ESSURE
Report
- Report Number
- 2951250-2018-02334
- Event Type
- Injury
- Date Received
- May 22, 2018
- Date of Event
- March 1, 2015
- 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
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CONSTANT PELVIC PAIN/ PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"), THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A16628-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVARING AND CRYSELLE. CONCURRENT CONDITIONS INCLUDED ABNORMAL CERVICAL CYTOLOGY, LOOP ELECTROSURGICAL EXCISION PROCEDURE SINCE (B)(6) 2014, CYSTITIS INTERSTITIAL, CONSTIPATION CHRONIC, GROIN ABSCESS, URINARY URGENCY, ADENOMYOSIS, OVARIAN CYST, UMBILICAL HERNIA, STENOSIS, POLYP OF VAGINA, MULTIPLE ALLERGIES SINCE 2011, ANXIETY SINCE 2012, STRESS SINCE 2012, GERD SINCE 2012, ATTENTION DEFICIT DISORDER SINCE 2011, CONSTIPATION CHRONIC SINCE 2012, HEADACHE, NUMBNESS OF EXTREMITIES, HEMORRHOIDS, GROIN ABSCESS, INSOMNIA AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED METRONIDAZOLE (FLAGYL) SINCE (B)(6) 2015 FOR VAGINITIS AS WELL AS AMOXICILLIN SINCE (B)(6) 2016, AXOTAL (FIORICET) SINCE (B)(6) 2015, CO-TRIMOXAZOLE (BACTRIM) SINCE (B)(6) 2015, COLECALCIFEROL (VITAMIN D) SINCE (B)(6) 2016, DIAZEPAM (VALIUM) SINCE (B)(6) 2016, FLUCONAZOLE (DIFLUCAN) SINCE (B)(6) 2015, FLUCONAZOLE SINCE (B)(6) 2016, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN 2012, PAROXETINE SINCE (B)(6) 2016, SERTRALINE (ZOLOFT) SINCE AUGUST 2017 AND TINIDAZOLE (TINDAMAX) SINCE (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). IN MARCH 2015, THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). IN 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN OCTOBER 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("VAGINAL INFECTION, VAGINITIS") WITH VAGINAL DISCHARGE. IN MAY 2017, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("CLOTTING DURING MENSES"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN, BOTH LEFT AND RIGHT SIDES"), THE SECOND EPISODE OF VAGINAL HAEMORRHAGE ("VAGINAL HAEMORRHAGE"), THE SECOND EPISODE OF MENORRHAGIA ("MENORRHAGIA") AND THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (ABLATION) AND SURGERY (ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, FATIGUE, DYSPAREUNIA, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, THE LAST EPISODE OF VAGINAL HAEMORRHAGE, THE LAST EPISODE OF MENORRHAGIA, MENOMETRORRHAGIA AND THE LAST EPISODE OF ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSFUNCTIONAL UTERINE BLEEDING, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL INFECTION, THE FIRST EPISODE OF ABDOMINAL PAIN, THE FIRST EPISODE OF MENORRHAGIA, THE FIRST EPISODE OF VAGINAL HAEMORRHAGE, THE SECOND EPISODE OF ABDOMINAL PAIN, THE SECOND EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF REPORTED TO BE IN THE SURGICAL INTERVENTION AND WAS UNABLE TO MAKE DETERMINATION WHETHER SYMPTOMS DECREASED OR RESOLVED FOLLOWING ESSURE REMOVAL RETAINED THE DEVICE OR ANY PORTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 3-JAN-2013: SATISFACTORY PLACEMENT, OCCLUSION OF BOTH TUBES (NORMAL) ULTRASOUND PELVIS - ON AN UNKNOWN DATE: BILATERAL ESSURE DEVICES 22-AUG-2017: PELVIC SONOGRAM: THE ENDOMETRIUM MEASURES 0.3 CM IN THICKNESS. NO FOCAL ENDOMETRIAL ABNORMALITY IS IDENTIFIED. BILATERAL ESSURE DEVICES ARE SEEN. IMPRESSION: 1. MARKED ADENOMYOSIS. 1. BILATERAL ESSURE DEVICES IN PLACE. 3. COMPLEX 1.1 CM RIGHT OVARIAN CYST SUGGESTING HEMORRHAGIC CYST. 4. OVARIAN APPEARANCE SUGGESTING THE POSSIBILITY OF POLYCYSTIC OVARIAN SYNDROME. 5. LIMITED EVALUATION OF THE VAGINA DEMONSTRATES POLYPOID MASSES OF UNCERTAIN ETIOLOGY. CLINICAL CORRELATION IS RECOMMENDED. FEMALE GENITALIA: ERYTHEMATOUS TEAR AT POSTERIOR INTROITUS. SMALL FIRM CYST 5 MM JUST ANTERIOR TO CERVIX AT ANTERIOR VAGINAL WALL, MILDLY TTP. UTERUS TENDER, NORMAL SIZE, SOLID FEELING, REPRODUCES ABDOMINAL PAIN. NO ADNEXAL MASSES. 04-JAN-2018: PATHOLOGY REPORT: TISSUES: UTERUS NOS ¿ UTERUS, CERVIX AND BILATERAL FALLOPIAN TUBES. OVARY, NOS ¿ RIGHT OVARIAN CYST. GROSS DESCRIPTION: THE SCARRED AND NARROW ENDOMETRIAL CAVITY MEASURES 3.5 X 0.6 CM WITH THE ENDOMETRIUM MEASURING LESS THAN 0.1CM. A SEGMENT OF 2.5 X 0.1 CM METALLIC COIL IS NOTED IN EACH CORNUAL REGION. FINAL DIAGNOSIS: ENDOMETRIUM ¿ FIBROTIC SCAR, METALLIC COILS IN EACH CORNUAL AREA . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CONSTANT PELVIC PAIN/ PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"), THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A16628) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVARING AND CRYSELLE. CONCURRENT CONDITIONS INCLUDED ABNORMAL CERVICAL CYTOLOGY, LOOP ELECTROSURGICAL EXCISION PROCEDURE SINCE 2014, CYSTITIS INTERSTITIAL, CONSTIPATION CHRONIC, GROIN ABSCESS, URINARY URGENCY, ADENOMYOSIS, OVARIAN CYST, UMBILICAL HERNIA, STENOSIS, POLYP OF VAGINA, MULTIPLE ALLERGIES SINCE 2011, ANXIETY SINCE 2012, STRESS SINCE 2012, GERD SINCE 2012, ATTENTION DEFICIT DISORDER SINCE 2011, CONSTIPATION CHRONIC SINCE 2012, HEADACHE, NUMBNESS OF EXTREMITIES, HEMORRHOIDS, GROIN ABSCESS, INSOMNIA AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED METRONIDAZOLE (FLAGYL) SINCE (B)(6) 2015 FOR VAGINITIS AS WELL AS AMOXICILLIN SINCE 19-SEP-2016, AXOTAL (FIORICET) SINCE (B)(6) 2015, CO-TRIMOXAZOLE (BACTRIM) SINCE (B)(6) 2015, COLECALCIFEROL (VITAMIN D) SINCE (B)(6) 2016, DIAZEPAM (VALIUM) SINCE (B)(6) 2016, FLUCONAZOLE (DIFLUCAN) SINCE (B)(6) 2016 FLUCONAZOLE SINCE (B)(6) 2016 MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN 2012, PAROXETINE SINCE (B)(6) 2016 , SERTRALINE (ZOLOFT) SINCE (B)(6) 2017 AND TINIDAZOLE (TINDAMAX) SINCE (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). IN 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("VAGINAL INFECTION, VAGINITIS") WITH VAGINAL DISCHARGE. IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("CLOTTING DURING MENSES"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN, BOTH LEFT AND RIGHT SIDES"), THE SECOND EPISODE OF VAGINAL HAEMORRHAGE ("VAGINAL HAEMORRHAGE"), THE SECOND EPISODE OF MENORRHAGIA ("MENORRHAGIA") AND THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (ABLATION) AND SURGERY (ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, FATIGUE, DYSPAREUNIA, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, THE LAST EPISODE OF VAGINAL HAEMORRHAGE, THE LAST EPISODE OF MENORRHAGIA, MENOMETRORRHAGIA AND THE LAST EPISODE OF ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSFUNCTIONAL UTERINE BLEEDING, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL INFECTION, THE FIRST EPISODE OF ABDOMINAL PAIN, THE FIRST EPISODE OF MENORRHAGIA, THE FIRST EPISODE OF VAGINAL HAEMORRHAGE, THE SECOND EPISODE OF ABDOMINAL PAIN, THE SECOND EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF REPORTED TO BE IN THE SURGICAL INTERVENTION AND WAS UNABLE TO MAKE DETERMINATION WHETHER SYMPTOMS DECREASED OR RESOLVED FOLLOWING ESSURE REMOVAL RETAINED THE DEVICE OR ANY PORTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: SATISFACTORY PLACEMENT, OCCLUSION OF BOTH TUBES (NORMAL) ULTRASOUND PELVIS - ON AN UNKNOWN DATE: BILATERAL ESSURE DEVICES 22-AUG-2017: PELVIC SONOGRAM: THE ENDOMETRIUM MEASURES 0.3 CM IN THICKNESS. NO FOCAL ENDOMETRIAL ABNORMALITY IS IDENTIFIED. BILATERAL ESSURE DEVICES ARE SEEN. IMPRESSION: 1. MARKED ADENOMYOSIS. 1. BILATERAL ESSURE DEVICES IN PLACE. 3. COMPLEX 1.1 CM RIGHT OVARIAN CYST SUGGESTING HEMORRHAGIC CYST. 4. OVARIAN APPEARANCE SUGGESTING THE POSSIBILITY OF POLYCYSTIC OVARIAN SYNDROME. 5. LIMITED EVALUATION OF THE VAGINA DEMONSTRATES POLYPOID MASSES OF UNCERTAIN ETIOLOGY. CLINICAL CORRELATION IS RECOMMENDED. FEMALE GENITALIA: ERYTHEMATOUS TEAR AT POSTERIOR INTROITUS. SMALL FIRM CYST 5 MM JUST ANTERIOR TO CERVIX AT ANTERIOR VAGINAL WALL, MILDLY TTP. UTERUS TENDER, NORMAL SIZE, SOLID FEELING, REPRODUCES ABDOMINAL PAIN. NO ADNEXAL MASSES. (B)(6) 2018: PATHOLOGY REPORT: TISSUES: UTERUS NOS ¿ UTERUS, CERVIX AND BILATERAL FALLOPIAN TUBES. OVARY, NOS ¿ RIGHT OVARIAN CYST. GROSS DESCRIPTION: THE SCARRED AND NARROW ENDOMETRIAL CAVITY MEASURES 3.5 X 0.6 CM WITH THE ENDOMETRIUM MEASURING LESS THAN 0.1CM. A SEGMENT OF 2.5 X 0.1 CM METALLIC COIL IS NOTED IN EACH CORNUAL REGION. FINAL DIAGNOSIS: ENDOMETRIUM ¿ FIBROTIC SCAR, METALLIC COILS IN EACH CORNUAL AREA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED,PATIENT CONCOMITANT CONDITION ADDED, EVENTS ADDED AS :- VAGINAL HAEMORRHAGE, MENORRHAGIA, MENOMETRORRHAGIA, ABDOMINAL PAIN. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CONSTANT PELVIC PAIN/ PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: A16628-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PRE-ECLAMPSIA AND CESAREAN SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVARING AND CRYSELLE. CONCURRENT CONDITIONS INCLUDED ABNORMAL CERVICAL CYTOLOGY, LOOP ELECTROSURGICAL EXCISION PROCEDURE SINCE ON (B)(6) 2014, CYSTITIS INTERSTITIAL, CONSTIPATION CHRONIC, GROIN ABSCESS, URINARY URGENCY, ADENOMYOSIS, OVARIAN CYST, UMBILICAL HERNIA, STENOSIS, POLYP OF VAGINA, MULTIPLE ALLERGIES SINCE 2011, ANXIETY SINCE 2012, STRESS SINCE 2012, GERD SINCE 2012, ATTENTION DEFICIT DISORDER SINCE 2011, CONSTIPATION CHRONIC SINCE 2012, HEADACHE, NUMBNESS OF EXTREMITIES, HEMORRHOIDS, GROIN ABSCESS, INSOMNIA AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED METRONIDAZOLE (FLAGYL) SINCE ON (B)(6) 2015 FOR VAGINITIS AS WELL AS AMOXICILLIN SINCE ON (B)(6) 2016, AXOTAL (FIORICET) SINCE ON (B)(6) 2015, CO-TRIMOXAZOLE (BACTRIM) SINCE ON (B)(6) 2015, COLECALCIFEROL (VITAMIN D) SINCE ON (B)(6) 2016, DIAZEPAM (VALIUM) SINCE ON (B)(6) 2016, FLUCONAZOLE (DIFLUCAN) SINCE ON (B)(6) 2015, FLUCONAZOLE SINCE ON (B)(6)2016, FLUOX ETINE HYDROCHLORIDE (FLUOXETIN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN 2012, PAROXETINE SINCE ON (B)(6) 2016, SERTRALINE (ZOLOFT) SINCE ON (B)(6) 2017 AND TINIDAZOLE (TINDAMAX) SINCE ON (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("VAGINAL INFECTION, VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)". ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("CLOTTING DURING MENSES"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)", THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN, BOTH LEFT AND RIGHT SIDES"), THE SECOND EPISODE OF VAGINAL HAEMORRHAGE ("VAGINAL HAEMORRHAGE") AND THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (ABLATION) AND SURGERY (ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, MENORRHAGIA, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, FATIGUE, DYSPAREUNIA, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, THE LAST EPISODE OF VAGINAL HAEMORRHAGE, MENOMETRORRHAGIA AND THE LAST EPISODE OF ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSFUNCTIONAL UTERINE BLEEDING, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL INFECTION, THE FIRST EPISODE OF ABDOMINAL PAIN, THE FIRST EPISODE OF VAGINAL HAEMORRHAGE, THE SECOND EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF REPORTED TO BE IN THE SURGICAL INTERVENTION AND WAS UNABLE TO MAKE DETERMINATION WHETHER SYMPTOMS DECREASED OR RESOLVED FOLLOWING ESSURE REMOVAL RETAINED THE DEVICE OR ANY PORTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2013: SATISFACTORY PLACEMENT, OCCLUSION OF BOTH TUBES (NORMAL). ULTRASOUND PELVIS: ON AN UNKNOWN DATE: BILATERAL ESSURE DEVICES ON (B)(6) 2017: PELVIC SONOGRAM: THE ENDOMETRIUM MEASURES 0.3 CM IN THICKNESS. NO FOCAL ENDOMETRIAL ABNORMALITY IS IDENTIFIED. BILATERAL ESSURE DEVICES ARE SEEN. IMPRESSION: 1. MARKED ADENOMYOSIS. 1. BILATERAL ESSURE DEVICES IN PLACE. 3. COMPLEX 1.1 CM RIGHT OVARIAN CYST SUGGESTING HEMORRHAGIC CYST. 4. OVARIAN APPEARANCE SUGGESTING THE POSSIBILITY OF POLYCYSTIC OVARIAN SYNDROME. 5. LIMITED EVALUATION OF THE VAGINA DEMONSTRATES POLYPOID MASSES OF UNCERTAIN ETIOLOGY. CLINICAL CORRELATION IS RECOMMENDED. FEMALE GENITALIA: ERYTHEMATOUS TEAR AT POSTERIOR INTROITUS. SMALL FIRM CYST 5 MM JUST ANTERIOR TO CERVIX AT ANTERIOR VAGINAL WALL, MILDLY TTP. UTERUS TENDER, NORMAL SIZE, SOLID FEELING, REPRODUCES ABDOMINAL PAIN. NO ADNEXAL MASSES. ON (B)(6) 2018: PATHOLOGY REPORT: TISSUES: UTERUS NOS, UTERUS, CERVIX AND BILATERAL FALLOPIAN TUBES. OVARY, NOS, RIGHT OVARIAN CYST. GROSS DESCRIPTION: THE SCARRED AND NARROW ENDOMETRIAL CAVITY MEASURES 3.5 X 0.6 CM WITH THE ENDOMETRIUM MEASURING LESS THAN 0.1CM. A SEGMENT OF 2.5 X 0.1 CM METALLIC COIL IS NOTED IN EACH CORNUAL REGION. FINAL DIAGNOSIS: ENDOMETRIUM: FIBROTIC SCAR, METALLIC COILS IN EACH CORNUAL AREA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: UPDATE OF INFORMATION (BATCH IS INVALID). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CONSTANT PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A16628) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ABNORMAL CERVICAL CYTOLOGY, LOOP ELECTROSURGICAL EXCISION PROCEDURE SINCE (B)(6) 2014, CYSTITIS INTERSTITIAL, CONSTIPATION CHRONIC, GROIN ABSCESS, URINARY URGENCY, ADENOMYOSIS, OVARIAN CYST, UMBILICAL HERNIA, STENOSIS AND POLYP OF VAGINA. CONCOMITANT PRODUCTS INCLUDED METRONIDAZOLE (FLAGYL) SINCE (B)(6) 2015 FOR VAGINITIS AS WELL AS AMOXICILLIN SINCE (B)(6) 2016, AXOTAL (FIORICET) SINCE (B)(6) 2015, CO-TRIMOXAZOLE (BACTRIM) SINCE (B)(6) 2015, COLECALCIFEROL (VITAMIN D) SINCE (B)(6) 2016, DIAZEPAM (VALIUM) SINCE (B)(6) 2016, FLUCONAZOLE (DIFLUCAN) SINCE (B)(6) 2015, FLUCONAZOLE SINCE (B)(6) 2016, PAROXETINE SINCE (B)(6) 2016, SERTRALINE (ZOLOFT) SINCE (B)(6) 2017 AND TINIDAZOLE (TINDAMAX) SINCE (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION, VAGINITIS") WITH VAGINAL DISCHARGE, MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("CLOTTING DURING MENSES"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN, BOTH LEFT AND RIGHT SIDES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC: HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, DYSFUNCTIONAL UTERINE BLEEDING, MENSTRUAL DISORDER, FATIGUE, VAGINAL HAEMORRHAGE, DYSPAREUNIA, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSFUNCTIONAL UTERINE BLEEDING, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF REPORTED TO BE IN THE SURGICAL INTERVENTION AND WAS UNABLE TO MAKE DETERMINATION WHETHER SYMPTOMS DECREASED OR RESOLVED FOLLOWING ESSURE REMOVAL RETAINED THE DEVICE OR ANY PORTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: SATISFACTORY PLACEMENT, OCCLUSION OF BOTH TUBES (NORMAL) ULTRASOUND PELVIS - ON (B)(6) 2017: BILATERAL ESSURE DEVICES (B)(6) 2017: PELVIC SONOGRAM: THE ENDOMETRIUM MEASURES 0.3 CM IN THICKNESS. NO FOCAL ENDOMETRIAL ABNORMALITY IS IDENTIFIED. BILATERAL ESSURE DEVICES ARE SEEN. IMPRESSION: 1. MARKED ADENOMYOSIS. 1. BILATERAL ESSURE DEVICES IN PLACE. 3. COMPLEX 1.1 CM RIGHT OVARIAN CYST SUGGESTING HEMORRHAGIC CYST. 4. OVARIAN APPEARANCE SUGGESTING THE POSSIBILITY OF POLYCYSTIC OVARIAN SYNDROME. 5. LIMITED EVALUATION OF THE VAGINA DEMONSTRATES POLYPOID MASSES OF UNCERTAIN ETIOLOGY. CLINICAL CORRELATION IS RECOMMENDED. FEMALE GENITALIA: ERYTHEMATOUS TEAR AT POSTERIOR INTROITUS. SMALL FIRM CYST 5 MM JUST ANTERIOR TO CERVIX AT ANTERIOR VAGINAL WALL, MILDLY TTP. UTERUS TENDER, NORMAL SIZE, SOLID FEELING, REPRODUCES ABDOMINAL PAIN. NO ADNEXAL MASSES. ON (B)(6) 2018: PATHOLOGY REPORT: TISSUES: UTERUS NOS ¿ UTERUS, CERVIX AND BILATERAL FALLOPIAN TUBES. OVARY, NOS ¿ RIGHT OVARIAN CYST. GROSS DESCRIPTION: THE SCARRED AND NARROW ENDOMETRIAL CAVITY MEASURES 3.5 X 0.6 CM WITH THE ENDOMETRIUM MEASURING LESS THAN 0.1CM. A SEGMENT OF 2.5 X 0.1 CM METALLIC COIL IS NOTED IN EACH CORNUAL REGION. FINAL DIAGNOSIS: ENDOMETRIUM ¿ FIBROTIC SCAR, METALLIC COILS IN EACH CORNUAL AREA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. ESSURE REMOVAL DATE ((B)(6) 2018) ADDED. LOT NUMBER (A16628) ADDED. CONCOMITANT MEDICATIONS ADDED. EVENTS ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), UTI, VAGINAL INFECTION, MIGRAINES, HEADACHES, DYSFUNCTIONAL UTERINE BLEEDING AND ABDOMINAL PAIN, BOTH LEFT AND RIGHT SIDES 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 |
|---|---|---|---|---|---|---|---|
| 377034 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A16628-INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | AMOXICILLIN| AMOXICILLIN| AMOXICILLIN| AMOXICILLIN| BACTRIM| BACTRIM| BACTRIM| BACTRIM| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DIFLUCAN| DIFLUCAN| DIFLUCAN| DIFLUCAN| FIORICET| FIORICET| FIORICET| FIORICET| FLAGYL| FLAGYL| FLAGYL| FLAGYL| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| FLUOXETIN| PAROXETINE| PAROXETINE| PAROXETINE| PAROXETINE| TINDAMAX| TINDAMAX| TINDAMAX| TINDAMAX| VALIUM| VALIUM| VALIUM| VALIUM| VITAMIN D| VITAMIN D| VITAMIN D| VITAMIN D| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| AMOXICILLIN| BACTRIM| DIFLUCAN| FIORICET| FLAGYL| FLUCONAZOLE| PAROXETINE| TINDAMAX| VALIUM| VITAMIN D| ZOLOFT |