BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6939870 · Received October 11, 2017

    Report

    Report Number
    2951250-2017-04531
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    June 1, 2015
    Report Date
    July 22, 2020
    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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: C35244) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 AND CESAREAN SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NEXPLANON. CONCOMITANT PRODUCTS INCLUDED SERTRALINE. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN JUNE 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES/ HEADACHE PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"), FATIGUE ("FATIGUE,") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (HYSTERECTOMY, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, VISION BLURRED, FATIGUE, WEIGHT INCREASED AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 154LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 154LBS, LEFT FALLOPIAN TUBE: 2 COILS RIGHT COILS: 3 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION, SHOWED COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES. PELVIC PAIN, DEPRESSION, DYSMENORRHEA, HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-DEC-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C35244) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 AND CESAREAN SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NEXPLANON. CONCOMITANT PRODUCTS INCLUDED SERTRALINE. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES/ HEADACHE PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"), FATIGUE ("FATIGUE,") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("2 MONTH OLD E-BABY"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (HYSTERECTOMY, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, VISION BLURRED, FATIGUE, WEIGHT INCREASED, ALOPECIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 154LBS APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 154LBS, LEFT FALLOPIAN TUBE: 2 COILS RIGHT COILS: 3 COILS. MOST, IF NOT ALL SYMPTOMS- DECREASED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION, SHOWED COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES. PELVIC PAIN, DEPRESSION, DYSMENORRHEA, HEADACHE, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2020: SOCIAL MEDIA RECEIVED- NEW EVENT 2 MONTH OLD E-BABY AND DEVICE INEFFECTIVE WERE ADDED. REPORTER INFORMATION WAS ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C35244) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 AND CESAREAN SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NEXPLANON. CONCOMITANT PRODUCTS INCLUDED SERTRALINE. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES/ HEADACHE PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"), FATIGUE ("FATIGUE,") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("2 MONTH OLD E-BABY"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (HYSTERECTOMY, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, VISION BLURRED, FATIGUE, WEIGHT INCREASED, ALOPECIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 154LBS APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 154LBS, LEFT FALLOPIAN TUBE: 2 COILS RIGHT COILS: 3 COILS. MOST, IF NOT ALL SYMPTOMS- DECREASED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION, SHOWED COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES. PELVIC PAIN, DEPRESSION, DYSMENORRHEA, HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUL-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL 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
    722281 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 C35244

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R IBUPROFEN| SERTRALINE| SERTRALINE| SERTRALINE| SERTRALINE