BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6175069 · Received December 15, 2016

    Report

    Report Number
    2951250-2016-02713
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    August 29, 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

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CHRONIC PELVIC PAIN / PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. CS80003R-INV, B53554) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OVARIAN CYST, BLEED IN LUTEAL CYST, ANXIETY, DIFFICULTY SLEEPING, ENDOMETRIOSIS, ECTOPIC PREGNANCY, BURNING MICTURITION, INFECTION NOS, HEADACHE AND OVARIAN CYST. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TYLENOL AND NORCO. CONCOMITANT PRODUCTS INCLUDED ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM (NEXIUM), LORAZEPAM (ATIVAN), ONDANSETRON, PROMETHAZINE AND VICODIN (NORCO). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("SEVERE AND PAINFUL BLOATING"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND MYALGIA ("MUSCLE PAIN"). ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2014, 1 MONTH 11 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA, ABDOMINAL PAIN UPPER AND MYALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MYALGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. LOT NUMBERS AND EXP/MFG DATES BATCH NUMBER CS80003R IS INVALID BATCH NUMBER B53554 : MANUFACTURE DATE:22-07-2013 EXPIRATION DATE:31-07-2016 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-AUG-2018: UPDATE OF QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. ( UPDATE OF FDA CODES, CORRECTION OF INVALID BATCH TO VALID) INCIDENT NO VALID 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CHRONIC PELVIC PAIN / PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. CS80003R-INV, B53554) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OVARIAN CYST, BLEED IN LUTEAL CYST, ANXIETY, DIFFICULTY SLEEPING, ENDOMETRIOSIS, ECTOPIC PREGNANCY, BURNING MICTURITION, INFECTION NOS, HEADACHE AND OVARIAN CYST. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TYLENOL AND NORCO. CONCOMITANT PRODUCTS INCLUDED ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM (NEXIUM), LORAZEPAM (ATIVAN), ONDANSETRON, PROMETHAZINE AND VICODIN (NORCO). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("SEVERE AND PAINFUL BLOATING"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND MYALGIA ("MUSCLE PAIN"). ON (B)(6) 2014, 1 MONTH 11 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA, ABDOMINAL PAIN UPPER AND MYALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MYALGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. LOT NUMBERS AND EXP/MFG DATES. BATCH NUMBER CS80003R IS INVALID. BATCH NUMBER B53554 : MANUFACTURE DATE:22-07-2013 EXPIRATION DATE:31-07-2016. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-AUG-2018: UPDATE OF QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. ( UPDATE OF FDA CODES, CORRECTION OF INVALID BATCH TO VALID). 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 PAIN ("SEVERE AND CHRONIC PELVIC PAIN / PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. CS80003R, B53554) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OVARIAN CYST, BLEED IN LUTEAL CYST, ANXIETY, DIFFICULTY SLEEPING, ENDOMETRIOSIS, ECTOPIC PREGNANCY, BURNING MICTURITION AND INFECTION NOS. CONCOMITANT PRODUCTS INCLUDED ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM (NEXIUM), LORAZEPAM (ATIVAN), ONDANSETRON, PROMETHAZINE AND VICODIN (NORCO). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("SEVERE AND PAINFUL BLOATING"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND MYALGIA ("MUSCLE PAIN"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 1 MONTH 11 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA, ABDOMINAL PAIN UPPER AND MYALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MYALGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: NEW EVENTS ADDED- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN, SEVERE AND PAINFUL BLOATING, HAIR LOSS, PAIN/STOMACH PAIN AND MUSCLE PAIN. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, 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: 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 IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF IN UNITED STATES ON 18-NOV-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2013. SOMETIME AFTER IMPLANT OF THE ESSURE DEVICE, PLAINTIFF BEGAN TO EXPERIENCE ONE OR MORE OF HE FOLLOWING SYMPTOMS INCLUDING BUT NOT LIMITED TO SEVERE ABNORMAL MENSTRUAL PAIN, ABNORMAL MENSTRUAL CYCLE EXCESSIVE BLEEDING, SEVERE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, PAIN DURING INTERCOURSE, HEADACHES, ALLERGIC REACTION, MOOD SWINGS, MIGRATION OF THE DEVICE, UNWANTED PREGNANCY AND FATIGUE. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING SEVERE AND CHRONIC PELVIC PAIN AS WELL AS EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION. ON (B)(6) 2015 PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT A HYSTERECTOMY AND BILATERAL SALPINGECTOMY. FOLLOW-UP RECEIVED ON 09-DEC-2016: QUALITY SAFETY EVALUATION OF PTC. PTC GLOBAL NUMBER: (B)(4). SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN. POSSIBLE, UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. SHE UNDERWENT HYSTERECTOMY AND BILATERAL SALPINGECTOMY 18 MONTHS AFTER PLACEMENT PROCEDURE. THIS EVENT IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THE IMPLIED TEMPORAL RELATIONSHIP AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSAL RELATIONSHIP WITH ESSURE DEVICE CANNOT BE EXCLUDED. SINCE SURGICAL INTERVENTION WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. TECHNICAL ANALYSIS HAS BEEN REQUESTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827275 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 CS80003R INVALID, B53554

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R ATIVAN| ATIVAN| ATIVAN| ESOMEPRAZOLE| ESOMEPRAZOLE| ESOMEPRAZOLE| NEXIUM| NEXIUM| NEXIUM| NORCO| NORCO| NORCO| ONDANSETRON| ONDANSETRON| ONDANSETRON| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE