ESSURE
Report
- Report Number
- 2951250-2017-03494
- Event Type
- Injury
- Date Received
- September 8, 2017
- Report Date
- July 19, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE MICROINSERTION INTO ABDOMEN OR LOWER PELVIC REGION (PER OTHER)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/BIG BLOOD CLOTS (PER OTHER)") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE DISORDER AFTER INSERTION (PER OTHER)") IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA ((B)(6) 2008, (B)(6) 2010, (B)(6) 2011.), BLEEDING BREAKTHROUGH IN 2011, INTRA-UTERINE CONTRACEPTIVE DEVICE INSERTION (MIRENA IUD (LEVONORGESTREL IUD). IN 2011, TUBAL LIGATION IN 2011, STERILIZATION (ESSURE STERILIZATION REMOVAL OF MIRENA IUD.) IN 2011, ADVERSE REACTION, D & C (FOR AUB ON DEPO PROVERA) ON (B)(6) 2014 AND CHOLECYSTECTOMY IN 2011. SHE DENIES ANY HISTORY OF STI'S. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ALDONET, VICTOZA SOPN, AUGMENTIN ORAL, CAL, D 2000 TABS, DEPO-PROVERA, DOXYCYCLINE HYCLATE, ESCITALOPRAM OXALTIE, FLAGYL, GABAPENTIN, HYDROCODONE COMPOUND ORAL, IBUPROFEN, IRON SUPPLEMENT, METFORMIN HCL, MIRENA IUD, MOBIC TABS, ORTHO EVRA AND ANAPROX OS 550 MG TABS. CONCURRENT CONDITIONS INCLUDED PARITY 3 ((B)(6) 2008, (B)(6) 2010, (B)(6) 2011.), UTERINE FIBROID SINCE (B)(6) 2013, CHANGE IN BOWEL HABITS, COLD INTOLERANCE, BLOATING, MOOD SWINGS SINCE (B)(6) 2015, HOT FLASHES SINCE (B)(6) 2015, YEAST INFECTION SINCE (B)(6) 2015, ITCHING SINCE (B)(6) 2015, BACTERIAL VAGINOSIS SINCE (B)(6) 2015, MORBID OBESITY SINCE (B)(6) 2015, TYPE II DIABETES MELLITUS SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, ELEVATED BP SINCE (B)(6) 2015, PENICILLIN ALLERGY ((PENICILLIN V POTASSIUM) (MODERATE).) SINCE (B)(6) 2016, ALLERGIC REACTION TO ANALGESICS SINCE (B)(6) 2016, LAPAROSCOPY SINCE (B)(6) 2016, SEPTOPLASTY SINCE (B)(6) 2016, HYPERTENSION SINCE (B)(6) 2016, ALLERGIC REACTION TO ANTIBIOTICS ((MODERATE)) SINCE (B)(6) 2016, ALLERGIC REACTION TO ANTIBIOTICS (MODERATE) SINCE (B)(6) 2016, ANXIETY AND DEPRESSION. FAMILY HISTORY INCLUDED HYPERTENSION (FATHER) AND DIABETES (FATHER). CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ PAIN DURING INTERCOURSE AFTER INSERTION (PER OTHER)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES /MIGRAINES / HEADACHES/ MIGRAINE AFTER INSERTION (PER OTHER)"), ALOPECIA ("HAIR LOSS /HAIR LOSS /HAIR LOSS AFTER (PER OTHER)INSERTION,"), HEADACHE ("MIGRAINES / HEADACHES/ MIGRAINE AFTER INSERTION (PER OTHER)") AND WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND PELVIC PAIN, AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("PROLONGED MENSES /PROLONGED MENSES AFTER INSERTION (PER OTHER)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING") AND BACK PAIN ("SEVERE BACK PAIN /SEVERE BACK PAIN/ SEVERE BACK PAIN AFTER INSERTION (PER OTHER)"). THE PATIENT WAS TREATED WITH MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), NSAID'S AND SURGERY (VAGINAL HYSTERECTOMY (PARTIAL) ON (B)(6) 2016, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, MIGRAINE, ALOPECIA, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, BACK PAIN, DYSPAREUNIA, VAGINAL HAEMORRHAGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE DISORDER, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER SURGERY, THE PLAINTIFF WAS LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED ON (B)(6) 2012 - HYSTEROSALPINGOGRAM (HSG) RESULT WAS, WHAT WERE THE RESULTS OF YOUR ESSURE CONFIRMATION TEST? OTHER (BILATERAL FALLOPIAN TUBAL OCCLUSION HISTORY: PATIENT WAS POST WIRE COIL FALLOPIAN TUBE OCCLUSION. FINDINGS: SCOUT IMAGES DEMONSTRATES BILATERAL METALLIC WIRES OVERLYING THE LOWER PELVIS, UNDER FLUOROSCOPIC GUIDANCE, THE GYNECOLOGIST INJECTED THE TUBE WHOSE TIP WAS PLACED WITHIN THE ENDOMETRIAL CAVI TY THERE IS OCCLUSION OF THE BILATERAL FALLOPIAN TUBES. ENDORNETRIAL CAVITY APPEARS UNREMARKABLE. DESCRIPTION: AFTER THE PATIENT WAS PLACED ON THE RADIOLOGY TABLE, A SPECULUM WAS PLACED IN THE VAGINA. THE CERVIX WAS PREPPED WITH BETADINE. A BALLOON CATHETER WAS PLACED IN THE ENDOMETRIAL CAVITY. BALLOON WAS INSUFFLATED WITH 4 ML OF AIR. THROUGH THIS CATHETER, A RADIOPAQUE CONTRAST DYE WAS INTRODUCED. PICTURES WERE TAKEN SHOWING THE UTERINE CAVITY FILLED, THE ESSURE IN PLACE AND NO PASSAGE OF THE DYE PAST THE ESSURE, SHOWING ADEQUATE STERILIZATION WITH THE ESSURE. THERE WERE NO COMPLICATIONS. THE DYE WAS REMOVED FROM THE UTERINE CAVITY. CATHETER WAS REMOVED. SPECULUM HAD BEEN REMOVED. THE PATIENT WAS CLEANED UP FROM SURGERY AND WAS DISCHARGED TO HOME WITH ADEQUATE STERILIZATION BY ESSURE. ON (B)(6) 2012, HYSTEROSALPINGOGRAM, RESULT WAS IMPRESSION: BILATERAL FALLOPIAN TUBE OCCLUSION. PELVIC ULTRASOUND: INDICATION ¿ INTERMITTENT BILATERAL PELVIC PAIN. ON (B)(6) 2016, LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, DIAGNOSIS OF PELVIC PAIN. ON THE SAME DAY, PREOPERATIVE & POSTOPERATIVE DIAGNOSIS: MENORRHAGIA AND PELVIC PAIN, OPERATION OF LAVH (LAPAROSCOPY ASSISTED VAGINAL HYSTERECTOMY) AND BILATERAL SALPINGECTOMY. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT WAS DIAGNOSIS: UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: MILD CHRONIC CERVICITIS. POLYPOID INACTIVE ENDOMETRIUM. BILATERAL FALLOPIAN TUBES, NO PATHOLOGIC DIAGNOSIS. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED WITH THE PATIENT'S NAME, DATE OF BIRTH, AND "UTERUS WITH BILATERAL FALLOPIAN TUBES" IS AN INTACT UTERUS WITH ATTACHED CERVIX AND ATTACHED BILATERAL FIMBRIATED FALLOPIAN TUBE, 182 GRAMS AND 9.4 X 4.5 X3.7 CM. THE OVARIES ARE NOT PRESENT. UTERINE SEROSA. IS PINK AND SMOOTH. THE ECTOCERVIX IS TAN AND SMOOTH WITH CENTRAL 0.6 CM PATENT SLIT LIKE OS. THE ENDOCERVIX IS GROSSLY UNREMARKABLE. THE ENDOMETRIUM IS TAN SLIGHTLY POLYPOID APPEARING AND UP TO 0.3 CM THICK. THE PINK RUBBERY MYOMETRIUM IS UP TO 2.1 CM THICK AND CONTAINS A SMALL FOCAL ILL DEFINE BULGING AREA SUGGESTIVE OF ADENOMYOSIS. NO NODULES ARE IDENTIFIED. THE RIGHT FALLOPIAN TUBE IS 5.S CM LONG AND UP TO 0.3 CM IN DIAMETER. THE PROXIMAL END OF THE TUBE CONTAINS AN INTACT THIN COILED METAL WIRE WHICH EXTENDS INTO THE CORNU OF THE UTERUS CONSISTENT WITH A STERILIZATION DEVICE. THE LEFT FALLOPIAN TUBE IS 5.5 CM LONG AND UP TO 0.3 CM IN DIAMETER. THE PROXIMAL END OF THE TUBE CONTAINS AN INTACT THIN COILED METAL WIRE WHICH EXTENDS INTO THE CORNU OF THE UTERUS CONSISTENT WITH A STERILIZATION DEVICE. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: AL-ANTERIOR AND POSTERIOR CERVIX, A2 - A4 ENDOMYOMETRIUM INCLUDING POSSIBLE ADENOMYOSIS, A5 - RIGHT FALLOPIAN TUBE, AND A6 - LEFT FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: GENITAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, PELVIC PAIN, WEIGHT GAIN, DEVICE DISLOCATION AND AUTOIMMUNE DISORDER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE MICROINSERTION INTO ABDOMEN OR LOWER PELVIC REGION (PER OTHER)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/BIG BLOOD CLOTS (PER OTHER)") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE DISORDER AFTER INSERTION (PER OTHER)") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA ((B)(6) 2008, (B)(6) 2010, (B)(6) 2011.), BLEEDING BREAKTHROUGH IN 2011, INTRA-UTERINE CONTRACEPTIVE DEVICE INSERTION (MIRENA IUD (LEVONORGESTREL IUD).) IN 2011, TUBAL LIGATION IN 2011, STERILIZATION (ESSURE STERILIZATION REMOVAL OF MIRENA IUD.) IN 2011, ADVERSE REACTION, D & C (FOR AUB ON DEPO PROVERA) ON (B)(6) 2014 AND CHOLECYSTECTOMY IN 2011. SHE DENIES ANY HISTORY OF STI'S. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ALDONET, VICTOZA SOPN, AUGMENTIN ORAL, CAL, D 2000 TABS, DEPO-PROVERA, DOXYCYCLINE HYCLATE, ESCITALOPRAM OXALTIE, FLAGYL, GABAPENTIN, HYDROCODONE COMPOUND ORAL, IBUPROFEN, IRON SUPPLEMENT, METFORMIN HCL, MIRENA IUD, MOBIC TABS, ORTHO EVRA AND ANAPROX OS 550 MG TABS. CONCURRENT CONDITIONS INCLUDED PARITY 3 ((B)(6) 2008, (B)(6) 2010, (B)(6) 2011.), UTERINE FIBROID SINCE (B)(6) 2013, CHANGE IN BOWEL HABITS, COLD INTOLERANCE, BLOATING, MOOD SWINGS SINCE (B)(6) 2015, HOT FLASHES SINCE (B)(6) 2015, YEAST INFECTION SINCE (B)(6) 2015, ITCHING SINCE (B)(6) 2015, BACTERIAL VAGINOSIS SINCE (B)(6) 2015, MORBID OBESITY SINCE (B)(6) 2015, TYPE II DIABETES MELLITUS SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, ELEVATED BP SINCE (B)(6) 2015, PENICILLIN ALLERGY ((PENICILLIN V POTASSIUM) (MODERATE).) SINCE (B)(6) 2016, SPECIFIC ALLERGY (DRUG) SINCE (B)(6) 2016, LAPAROSCOPY SINCE (B)(6) 2016, SEPTOPLASTY SINCE (B)(6) 2016, HYPERTENSION SINCE (B)(6) 2016, SPECIFIC ALLERGY (DRUG) ((MODERATE)) SINCE (B)(6) 2016 AND SPECIFIC ALLERGY (DRUG) ((MODERATE)) SINCE (B)(6) 2016. FAMILY HISTORY INCLUDED HYPERTENSION ((FATHER)) AND DIABETES ((FATHER)). CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ PAIN DURING INTERCOURSE AFTER INSERTION (PER OTHER)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES /MIGRAINES / HEADACHES/ MIGRAINE AFTER INSERTION (PER OTHER)"), ALOPECIA ("HAIR LOSS /HAIR LOSS /HAIR LOSS AFTER (PER OTHER)INSERTION,"), HEADACHE ("MIGRAINES / HEADACHES/ MIGRAINE AFTER INSERTION (PER OTHER)") AND WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND PELVIC PAIN, AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("PROLONGED MENSES /PROLONGED MENSES AFTER INSERTION (PER OTHER)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING") AND BACK PAIN ("SEVERE BACK PAIN /SEVERE BACK PAIN/ SEVERE BACK PAIN AFTER INSERTION (PER OTHER)"). THE PATIENT WAS TREATED WITH MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), NSAID'S AND SURGERY (HYSTERECTOMY (PARTIAL) ON (B)(6) 2016, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, MIGRAINE, ALOPECIA, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, BACK PAIN, DYSPAREUNIA, VAGINAL HAEMORRHAGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE DISORDER, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER SURGERY, THE PLAINTIFF WAS LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. ON (B)(6) 2012 - HYSTEROSALPINGOGRAM (HSG) RESULT WAS, WHAT WERE THE RESULTS OF YOUR ESSURE CONFIRMATION TEST? OTHER (BILATERAL FALLOPIAN TUBAL OCCLUSION HISTORY: PATIENT WAS POST WIRE COIL FALLOPIAN TUBE OCCLUSION. FINDINGS: SCOUT IMAGES DEMONSTRATES BILATERAL METALLIC WIRES OVERLYING THE LOWER PELVIS, UNDER FLUOROSCOPIC GUIDANCE, THE GYNECOLOGIST INJECTED THE TUBE WHOSE TIP WAS PLACED WITHIN THE ENDOMETRIAL CAVI TY THERE IS OCCLUSION OF THE BILATERAL FALLOPIAN TUBES. ENDORNETRIAL CAVITY APPEARS UNREMARKABLE. DESCRIPTION: AFTER THE PATIENT WAS PLACED ON THE RADIOLOGY TABLE, A SPECULUM WAS PLACED IN THE VAGINA. THE CERVIX WAS PREPPED WITH BETADINE. A BALLOON CATHETER WAS PLACED IN THE ENDOMETRIAL CAVITY. BALLOON WAS INSUFFLATED WITH 4 ML OF AIR. THROUGH THIS CATHETER, A RADIOPAQUE CONTRAST DYE WAS INTRODUCED. PICTURES WERE TAKEN SHOWING THE UTERINE CAVITY FILLED, THE ESSURE IN PLACE AND NO PASSAGE OF THE DYE PAST THE ESSURE, SHOWING ADEQUATE STERILIZATION WITH THE ESSURE. THERE WERE NO COMPLICATIONS. THE DYE WAS REMOVED FROM THE UTERINE CAVITY. CATHETER WAS REMOVED. SPECULUM HAD BEEN REMOVED. THE PATIENT WAS CLEANED UP FROM SURGERY AND WAS DISCHARGED TO HOME WITH ADEQUATE STERILIZATION BY ESSURE. ON (B)(6) 2012, HYSTEROSALPINGOGRAM, RESULT WAS IMPRESSION: BILATERAL FALLOPIAN TUBE OCCLUSION. PELVIC ULTRASOUND: INDICATION ¿ INTERMITTENT BILATERAL PELVIC PAIN. ON (B)(6) 2016, LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, DIAGNOSIS OF PELVIC PAIN. ON THE SAME DAY, PREOPERATIVE & POSTOPERATIVE DIAGNOSIS: MENORRHAGIA AND PELVIC PAIN, OPERATION OF LAVH (LAPAROSCOPY ASSISTED VAGINAL HYSTERECTOMY) AND BILATERAL SALPINGECTOMY. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT WAS DIAGNOSIS: UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: MILD CHRONIC CERVICITIS. POLYPOID INACTIVE ENDOMETRIUM. BILATERAL FALLOPIAN TUBES, NO PATHOLOGIC DIAGNOSIS. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED WITH THE PATIENT'S NAME, DATE OF BIRTH, AND "UTERUS WITH BILATERAL FALLOPIAN TUBES" IS AN INTACT UTERUS WITH ATTACHED CERVIX AND ATTACHED BILATERAL FIMBRIATED FALLOPIAN TUBE, 182 GRAMS AND 9.4 X 4.5 X3.7 CM. THE OVARIES ARE NOT PRESENT. UTERINE SEROSA. IS PINK AND SMOOTH. THE ECTOCERVIX IS TAN AND SMOOTH WITH CENTRAL 0.6 CM PATENT SLIT LIKE OS. THE ENDOCERVIX IS GROSSLY UNREMARKABLE. THE ENDOMETRIUM IS TAN SLIGHTLY POLYPOID APPEARING AND UP TO 0.3 CM THICK. THE PINK RUBBERY MYOMETRIUM IS UP TO 2.1 CM THICK AND CONTAINS A SMALL FOCAL ILL DEFINE BULGING AREA SUGGESTIVE OF ADENOMYOSIS. NO NODULES ARE IDENTIFIED. THE RIGHT FALLOPIAN TUBE IS 5.S CM LONG AND UP TO 0.3 CM IN DIAMETER. THE PROXIMAL END OF THE TUBE CONTAINS AN INTACT THIN COILED METAL WIRE WHICH EXTENDS INTO THE CORNU OF THE UTERUS CONSISTENT WITH A STERILIZATION DEVICE. THE LEFT FALLOPIAN TUBE IS 5.5 CM LONG AND UP TO 0.3 CM IN DIAMETER. THE PROXIMAL END OF THE TUBE CONTAINS AN INTACT THIN COILED METAL WIRE WHICH EXTENDS INTO THE CORNU OF THE UTERUS CONSISTENT WITH A STERILIZATION DEVICE. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: AL-ANTERIOR AND POSTERIOR CERVIX A2 - A4 ENDOMYOMETRIUM INCLUDING POSSIBLE ADENOMYOSIS, A5 - RIGHT FALLOPIAN TUBE A6 - LEFT FALLOPIAN TUBE . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: GENITAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, PELVIC PAIN, WEIGHT GAIN, DEVICE DISLOCATION AND AUTOIMMUNE DISORDER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-FEB-2018: PATIENT¿S DETAILS, FAMILY HISTORY, HISTORICAL CONDITION, HISTORICAL DRUGS, CONCOMITANT CONDITIONS, CONCOMITANT DRUG AND TREATMENT DRUG WERE ADDED. UNSTRUCTURED RELEVANT TESTS WERE ADDED. ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), MIGRAINES / HEADACHES/ MIGRAINE AFTER INSERTION (PER OTHER), PAIN /SEVERE PELVIC PAIN, WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN, MIGRATION OF ESSURE MICROINSERT INTO ABDOMEN OR LOWER PELVIC REGION (PER OTHER), MALPOSITION OF ESSURE DEVICE /MIGRATION OF ESSURE DEVICE /MIGRATION OF ESSURE MICROINSERT INTO ABDOMEN OR LOWER PELVIC REGION (PER OTHER), BIG BLOOD CLOTS (PER OTHER) AND AUTO-IMMUNE DISORDER AFTER INSERTION (PER OTHER) WERE ADDED AS EVENTS. ESSURE LOT NUMBER WAS 910512. REPORTERS 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 ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINE HEADACHES"), ALOPECIA ("HAIR LOSS"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, MIGRAINE, ALOPECIA, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, BACK PAIN AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER SURGERY, THE PLAINTIFF WAS LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 631708 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | IBUPROFEN| IBUPROFEN |