGINAL MYCOTIC INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.7 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2010: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-2018: QUALITY SAFETY EVALUATION OF 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 PELVIC PAIN ("PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. 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
    834310 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 20227411

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R HYDROCORTISONE| HYDROCORTISONE| LIDOCAINE| LIDOCAINE| MELATONIN| MELATONIN| OMEPRAZOLE| OMEPRAZOLE| PROCTOFOAM [PRAMOCAINE HYDROCHLORIDE]| PROCTOFOAM [PRAMOCAINE HYDROCHLORIDE]| SOMAC| SOMAC| WELLBUTRIN| WELLBUTRIN