ESSURE
Report
- Report Number
- 2951250-2017-01095
- Event Type
- Injury
- Date Received
- March 27, 2017
- Date of Event
- October 1, 2011
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN/PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES:3), PARITY 2 (NUMBER OF LIVE BIRTHS:2 NSVD((B)(6) 2009, (B)(6) 2011)) AND SPONTANEOUS ABORTION IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE ALLERGY. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH CODEINE ALLERGY. CONCURRENT CONDITIONS INCLUDED ANXIETY AND ALLERGY (ALLERGIES, SPECIFY: PCU UPSET BI). FAMILY HISTORY INCLUDED CARCINOMA BREAST (MATERNAL GRAND MOTHER) AND DIABETES (PATERNAL GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FOR CONTRACEPTION AS WELL AS ALPRAZOLAM (XANAX) SINCE 2008 AND ANESTHETICS, GENERAL (GENERAL ANESTHESIA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("SEVERE HEADACHES/MIGRAINE/HEADACHE"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINALABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN/LOSS SPECIFY: GAIN") AND FATIGUE ("FATIGUE"). IN 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA/NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN AND DYSMENORRHOEA ("CONSTANT DYSMENORRHEA ( CRAMPING)/DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND FATIGUE OUTCOME WAS UNKNOWN AND THE HEADACHE, DYSPAREUNIA, MIGRAINE, NAUSEA AND DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RING USED IN 2016 TO REGULATE PERIOD AND IT WAS DISCONTINUED DUE TO OTHER (PLEASE SPECIFY) ¿ PERIOD REGULATED (MENTIONED IN PFS). SHE DID NOT RETAINED THE ESSURE DEVICE OR ANY PORTION OF IT. NO ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SOCIAL HISTORY: PATIENT AGRESS THE INFUSIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: SATISFACTORY POSITION AND BOTH TUBES OCCLUDED PREGNANCY TEST - ON (B)(6) 2011: NEGATIVE ULTRASOUND SCAN - ON (B)(6) 2012: NORMAL EXAM / ESSURE WAS IN PLACE (B)(6) 2011, HYSTEROSALPINGOGRAPHY: ESSURE INSERTS ARE PRESENT IN BOTH FALLOPIAN TUBES. THEY ARE IN SATISFACTORY POSITION. NO TUBAL PATENCY IS SEEN. NO INTRAPERITONEAL SPILLAGE IS PRESENT. A FILLING DEFECT IS SEEN IN THE LEFT CORNU WHICH MAY REPRESENT A BUBBLE. IMPRESSION: OCCLUSION OF BOTH FALLOPIAN TUBES SECONDARY TO ESSURE INSERTS. US PELVIC[NON 08] COMPLETE W/TRANSVAG : ULTRASOUND OF THE PELVIS: THE PELVIS IS EXAMINED WITH TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND. THE UTERUS MEASURES L 6.6 CM X D 4.2 CM X W 6.0 CM. ENDOMETRIAL ECHOES MEASURE 0.7 CM IN THICKNESS WHICH IS WITHIN NORMAL LIMITS. THE RIGHT OVARY MEASURES L 2.7 CM X D 1.7 CM X W 1.7 CM AND IS NORMAL APPEARING THE LEFT OVARY MEASURES L 2.9 CM X D 1.5 CM X W 1.7 CM AND CONTAINS A DOMINANT FOLLICLE. DOPPLER IMAGING SHOWS NORMAL FLOW TO BOTH OVARIES. THE ECHOGENIC TIPS OF BILATERAL ESSURE IMPLANTS CAN BE SEEN IN THE FALLOPIAN TUBES BILATERALLY. NO FREE FLUID OR OTHER ABNORMALITY. IMPRESSION : NORMAL PELVIC SONOGRAM WITH ESSURE IMPLANTS IN PLACE. FINAL DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: TWO FALLOPIAN TUBE WITH FIMBRIATED ENDS AND BENIGN PARATUBAL CYSTS. METAL COILS PRESENT MOST CONSISTENT WITH INTRAMURAL FALLOPIAN TUBESTERILIZATION DEVICE). NO ATYPICAL OR MALIGNANT FEATURES IDENTIFIED. RT AND LT FALLOPIAN TUBE: RECEIVED IN FORMALINE LABLED. RT AND LT FALLOPIAN TUBE ARE TWO FRAGMENTED FIMBRIATED FALLOPIAN TUB SEGMENT. 4.0X2.6X1.5CM AGGREGATES DIMENSION. ONE FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 2.3X1.3X0.8CM. A SECTION REVEALS STERILE LUMEN. SECOND FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 0.4X0.7X0.6CM. SECTIONING OF THIS LUMEN ALSO REVEALS STERILE LUMEN. SECTIONING OF SMALLER FALLOPIAN TUBE SEGMENT RECEIVED WITH IN THE SPECIMEN CONTAINER DISPLAY A FAN PINPOINT LUMEN. THE FIMBRIATED AND OF THE EACH FALLOPIAN TUBE IS SUBMITTED IN ITS ANTIRELY IN BRCA PROTOCOL. HYSTEROSALPINGOGRAM: GOOD, NO DYE WENT THROUGH TUBES MEANING IT WAS SUCCESSFUL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN/PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES:3), PARITY 2 (NUMBER OF LIVE BIRTHS:2 NSVD((B)(6) 2009,(B)(6) 2011)) AND SPONTANEOUS ABORTION IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE ALLERGY. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH CODEINE ALLERGY. CONCURRENT CONDITIONS INCLUDED ANXIETY AND ALLERGY (ALLERGIES, SPECIFY: PCU UPSET BI). FAMILY HISTORY INCLUDED CARCINOMA BREAST (MATERNAL GRAND MOTHER) AND DIABETES (PATERNAL GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FOR CONTRACEPTION AS WELL AS ALPRAZOLAM (XANAX) SINCE 2008, ANESTHETICS, GENERAL (GENERAL ANESTHESIA) AND SERTRALINE (ZOLOFT). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("SEVERE HEADACHES/MIGRAINE/HEADACHE"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINALABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN/LOSS SPECIFY: GAIN") AND FATIGUE ("FATIGUE"). IN 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA/NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("CONSTANT DYSMENORRHEA ( CRAMPING)/DYSMENORRHEA (CRAMPING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS; DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014) AND SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, FATIGUE, DEPRESSION, ANXIETY AND BACK PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, HEADACHE, DYSPAREUNIA, MIGRAINE, NAUSEA AND DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RING USED IN 2016 TO REGULATE PERIOD AND IT WAS DISCONTINUED DUE TO OTHER (PLEASE SPECIFY) ¿ PERIOD REGULATED (MENTIONED IN PFS). SHE DID NOT RETAINED THE ESSURE DEVICE OR ANY PORTION OF IT. NO ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SOCIAL HISTORY: PATIENT AGRESS THE INFUSIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: SATISFACTORY POSITION AND BOTH TUBES OCCLUDED PREGNANCY TEST - ON (B)(6) 2011: NEGATIVE ULTRASOUND SCAN - ON (B)(6) 2012: NORMAL EXAM / ESSURE WAS IN PLACE 19-JUL-2011, HYSTEROSALPINGOGRAPHY: ESSURE INSERTS ARE PRESENT IN BOTH FALLOPIAN TUBES. THEY ARE IN SATISFACTORY POSITION. NO TUBAL PATENCY IS SEEN. NO INTRAPERITONEAL SPILLAGE IS PRESENT. A FILLING DEFECT IS SEEN IN THE LEFT CORNU WHICH MAY REPRESENT A BUBBLE. IMPRESSION: OCCLUSION OF BOTH FALLOPIAN TUBES SECONDARY TO ESSURE INSERTS. US PELVIC[NON 08] COMPLETE W/TRANSVAG : ULTRASOUND OF THE PELVIS: THE PELVIS IS EXAMINED WITH TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND. THE UTERUS MEASURES L 6.6 CM X D 4.2 CM X W 6.0 CM. ENDOMETRIAL ECHOES MEASURE 0.7 CM IN THICKNESS WHICH IS WITHIN NORMAL LIMITS. THE RIGHT OVARY MEASURES L 2.7 CM X D 1.7 CM X W 1.7 CM AND IS NORMAL APPEARING THE LEFT OVARY MEASURES L 2.9 CM X D 1.5 CM X W 1.7 CM AND CONTAINS A DOMINANT FOLLICLE. DOPPLER IMAGING SHOWS NORMAL FLOW TO BOTH OVARIES. THE ECHOGENIC TIPS OF BILATERAL ESSURE IMPLANTS CAN BE SEEN IN THE FALLOPIAN TUBES BILATERALLY. NO FREE FLUID OR OTHER ABNORMALITY. IMPRESSION : NORMAL PELVIC SONOGRAM WITH ESSURE IMPLANTS IN PLACE. FINAL DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: TWO FALLOPIAN TUBE WITH FIMBRIATED ENDS AND BENIGN PARATUBAL CYSTS. METAL COILS PRESENT MOST CONSISTENT WITH INTRAMURAL FALLOPIAN TUBESTERILIZATION DEVICE). NO ATYPICAL OR MALIGNANT FEATURES IDENTIFIED. RT AND LT FALLOPIAN TUBE: RECEIVED IN FORMALINE LABLED. RT AND LT FALLOPIAN TUBE ARE TWO FRAGMENTED FIMBRIATED FALLOPIAN TUB SEGMENT. 4.0X2.6X1.5CM AGGREGATES DIMENSION. ONE FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 2.3X1.3X0.8CM. A SECTION REVEALS STERILE LUMEN. SECOND FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 0.4X0.7X0.6CM. SECTIONING OF THIS LUMEN ALSO REVEALS STERILE LUMEN. SECTIONING OF SMALLER FALLOPIAN TUBE SEGMENT RECEIVED WITH IN THE SPECIMEN CONTAINER DISPLAY A FAN PINPOINT LUMEN. THE FIMBRIATED AND OF THE EACH FALLOPIAN TUBE IS SUBMITTED IN ITS ANTIRELY IN BRCA PROTOCOL. HYSTEROSALPINGOGRAM: GOOD, NO DYE WENT THROUGH TUBES MEANING IT WAS SUCCESSFUL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2018: PFS RECEIVED: CONCOMITANT DRUG AND EVENTS ABNORMAL BLEEDING, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS; DEPRESSION, MENTAL ANGUISH, LOWER BACK PAIN WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN/PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES:3), PARITY 2 (NUMBER OF LIVE BIRTHS:2 NSVD((B)(6) 2009, (B)(6) 2011)) AND SPONTANEOUS ABORTION IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE ALLERGY. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH CODEINE ALLERGY. CONCURRENT CONDITIONS INCLUDED ANXIETY AND ALLERGY (ALLERGIES, SPECIFY: PCU UPSET BI). FAMILY HISTORY INCLUDED CARCINOMA BREAST (MATERNAL GRAND MOTHER) AND DIABETES (PATERNAL GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FOR CONTRACEPTION AS WELL AS ALPRAZOLAM (XANAX) SINCE 2008 AND ANESTHETICS, GENERAL (GENERAL ANESTHESIA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("SEVERE HEADACHES/MIGRAINE/HEADACHE"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN/LOSS SPECIFY: GAIN") AND FATIGUE ("FATIGUE"). IN 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA/NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN AND DYSMENORRHOEA ("CONSTANT DYSMENORRHEA ( CRAMPING)/DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014) AND SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND FATIGUE OUTCOME WAS UNKNOWN AND THE HEADACHE, DYSPAREUNIA, MIGRAINE, NAUSEA AND DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RING USED IN 2016 TO REGULATE PERIOD AND IT WAS DISCONTINUED DUE TO OTHER (PLEASE SPECIFY) ¿ PERIOD REGULATED (MENTIONED IN PFS). SHE DID NOT RETAINED THE ESSURE DEVICE OR ANY PORTION OF IT. NO ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SOCIAL HISTORY: PATIENT AGRESS THE INFUSIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: SATISFACTORY POSITION AND BOTH TUBES OCCLUDED. PREGNANCY TEST - ON (B)(6) 2011: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2012: NORMAL EXAM / ESSURE WAS IN PLACE. (B)(6) 2011, HYSTEROSALPINGOGRAPHY: ESSURE INSERTS ARE PRESENT IN BOTH FALLOPIAN TUBES. THEY ARE IN SATISFACTORY POSITION. NO TUBAL PATENCY IS SEEN. NO INTRAPERITONEAL SPILLAGE IS PRESENT. A FILLING DEFECT IS SEEN IN THE LEFT CORNU WHICH MAY REPRESENT A BUBBLE. IMPRESSION: OCCLUSION OF BOTH FALLOPIAN TUBES SECONDARY TO ESSURE INSERTS. US PELVIC[NON 08] COMPLETE W/TRANSVAG : ULTRASOUND OF THE PELVIS: THE PELVIS IS EXAMINED WITH TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND. THE UTERUS MEASURES L 6.6 CM X D 4.2 CM X W 6.0 CM. ENDOMETRIAL ECHOES MEASURE 0.7 CM IN THICKNESS WHICH IS WITHIN NORMAL LIMITS. THE RIGHT OVARY MEASURES L 2.7 CM X D 1.7 CM X W 1.7 CM AND IS NORMAL APPEARING THE LEFT OVARY MEASURES L 2.9 CM X D 1.5 CM X W 1.7 CM AND CONTAINS A DOMINANT FOLLICLE. DOPPLER IMAGING SHOWS NORMAL FLOW TO BOTH OVARIES. THE ECHOGENIC TIPS OF BILATERAL ESSURE IMPLANTS CAN BE SEEN IN THE FALLOPIAN TUBES BILATERALLY. NO FREE FLUID OR OTHER ABNORMALITY. IMPRESSION : NORMAL PELVIC SONOGRAM WITH ESSURE IMPLANTS IN PLACE. FINAL DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: TWO FALLOPIAN TUBE WITH FIMBRIATED ENDS AND BENIGN PARATUBAL CYSTS. METAL COILS PRESENT MOST CONSISTENT WITH INTRAMURAL FALLOPIAN TUBE STERILIZATION DEVICE). NO ATYPICAL OR MALIGNANT FEATURES IDENTIFIED. RT AND LT FALLOPIAN TUBE: RECEIVED IN FORMALINE LABLED. RT AND LT FALLOPIAN TUBE ARE TWO FRAGMENTED FIMBRIATED FALLOPIAN TUB SEGMENT. 4.0X2.6X1.5CM AGGREGATES DIMENSION. ONE FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 2.3X1.3X0.8CM. A SECTION REVEALS STERILE LUMEN. SECOND FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 0.4X0.7X0.6CM. SECTIONING OF THIS LUMEN ALSO REVEALS STERILE LUMEN. SECTIONING OF SMALLER FALLOPIAN TUBE SEGMENT RECEIVED WITH IN THE SPECIMEN CONTAINER DISPLAY A FAN PINPOINT LUMEN. THE FIMBRIATED AND OF THE EACH FALLOPIAN TUBE IS SUBMITTED IN ITS ANTIRELY IN BRCA PROTOCOL. HYSTEROSALPINGOGRAM: GOOD, NO DYE WENT THROUGH TUBES MEANING IT WAS SUCCESSFUL. QUALITY-SAFETY EVALUATION OF PTC: 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. 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2018: PFS RECEIVED. OUTCOME OF THE EVENTS WERE UPDATED, EVENT ONSET DATE WAS UPDATED. 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 DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE') AND PELVIC PAIN ('SEVERE PELVIC PAIN/PAIN/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SPONTANEOUS ABORTION IN 2008, MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES:3), PARITY 2 (NUMBER OF LIVE BIRTHS:2 NSVD((B)(6) 2009, (B)(6) 2011)), DEPRESSION AND MISCARRIAGE. FINAL DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: TWO FALLOPIAN TUBE WITH FIMBRIATED ENDS AND BENIGN PARATUBAL CYSTS. METAL COILS PRESENT MOST CONSISTENT WITH INTRAMURAL FALLOPIAN TUBE STERILIZATION DEVICE). NO ATYPICAL OR MALIGNANT FEATURES IDENTIFIED. RT AND LT FALLOPIAN TUBE: RECEIVED IN FORMALINE LABLED. RT AND LT FALLOPIAN TUBE ARE TWO FRAGMENTED FIMBRIATED FALLOPIAN TUB SEGMENT. 4.0X2.6X1.5CM AGGREGATES DIMENSION. ONE FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 2.3X1.3X0.8CM. A SECTION REVEALS STERILE LUMEN. SECOND FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 0.4X0.7X0.6CM. SECTIONING OF THIS LUMEN ALSO REVEALS STERILE LUMEN. SECTIONING OF SMALLER FALLOPIAN TUBE SEGMENT RECEIVED WITH IN THE SPECIMEN CONTAINER DISPLAY A FAN PINPOINT LUMEN. THE FIMBRIATED AND OF THE EACH FALLOPIAN TUBE IS SUBMITTED IN ITS ENTIRELY IN BRCA PROTOCOL. HYSTEROSALPINGOGRAM: GOOD, NO DYE WENT THROUGH TUBES MEANING IT WAS SUCCESSFUL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: NUVARING; FOR AN UNREPORTED INDICATION: CODEINE ALLERGY. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH CODEINE ALLERGY. CONCURRENT CONDITIONS INCLUDED ANXIETY, ALLERGY (ALLERGIES, SPECIFY: PCU UPSET BI), OBESITY, INSOMNIA, LOSS OF ENERGY, IRRITABILITY, ALLERGIC REACTION TO ANALGESICS AND OVARIAN CYST. FAMILY HISTORY INCLUDED CARCINOMA BREAST (MATERNAL GRAND MOTHER) AND DIABETES (PATERNAL GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FOR CONTRACEPTION, ALPRAZOLAM (XANAX) SINCE 2008 FOR DEPRESSION AND ANXIETY AS WELL AS ANESTHETICS, GENERAL, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2008 TO FEBRUARY 2009, IRON AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND DYSMENORRHOEA ("CONSTANT DYSMENORRHEA ( CRAMPING)/DYSMENORRHEA (CRAMPING)"), 5 MONTHS 18 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("SEVERE HEADACHES/MIGRAINE/HEADACHE"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE") AND FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN/LOSS SPECIFY: GAIN"). IN 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA/NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN/CONSTANT ABDOMINAL PAIN"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS; DEPRESSION"), ANXIETY ("MENTAL ANGUISH/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), BACK PAIN ("LOWER BACK PAIN") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014 AND DIAGNOSTIC LAPAROSCOPY HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, WEIGHT INCREASED, FATIGUE, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BACK PAIN AND HYPERSENSITIVITY HAD RESOLVED AND THE HEADACHE, DYSPAREUNIA, MIGRAINE, NAUSEA AND DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RING USED IN 2016 TO REGULATE PERIOD AND IT WAS DISCONTINUED DUE TO OTHER (PLEASE SPECIFY) ¿ PERIOD REGULATED (MENTIONED IN PFS). SHE DID NOT RETAINED THE ESSURE DEVICE OR ANY PORTION OF IT. NO ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SOCIAL HISTORY: PATIENT AGREES THE INFUSIONS DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2011. CURRENT WEIGHT 220 LBS. NUMBER OF PROXIMAL COILS: RIGHT-7. NUMBER OF PROXIMAL COILS: LEFT-4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: ESSURE INSERTS ARE PRESENT IN BOTH FALLOPIAN TUBES. THEY ARE IN SATISFACTORY POSITION. NO TUBAL PATENCY IS SEEN. NO INTRAPERITONEAL SPILLAGE IS PRESENT. A FILLING DEFECT IS SEEN IN THE LEFT CORNUA WHICH MAY REPRESENT A BUBBLE. PREGNANCY TEST - ON (B)(6) 2011: RESULTS: NEGATIVE. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS:THE PELVIS IS EXAMINED WITH TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND. THE UTERUS MEASURES L 6.6 CM X D 4.2 CM X W 6.0 CM. ENDOMETRIAL ECHOES MEASURE 0.7 CM IN THICKNESS WHICH IS WITHIN NORMAL LIMITS. THE RIGHT OVARY MEASURES L 2.7 CM X D 1.7 CM X W 1.7 CM AND IS NORMAL APPEARING THE LEFT OVARY MEASURES L 2.9 CM X D 1.5 CM X W 1.7 CM AND CONTAINS A DOMINANT FOLLICLE. DOPPLER IMAGING SHOWS NORMAL FLOW TO BOTH OVARIES. THE ECHOGENIC TIPS OF BILATERAL ESSURE IMPLANTS CAN BE SEEN IN THE FALLOPIAN TUBES BILATERALLY. NO FREE FLUID OR OTHER ABNORMALITY.; ON (B)(6) 2012: RESULTS: NORMAL EXAM / ESSURE WAS IN PLACE; ON (B)(6) 2014: HOMOGENEOUS ANTEVERTED UTERUS WITH NORMAL APPEARANCE OF THE ENDOMETRIUM. THE ESSURE IUD APPEARS TO BE SEATED IN THE CORRECT POSITION. 1.9CM CYST IN THE RIGHT OVARY. LEFT OVARY AND ADNEXA APPEAR NORMAL. NO FREE FLUID IN THE CUL-DE-SAC. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN ,DYSPAREUNIA, WEIGHT GAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. NEW EVENT ALLERGIC REACTION WAS ADDED. OUTCOME OF EVENTS PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, GENITAL HEMORRHAGE, VAGINAL HEMORRHAGE AND ALLERGIC REACTION WAS UPDATED TO RECOVERED. NEW REPORTER ADDED. SERIOUSNESS CRITERIA FOR GENITAL HEMORRHAGE UPDATED TO NON SERIOUS. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES:3), PARITY 2 (NUMBER OF LIVE BIRTHS:2 NSVD((B)(6) 2009,(B)(6) 2011)) AND SPONTANEOUS ABORTION IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE ALLERGY. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH CODEINE ALLERGY. CONCURRENT CONDITIONS INCLUDED ANXIETY AND ALLERGY (ALLERGIES, SPECIFY: PCU UPSET BI). FAMILY HISTORY INCLUDED CARCINOMA BREAST (MATERNAL GRAND MOTHER) AND DIABETES (PATERNAL GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FOR CONTRACEPTION AS WELL AS ALPRAZOLAM (XANAX) SINCE 2008 AND ANESTHETICS, GENERAL (GENERAL ANESTHESIA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA,") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, HEADACHE ("SEVERE HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND DYSMENORRHOEA ("CONSTANT DYSMENORRHEA ( CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014) AND SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND FATIGUE OUTCOME WAS UNKNOWN, THE HEADACHE AND MIGRAINE WAS RESOLVING AND THE DYSPAREUNIA, NAUSEA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RING USED IN 2016 TO REGULATE PERIOD AND IT WAS DISCONTINUED DUE TO OTHER (PLEASE SPECIFY) ¿ PERIOD REGULATED (MENTIONED IN PFS). SHE DID NOT RETAINED THE ESSURE DEVICE OR ANY PORTION OF IT. NO ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SOCIAL HISTORY: PATIENT AGRESS THE INFUSIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2011: NEGATIVE ULTRASOUND SCAN - ON (B)(6) 2012: NORMAL EXAM / ESSURE WAS IN PLACE. ON (B)(6) 2011, HYSTEROSALPINGOGRAPHY: ESSURE INSERTS ARE PRESENT IN BOTH FALLOPIAN TUBES. THEY ARE IN SATISFACTORY POSITION. NO TUBAL PATENCY IS SEEN. NO INTRAPERITONEAL SPILLAGE IS PRESENT. A FILLING DEFECT IS SEEN IN THE LEFT CORNU WHICH MAY REPRESENT A BUBBLE. IMPRESSION: OCCLUSION OF BOTH FALLOPIAN TUBES SECONDARY TO ESSURE INSERTS. US PELVIC[NON 08] COMPLETE W/TRANSVAG : ULTRASOUND OF THE PELVIS: THE PELVIS IS EXAMINED WITH TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND. THE UTERUS MEASURES L 6.6 CM X D 4.2 CM X W 6.0 CM. ENDOMETRIAL ECHOES MEASURE 0.7 CM IN THICKNESS WHICH IS WITHIN NORMAL LIMITS. THE RIGHT OVARY MEASURES L 2.7 CM X D 1.7 CM X W 1.7 CM AND IS NORMAL APPEARING THE LEFT OVARY MEASURES L 2.9 CM X D 1.5 CM X W 1.7 CM AND CONTAINS A DOMINANT FOLLICLE. DOPPLER IMAGING SHOWS NORMAL FLOW TO BOTH OVARIES. THE ECHOGENIC TIPS OF BILATERAL ESSURE IMPLANTS CAN BE SEEN IN THE FALLOPIAN TUBES BILATERALLY. NO FREE FLUID OR OTHER ABNORMALITY. IMPRESSION : NORMAL PELVIC SONOGRAM WITH ESSURE IMPLANTS IN PLACE. FINAL DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: TWO FALLOPIAN TUBE WITH FIMBRIATED ENDS AND BENIGN PARATUBAL CYSTS. METAL COILS PRESENT MOST CONSISTENT WITH INTRAMURAL FALLOPIAN TUBESTERILIZATION DEVICE). NO ATYPICAL OR MALIGNANT FEATURES IDENTIFIED. RT AND LT FALLOPIAN TUBE: RECEIVED IN FORMALINE LABLED. RT AND LT FALLOPIAN TUBE ARE TWO FRAGMENTED FIMBRIATED FALLOPIAN TUB SEGMENT. 4.0X2.6X1.5CM AGGREGATES DIMENSION. ONE FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 2.3X1.3X0.8CM. A SECTION REVEALS STERILE LUMEN. SECOND FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 0.4X0.7X0.6CM. SECTIONING OF THIS LUMEN ALSO REVEALS STERILE LUMEN. SECTIONING OF SMALLER FALLOPIAN TUBE SEGMENT RECEIVED WITH IN THE SPECIMEN CONTAINER DISPLAY A FAN PINPOINT LUMEN. THE FIMBRIATED AND OF THE EACH FALLOPIAN TUBE IS SUBMITTED IN ITS ANTIRELY IN BRCA PROTOCOL. QUALITY-SAFETY EVALUATION OF PTC: 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. 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-FEB-2018: PFS AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. LOT NUMBER ADDED. CASE MEDICALLY CONFIRMED. EVENT MIGRATION OF ESSURE DEVICE, ABNORMAL BLEEDING MENORRHAGIA AND VAGINAL, MIGRAINES, NAUSEA, WEIGHT GAIN, FATIGUE, CONSTANT DYSMENORRHEA ( CRAMPING). HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE') AND PELVIC PAIN ('SEVERE PELVIC PAIN/PAIN/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SPONTANEOUS ABORTION IN 2008, MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES:3), PARITY 2 (NUMBER OF LIVE BIRTHS:2 NSVD((B)(6) 2009, (B)(6) 2011)), DEPRESSION AND MISCARRIAGE. FINAL DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: TWO FALLOPIAN TUBE WITH FIMBRIATED ENDS AND BENIGN PARATUBAL CYSTS. METAL COILS PRESENT MOST CONSISTENT WITH INTRAMURAL FALLOPIAN TUBESTERILIZATION DEVICE). NO ATYPICAL OR MALIGNANT FEATURES IDENTIFIED. RT AND LT FALLOPIAN TUBE: RECEIVED IN FORMALINE LABLED. RT AND LT FALLOPIAN TUBE ARE TWO FRAGMENTED FIMBRIATED FALLOPIAN TUB SEGMENT. 4.0X2.6X1.5CM AGGREGATES DIMENSION. ONE FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 2.3X1.3X0.8CM. A SECTION REVEALS STERILE LUMEN. SECOND FALLOPIAN TUBE SEGMENT DISPLAYING FIMBRIA IS 0.4X0.7X0.6CM. SECTIONING OF THIS LUMEN ALSO REVEALS STERILE LUMEN. SECTIONING OF SMALLER FALLOPIAN TUBE SEGMENT RECEIVED WITH IN THE SPECIMEN CONTAINER DISPLAY A FAN PINPOINT LUMEN. THE FIMBRIATED AND OF THE EACH FALLOPIAN TUBE IS SUBMITTED IN ITS ANTIRELY IN BRCA PROTOCOL. HYSTEROSALPINGOGRAM: GOOD, NO DYE WENT THROUGH TUBES MEANING IT WAS SUCCESSFUL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: NUVARING; FOR AN UNREPORTED INDICATION: CODEINE ALLERGY. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH CODEINE ALLERGY. CONCURRENT CONDITIONS INCLUDED ANXIETY, ALLERGY (ALLERGIES, SPECIFY: PCU UPSET BI), OBESITY, INSOMNIA, LOSS OF ENERGY, IRRITABILITY, ALLERGIC REACTION TO ANALGESICS AND OVARIAN CYST. FAMILY HISTORY INCLUDED CARCINOMA BREAST (MATERNAL GRAND MOTHER) AND DIABETES (PATERNAL GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FOR CONTRACEPTION, ALPRAZOLAM (XANAX) SINCE 2008 FOR DEPRESSION AND ANXIETY AS WELL AS ANESTHETICS, GENERAL, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2008 TO (B)(6) 2009, IRON AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND DYSMENORRHOEA ("CONSTANT DYSMENORRHEA ( CRAMPING)/DYSMENORRHEA (CRAMPING)"), 5 MONTHS 18 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("SEVERE HEADACHES/MIGRAINE/HEADACHE"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINALABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE") AND FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN/LOSS SPECIFY: GAIN"). IN 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA/NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN/CONSTANT ABDOMINAL PAIN"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS; DEPRESSION"), ANXIETY ("MENTAL ANGUISH/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), BACK PAIN ("LOWER BACK PAIN") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014 AND DIAGNOSTIC LAPAROSCOPY HYSTERCTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, WEIGHT INCREASED, FATIGUE, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BACK PAIN AND HYPERSENSITIVITY HAD RESOLVED AND THE HEADACHE, DYSPAREUNIA, MIGRAINE, NAUSEA AND DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RING USED IN 2016 TO REGULATE PERIOD AND IT WAS DISCONTINUED DUE TO OTHER (PLEASE SPECIFY) ¿ PERIOD REGULATED (MENTIONED IN PFS). SHE DID NOT RETAINED THE ESSURE DEVICE OR ANY PORTION OF IT. NO ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. SHE DID NOT ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SOCIAL HISTORY: PATIENT AGRESS THE INFUSIONS DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2011 & (B)(6) 2011. CURRENT WEIGHT 220 LBS. NUMBER OF PROXIMAL COILS: RIGHT-7. NUMBER OF PROXIMAL COILS: LEFT-4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: ESSURE INSERTS ARE PRESENT IN BOTH FALLOPIAN TUBES. THEY ARE IN SATISFACTORY POSITION. NO TUBAL PATENCY IS SEEN. NO INTRAPERITONEAL SPILLAGE IS PRESENT. A FILLING DEFECT IS SEEN IN THE LEFT CORNUA WHICH MAY REPRESENT A BUBBLE. PREGNANCY TEST - ON (B)(6) 2011: RESULTS: NEGATIVE. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS:THE PELVIS IS EXAMINED WITH TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND. THE UTERUS MEASURES L 6.6 CM X D 4.2 CM X W 6.0 CM. ENDOMETRIAL ECHOES MEASURE 0.7 CM IN THICKNESS WHICH IS WITHIN NORMAL LIMITS. THE RIGHT OVARY MEASURES L 2.7 CM X D 1.7 CM X W 1.7 CM AND IS NORMAL APPEARING THE LEFT OVARY MEASURES L 2.9 CM X D 1.5 CM X W 1.7 CM AND CONTAINS A DOMINANT FOLLICLE. DOPPLER IMAGING SHOWS NORMAL FLOW TO BOTH OVARIES. THE ECHOGENIC TIPS OF BILATERAL ESSURE IMPLANTS CAN BE SEEN IN THE FALLOPIAN TUBES BILATERALLY. NO FREE FLUID OR OTHER ABNORMALITY.; ON (B)(6) 2012: RESULTS: NORMAL EXAM / ESSURE WAS IN PLACE; ON (B)(6) 2014: HOMOGENEOUS ANTEVERTED UTERUS WITH NORMAL APPEARANCE OF THE ENDOMETRIUM. THE ESSURE IUD APPEARS TO BE SEATED IN THE CORRECT POSITION.1.9CM CYST IN THE RIGHT OVARY. LEFT OVARY AND ADNEXA APPEAR NORMAL. NO FREE FLUID IN THE CUL-DE-SAC. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2020: 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.
QUALITY-SAFETY EVALUATION OF PTC: 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. 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAR-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A PLAINTIFF WHO HAD ESSURE INSERTED AND EXPERIENCED SEVERE PELVIC PAIN. SHE UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY AROUND THREE YEARS AFTER ESSURE INSERTION. PELVIC PAIN IS ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. PELVIC PAIN MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. BASED ON A POSITIVE TEMPORAL RELATIONSHIP AND THE LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THIS EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE SURGICAL PROCEDURE REQUIRED. IN ADDITION, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), HEADACHE ("SEVERE HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY ON (B)(6) 2014). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, DYSPAREUNIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN, HEADACHE, DYSPAREUNIA AND ABDOMINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ON (B)(6) 2011: HYSTEROSALPINGOGRAM RESULT WAS SATISFACTORY POSITION AND BOTH TUBES OCCLUDED. ON (B)(6) 2012: ULTRASOUND SCAN RESULT WAS NORMAL EXAM / ESSURE WAS IN PLACE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A PLAINTIFF WHO HAD ESSURE INSERTED AND EXPERIENCED SEVERE PELVIC PAIN. SHE UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND BILATERAL SALPINGECTOMY AROUND THREE YEARS AFTER ESSURE INSERTION. PELVIC PAIN IS ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. PELVIC PAIN MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. BASED ON A POSITIVE TEMPORAL RELATIONSHIP AND THE LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THIS EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE SURGICAL PROCEDURE REQUIRED. IN ADDITION, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217520 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ANESTHETICS, GENERAL| ANESTHETICS, GENERAL| GENERAL ANESTHESIA| GENERAL ANESTHESIA| GENERAL ANESTHESIA| GENERAL ANESTHESIA| IRON| IRON| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| WELLBUTRIN| WELLBUTRIN| XANAX| XANAX| XANAX| XANAX| XANAX| XANAX| ZOLOFT| ZOLOFT| ZOLOFT |