BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9175096 · Received October 10, 2019

    Report

    Report Number
    2951250-2019-10064
    Event Type
    Injury
    Date Received
    October 10, 2019
    Report Date
    October 29, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PAIN'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R-827923,L-841531) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC ADHESIONS (PATIENT WITH HISTORY OF FAILED ATTEMPT AT ESSURE IMPLANT PLACEMENT. ATTEMPTED LAPAROSCOPIC TUBAL LIGATION WAS UNSUCCESSFUL SECONDARY TO PELVIC ADHESIONS.), HYPERLIPIDAEMIA, LOWER ABDOMINAL PAIN, PELVIC PAIN, URINARY INCONTINENCE AND POISON IVY RASH. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IN 2004. CONCURRENT CONDITIONS INCLUDED OBESITY AND YEAST INFECTION. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN TRIHYDRATE;CLARITHROMYCIN;ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) SINCE 2000 FOR ACID REFLUX (OESOPHAGEAL), ORAL CONTRACEPTIVE NOS SINCE MARCH 2011 FOR CONTRACEPTION AND LISINOPRIL SINCE 2015 FOR HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), IRON DEFICIENCY ANAEMIA ("ANEMIA"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURIES"), BLADDER DISORDER ("BLADDER PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), GASTROINTESTINAL DISORDER ("GI CONDITION"), TOOTH DISORDER ("DENTAL PROBLEM"), MIGRAINE ("MIGRAINE"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NUERO, CONDIT/PROBLEM"), VISUAL IMPAIRMENT ("VISION PROBLEMS") AND AMNESIA ("MEMORY LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL ABLATION ON (B)(6) 2011 AND HYSTERECTOMY(PARTIAL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, DYSPAREUNIA AND WEIGHT INCREASED HAD RESOLVED, THE HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GASTROINTESTINAL DISORDER, TOOTH DISORDER, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, VISUAL IMPAIRMENT AND AMNESIA OUTCOME WAS UNKNOWN AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, BLADDER DISORDER, CYSTITIS, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2011. PATIENT RECEIVED TREATMENT FOR- BLADDER PROBS., BLADDER INFECT., UTI, VAGINAL INFECTION AND VAGINAL DISCHARGE. 3 BLEEDING COILS ON THE RIGHT SIDE OF THE TUBE AND 6 BLEEDING COILS LEFT ON THE LEFT SIDE. PATIENT HAD DONE ESSURE CONFIRMATION TEST: MIF RFDX HYSTEROSALPINGOGRAPHY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: MICRO INSERTS APPEAR APPROPRIATELY PLACED BILATERALLY WITH NO CONTRAST BEYOND EITHER CORNUA.; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 827923 MANUFACTURE DATE: 2011-02 EXPIRATION DATE: 2014-02. LOT NUMBER: 841531 MANUFACTURE DATE: 2011-03 EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PAIN'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R-827923,L-841531) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC ADHESIONS (PATIENT WITH HISTORY OF FAILED ATTEMPT AT ESSURE IMPLANT PLACEMENT. ATTEMPTED LAPAROSCOPIC TUBAL LIGATION WAS UNSUCCESSFUL SECONDARY TO PELVIC ADHESIONS.), HYPERLIPIDAEMIA, LOWER ABDOMINAL PAIN, PELVIC PAIN, URINARY INCONTINENCE AND POISON IVY RASH. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IN 2004. CONCURRENT CONDITIONS INCLUDED OBESITY AND YEAST INFECTION. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN TRIHYDRATE;CLARITHROMYCIN;ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) SINCE 2000 FOR ACID REFLUX (OESOPHAGEAL), ORAL CONTRACEPTIVE NOS SINCE MARCH 2011 FOR CONTRACEPTION AND LISINOPRIL SINCE 2015 FOR HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), IRON DEFICIENCY ANAEMIA ("ANEMIA"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURIES"), BLADDER DISORDER ("BLADDER PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), GASTROINTESTINAL DISORDER ("GI CONDITION"), TOOTH DISORDER ("DENTAL PROBLEM"), MIGRAINE ("MIGRAINE"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NEURO, CONDIT/PROBLEM"), VISUAL IMPAIRMENT ("VISION PROBLEMS") AND AMNESIA ("MEMORY LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL ABLATION ON (B)(6) 2011 AND HYSTERECTOMY(PARTIAL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, DYSPAREUNIA AND WEIGHT INCREASED HAD RESOLVED, THE HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GASTROINTESTINAL DISORDER, TOOTH DISORDER, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, VISUAL IMPAIRMENT AND AMNESIA OUTCOME WAS UNKNOWN AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, BLADDER DISORDER, CYSTITIS, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2011. PATIENT RECEIVED TREATMENT FOR- BLADDER PROBS., BLADDER INFECT., UTI, VAGINAL INFECTION AND VAGINAL DISCHARGE. 3 BLEEDING COILS ON THE RIGHT SIDE OF THE TUBE AND 6 BLEEDING COILS LEFT ON THE LEFT SIDE. PATIENT HAD DONE ESSURE CONFIRMATION TEST: MIF RFDX HYSTEROSALPINGOGRAPHY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: MICRO INSERTS APPEAR APPROPRIATELY PLACED BILATERALLY WITH NO CONTRAST BEYOND EITHER CORNUA.; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-2019: PFS RECEIVED- THIS CASE UPGRADED FROM OTHER EVENT TO INCIDENT. EVENT INJURY TO HERSELF UPDATED AND NEW EVENT DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), ANEMIA, HYPERSENSITIVITY, PSYCHOLOGICAL INJURIES, BLADDER PROBLEM, BLADDER INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, DENTAL PROBLEM, HORMONAL CHANGES, MIGRAINE, NAUSEA, NEURO, CONDIT/PROBLEM, VISION PROBLEMS, WEIGHT GAIN AND MEMORY LOSS WERE ADDED. PATIENT DEMOGRAPHY ADDED. LAB DATA WAS ADDED. FU 2 AND 3 WERE PROCESSED TOGETHER. ON 19-SEP-2019: PFS RECEIVED- NEW EVENT ABNORMAL BLEEDING (VAGINAL), GENERAL ABNORMAL BLEEDING AND ABDOMINAL PAIN WERE ADDED. PATIENT DEMOGRAPHY ADDED. MEDICAL HISTORY, LOT NUMBER AND CONCOMITANT DRUG WERE ADDED. FU 2 AND 3 WERE PROCESSED TOGETHER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970143 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 R-827923,L-841531 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R LISINOPRIL| LISINOPRIL| NEXIUM 1-2-3| NEXIUM 1-2-3| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS