BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7420520 · Received April 11, 2018

    Report

    Report Number
    2951250-2018-01671
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    December 1, 2011
    Report Date
    August 7, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE"), PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY, DIABETES SINCE 2002, HYPERTENSION SINCE 2002, URINARY FREQUENCY, BENIGN OVARIAN CYST, ANEMIA AND HYPERTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN) SINCE 1974, ATENOLOL SINCE 2002, GLIPIZIDE SINCE 2002, GLYCERYL TRINITRATE (NITROGLYCERIN) SINCE APRIL 2012, HYDROCODONE SINCE 2002, LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2002, METFORMIN SINCE 2002, POTASSIUM SINCE NOVEMBER 2012 AND TRAZODONE SINCE 2006. IN 2011, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDER"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 MONTH 12 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAIN DURING SEXUAL INTERCOURSE)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION / MENORRHAGIA"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN / LEFT LOWER QUADRANT"), BACK PAIN ("BACK PAIN HEN NOT MENSTRUATING") AND PAIN IN EXTREMITY ("CHRONIC LEG PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF MIGRAINE ("MIGRAINE HEADACHES"), THE SECOND EPISODE OF MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT FLUCTUATION ("WEIGHT GAIN /WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("SEVERE HIP PAIN"), VAGINAL INFECTION ("VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE, LOSS OF LIBIDO ("LOSS OF LIBIDO"), MALAISE ("GENERAL MALAISE"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"), DEPRESSION ("WORSENING OF HER DEPRESSION"), ANXIETY ("ANXIETY"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATION"), ABDOMINAL DISTENSION ("STOMACH BLOATING"), NAUSEA ("NAUSEA") AND DYSPEPSIA ("DYSPEPSIA"). THE PATIENT WAS TREATED WITH PAROXETINE HYDROCHLORIDE (PAXIL), SURGERY (ON (B)(6) 2017, UNILATERAL SALPINGOOOPHERECTOMY) AND SURGERY (ON (B)(6) 2017, UNILATERAL SALPINGOOOPHERECTOMY TO REMOVE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, ARTHRALGIA, PAIN IN EXTREMITY, VAGINAL INFECTION, LOSS OF LIBIDO, MALAISE, ALOPECIA, DYSGEUSIA, WEIGHT FLUCTUATION, DEPRESSION, ANXIETY, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, THE LAST EPISODE OF MIGRAINE, HEADACHE, FATIGUE, ABDOMINAL DISTENSION, NAUSEA, GASTROINTESTINAL DISORDER AND DYSPEPSIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, LOSS OF LIBIDO, MALAISE, MENORRHAGIA, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF MIGRAINE AND THE SECOND EPISODE OF MIGRAINE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: HAS NOT YET UNDERGONE SURGERY TO REMOVE THE ESSURE MICRO-INSERTS, AND STILL SUFFERS TO THIS DAY FROM THE SYMPTOMS. ON (B)(6) 2016, ESSURE DEVICE NEEDED TO BE REMOVED BECAUSE OF CYST AND OTHER DAMAGE TO LEFT OVARY AND FALLOPIAN TUBE AND UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.2 KG/SQM. HYSTEROSALPINGOGRAM - ON 5-JAN-2012: CONFIRMING FULL OCCLUSION OF FALLOPIANTUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENTS DYSMENORRHEA, PELVIC PAIN, DEPRESSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT ). INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE"), PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DIABETES SINCE 2002 AND HYPERTENSION SINCE 2002. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN) SINCE 1974, ATENOLOL SINCE 2002, GLIPIZIDE SINCE 2002, GLYCERYL TRINITRATE (NITROGLYCERIN) SINCE (B)(6) 2012, HYDROCODONE SINCE 2002, LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2002, METFORMIN SINCE 2002, POTASSIUM SINCE (B)(6) 2012 AND TRAZODONE SINCE 2006. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 MONTH 12 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAIN DURING SEXUAL INTERCOURSE)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION / MENORRHAGIA"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN / LEFT LOWER QUADRANT"), BACK PAIN ("BACK PAIN HEN NOT MENSTRUATING") AND PAIN IN EXTREMITY ("CHRONIC LEG PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF MIGRAINE ("MIGRAINE HEADACHES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT FLUCTUATION ("WEIGHT GAIN /WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("SEVERE HIP PAIN"), VAGINAL INFECTION ("VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE, LOSS OF LIBIDO ("LOSS OF LIBIDO"), MALAISE ("GENERAL MALAISE"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"), DEPRESSION ("WORSENING OF HER DEPRESSION"), ANXIETY ("ANXIETY"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATION"), THE SECOND EPISODE OF MIGRAINE ("MIGRAINES"), ABDOMINAL DISTENSION ("STOMACH BLOATING"), NAUSEA ("NAUSEA"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDER") AND DYSPEPSIA ("DYSPEPSIA"). THE PATIENT WAS TREATED WITH PAROXETINE HYDROCHLORIDE (PAXIL), SURGERY (ON (B)(6) 2017, UNILATERAL SALPINGOOOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, ARTHRALGIA, PAIN IN EXTREMITY, VAGINAL INFECTION, LOSS OF LIBIDO, MALAISE, ALOPECIA, DYSGEUSIA, WEIGHT FLUCTUATION, DEPRESSION, ANXIETY, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, THE LAST EPISODE OF MIGRAINE, HEADACHE, FATIGUE, ABDOMINAL DISTENSION, NAUSEA, GASTROINTESTINAL DISORDER AND DYSPEPSIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, LOSS OF LIBIDO, MALAISE, MENORRHAGIA, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT FLUCTUATION, THE FIRST EPISODE OF MIGRAINE AND THE SECOND EPISODE OF MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS NOT YET UNDERGONE SURGERY TO REMOVE THE ESSURE MICRO-INSERTS, AND STILL SUFFERS TO THIS DAY FROM THE SYMPTOMS. ON (B)(6) 2016, ESSURE DEVICE NEEDED TO BE REMOVED BECAUSE OF CYST AND OTHER DAMAGE TO LEFT OVARY AND FALLOPIAN TUBE AND UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. CONCOMITANT DISEASE, CONCOMITANT DRUGS, WERE ADDED. UPDATED SUSPECT DRUG INDICATION, INSERTION AND REMOVAL DATE AND LOT NUMBER. EVENTS MIGRATION OF ESSURE, ABNORMAL BLEEDING, VAGINAL BLEEDING, APAREUNIA, MIGRAINES, HEADACHES, FATIGUE, STOMACH BLOATING, NAUSEA, GASTROINTESTINAL DISORDER, DYSPEPSIA ADDED, EVENT ONSET DATE WAS ADDED, EVENT OUTCOME WAS ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265617 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 863570

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R ASPIRIN| ASPIRIN| ATENOLOL| ATENOLOL| GLIPIZIDE| GLIPIZIDE| HYDROCODONE| HYDROCODONE| METFORMIN| METFORMIN| NITROGLYCERIN| NITROGLYCERIN| POTASSIUM| POTASSIUM| SYNTHROID| SYNTHROID| TRAZODONE| TRAZODONE| ASPIRIN| ATENOLOL| GLIPIZIDE| HYDROCODONE| METFORMIN| NITROGLYCERIN| POTASSIUM| SYNTHROID| TRAZODONE