BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6787595 · Received August 11, 2017

    Report

    Report Number
    2951250-2017-02827
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    April 1, 2011
    Report Date
    February 25, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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/CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING/ABNORMAL BLEEDING GENERAL") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369, 12474207) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANXIETY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES-CRAZY MOOD SWINGS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, DYSMENORRHOEA, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, VAGINAL DISCHARGE AND BACK PAIN WAS RESOLVING AND THE DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: CYSTOSCOPY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN JULY 2011: TOTAL BILATERAL OCCLUSION CURRENT WEIGHT 180 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. LOT NUMBER ADDED. EVENT ADDED AS HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE. HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS 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

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING/ABNORMAL BLEEDING GENERAL") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369,12474207 (INVALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED ANXIETY AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS ANTIBIOTICS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), MOOD SWINGS ("HORMONAL CHANGES-CRAZY MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), ANXIETY ("ANXIETY") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, DYSMENORRHOEA, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, VAGINAL DISCHARGE, BACK PAIN, FATIGUE, ALOPECIA, VAGINAL INFECTION, MIGRAINE, HEADACHE, ANXIETY AND WEIGHT INCREASED WAS RESOLVING AND THE DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: CYSTOSCOPY. THE ESSURE WAS PASSED BILATERALLY ON THE LEFT SIDE. WE HAD 2 COILS ON THE RIGHT SIDE. WE HAD APPROXIMATELY 3-4 COILS VISIBLE. THE PATIENT DID TOLERATE THE PROCEDURE EXTREMELY WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CURRENT WEIGHT 180 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUL-2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION ADDED. ADDED EVENT FATIGUE, HAIR LOSS, MIGRAINES, HEADACHES, ANXIETY, VAGINAL INFECTION , WEIGHT GAIN. UPDATED ONSET DATE,OUTCOME. ON 25-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 PELVIC PAIN ('PELVIC PAIN/CHRONIC PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY ABNORMAL BLEEDING/ABNORMAL BLEEDING GENERAL') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369,12474207) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED ANXIETY, MENORRHAGIA AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS ANTIBIOTICS. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), MOOD SWINGS ("HORMONAL CHANGES-CRAZY MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ANXIETY ("ANXIETY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN NOVEMBER 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, DYSMENORRHOEA, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, VAGINAL DISCHARGE, BACK PAIN, FATIGUE, ALOPECIA, VAGINAL INFECTION, MIGRAINE, HEADACHE, ANXIETY AND WEIGHT INCREASED WAS RESOLVING AND THE DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: CYSTOSCOPY. THE ESSURE WAS PASSED BILATERALLY ON THE LEFT SIDE. WE HAD 2 COILS ON THE RIGHT SIDE. WE HAD APPROXIMATELY 3-4 COILS VISIBLE. THE PATIENT DID TOLERATE THE PROCEDURE EXTREMELY WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. CURRENT WEIGHT 180 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150 LBS. LOT NUMBER: 822369 MANUFACTURING DATE: 2011-01 EXPIRATION DATE: 2014-01 . LOT NUMBER: 12474207 MANUFACTURING DATE: 2010/12 EXPIRATION DATE: 2013/12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-FEB-2020: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: 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. ON (B)(6) 2011, 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 LOWER ("ABDOMINAL PAIN / SEVERE CRAMPING") AND VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2014, SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED 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
    569583 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822369,12474207

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R ANTIBIOTICS| ANTIBIOTICS| DEPO-PROVERA| DEPO-PROVERA