BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10559752 · Received September 21, 2020

    Report

    Report Number
    2951250-2020-14521
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    January 1, 2015
    Report Date
    September 29, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND SHORT-BOWEL SYNDROME ('POST GASTRECTOMY MALABSORPTION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "SHE HAD SOME DIFFICULTY GETTING THE RIGHT COIL IMPLANTED". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CUSHING'S DISEASE, OBESITY, DIABETES, HIGH CHOLESTEROL, FIBROMYALGIA AND MALPOSITION OF UTERUS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS DICLOFENAC SINCE 2018, GABAPENTIN SINCE 2015, HYOSCYAMINE SINCE 2018, INSULIN SINCE 2014, LEVOTHYROXINE SINCE 2018, LINACLOTIDE (LINZESS) SINCE 2018, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2019, PREGABALIN (LYRICA) SINCE 2015, SERTRALINE SINCE 2017, SUMATRIPTAN SINCE (B)(6) 2019, TIZANIDINE HYDROCHLORIDE (TIZANIDIN) SINCE (B)(6) 2019 AND TOPIRAMATE (TOPIRAMAAT) SINCE 2018. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND PERINEAL PAIN ("PERINEAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN APRIL 2015, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("CHRONIC,DYSMENNORHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBS"), PITUITARY-DEPENDENT CUSHING'S SYNDROME ("CUSHINGS DISEASE"), SHORT-BOWEL SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), LUMBAR RADICULOPATHY ("LUMBAR RADICULOPATHY") AND MUSCULAR WEAKNESS ("BILATERAL LEG WEAKNESS") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS") AND PITUITARY TUMOUR BENIGN ("PITUITARY MICROADENOMA"). THE PATIENT WAS TREATED WITH NAPROXEN AND SURGERY (REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, METRORRHAGIA, IRON DEFICIENCY ANAEMIA, GASTROINTESTINAL DISORDER, ALOPECIA, HEADACHE, NAUSEA, NEOPLASM, VISUAL IMPAIRMENT, PITUITARY-DEPENDENT CUSHING'S SYNDROME, SHORT-BOWEL SYNDROME, PITUITARY TUMOUR BENIGN, LUMBAR RADICULOPATHY, MUSCULAR WEAKNESS, VAGINAL HAEMORRHAGE, MIGRAINE AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, GASTROINTESTINAL DISORDER, HEADACHE, IRON DEFICIENCY ANAEMIA, LUMBAR RADICULOPATHY, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MUSCULAR WEAKNESS, NAUSEA, NEOPLASM, PELVIC PAIN, PERINEAL PAIN, PITUITARY TUMOUR BENIGN, PITUITARY-DEPENDENT CUSHING'S SYNDROME, SHORT-BOWEL SYNDROME, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR CUSHINGS DISEASE, POST GASTRECTOMY MALABSORPTION, PITUITARY MICROADENOMA, LUMBAR RADICULOPATHY, CHRONIC,DYSMENNORHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: ESSURE CONFIRMATION TEST - TOTAL BILATERAL OCCLUSION. EVERYTHING IS OK. SATISFACTORY BILATERAL TUBAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND SHORT-BOWEL SYNDROME ('POST GASTRECTOMY MALABSORPTION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "SHE HAD SOME DIFFICULTY GETTING THE RIGHT COIL IMPLANTED". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CUSHING'S DISEASE, OBESITY, DIABETES, HIGH CHOLESTEROL, FIBROMYALGIA AND MALPOSITION OF UTERUS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS DICLOFENAC SINCE 2018, GABAPENTIN SINCE 2015, HYOSCYAMINE SINCE 2018, INSULIN SINCE 2014, LEVOTHYROXINE SINCE 2018, LINACLOTIDE (LINZESS) SINCE 2018, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2019, PREGABALIN (LYRICA) SINCE 2015, SERTRALINE SINCE 2017, SUMATRIPTAN SINCE (B)(6) 2019, TIZANIDINE HYDROCHLORIDE (TIZANIDIN) SINCE (B)(6) 2019 AND TOPIRAMATE (TOPIRAMAAT) SINCE 2018. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND PERINEAL PAIN ("PERINEAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("CHRONIC, DYSMENNORHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBS"), PITUITARY-DEPENDENT CUSHING'S SYNDROME ("CUSHINGS DISEASE"), SHORT-BOWEL SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), LUMBAR RADICULOPATHY ("LUMBAR RADICULOPATHY") AND MUSCULAR WEAKNESS ("BILATERAL LEG WEAKNESS") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS") AND PITUITARY TUMOUR BENIGN ("PITUITARY MICROADENOMA"). THE PATIENT WAS TREATED WITH NAPROXEN AND SURGERY (REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, METRORRHAGIA, IRON DEFICIENCY ANAEMIA, GASTROINTESTINAL DISORDER, ALOPECIA, HEADACHE, NAUSEA, NEOPLASM, VISUAL IMPAIRMENT, PITUITARY-DEPENDENT CUSHING'S SYNDROME, SHORT-BOWEL SYNDROME, PITUITARY TUMOUR BENIGN, LUMBAR RADICULOPATHY, MUSCULAR WEAKNESS, VAGINAL HAEMORRHAGE, MIGRAINE AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, GASTROINTESTINAL DISORDER, HEADACHE, IRON DEFICIENCY ANAEMIA, LUMBAR RADICULOPATHY, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MUSCULAR WEAKNESS, NAUSEA, NEOPLASM, PELVIC PAIN, PERINEAL PAIN, PITUITARY TUMOUR BENIGN, PITUITARY-DEPENDENT CUSHING'S SYNDROME, SHORT-BOWEL SYNDROME, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR CUSHINGS DISEASE, POST GASTRECTOMY MALABSORPTION, PITUITARY MICROADENOMA, LUMBAR RADICULOPATHY, CHRONIC DYSMENNORHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 06-MAY-2015: ESSURE CONFIRMATION TEST - TOTAL BILATERAL OCCLUSION. EVERYTHING IS OK. SATISFACTORY BILATERAL TUBAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2020: PIF RECEIVED- REMOVAL WAS ADDED. CASE BECOME INCIDENT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027507 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| DICLOFENAC| DICLOFENAC| GABAPENTIN| GABAPENTIN| HYOSCYAMINE| HYOSCYAMINE| INSULIN| INSULIN| LEVOTHYROXINE| LEVOTHYROXINE| LINZESS| LINZESS| LYRICA| LYRICA| MIRENA| MIRENA| SERTRALINE| SERTRALINE| SUMATRIPTAN| SUMATRIPTAN| TIZANIDIN| TIZANIDIN| TOPIRAMAAT| TOPIRAMAAT| ACETAMINOPHEN| DICLOFENAC| GABAPENTIN| HYOSCYAMINE| INSULIN| LEVOTHYROXINE| LINZESS| LYRICA| MIRENA| SERTRALINE| SUMATRIPTAN| TIZANIDIN| TOPIRAMAAT