BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056404 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08207
    Event Type
    Injury
    Date Received
    November 23, 2017
    Report Date
    August 13, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B60749) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST". CONCOMITANT PRODUCTS INCLUDED CARVEDILOL, ESOMEPRAZOLE MAGNESIUM (NEXIUM), FUROSEMIDE, LISINOPRIL, ONDANSETRON, PANADIENE CO (TYLENOL #3), ROPINIROLE HYDROCHLORIDE (REQUIP), SALBUTAMOL (VENTOLIN), SPIRONOLACTONE, TOPIRAMATE (TOPAMAX), TRAMADOL, VICODIN (NORCO) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT STARTED ZOLPIDEM AT AN UNSPECIFIED DOSE AND FREQUENCY. IN (B)(6)2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT) AND SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6)2017, PATIENT SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. NEED FOR ADDITIONAL SURGERY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-AUG-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 PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B60749) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST". CONCOMITANT PRODUCTS INCLUDED CARVEDILOL, ESOMEPRAZOLE MAGNESIUM (NEXIUM), FUROSEMIDE, LISINOPRIL, ONDANSETRON, PANADEINE CO (TYLENOL #3), ROPINIROLE HYDROCHLORIDE (REQUIP), SALBUTAMOL (VENTOLIN), SPIRONOLACTONE, TOPIRAMATE (TOPAMAX), TRAMADOL, VICODIN (NORCO) AND ZOLPIDEM TARTRATE (AMBIEN). ON AN UNKNOWN DATE, THE PATIENT STARTED ZOLPIDEM AT AN UNSPECIFIED DOSE AND FREQUENCY. ON 11-MAR-2014, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT) AND SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED IN JULY 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT APRIL 2017, PATIENT SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAY-2018: PFS AND MEDICAL RECORD RECEIVED:THE EVENT ABNORMAL VAGINAL BLEEDING, SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST ADDED.CONCURRENT CONDITION,REPORTERS,EVENTS OUTCOME,CONCOMITANT MEDICATION,LOT NUMBER 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE 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) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT) AND SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6) 2017, PATIENT SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-NOV-2017: FOLLOW UP RECEIVED VIA A SUMMONS FORM: NEW REPORTERS ADDED, NEW EVENT "PELVIC PAIN" WAS ADDED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE 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), THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6), PATIENT SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. 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
    836287 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B60749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AMBIEN| AMBIEN| CARVEDILOL| CARVEDILOL| FUROSEMIDE| FUROSEMIDE| LISINOPRIL| LISINOPRIL| NEXIUM| NEXIUM| NORCO| NORCO| ONDANSETRON| ONDANSETRON| REQUIP| REQUIP| SPIRONOLACTONE| SPIRONOLACTONE| TOPAMAX| TOPAMAX| TRAMADOL| TRAMADOL| TYLENOL #3| TYLENOL #3| VENTOLIN| VENTOLIN