BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7166896 · Received January 5, 2018

    Report

    Report Number
    2951250-2018-00142
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    August 1, 2013
    Report Date
    July 20, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA DIVISION DIRECTOR, REFERENCE NUMBER: MW5033896) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("COIL MIGRATION"), PELVIC PAIN ("PERSISTENT PELVIC PAIN, SEVERE PELVIC PAIN"), RASH GENERALISED ("SKIN RASHES ON BODY, CHRONIC RASHES") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE, WHETHER AT THE ADVICE OF A PHYSICIAN OR OTHERWISE : NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3 (B)(6) 2013, (B)(6) 2004, (B)(6) 2008). PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS OF PREVIOUS PREGNANCY OR DELIVERY. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD FROM 2008 TO 2012. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND PSYCHIATRIC DISORDER NOS. IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND LICHEN PLANUS ("ONGOING SKIN DISEASE LICHEN PLANUS"). IN AUGUST 2013, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA") AND ABDOMINAL DISTENSION ("BLOATING"). IN SEPTEMBER 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN OCTOBER 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH GENERALISED (SERIOUSNESS CRITERION DISABILITY), CERVICITIS ("CHRONIC CERVICITIS"), ALLERGY TO METALS ("ALLERGIC TO NICKEL (SHE MAY HAS BEEN ALLERGIC TO A COMPONENT OF ESSURE DUE TO THE SEVERE SKIN REACTIONS THAT SHE BEGAN TO SUFFER FROM APPROXIMATELY TWO MONTHS AFTER ITS PLACEMENT IN 2013)"), INFLAMMATION ("INFLAMMATION ALL OVER HER BODY EXCEPT FOR HER FACE. (SHE FIRST BEGAN EXPERIENCING THESE REACTIONS APPROXIMATELY TWO MONTHS AFTER HER ESSURE PLACEMENT IN 2013)"), MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), SKIN IRRITATION ("IRRITATION") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY) AND SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, RASH GENERALISED, CERVICITIS, DYSMENORRHOEA, ALLERGY TO METALS, INFLAMMATION AND MENTAL DISORDER OUTCOME WAS UNKNOWN, THE PELVIC PAIN, UTERINE HAEMORRHAGE AND ABDOMINAL DISTENSION HAD RESOLVED, THE ALOPECIA, WEIGHT INCREASED, MIGRAINE AND ABDOMINAL PAIN LOWER WAS RESOLVING AND THE LICHEN PLANUS AND SKIN IRRITATION HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, CERVICITIS, DYSMENORRHOEA, INFLAMMATION, LICHEN PLANUS, MENTAL DISORDER, MIGRAINE, PELVIC PAIN, RASH GENERALISED, SKIN IRRITATION, UTERINE HAEMORRHAGE AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER AND DEVICE DISLOCATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. IN NOV- 2013, PATIENT HAD ESSURE CONFIRMATION TEST HYSTEROSALPINGOGRAM. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT NO LOT NUMBER PROVIDED; THEREFORE, NO LOT HISTORY RECORD (LHR) REVIEW COULD BE DONE. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. NO CAPA INVESTIGATION IS REQUIRED PER CRITERIA ESTABLISHED IN WI-03635, ¿PROCESSING ESSURE CASES IN DEV@COM.¿ MEDICAL ASSESSMENT THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED ¿UNCONFIRMED QUALITY DEFECT¿. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "COIL MIGRATION, CRAMPING" ADDED, EVENTS- "HAIR LOSS, MIGRAINES" OUTCOME UPDATED TO "RECOVERING/RESOLVING" ADDED FROM PFS. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FDA DIVISION DIRECTOR (REFERENCE NUMBER: MW5033896) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN, SEVERE PELVIC PAIN"), RASH GENERALISED ("SKIN RASHES ON BODY, CHRONIC RASHES") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3 ((B)(6) 2013, (B)(6) 2004, (B)(6) 2008). PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS OF PREVIOUS PREGNANCY OR DELIVERY. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD FROM 2008 TO 2012. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND PSYCHIATRIC DISORDER NOS. IN 2013, 61 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED LICHEN PLANUS ("ONGOING SKIN DISEASE LICHEN PLANUS"). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH GENERALISED (SERIOUSNESS CRITERION DISABILITY), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CERVICITIS ("CHRONIC CERVICITIS"), DYSMENORRHOEA ("DYSMENORRHEA"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), WEIGHT INCREASED ("WEIGHT GAIN"), MIGRAINE ("MIGRAINES"), ALLERGY TO METALS ("ALLERGIC TO NICKEL (SHE MAY HAS BEEN ALLERGIC TO A COMPONENT OF ESSURE DUE TO THE SEVERE SKIN REACTIONS THAT SHE BEGAN TO SUFFER FROM APPROXIMATELY TWO MONTHS AFTER ITS PLACEMENT IN 2013)"), INFLAMMATION ("INFLAMMATION ALL OVER HER BODY EXCEPT FOR HER FACE. (SHE FIRST BEGAN EXPERIENCING THESE REACTIONS APPROXIMATELY TWO MONTHS AFTER HER ESSURE PLACEMENT IN 2013)"), MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), SKIN IRRITATION ("IRRITATION") AND TREATMENT NONCOMPLIANCE ("DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE, WHETHER AT THE ADVICE OF A PHYSICIAN OR OTHERWISE : NO"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE AND ABDOMINAL DISTENSION HAD RESOLVED, THE RASH GENERALISED, CERVICITIS, DYSMENORRHOEA, ALOPECIA, WEIGHT INCREASED, MIGRAINE, ALLERGY TO METALS, INFLAMMATION, MENTAL DISORDER AND TREATMENT NONCOMPLIANCE OUTCOME WAS UNKNOWN AND THE LICHEN PLANUS AND SKIN IRRITATION HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, CERVICITIS, DYSMENORRHOEA, INFLAMMATION, LICHEN PLANUS, MENTAL DISORDER, MIGRAINE, PELVIC PAIN, RASH GENERALISED, SKIN IRRITATION, UTERINE HAEMORRHAGE AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED TREATMENT NONCOMPLIANCE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). IN (B)(6) 2013, PATIENT HAD ESSURE CONFIRMATION TEST HYSTEROSALPINGOGRAM. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT NO LOT NUMBER PROVIDED; THEREFORE, NO LOT HISTORY RECORD (LHR) REVIEW COULD BE DONE. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. NO CAPA INVESTIGATION IS REQUIRED PER CRITERIA ESTABLISHED IN (B)(4), ¿PROCESSING ESSURE CASES IN (B)(4).¿ MEDICAL ASSESSMENT THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED ¿UNCONFIRMED QUALITY DEFECT¿. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: NEW REPORTERS, PATIENT DOB, HEIGHT, HISTORICAL CONDITIONS, CONCOMITANT DISEASES, PRODUCT INDICATION, LOT NO UPDATED, ONSET AND REMOVAL DATE, CONCOMITANT DRUG, TREATMENT MEDICATION, NEW EVENTS CHRONIC CERVICITIS, DYSMENORRHEA, BLOATING, ABNORMAL UTERINE BLEEDING, HAIR LOSS, WEIGHT GAIN, MIGRAINES, LICHEN PLANUS, ALLERGIC TO NICKEL, INFLAMMATION, MENTAL DISORDER AND IRRITATION. OUTCOME FOR THE EVENTS LICHEN PLANUS, CHRONIC RASHES AND IRRITATION ADDED AS NOT RECOVERED / NOT RESOLVED AND FOR EVENTS, PELVIC PAIN, BLOATING AND ABNORMAL UTERINE BLEEDING ADDED AS RECOVERED / RESOLVED. SURGERY ADDED FOR THE EVENT PELVIC PAIN. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE,(B)(4) TO BAYER (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    11912 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R| S