BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6568898 · Received May 16, 2017

    Report

    Report Number
    2951250-2017-01919
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    January 1, 2012
    Report Date
    June 21, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE COILS HAD MIGRATED WITHIN THE FALLOPIAN TUBES') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING WITH BLOOD CLOTS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DYSURIA, FREQUENCY URINARY AND URINARY URGENCY. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAINS/ PAIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING/LOWER ABDOMEN PAIN") AND BACK PAIN ("BACK PAIN"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (EXPLORATORY MINI LAPAROTOMY AND BILATERAL ESSURE COIL REMOVAL AND BILATERAL MICROTUBAL REANASTOMOSIS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, BACK PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN LOWER, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, ALLERGY TO METALS, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS NOTED TO BE PROTRUDING FROM THE TUBAL OSTIA : LEFT SIDE. 2 COILS WERE NOTED TO BE PROTRUDING FROM THE TUBAL OSTIA : RIGHT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58.96 KGS. HYSTEROSALPINGOGRAM - IN (B)(6) 2011: RESULTS: COILS WERE PROPERLY PLACED. TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: WE RECEIVED A LOT NUMBER 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 DEVICE DISLOCATION ('ESSURE COILS HAD MIGRATED WITHIN THE FALLOPIAN TUBES') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING WITH BLOOD CLOTS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DYSURIA, FREQUENCY URINARY AND URINARY URGENCY. IN MAY 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAINS/ PAIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING/LOWER ABDOMEN PAIN") AND BACK PAIN ("BACK PAIN"). IN JUNE 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN AUGUST 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (EXPLORATORY MINI LAPAROTOMY AND BILATERAL ESSURE COIL REMOVAL AND BILATERAL MICROTUBAL REANASTOMOSIS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, BACK PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN LOWER, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, ALLERGY TO METALS, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS NOTED TO BE PROTRUDING FROM THE TUBAL OSTIA : LEFT SIDE. 2 COILS WERE NOTED TO BE PROTRUDING FROM THE TUBAL OSTIA : RIGHT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58.96 KGS. HYSTEROSALPINGOGRAM - IN AUGUST 2011: RESULTS: COILS WERE PROPERLY PLACED. TOTAL BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: PFS AND MR RECEIVED. REPORTER INFORMATION WERE ADDED. MEDICAL HISTORY AND LAB DATA WERE ADDED. DATE OF REMOVAL WERE ADDED. LOT NUMBER WERE ADDED. EVENT : UTI, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, WEIGHT GAIN, HAIR LOSS WERE ADDED. EVENT VERBATIM WERE UPDATED AS PELVIC PAINS/ PAIN, CRAMPING/LOWER ABDOMEN PAIN. OUTCOME OF THE EVENT CRAMPING/LOWER ABDOMEN PAIN, PELVIC PAINS/ PAIN WERE UPDATED. INCIDENT: WE RECEIVED A LOT NUMBER 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE COILS HAD MIGRATED WITHIN THE FALLOPIAN TUBES") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING WITH BLOOD CLOTS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAINS"), ABDOMINAL PAIN LOWER ("CRAMPING") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (EXPLORATORY MINI LAPAROTOMY AND BILATERAL ESSURE COIL REMOVAL AND BILATERAL MICROTUBAL REANASTOMOSIS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, BACK PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COILS WERE PROPERLY PLACED. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO UNSPECIFIED AGED FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ON (B)(6) 2011 AND REPORTED ADVERSE EVENTS INCLUDING ESSURE COILS HAD MIGRATED WITHIN THE FALLOPIAN TUBES AND HEAVY BLEEDING WITH BLOOD CLOTS (REGARDED AS GENITAL BLEEDING). SHE UNDERWENT EXPLORATORY MINI LAPAROTOMY AND BILATERAL ESSURE COIL REMOVAL AND BILATERAL MICROTUBAL RE-ANASTOMOSIS. IN THIS CASE, THE PLAINTIFF UNDERWENT FOLLOW UP HYSTEROSALPINGOGRAM 3 MONTHS AFTER ESSURE INSERTION. THE TEST INDICATED THAT THE COILS WERE PROPERLY PLACED. LATER SHE UNDERWENT SURGERY AND IT WAS REVEALED THAT THE ESSURE COILS HAD MIGRATED WITHIN FALLOPIAN TUBES. REGARDING GENITAL BLEEDING, IT HAS MULTIPLE CAUSES. IN THIS CASE AN ALTERNATIVE EXPLANATION WAS NOT PROVIDED FOR THIS EVENT. THE CASE WAS CLASSIFIED INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE COILS HAD MIGRATED WITHIN THE FALLOPIAN TUBES") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING WITH BLOOD CLOTS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAINS"), ABDOMINAL PAIN LOWER ("CRAMPING") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (EXPLORATORY MINI LAPAROTOMY AND BILATERAL ESSURE COIL REMOVAL AND BILATERAL MICROTUBAL REANASTOMOSIS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, BACK PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COILS WERE PROPERLY PLACED. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-MAY-2017: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO UNSPECIFIED AGED FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ON (B)(6) 2011 AND REPORTED ADVERSE EVENTS INCLUDING ESSURE COILS HAD MIGRATED WITHIN THE FALLOPIAN TUBES AND HEAVY BLEEDING WITH BLOOD CLOTS (REGARDED AS GENITAL BLEEDING). SHE UNDERWENT EXPLORATORY MINI LAPAROTOMY AND BILATERAL ESSURE COIL REMOVAL AND BILATERAL MICROTUBAL RE-ANASTOMOSIS. IN THIS CASE, THE PLAINTIFF UNDERWENT FOLLOW UP HYSTEROSALPINGOGRAM 3 MONTHS AFTER ESSURE INSERTION. THE TEST INDICATED THAT THE COILS WERE PROPERLY PLACED. LATER SHE UNDERWENT SURGERY AND IT WAS REVEALED THAT THE ESSURE COILS HAD MIGRATED WITHIN FALLOPIAN TUBES. REGARDING GENITAL BLEEDING, IT HAS MULTIPLE CAUSES. IN THIS CASE AN ALTERNATIVE EXPLANATION WAS NOT PROVIDED FOR THIS EVENT. THE CASE WAS CLASSIFIED INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350399 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 841531

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R