BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8767285 · Received July 8, 2019

    Report

    Report Number
    2951250-2019-03450
    Event Type
    Injury
    Date Received
    July 8, 2019
    Report Date
    July 15, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('A SMALL FRAGMENT OF ESSURE DEVICE WAS RETAINED'), DEVICE EXPULSION ('MISSING PIECE WAS RETAINED IN THE UTERUS'), PELVIC INFLAMMATORY DISEASE ('NORMAL X-RAY RESULTS EXCEPT FOR INFLAMMATION SEEN IN PELVIC REGION'), BARRETT'S OESOPHAGUS ('BARRETT'S ESOPHAGUS CYSTS') AND GENITAL HAEMORRHAGE ('BLEEDING/EXCESSIVE BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FREQUENCY URINARY, DYSURIA, PELVIC INFLAMMATORY DISEASE, UTI, PREGNANCY AND PID PELVIC INFLAMMATORY DISEASE. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, NAUSEA, LOW BACK PAIN, KIDNEY STONES, BLADDER INFECTION, ACUTE PHARYNGITIS, CALCULUS OF KIDNEY, ACNE, NASAL CONGESTION, ESOPHAGEAL REFLUX, NECK PAIN, THROAT PAIN, NASAL CONGESTION, RHINITIS, BREAST PAIN, CALCULUS OF KIDNEY, TRANSAMINASES INCREASED, MIGRAINE, DIZZINESS, ABDOMINAL PAIN, MALAISE, DYSMENORRHEA, BLOODY VAGINAL DISCHARGE, FEVER, COUGH, FATIGUE AND DIARRHEA. CONCOMITANT PRODUCTS INCLUDED AZITHROMYCIN (ZITHROMAX), DOCUSATE SODIUM, NORTRIPTYLINE, PANTOPRAZOLE, PARACETAMOL (ACETAMINOPHEN), SIMETICONE (SIMETHICONE), SODIUM FLUORIDE, SPIRONOLACTONE, SUMATRIPTAN AND TRIAMCINOLONE ACETONIDE. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), ALLERGY TO METALS ("NICKEL SENSITIVITY"), OVARIAN CYST ("OVARIAN CYSTS"), TOOTH DISORDER ("DENTAL ISSUES"), DRUG HYPERSENSITIVITY ("ALLERGY TO ASPIRIN"), BARRETT'S OESOPHAGUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OVULATION PAIN ("PAINFUL OVULATION"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HIRSUTISM ("EXCESSIVE HAIR GROWTH FACIAL"), MENSTRUAL DISORDER ("ABNORMAL MENSES") AND ACNE ("ACNE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, ESSURE REMOVAL). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, ALLERGY TO METALS, OVARIAN CYST, TOOTH DISORDER, WEIGHT INCREASED, DRUG HYPERSENSITIVITY, BARRETT'S OESOPHAGUS, OVULATION PAIN, GENITAL HAEMORRHAGE, HIRSUTISM, MENSTRUAL DISORDER AND ACNE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, BARRETT'S OESOPHAGUS, DEVICE BREAKAGE, DEVICE EXPULSION, DRUG HYPERSENSITIVITY, GENITAL HAEMORRHAGE, HIRSUTISM, MENSTRUAL DISORDER, OVARIAN CYST, OVULATION PAIN, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, TOOTH DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SUSPECT PRIOR TUBAL LIGATION. IMPRESSION: METALLIC OBJECT PROJECTED OVER THE MID ABDOMEN IN THE MIDLINE, PRESUMED TO REPRESENT PART OF THE SURGICAL DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2011: MINIMAL DILATATION OF THE RIGHT INTRARENAL COLLECTING SYSTEM. NO STONES SEEN. 2. MILD DIFFUSE FATTY INFILTRATION OF THE LIVER. 3, OTHERWISE, UNREMARKABLE PELVIC SONOGRAM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: IMPRESSION: .DEMONSTRATES SUCCESSFUL BILATERAL OCCLUSION OF FALLOPIAN TUBES. PATHOLOGY TEST - ON AN UNKNOWN DATE: -PROLIFERATIVE ENDOMETRIUM & SECRETORY ENDOMETRIUM WITH FOCAL SHEDDING FEATURES; NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: FALLOPIAN TUBE, INCLUDING THE ENTIRE FIMBRIATED END, SHOWING CONGESTION & EVIDENCE OF COMPLETE TRANSECTION; NO EVIDENCE OF DYSPLASIA OR MALIGNANCY. C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: FALLOPIAN TUBE, INCLUDING THE ENTIRE FIMBRIATED END, SHOWING CONGESTION, PARATUBAL CYSTS & EVIDENCE OF COMPLETE TRANSECTION; NO EVIDENCE OF DYSPLASIA OR MALIGNANCY. D. UTERUS AND CERVIX, WITH FALLOPIAN TUBES, HYSTERECTOMY: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. NABOTHIAN CYSTS. ATROPHIC/INACTIVE TO WEAKLY PROLIFERATIVE ENDOMETRIUM; NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE CONFIRMED VIA PATIENTS MEDICAL RECORD : WEIGHT GAIN, DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, DEVICE BREAKAGE, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUL-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. NO LOT NUMBER WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 DEVICE BREAKAGE ('A SMALL FRAGMENT OF ESSURE DEVICE WAS RETAINED'), DEVICE EXPULSION ('MISSING PIECE WAS RETAINED IN THE UTERUS'), PELVIC INFLAMMATORY DISEASE ('NORMAL X-RAY RESULTS EXCEPT FOR INFLAMMATION SEEN IN PELVIC REGION'), BARRETT'S OESOPHAGUS ('BARRETT'S ESOPHAGUS CYSTS') AND GENITAL HAEMORRHAGE ('BLEEDING/EXCESSIVE BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FREQUENCY URINARY, DYSURIA, PELVIC INFLAMMATORY DISEASE, UTI, PREGNANCY AND PID PELVIC INFLAMMATORY DISEASE. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, NAUSEA, LOW BACK PAIN, KIDNEY STONES, BLADDER INFECTION, ACUTE PHARYNGITIS, CALCULUS OF KIDNEY, ACNE, NASAL CONGESTION, ESOPHAGEAL REFLUX, NECK PAIN, THROAT PAIN, NASAL CONGESTION, RHINITIS, BREAST PAIN, CALCULUS OF KIDNEY, TRANSAMINASES INCREASED, MIGRAINE, DIZZINESS, ABDOMINAL PAIN, MALAISE, DYSMENORRHEA, BLOODY VAGINAL DISCHARGE, FEVER, COUGH, FATIGUE AND DIARRHEA. CONCOMITANT PRODUCTS INCLUDED AZITHROMYCIN (ZITHROMAX), DOCUSATE SODIUM, NORTRIPTYLINE, PANTOPRAZOLE, PARACETAMOL (ACETAMINOPHEN), SIMETICONE (SIMETHICONE), SODIUM FLUORIDE, SPIRONOLACTONE, SUMATRIPTAN AND TRIAMCINOLONE ACETONIDE. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), ALLERGY TO METALS ("NICKEL SENSITIVITY"), OVARIAN CYST ("OVARIAN CYSTS"), TOOTH DISORDER ("DENTAL ISSUES"), DRUG HYPERSENSITIVITY ("ALLERGY TO ASPIRIN"), BARRETT'S OESOPHAGUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OVULATION PAIN ("PAINFUL OVULATION"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HIRSUTISM ("EXCESSIVE HAIR GROWTH FACIAL"), MENSTRUAL DISORDER ("ABNORMAL MENSES") AND ACNE ("ACNE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, ESSURE REMOVAL). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, ALLERGY TO METALS, OVARIAN CYST, TOOTH DISORDER, WEIGHT INCREASED, DRUG HYPERSENSITIVITY, BARRETT'S OESOPHAGUS, OVULATION PAIN, GENITAL HAEMORRHAGE, HIRSUTISM, MENSTRUAL DISORDER AND ACNE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, BARRETT'S OESOPHAGUS, DEVICE BREAKAGE, DEVICE EXPULSION, DRUG HYPERSENSITIVITY, GENITAL HAEMORRHAGE, HIRSUTISM, MENSTRUAL DISORDER, OVARIAN CYST, OVULATION PAIN, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, TOOTH DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SUSPECT PRIOR TUBAL LIGATION. IMPRESSION: METALLIC OBJECT PROJECTED OVER THE MID ABDOMEN IN THE MIDLINE, PRESUMED TO REPRESENT PART OF THE SURGICAL DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2011: MINIMAL DILATATION OF THE RIGHT INTRARENAL COLLECTING SYSTEM. NO STONES SEEN. MILD DIFFUSE FATTY INFILTRATION OF THE LIVER. OTHERWISE, UNREMARKABLE PELVIC SONOGRAM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: IMPRESSION: .DEMONSTRATES SUCCESSFUL BILATERAL OCCLUSION OF FALLOPIAN TUBES. PATHOLOGY TEST - ON AN UNKNOWN DATE: PROLIFERATIVE ENDOMETRIUM & SECRETORY ENDOMETRIUM WITH FOCAL SHEDDING FEATURES; NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: FALLOPIAN TUBE, INCLUDING THE ENTIRE FIMBRIATED END, SHOWING CONGESTION & EVIDENCE OF COMPLETE TRANSECTION; NO EVIDENCE OF DYSPLASIA OR MALIGNANCY. LEFT FALLOPIAN TUBE, SALPINGECTOMY: FALLOPIAN TUBE, INCLUDING THE ENTIRE FIMBRIATED END, SHOWING CONGESTION, PARATUBAL CYSTS & EVIDENCE OF COMPLETE TRANSECTION; NO EVIDENCE OF DYSPLASIA OR MALIGNANCY. UTERUS AND CERVIX, WITH FALLOPIAN TUBES, HYSTERECTOMY: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. NABOTHIAN CYSTS. ATROPHIC/INACTIVE TO WEAKLY PROLIFERATIVE ENDOMETRIUM; NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE CONFIRMED VIA PATIENTS MEDICAL RECORD: WEIGHT GAIN, DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, DEVICE BREAKAGE, PELVIC PAIN. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560947 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ACETAMINOPHEN| ACETAMINOPHEN| DOCUSATE SODIUM| DOCUSATE SODIUM| NORTRIPTYLINE| NORTRIPTYLINE| PANTOPRAZOLE| PANTOPRAZOLE| SIMETHICONE| SIMETHICONE| SODIUM FLUORIDE| SODIUM FLUORIDE| SPIRONOLACTONE| SPIRONOLACTONE| SUMATRIPTAN| SUMATRIPTAN| TRIAMCINOLONE ACETONIDE| TRIAMCINOLONE ACETONIDE| ZITHROMAX| ZITHROMAX| ACETAMINOPHEN| DOCUSATE SODIUM| NORTRIPTYLINE| PANTOPRAZOLE| SIMETHICONE| SODIUM FLUORIDE| SPIRONOLACTONE| SUMATRIPTAN| TRIAMCINOLONE ACETONIDE| ZITHROMAX