BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055642 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07443
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    December 1, 2012
    Report Date
    April 9, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("CANNOT WALK AS OFTEN AS I WOULD LIKE DUE TO CONSTANT PELVIC PAIN AND INFLAMMATION"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING") AND ENDOMETRIAL ADENOCARCINOMA ("BLOOD OR HEART DISORDER/CONDITION TYPE: PREMURE, TUMOR / TERATOMA / CANCER TYPE: ENDOMETRIOID") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PREGNANCY TEST- NEGATIVE. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CHLORMEZANONE (RELIZON) SINCE 2015, DIAZEPAM (VALIUM) FROM 2014 TO 2015, ESTRADIOL FROM 2014 TO 2015, NITROFURANTOIN (MACROBID) FROM 2013 TO 2017, OXYCODONE SINCE 2014, PARACETAMOL (ACETAMINOPHEN) FROM 2014 TO 2015, PROGESTERONE FROM 2014 TO 2015, TRAMADOL SINCE 2014 AND VICODIN FROM 2014 TO 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES") AND HYPERHIDROSIS ("SWEATING"). IN DECEMBER 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER") AND URINARY TRACT INFECTION ("UTI"). IN NOVEMBER 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("CANNOT WALK AS OFTEN AS I WOULD LIKE DUE TO CONSTANT PELVIC PAIN AND INFLAMMATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DEBILITATING MENSTRUAL PAIN"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), ENDOMETRIAL ADENOCARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: STOMACH WOULD SWELL"), BLOOD PRESSURE ABNORMAL ("BLOOD PRESSURE"), NAUSEA ("NAUSEA") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERGO A BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES) AND SURGERY (UNDERGO A BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, HOT FLUSH, HYPERHIDROSIS, CYSTITIS, URINARY TRACT INFECTION, ENDOMETRIAL ADENOCARCINOMA, VISION BLURRED, ABDOMINAL DISTENSION, PELVIC PAIN, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, BLOOD PRESSURE ABNORMAL, NAUSEA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ANXIETY, BLOOD PRESSURE ABNORMAL, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ADENOCARCINOMA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HOT FLUSH, HYPERHIDROSIS, MIGRAINE, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URINARY TRACT INFECTION AND VISION BLURRED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING AND NUGRAINES, SEVERE HIP AND LEG PAIN, AMONG OTHER COMPLICATIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: REPORTERS ADDED AND PATIENT DEMOGRAPHIC ADDED. ON (B)(6) 2012, SHE IMPLANTED ESSURE (PREVIOUSLY REPORTED AS (B)(6) 2012). UPDATED SUSPECT DRUG INDICATION AND LOT NUMBER ADDED. ADDED EVENTS HORMONAL CHANGES DESCRIBE: HOT FLASHES AND SWEATING, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER, UTI, BLOOD OR HEART DISORDER/CONDITION TYPE: PREMURE, TUMOR / TERATOMA / CANCER TYPE: ENDOMETRIOID, VISION/EYE PROBLEMS TYPE: BLURRY VISION, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: STOMACH WOULD SWELL, CANNOT WALK AS OFTEN AS I WOULD LIKE DUE TO CONSTANT PELVIC PAIN AND INFLAMMATION. PAINFUL INTERCOURSE, APAREUNIA, BLOOD PRESSURE, NAUSEA. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("CANNOT WALK AS OFTEN AS I WOULD LIKE DUE TO CONSTANT PELVIC PAIN AND INFLAMMATION"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING"), ENDOMETRIAL ADENOCARCINOMA ("BLOOD OR HEART DISORDER/CONDITION TYPE: PREMURE, TUMOR / TERATOMA / CANCER TYPE: ENDOMETRIOID") AND PROCEDURAL HAEMORRHAGE ("ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE : BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CYST, OVARIAN CYST AND RETROVERTED UTERUS. PREGNANCY TEST- NEGATIVE. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CHLORMEZANONE (RELIZON) SINCE (B)(6) , DIAZEPAM (VALIUM) FROM (B)(6) TO (B)(6) , ESTRADIOL FROM (B)(6) TO (B)(6) , HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) FROM (B)(6) TO (B)(6) , NITROFURANTOIN (MACROBID) FROM (B)(6) TO (B)(6) , OXYCODONE SINCE (B)(6) , PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) TO (B)(6) , PROGESTERONE FROM (B)(6) TO (B)(6) AND TRAMADOL SINCE (B)(6) . ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES") AND HYPERHIDROSIS ("SWEATING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), URINARY TRACT INFECTION ("UTI"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("CANNOT WALK AS OFTEN AS I WOULD LIKE DUE TO CONSTANT PELVIC PAIN AND INFLAMMATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DEBILITATING MENSTRUAL PAIN"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: STOMACH WOULD SWELL"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN LOWER ("CRAMPING"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), PYREXIA ("ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE : FEVER") AND PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE ENDOMETRIAL ADENOCARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD PRESSURE ABNORMAL ("BLOOD PRESSURE") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERGO A BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES AND UNDERGO A BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES, ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, ENDOMETRIAL ADENOCARCINOMA, VISION BLURRED, ABDOMINAL DISTENSION, FEMALE SEXUAL DYSFUNCTION, NAUSEA, UTERINE LEIOMYOMA, BLADDER DISORDER, URINARY TRACT DISORDER, PYREXIA AND PROCEDURAL HAEMORRHAGE OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, MIGRAINE, HOT FLUSH, HYPERHIDROSIS, CYSTITIS, URINARY TRACT INFECTION, PELVIC PAIN, DYSPAREUNIA, BLOOD PRESSURE ABNORMAL, ABDOMINAL PAIN LOWER AND VAGINAL HAEMORRHAGE WAS RESOLVING AND THE DYSMENORRHOEA, ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, BLOOD PRESSURE ABNORMAL, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ADENOCARCINOMA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HOT FLUSH, HYPERHIDROSIS, MIGRAINE, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PROCEDURAL HAEMORRHAGE, PYREXIA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VISION BLURRED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING AND MIGRAINES, SEVERE HIP AND LEG PAIN, AMONG OTHER COMPLICATIONS. PLAINTIFF STILL DEALING WITH PAIN. ESSURE PLACEMENT COILS- RIGHT -3, LEFT- 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-APR-2019: PFS RECEIVED- EVENT "FIBROIDS AND VAGINAL BLEEDING ", REPORTER ADDED. SIGNIFICANT AMENDMENT DONE EVENTS- "BLADDER PROBLEMS, URINARY PROBLEMS, STOMACH AREA PAIN, ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE : FEVER, ADVISED OF ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE : BLEEDING" ADDED FROM FU OF (B)(6) 2019. 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 GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DEBILITATING MENSTRUAL PAIN"), MIGRAINE ("MIGRAINES"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (UNDERGO A BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING AND MIGRAINES, SEVERE HIP AND LEG PAIN, AMONG OTHER COMPLICATIONS. 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
    834313 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922613

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| ESTRADIOL| ESTRADIOL| MACROBID| OTHER THERAPEUTIC PRODUCTS| OXYCODONE| OXYCODONE| PROGESTERONE| PROGESTERONE| RELIZON| RELIZON| TRAMADOL| TRAMADOL| VALIUM| VALIUM| VICODIN| VICODIN