BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10605156 · Received September 30, 2020

    Report

    Report Number
    2951250-2020-14717
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    July 31, 2015
    Report Date
    October 1, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 / PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184, 893015) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY, PAP SMEAR ABNORMAL, CARPAL TUNNEL RELEASE, VITAMIN D DEFICIENCY AND GASTROESOPHAGEAL REFLUX DISEASE. (B)(6) 2011 : URINE PREGNANCY TEST : NEGATIVE. CONCURRENT CONDITIONS INCLUDED PERINEAL PAIN, MORBID OBESITY, UMBILICAL HERNIA, HIRSUTISM, UTERINE BLEEDING, NABOTHIAN CYST, UTERINE FIBROID, DIABETIC NEUROPATHY, WEAKNESS, DIABETES MELLITUS, EPIGASTRIC PAIN, INDIGESTION, DYSPEPSIA, STOMACH PAIN, CONSTIPATION, HYPERTENSION AND ANGIOPATHY. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FOR UTERINE BLEEDING AS WELL AS ACETYLSALICYLIC ACID (ASPIRIN) SINCE (B)(6) 2016, AMITRIPTYLINE, AMLODIPINE, ATORVASTATIN, CILOSTAZOL, EXENATIDE (BYETTA), GABAPENTIN, INSULIN ASPART (NOVOLOG), INSULIN DETEMIR (LEVEMIR), INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) FROM (B)(6) 2015 TO (B)(6) 2016, LIRAGLUTIDE (VICTOZA), LISINOPRIL, METFORMIN, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN), MORPHINE, MORPHINE SULFATE (MS CONTIN), NALTREXONE, NORETHISTERONE ACETATE (AYGESTIN), OMEPRAZOLE, OXYCODONE, PARACETAMOL (ACETAMINOPHEN) AND PREGABALIN (LYRICA) SINCE (B)(6) 2016. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), 24 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") AND BACK PAIN ("LOWER BACK AREA PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND DYSPAREUNIA HAD NOT RESOLVED AND THE UTERINE HAEMORRHAGE AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT AND LEFT SIDE - 1 COIL WAS VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. BATCH NUMBER: 882184, EXP DATE:2014/07, MAN DATE:2011/07. BATCH NUMBER: 893015, EXP DATE:2014-08-31, MAN DATE:2011/08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. 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 / PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184, 893015) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY, PAP SMEAR ABNORMAL, CARPAL TUNNEL RELEASE, VITAMIN D DEFICIENCY AND GASTROESOPHAGEAL REFLUX DISEASE. CONCURRENT CONDITIONS INCLUDED PERINEAL PAIN, MORBID OBESITY, UMBILICAL HERNIA, HIRSUTISM, UTERINE BLEEDING, NABOTHIAN CYST, UTERINE FIBROID, DIABETIC NEUROPATHY, WEAKNESS, DIABETES MELLITUS, EPIGASTRIC PAIN, INDIGESTION, DYSPEPSIA, STOMACH PAIN, CONSTIPATION, HYPERTENSION AND ANGIOPATHY. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FOR UTERINE BLEEDING AS WELL AS ACETYLSALICYLIC ACID (ASPIRIN) SINCE (B)(6) 2016, AMITRIPTYLINE, AMLODIPINE, ATORVASTATIN, CILOSTAZOL, EXENATIDE (BYETTA), GABAPENTIN, INSULIN ASPART (NOVOLOG), INSULIN DETEMIR (LEVEMIR), INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) FROM (B)(6) 2015 TO (B)(6) 2016, LIRAGLUTIDE (VICTOZA), LISINOPRIL, METFORMIN, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN), MORPHINE, MORPHINE SULFATE (MS CONTIN), NALTREXONE, NORETHISTERONE ACETATE (AYGESTIN), OMEPRAZOLE, OXYCODONE, PARACETAMOL (ACETAMINOPHEN) AND PREGABALIN (LYRICA) SINCE (B)(6) 2016. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), 24 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") AND BACK PAIN ("LOWER BACK AREA PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND DYSPAREUNIA HAD NOT RESOLVED AND THE UTERINE HAEMORRHAGE AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT AND LEFT SIDE - 1 COIL WAS VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: (B)(6) 2011 : URINE PREGNANCY TEST : NEGATIVE. BATCH NUMBER: 882184 EXP DATE:(B)(6) 2014 MAN DATE:(B)(6) 2011. BATCH NUMBER: 893015 EXP DATE:(B)(6) 2014 MAN DATE:(B)(6) 2011. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2020: PFS RECEIVED: CASE BECOME SERIOUS INCIDENT. REMOVAL OF ESSURE REPORTED. PREVIOUSLY ADDED EVENT "ABNORMAL UTERINE BLEEDING" DOWNGRADED TO NON-SERIOUS EVENT. SURGERY ADDED TO EVENT PELVIC PAIN. ACTION TAKEN WITH DRUG WAS UPDATED. 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 RELEVANT 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
    1074571 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882184, 893015 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| AMITRIPTYLINE| AMITRIPTYLINE| AMLODIPINE| AMLODIPINE| ASPIRIN [ACETYLSALICYLIC ACID]| ASPIRIN [ACETYLSALICYLIC ACID]| ATORVASTATIN| ATORVASTATIN| AYGESTIN| AYGESTIN| BYETTA| BYETTA| CILOSTAZOL| CILOSTAZOL| GABAPENTIN| GABAPENTIN| IUD NOS| IUD NOS| LEVEMIR| LEVEMIR| LISINOPRIL| LISINOPRIL| LYRICA| LYRICA| METFORMIN| METFORMIN| MIRENA| MIRENA| MORPHINE| MORPHINE| MS CONTIN| MS CONTIN| NALTREXONE| NALTREXONE| NOVOLOG| NOVOLOG| OMEPRAZOLE| OMEPRAZOLE| OXYCODONE| OXYCODONE| REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]| REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]| VICTOZA| VICTOZA