ESSURE
Report
- Report Number
- 2951250-2017-02601
- Event Type
- Injury
- Date Received
- July 24, 2017
- Date of Event
- November 1, 2012
- Report Date
- November 29, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN / PELVIC PAIN (INFREQUENT AT TIMES; CONSTANT AT OTHERS AND SEVERE)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 37-YEAR-OLD PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (B)(6)1992, (B)(6)1993 AND (B)(6)1995), DEPRESSION, MENSES IRREGULAR AND ALLERGIC RHINITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: TRINESSA FROM 2007 TO (B)(6)2010; FOR AN UNREPORTED INDICATION: AVIANE FROM (B)(6)2010 TO (B)(6)2012. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, BACTERIAL VAGINOSIS, VAGINAL YEAST INFECTION, VAGINAL ITCHING, ENDOMETRIOSIS AND ALLERGIC REACTION TO ANTIBIOTICS (ALLERGIC TO MACROBID AND SULFA-DRUGS). FAMILY HISTORY INCLUDED HYPERTENSION (MOTHER) AND MULTIPLE SCLEROSIS (MOTHER). CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) FROM (B)(6)2017 TO (B)(6)2017 FOR PELVIC PAIN AS WELL AS CETIRIZINE HYDROCHLORIDE (ZYRTEC) FROM (B)(6)2014 TO (B)(6)2017, CHOLECALCIFEROL (VITAMIN D3), ETHINYL ESTRADIOL W/NORGESTREL FROM (B)(6)2011 TO (B)(6)2015, FLUTICASONE FROM (B)(6)2016 TO (B)(6)2017, LEVONORGESTREL (MIRENA), MARVELON (APRI) FROM (B)(6)2015 TO (B)(6)2016, MARVELON (RECLIPSEN) FROM (B)(6)2013 TO (B)(6)2015, NAPROXEN FROM JUNE 2016 TO (B)(6)2017, ORAL CONTRACEPTIVE NOS AND SERTRALINE (ZOLOFT) FROM (B)(6)2017 TO (B)(6)2017. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6)2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6)2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6)2017, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH MARVELON (DESOGEN), IBUPROFEN, TRAMADOL AND SURGERY (SHE HAD TOTAL HYSTERECTOMY/TOTAL LAPAROSCOPIC HYSTERECTOMY,BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6)2016: NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6)-2013: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - ON (B)(6)2017: IUD IN PLACE. SMALL FIBROID. ON (B)(6)2016 PATIENT HAD PELVIS ULTRASOUND RESULTED IN INTRAUTERINE DEVICE IN A GOOD POSITION WITHIN THE ENDOMETRIAL CANAL. HOWEVER A SMALLER FIBROID IS SEEN IN THE MYOMETRIUM OF THE UTERUS. BOTH OVARIES APPEAR NORMAL. ON (B)(6)2017 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST. GROSS DESCRIPTION: THE REMNANTS OF THE BILATERAL FALLOPIAN TUBES ARE NOTED ON THE SPECIMEN AND METAL COILED WIRES EXTEND FROM THE RESECTED MARGINS WITH THE WIRES MEASURING UP TO 1.7 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. AS PREVIOUSLY MENTIONED, THE SEGMENTS OF FALLOPIAN TUBES ARE DETACHED AND SUBMITTED IN THE CONTAINER, AND ARE NOT ORIENTED AND ARE DESCRIBED ARBITRARILY. THE FIRST SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 4.1 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, WRINKLED, LIGHT GRAY/DARK RED APPEARANCE. ATTACHED NEAR THE FIMBRIATED END IS AN OPAQUE WALL CYST MEASURING APPROXIMATELY 1.5 CM, AND IS FILLED WITH A CLEAR FLUID. THE SECOND SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 5.7 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, SLIGHTLY WRINKLED, LIGHT GRAY/DARK BLURRED APPEARANCE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-OCT-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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN / PELVIC PAIN (INFREQUENT AT TIMES; CONSTANT AT OTHERS AND SEVERE)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 37-YEAR-OLD PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 1992, (B)(6) 1993 AND (B)(6) 1995), DEPRESSION, MENSES IRREGULAR AND ALLERGIC RHINITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: TRINESSA FROM 2007 TO (B)(6) 2010; FOR AN UNREPORTED INDICATION: AVIANE FROM (B)(6) 2010 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, BACTERIAL VAGINOSIS, VAGINAL YEAST INFECTION, VAGINAL ITCHING, ENDOMETRIOSIS AND ALLERGIC REACTION TO ANTIBIOTICS (ALLERGIC TO MACROBID AND SULFA-DRUGS). FAMILY HISTORY INCLUDED HYPERTENSION (MOTHER) AND MULTIPLE SCLEROSIS (MOTHER). CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) FROM (B)(6) 2017 TO (B)(6) 2017 FOR PELVIC PAIN AS WELL AS CETIRIZINE HYDROCHLORIDE (ZYRTEC) FROM (B)(6) 2014 TO (B)(6) 2017, COLECALCIFEROL (VITAMIN D3), ETHINYL ESTRADIOL W/NORGESTREL FROM (B)(6) 2011 TO (B)(6) 2015, FLUTICASONE FROM (B)(6) 2016 TO (B)(6) 2017, LEVONORGESTREL (MIRENA), MARVELON (APRI) FROM (B)(6) 2015 TO (B)(6) 2016, MARVELON (RECLIPSEN) FROM (B)(6) 2013 TO (B)(6) 2015, NAPROXEN FROM (B)(6) 2016 TO (B)(6) 2017, ORAL CONTRACEPTIVE NOS AND SERTRALINE (ZOLOFT) FROM (B)(6) 2017 TO (B)(6) 2017. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH MARVELON (DESOGEN), IBUPROFEN, TRAMADOL AND SURGERY (SHE HAD TOTAL HYSTERECTOMY/TOTAL LAPAROSCOPIC HYSTERECTOMY,BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2016: NEGATIVE HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION ULTRASOUND PELVIS - ON (B)(6) 2017: IUD IN PLACE. SMALL FIBROID. ON (B)(6) 2016 PATIENT HAD PELVIS ULTRSOUND RESULTED IN INTRAUTERINE DEVICE IN A GOOD POSITION WITHIN THE ENDOMETRIAL CANAL. HOWEVER A SMALLER FIBROID IS SEEN IN THE MYOMETRIUM OF THE UTERUS. BOTH OVARIES APPEAR NORMAL. ON (B)(6) 2017 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST. GROSS DESCRIPTION: THE REMNANTS OF THE BILATERAL FALLOPIAN TUBES ARE NOTED ON THE SPECIMEN AND METAL COILED WIRES EXTEND FROM THE RESECTED MARGINS WITH THE WIRES MEASURING UP TO 1.7 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. AS PREVIOUSLY MENTIONED, THE SEGMENTS OF FALLOPIAN TUBES ARE DETACHED AND SUBMITTED IN THE CONTAINER, AND ARE NOT ORIENTED AND ARE DESCRIBED ARBITRARILY. THE FIRST SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 4.1 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, WRINKLED, LIGHT GRAY/DARK RED APPEARANCE. ATTACHED NEAR THE FIMBRIATED END IS AN OPAQUE WALL CYST MEASURING APPROXIMATELY 1.5 CM, AND IS FILLED WITH A CLEAR FLUID. THE SECOND SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 5.7 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, SLIGHTLY WRINKLED, LIGHT GRAY/DARK BLUERED APPEARANCE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUL-2018: QUALITY-SAFETY EVALUATION OF 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN / PELVIC PAIN (INFREQUENT AT TIMES; CONSTANT AT OTHERS AND SEVERE)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A (B)(6) YEAR-OLD PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 3 ((B)(6) 1992, (B)(6) 1993 AND (B)(6) 1995), DEPRESSION, MENSES IRREGULAR AND ALLERGIC RHINITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: TRINESSA FROM 2007 TO (B)(6) 2010; FOR AN UNREPORTED INDICATION: AVIANE FROM (B)(6) 2010 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, BACTERIAL VAGINOSIS, VAGINAL YEAST INFECTION, VAGINAL ITCHING, ENDOMETRIOSIS AND ALLERGIC REACTION TO ANTIBIOTICS (ALLERGIC TO MACROBID AND SULFA-DRUGS). FAMILY HISTORY INCLUDED HYPERTENSION (MOTHER) AND MULTIPLE SCLEROSIS (MOTHER). CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) FROM (B)(6) 2017 TO (B)(6) 2017 FOR PELVIC PAIN AS WELL AS CETIRIZINE HYDROCHLORIDE (ZYRTEC) FROM (B)(6) 2014 TO (B)(6) 2017, COLECALCIFEROL (VITAMIN D3), ETHINYL ESTRADIOL W/NORGESTREL FROM (B)(6) 2011 TO (B)(6) 2015, FLUTICASONE FROM (B)(6) 2016 TO (B)(6) 2017, LEVONORGESTREL (MIRENA), MARVELON (APRI) FROM (B)(6) 2015 TO (B)(6) 2016, MARVELON (RECLIPSEN) FROM (B)(6) 2013 TO (B)(6) 2015, NAPROXEN FROM (B)(6) 2016 TO (B)(6) 2017, ORAL CONTRACEPTIVE NOS AND SERTRALINE (ZOLOFT) FROM (B)(6) 2017 TO (B)(6) 2017. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH MARVELON (DESOGEN), IBUPROFEN, TRAMADOL AND SURGERY (SHE HAD TOTAL HYSTERECTOMY/TOTAL LAPAROSCOPIC HYSTERECTOMY,BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2016: NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - ON (B)(6) 2017: IUD IN PLACE. SMALL FIBROID. ON (B)(6) 2016 PATIENT HAD PELVIS ULTRSOUND RESULTED IN INTRAUTERINE DEVICE IN A GOOD POSITION WITHIN THE ENDOMETRIAL CANAL. HOWEVER A SMALLER FIBROID IS SEEN IN THE MYOMETRIUM OF THE UTERUS. BOTH OVARIES APPEAR NORMAL. ON (B)(6) 2017 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST. GROSS DESCRIPTION: THE REMNANTS OF THE BILATERAL FALLOPIAN TUBES ARE NOTED ON THE SPECIMEN AND METAL COILED WIRES EXTEND FROM THE RESECTED MARGINS WITH THE WIRES MEASURING UP TO 1.7 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. AS PREVIOUSLY MENTIONED, THE SEGMENTS OF FALLOPIAN TUBES ARE DETACHED AND SUBMITTED IN THE CONTAINER, AND ARE NOT ORIENTED AND ARE DESCRIBED ARBITRARILY. THE FIRST SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 4.1 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, WRINKLED, LIGHT GRAY/DARK RED APPEARANCE. ATTACHED NEAR THE FIMBRIATED END IS AN OPAQUE WALL CYST MEASURING APPROXIMATELY 1.5 CM, AND IS FILLED WITH A CLEAR FLUID. THE SECOND SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 5.7 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, SLIGHTLY WRINKLED, LIGHT GRAY/DARK BLUERED APPEARANCE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2018: REPORTER ADDED, PATIENT HISTORICAL CONDITION, CONCOMITANT CONDITION ADDED, TREATMENT DRUG AND CONCOMITANT DRUG ADDED, EVENTS ADDED AS FOLLOWS:- GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DEVICE EXPULSION, DYSMENORRHEA , DYSPAREUNIA, PELVIC PAIN, VAGINAL DISCHARGE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN / PAIN / PELVIC PAIN (INFREQUENT AT TIMES; CONSTANT AT OTHERS AND SEVERE)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 1992, (B)(6) 1993 AND (B)(6) 1995), DEPRESSION, MENSES IRREGULAR, ALLERGIC RHINITIS, LEIOMYOMA NOS, PARATUBAL CYST AND RETROPERITONEAL FIBROSIS. ON (B)(6) 2016 PATIENT HAD PELVIS ULTRSOUND RESULTED IN INTRAUTERINE DEVICE IN A GOOD POSITION WITHIN THE ENDOMETRIAL CANAL. HOWEVER A SMALLER FIBROID IS SEEN IN THE MYOMETRIUM OF THE UTERUS. BOTH OVARIES APPEAR NORMAL. ON (B)(6) 2017 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST. GROSS DESCRIPTION: THE REMNANTS OF THE BILATERAL FALLOPIAN TUBES ARE NOTED ON THE SPECIMEN AND METAL COILED WIRES EXTEND FROM THE RESECTED MARGINS WITH THE WIRES MEASURING UP TO 1.7 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. AS PREVIOUSLY MENTIONED, THE SEGMENTS OF FALLOPIAN TUBES ARE DETACHED AND SUBMITTED IN THE CONTAINER, AND ARE NOT ORIENTED AND ARE DESCRIBED ARBITRARILY. THE FIRST SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 4.1 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, WRINKLED, LIGHT GRAY/DARK RED APPEARANCE. ATTACHED NEAR THE FIMBRIATED END IS AN OPAQUE WALL CYST MEASURING APPROXIMATELY 1.5 CM, AND IS FILLED WITH A CLEAR FLUID. THE SECOND SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 5.7 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, SLIGHTLY WRINKLED, LIGHT GRAY/DARK BLUERED APPEARANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: TRINESSA FROM 2007 TO (B)(6) 2010; FOR AN UNREPORTED INDICATION: AVIANE FROM (B)(6) 2010 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, BACTERIAL VAGINOSIS, VAGINAL YEAST INFECTION, VAGINAL ITCHING, ENDOMETRIOSIS AND ALLERGIC REACTION TO ANTIBIOTICS (ALLERGIC TO MACROBID AND SULFA-DRUGS). FAMILY HISTORY INCLUDED HYPERTENSION (MOTHER) AND MULTIPLE SCLEROSIS (MOTHER). CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) FROM (B)(6) 2017 FOR PELVIC PAIN AS WELL AS CETIRIZINE HYDROCHLORIDE FROM (B)(6) 2014 TO (B)(6) 2017, COLECALCIFEROL (VITAMIN D3), DESOGESTREL;ETHINYLESTRADIOL (APRI) FROM (B)(6) 2015 TO (B)(6) 2016, DESOGESTREL;ETHINYLESTRADIOL (RECLIPSEN) FROM (B)(6) 2013 TO (B)(6) 2015, ETHINYLESTRADIOL;NORGESTREL FROM (B)(6) 2011 TO (B)(6) 2015, FLUTICASONE FROM (B)(6) 2016 TO (B)(6) 2017, LEVONORGESTREL (MIRENA), NAPROXEN FROM (B)(6) 2016 TO (B)(6) 2017, ORAL CONTRACEPTIVE NOS AND SERTRALINE HYDROCHLORIDE (ZOLOFT) FROM (B)(6) 2017. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH DESOGESTREL;ETHINYLESTRADIOL (DESOGEN), IBUPROFEN, TRAMADOL AND SURGERY (SHE HAD TOTAL HYSTERECTOMY/TOTAL LAPAROSCOPIC HYSTERECTOMY,BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2016: RESULTS: NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2017: UTERUS, CERVIX, HYSTERECTOMY: NO HISTOPATHOLOGIC ABNORMALITY UTERUS, ENDOMETRIUM, HYSTERECTOMY: PROLIFERATIVE PHASE ENDOMETRIUM UTERUS, MYOMETRIUM, HYSTERECTOMY: LEIOMYOMATA, LARGEST = 1.2 CM FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST B. SOFT TISSUE, PERITONEUM, BIOPSY: ENDOMETRIOSIS C. SOFT TISSUE, "ENDOMETRIOMA," BIOPSY: ENDOMETRIOSIS. ULTRASOUND PELVIS - ON (B)(6) 2017: RESULTS: IUD IN PLACE. SMALL FIBROID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-APR-2021: NO NEW INFORMATION WAS RECEIVED, THEN MENTION THE UPDATE OF BOTH IMDRF/FDA CODES AS THE ONLY CHANGE.MR RECEIVED- NEW REPORTER, MEDICAL HISTORY, LAB DATA WERE ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN / PAIN / PELVIC PAIN (INFREQUENT AT TIMES; CONSTANT AT OTHERS AND SEVERE)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 1992, (B)(6) 1993 AND (B)(6) 1995), DEPRESSION, MENSES IRREGULAR, ALLERGIC RHINITIS, LEIOMYOMA NOS, PARATUBAL CYST AND RETROPERITONEAL FIBROSIS. ON (B)(6) 2016 PATIENT HAD PELVIS ULTRSOUND RESULTED IN INTRAUTERINE DEVICE IN A GOOD POSITION WITHIN THE ENDOMETRIAL CANAL. HOWEVER A SMALLER FIBROID IS SEEN IN THE MYOMETRIUM OF THE UTERUS. BOTH OVARIES APPEAR NORMAL. ON (B)(6) 2017 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST. GROSS DESCRIPTION: THE REMNANTS OF THE BILATERAL FALLOPIAN TUBES ARE NOTED ON THE SPECIMEN AND METAL COILED WIRES EXTEND FROM THE RESECTED MARGINS WITH THE WIRES MEASURING UP TO 1.7 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. AS PREVIOUSLY MENTIONED, THE SEGMENTS OF FALLOPIAN TUBES ARE DETACHED AND SUBMITTED IN THE CONTAINER, AND ARE NOT ORIENTED AND ARE DESCRIBED ARBITRARILY. THE FIRST SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 4.1 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, WRINKLED, LIGHT GRAY/DARK RED APPEARANCE. ATTACHED NEAR THE FIMBRIATED END IS AN OPAQUE WALL CYST MEASURING APPROXIMATELY 1.5 CM, AND IS FILLED WITH A CLEAR FLUID. THE SECOND SEGMENT OF FALLOPIAN TUBE IS FIMBRIATED AND MEASURES 5.7 CM IN LENGTH X 1.0 CM IN DIAMETER WITH THE SEROSAL SURFACE HAVING A DULL, SLIGHTLY WRINKLED, LIGHT GRAY/DARK BLUERED APPEARANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: TRINESSA FROM 2007 TO (B)(6) 2010; FOR AN UNREPORTED INDICATION: AVIANE FROM (B)(6) 2010 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, BACTERIAL VAGINOSIS, VAGINAL YEAST INFECTION, VAGINAL ITCHING, ENDOMETRIOSIS AND ALLERGIC REACTION TO ANTIBIOTICS (ALLERGIC TO MACROBID AND SULFA-DRUGS). FAMILY HISTORY INCLUDED HYPERTENSION (MOTHER) AND MULTIPLE SCLEROSIS (MOTHER). CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) FROM (B)(6) 2017 TO (B)(6) 2017 FOR PELVIC PAIN AS WELL AS CETIRIZINE HYDROCHLORIDE FROM (B)(6) 2014 TO (B)(6) 2017, COLECALCIFEROL (VITAMIN D3), DESOGESTREL;ETHINYLESTRADIOL (APRI) FROM (B)(6) 2015 TO (B)(6) 2016, DESOGESTREL; ETHINYLESTRADIOL (RECLIPSEN) FROM (B)(6) 2013 TO (B)(6) 2015, ETHINYLESTRADIOL; NORGESTREL FROM (B)(6) 2011 TO (B)(6) 2015, FLUTICASONE FROM (B)(6) 2016 TO (B)(6) 2017, LEVONORGESTREL (MIRENA), NAPROXEN FROM (B)(6) 2016 TO (B)(6) 2017, ORAL CONTRACEPTIVE NOS AND SERTRALINE HYDROCHLORIDE (ZOLOFT) FROM (B)(6) 2017 TO (B)(6) 2017. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: UTERUS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH DESOGESTREL;ETHINYLESTRADIOL (DESOGEN), IBUPROFEN, TRAMADOL AND SURGERY (TOTAL HYSTERECTOMY/TOTAL LAPAROSCOPIC HYSTERECTOMY,BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, VAGINAL HAEMORRHAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2016: RESULTS: NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2017: UTERUS, CERVIX, HYSTERECTOMY: NO HISTOPATHOLOGIC ABNORMALITY UTERUS, ENDOMETRIUM, HYSTERECTOMY: PROLIFERATIVE PHASE ENDOMETRIUM UTERUS, MYOMETRIUM, HYSTERECTOMY: LEIOMYOMATA, LARGEST = 1.2 CM FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN PARATUBAL CYST B. SOFT TISSUE, PERITONEUM, BIOPSY: ENDOMETRIOSIS C. SOFT TISSUE, "ENDOMETRIOMA," BIOPSY: ENDOMETRIOSIS. ULTRASOUND PELVIS - ON (B)(6) 2017: RESULTS: IUD IN PLACE. SMALL FIBROID. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (ON OR ABOUT (B)(6) 2017, SHE HAD TOTAL HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 516495 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| O | APRI| APRI| APRI| APRI| APRI| CELEBREX| CELEBREX| CELEBREX| CELEBREX| CELEBREX| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| ETHINYL ESTRADIOL W/NORGESTREL| ETHINYL ESTRADIOL W/NORGESTREL| ETHINYL ESTRADIOL W/NORGESTREL| ETHINYLESTRADIOL,NORGESTREL| ETHINYLESTRADIOL,NORGESTREL| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| MIRENA| MIRENA| MIRENA| MIRENA| MIRENA| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| RECLIPSEN| RECLIPSEN| RECLIPSEN| RECLIPSEN| RECLIPSEN| VITAMIN D3| VITAMIN D3| VITAMIN D3| VITAMIN D3| VITAMIN D3| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZYRTEC| ZYRTEC| ZYRTEC |