BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6916672 · Received October 5, 2017

    Report

    Report Number
    2951250-2017-04324
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    February 3, 2009
    Report Date
    August 7, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627755) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: YASMIN FROM 2005 TO 2006. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED NAUSEA WITH YASMIN. CONCURRENT CONDITIONS INCLUDED OBESITY AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED OMEPRAZOLE (PRILOSEC) FROM 2008 TO 2017 FOR GERD AND TOPIRAMATE (TOPAMAX) SINCE 2011 FOR MIGRAINE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PELVIC PAIN/PAIN"). IN (B)(6) 2009, THE PATIENT EXPERIENCED ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2009, THE PATIENT EXPERIENCED INCONTINENCE ("INCONTINENCE"). IN (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), RASH ("RASHES"), PRURITUS ("EXTREME ITCHING"), ABDOMINAL DISTENSION ("SEVERE BLOATING") AND LOSS OF LIBIDO ("LOSS OF LIBIDO"). THE PATIENT WAS TREATED WITH SURGERY ((SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY), BILATERAL SALPINGOOOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, RASH, PRURITUS, ABDOMINAL DISTENSION, LOSS OF LIBIDO AND HEADACHE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA, DYSMENORRHOEA, ALLERGY TO METALS, ABNORMAL WEIGHT GAIN, ALOPECIA, MIGRAINE, FEMALE SEXUAL DYSFUNCTION, INCONTINENCE, FATIGUE AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, INCONTINENCE, LOSS OF LIBIDO, MIGRAINE, NAUSEA, PELVIC PAIN, PRURITUS AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS FORCED TO UNDERGO A MAJOR SURGERY AS A RESULT OF HER ESSURE IMPLANTS. CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 ("CHRONIC ABDOMINAL PAIN") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627755) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: YASMIN FROM 2005 TO 2006. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED NAUSEA WITH YASMIN. CONCURRENT CONDITIONS INCLUDED OBESITY AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED OMEPRAZOLE (PRILOSEC) FROM 2008 TO 2017 FOR GERD AND TOPIRAMATE (TOPAMAX) SINCE 2011 FOR MIGRAINE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PELVIC PAIN/PAIN"). IN (B)(6) 2009, THE PATIENT EXPERIENCED ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2009, THE PATIENT EXPERIENCED INCONTINENCE ("INCONTINENCE"). IN (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), RASH ("RASHES"), PRURITUS ("EXTREME ITCHING"), ABDOMINAL DISTENSION ("SEVERE BLOATING") AND LOSS OF LIBIDO ("LOSS OF LIBIDO"). THE PATIENT WAS TREATED WITH SURGERY ((SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY), BILATERAL SALPINGOOOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, RASH, PRURITUS, ABDOMINAL DISTENSION, LOSS OF LIBIDO AND HEADACHE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA, DYSMENORRHOEA, ALLERGY TO METALS, ABNORMAL WEIGHT GAIN, ALOPECIA, MIGRAINE, FEMALE SEXUAL DYSFUNCTION, INCONTINENCE, FATIGUE AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, INCONTINENCE, LOSS OF LIBIDO, MIGRAINE, NAUSEA, PELVIC PAIN, PRURITUS AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS FORCED TO UNDERGO A MAJOR SURGERY AS A RESULT OF HER ESSURE IMPLANTS. CURRENT WEIGHT 250 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. ESSURE INSERTION DATE UPDATED TO (B)(6) 2009. CONCOMITANT MEDICATIONS ADDED. LOT NUMBER ADDED. EVENTS APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), INCONTINENCE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, HEADACHES, NAUSEA, PELVIC PAIN) 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"), ABDOMINAL DISTENSION ("SEVERE BLOATING"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN"), RASH ("RASHES"), PRURITUS ("EXTREME ITCHING"), LOSS OF LIBIDO ("LOSS OF LIBIDO") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT SURGICAL REMOVAL OF THE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ABDOMINAL DISTENSION, ALOPECIA, MIGRAINE, BACK PAIN, RASH, PRURITUS, LOSS OF LIBIDO AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, LOSS OF LIBIDO, MIGRAINE, PRURITUS AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS FORCED TO UNDERGO A MAJOR SURGERY AS A RESULT OF HER ESSURE IMPLANTS. 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
    697661 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 627755

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R PRILOSEC| PRILOSEC| TOPAMAX| TOPAMAX