BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8784084 · Received July 12, 2019

    Report

    Report Number
    2951250-2019-03782
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    January 1, 2016
    Report Date
    July 17, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    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 ABDOMINAL PAIN ('ABDOMINAL PAIN'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND NEUROPATHY PERIPHERAL ('NEUROPATHY-BILATERAL ARM') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN, PAIN, MUSCULOSKELETAL PAIN, PAIN IN ARM, SPOTTING VAGINAL, COUGH, URIC ACID NEPHROLITHIASIS, DRUG HYPERSENSITIVITY, PAIN IN HIP, SUNBURN, STOMACH PAIN, NEUROPATHY, DEPRESSION, EMOTIONAL LABILITY AND HEADACHE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD AND GABAPENTIN. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING, MUSCLE CRAMPS, INSOMNIA, MIGRAINE, PHOTOPHOBIA, NAUSEA, DIARRHEA, ABDOMINAL PAIN, GERD, OBESITY, APPENDECTOMY, HEPATIC STEATOSIS, MENOMETRORRHAGIA, MENSES IRREGULAR, NEUROPATHIC PAIN AND PAIN ESOPHAGEAL. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL; CAFFEINE; PARACETAMOL (FIORICET), CELECOXIB (CELEXA), DICLOFENAC POTASSIUM (CAMBIA), DICLOFENAC SINCE 2014, HYDROCODONE BITARTRATE; PARACETAMOL (NORCO) FROM 2014 TO 2015, HYOSCINE (SCOPOLAMINE) SINCE 2018, IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, NAPROXEN (NAPROSYN), NARATRIPTAN HYDROCHLORIDE (AMERGE) FROM 2014 TO 2017, ONDANSETRON HYDROCHLORIDE (ZOFRAN) FROM 2014 TO 2018, PREGABALIN (LYRICA) SINCE MARCH 2013, PROCHLORPERAZINE FROM 2014 TO 2018, RIZATRIPTAN BENZOATE (MAXALT), SUMATRIPTAN, SUMATRIPTAN SUCCINATE (IMITREX DF) AND TIZANIDINE FROM 2014 TO 2015. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/VAGINAL PAIN (DURING SEX)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). IN 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("PAIN IN LOWER BACK"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NEUROPATHY PERIPHERAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES/ HEADACHE") AND VULVOVAGINAL PAIN ("VAGINAL PAIN (DURING SEX)"). THE PATIENT WAS TREATED WITH FLUOXETINE HYDROCHLORIDE (PROZAC), GABAPENTIN AND SURGERY (DILATION AND CURETTAGE AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, NEUROPATHY PERIPHERAL, BACK PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, NAUSEA, NEUROPATHY PERIPHERAL, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THREE COILS WERE VISUALIZED IN THE ENDOMETRIAL CAVITY ON THE RIGHT SIDE AND THREE ON THE LEFT. DISCREPANCY IN INSERTION DATE - PREVIOUSLY (B)(6) 2012 AND NOW IN PFS (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL TUBAL BLOCKAGE; ON (B)(6) 2012: SATISFACTORY PLACEMENT OF THE MICRO-INSERTS IN THE BILATERAL FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUL-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 ABDOMINAL PAIN ('ABDOMINAL PAIN'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND NEUROPATHY PERIPHERAL ('NEUROPATHY-BILATERAL ARM') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN, PAIN, MUSCULOSKELETAL PAIN, PAIN IN ARM, PER VAGINAL BLEEDING, COUGH, URIC ACID NEPHROLITHIASIS, DRUG HYPERSENSITIVITY, PAIN IN HIP, SUNBURN, STOMACH PAIN, NEUROPATHY, DEPRESSION, EMOTIONAL LABILITY AND HEADACHE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD AND GABAPENTIN. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING, CRAMP, INSOMNIA, MIGRAINE, PHOTOPHOBIA, NAUSEA, DIARRHEA, ABDOMINAL PAIN, GERD, OBESITY, APPENDECTOMY, HEPATIC STEATOSIS, MENOMETRORRHAGIA, MENSES IRREGULAR, NEUROPATHIC PAIN AND PAIN ESOPHAGEAL. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), CELECOXIB (CELEXA), DICLOFENAC POTASSIUM (CAMBIA), DICLOFENAC SINCE 2014, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) FROM 2014 TO 2015, HYOSCINE (SCOPOLAMINE) SINCE 2018, IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, NAPROXEN, NARATRIPTAN HYDROCHLORIDE (AMERGE) FROM 2014 TO 2017, ONDANSETRON HYDROCHLORIDE (ZOFRAN) FROM 2014 TO 2018, PREGABALIN (LYRICA) SINCE (B)(6) 2013, PROCHLORPERAZINE FROM 2014 TO 2018, RIZATRIPTAN BENZOATE (MAXALT), SUMATRIPTAN, SUMATRIPTAN SUCCINATE (IMITREX DF) AND TIZANIDINE FROM 2014 TO 2015. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). IN 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("PAIN IN LOWER BACK"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NEUROPATHY PERIPHERAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VULVOVAGINAL PAIN ("VAGINAL PAIN (DURING SEX)") AND MIGRAINE ("MIGRAINES/ HEADACHE"). THE PATIENT WAS TREATED WITH FLUOXETINE HYDROCHLORIDE (PROZAC), GABAPENTIN AND SURGERY (DILATION AND CURETTAGE AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, NEUROPATHY PERIPHERAL, VULVOVAGINAL PAIN, BACK PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSPAREUNIA, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, NAUSEA, NEUROPATHY PERIPHERAL, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THREE COILS WERE VISUALIZED IN THE ENDOMETRIAL CAVITY ON THE RIGHT SIDE AND THREE ON THE LEFT. DISCREPANCY IN INSERTION DATE - PREVIOUSLY (B)(6) 2012 AND NOW IN PFS (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL TUBAL BLOCKAGE; ON (B)(6) 2012: SATISFACTORY PLACEMENT OF THE MICRO-INSERTS IN THE BILATERAL FALLOPIAN TUBES.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUL-2019: PFS RECEIVED. THIS CASE BECAME INCIDENT. PREVIOUSLY REPORTED EVENT INJURY NOS WAS REPLACED WITH NEW EVENTS FROM PFS- ABDOMINAL PAIN, PAIN IN LOWER BACK, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINES, HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, VAGINAL PAIN (DURING SEX), NEUROPATHY-BILATERAL ARM, PATIENT DETAILS, NEW REPORTER INFORMATION, LAB DATA, MEDICAL HISTORY WERE ADDED. LOT NUMBER, RACE, PATIENT DETAILS, MEDICAL HISTORY, NEW REPORTER INFORMATION, LAB TEST, PRODUCT INFORMATION WERE ADDED. ON 01-JUL-2019: FU 2 AND FU 3 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-CONFORMANCE'S 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
    577451 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882183 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R AMERGE.| AMERGE.| CAMBIA.| CAMBIA.| CELEXA [CELECOXIB].| CELEXA [CELECOXIB].| DEPO-PROVERA.| DEPO-PROVERA.| DICLOFENAC.| DICLOFENAC.| FIORICET.| FIORICET.| IBUPROFEN.| IBUPROFEN.| IMITREX DF.| IMITREX DF.| LYRICA.| LYRICA.| MAXALT.| MAXALT.| NAPROSYN [NAPROXEN].| NAPROXEN.| NORCO.| NORCO.| PROCHLORPERAZINE.| PROCHLORPERAZINE.| SCOPOLAMINE [HYOSCINE].| SCOPOLAMINE [HYOSCINE].| SUMATRIPTAN.| SUMATRIPTAN.| TIZANIDINE.| TIZANIDINE.| TORADOL.| TORADOL.| ZOFRAN [ONDANSETRON HYDROCHLORIDE].| ZOFRAN [ONDANSETRON HYDROCHLORIDE].| AMERGE| CAMBIA| CELEXA [CELECOXIB]| DEPO-PROVERA| DICLOFENAC| FIORICET| IBUPROFEN| IMITREX DF| LYRICA| MAXALT| NAPROXEN| NORCO| PROCHLORPERAZINE| SCOPOLAMINE [HYOSCINE]| SUMATRIPTAN| TIZANIDINE| TORADOL| ZOFRAN [ONDANSETRON HYDROCHLORIDE]