ESSURE
Report
- Report Number
- 2951250-2017-03462
- Event Type
- Injury
- Date Received
- September 8, 2017
- Date of Event
- January 20, 2015
- Report Date
- May 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX"), EMBEDDED DEVICE ("WAS LOCATED WITHIN THE LEFT MESOSALPINX") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BACK PAIN IN 2003, MIGRAINE IN 2007, TYMPANOPLASTY (ALSO IN 2007) IN 1999, TONSILLECTOMY IN 2007, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (((B)(6) 2013)). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD ON (B)(6) 2013, AMITRIPTYLINE, CAMILA AND MIDRIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED EUGYNON (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ANOVLAR (MICROGESTIN), ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, COLECALCIFEROL (VITAMIN D) SINCE 2010, FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, METAXALONE (SKELAXIN), PAROXETINE (PAROXETIN) FROM 2009 TO 2010 AND PROMETHAZINE SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY) AND SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY PATENT; ON (B)(6) 2014: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT PREGNANCY TEST URINE - ON (B)(6) 2012: POSITIVE. ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, ULTRASOUND SCAN VAGINA REVEALED THAT NORMAL SONOGRAPHIC APPEARANCE OF THE UTERUS AND OVARIES WITHOUT EVIDENCE OF OVARIAN TORSION. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. ON (B)(6) 2015, SURGICAL PATHOLOGY REPORT SHOWED, ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. FRAGMENTS OF ENDOMETRIAL POLYP. FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED LEFT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX"), EMBEDDED DEVICE ("WAS LOCATED WITHIN THE LEFT MESOSALPINX") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BACK PAIN IN 2003, MIGRAINE IN 2007, TYMPANOPLASTY (ALSO IN 2007) IN 1999, TONSILLECTOMY IN 2007, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (((B)(6)2013)). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD ON (B)(6)2013, CAMILA, MIDRIN AND AMITRIPTYLINE. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED EUGYNON (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ANOVLAR (MICROGESTIN), ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, COLECALCIFEROL (VITAMIN D) SINCE 2010, FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, METAXALONE (SKELAXIN), PAROXETINE (PAROXETIN) FROM 2009 TO 2010 AND PROMETHAZINE SINCE 2010. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6)2015, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY) AND SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON(B)(6)2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2014: FALLOPIAN TUBES WERE BILATERALLY PATENT; ON (B)(6) 2014: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6)2014: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6)2014: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT PREGNANCY TEST URINE - ON (B)(6)2012: POSITIVE. ON (B)(6)2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6)2014, HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY. ON (B)(6)2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6)2014, ULTRASOUND SCAN VAGINA REVEALED THAT NORMAL SONOGRAPHIC APPEARANCE OF THE UTERUS AND OVARIES WITHOUT EVIDENCE OF OVARIAN TORSION. ON (B)(6)2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6)2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. ON (B)(6)2015, SURGICAL PATHOLOGY REPORT SHOWED, A. ENDOMETRIUM, CURETTAGE: - PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. - FRAGMENTS OF ENDOMETRIAL POLYP. - FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. - NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF'S FACT SHEET RECEIVED. EVENT PER PFS: ABNORMAL BLEEDING WAS ADDED. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS 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 ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX'), EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (((B)(6) 2013)). ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE") AND PROCEDURAL NAUSEA ("VERY NAUSEOUS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE PROCEDURAL NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, PROCEDURAL NAUSEA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT. PATHOLOGY TEST - ON (B)(6) 2015: A. ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. FRAGMENTS OF ENDOMETRIAL POLYP. FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: POSITIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: SIGNIFICANT CORRECTION DONE. CCC UPDATED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX'), EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 ((B)(6) 2013)). ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE") AND PROCEDURAL NAUSEA ("VERY NAUSEOUS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE PROCEDURAL NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, PROCEDURAL NAUSEA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION, FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION, FAILURE TO OCCLUDE (CLOSE) FT. PATHOLOGY TEST - ON (B)(6) 2015: A. ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. FRAGMENTS OF ENDOMETRIAL POLYP. FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. GROSS DESCRIPTION: A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: POSITIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: SOCIAL MEDIA RECEIVED: REPORTERS ADDED. NEW EVENT POST PROCEDURAL NAUSEA WAS ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 DEVICE DISLOCATION ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX'), EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX'), DEVICE BREAKAGE ('DEVICE BREAKAGE') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY TEST URINE ¿ ON (B)(6)2012 RESULT: POSITIVE.') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (B)(6)2013)). ON (B)(6)2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6)2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6)2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6)2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),/ TAMPON OUT WITH BIG CLOT"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6)2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), PROCEDURAL NAUSEA ("VERY NAUSEOUS"), CYSTITIS ("BLADDER INFECTION") AND FLANK PAIN ("LEFT SIDE HURTING") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL NAUSEA, CYSTITIS AND FLANK PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FLANK PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL NAUSEA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY.; ON (B)(6)2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6)2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6)2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT. MAGNETIC RESONANCE IMAGING - ON (B)(6)2010: RESULTS: 9MML TEMPORAL CAVERNOUS ANGIOMA WITH ENHANCEMENT.. PATHOLOGY TEST - ON (B)(6)2015: A. ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. FRAGMENTS OF ENDOMETRIAL POLYP. FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED GROSS DESCRIPTION: A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6)2012: RESULTS: POSITIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAY-2020: QUALITY-SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). EVENT ADDED DEVICE BREAKAGE AND DEVICE INEFFECTIVE, PREGNANCY TEST URINE ¿ ON (B)(6)2012 RESULT: POSITIVE. 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 DEVICE DISLOCATION ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX') AND EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 ((B)(6) 2013)). ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN JUNE 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), PROCEDURAL NAUSEA ("VERY NAUSEOUS") AND CYSTITIS ("BLADDER INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE PROCEDURAL NAUSEA AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, PROCEDURAL NAUSEA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2010: RESULTS: 9MML TEMPORAL CAVERNOUS ANGIOMA WITH ENHANCEMENT.. PATHOLOGY TEST - ON (B)(6) 2015: A. ENDOMETRIUM, CURETTAGE: - PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. - FRAGMENTS OF ENDOMETRIAL POLYP. - FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. - NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: POSITIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: CONTENT FROM PLAINTIFF FACT SHEET RECEIVED. EVENTS BLADDER INFECTION WAS ADDED. REPORTER INFORMATION UPDATED. 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 DEVICE DISLOCATION ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX') AND EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 ((B)(6) 2013)). ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL; NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),/ TAMPON OUT WITH BIG CLOT"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), PROCEDURAL NAUSEA ("VERY NAUSEOUS"), CYSTITIS ("BLADDER INFECTION") AND FLANK PAIN ("LEFT SIDE HURTING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE PROCEDURAL NAUSEA, CYSTITIS AND FLANK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FLANK PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, PROCEDURAL NAUSEA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2010: RESULTS: 9MML TEMPORAL CAVERNOUS ANGIOMA WITH ENHANCEMENT. PATHOLOGY TEST - ON (B)(6) 2015: A. ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. FRAGMENTS OF ENDOMETRIAL POLYP. FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: POSITIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: FU10 AND FU11 WERE PROCESSED TOGETHER.CONTENT FROM SOCIAL MEDIA RECEIVED. EVENT LEFT SIDE HURTING WAS 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 DEVICE DISLOCATION ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX'), EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX') AND DEVICE BREAKAGE ('DEVICE BREAKAGE') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (((B)(6) 2013)). ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),/ TAMPON OUT WITH BIG CLOT"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), PROCEDURAL NAUSEA ("VERY NAUSEOUS"), CYSTITIS ("BLADDER INFECTION"), FLANK PAIN ("LEFT SIDE HURTING"), ADNEXA UTERI PAIN ("HURTS WHEN I PRESS ON THE AREA OF LEFT TUBE") AND UTERINE PAIN ("UTERINE PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TEST URINE ¿ ON (B)(6) 2012 RESULT: POSITIVE."). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL NAUSEA, CYSTITIS, FLANK PAIN, ADNEXA UTERI PAIN AND UTERINE PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FLANK PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL NAUSEA, UTERINE PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2010: RESULTS: 9MML TEMPORAL CAVERNOUS ANGIOMA WITH ENHANCEMENT.. PATHOLOGY TEST - ON (B)(6) 2015: A. ENDOMETRIUM, CURETTAGE: - PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. - FRAGMENTS OF ENDOMETRIAL POLYP. - FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. - NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: - SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: POSITIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECIEVED. NEW EVENTS: UTERINE PAIN, FALLOPIAN TUBE PAIN ADDED. NEW REPORTER ADDED. 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 DEVICE DISLOCATION ('LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT MESOSALPINX'), EMBEDDED DEVICE ('WAS LOCATED WITHIN THE LEFT MESOSALPINX') AND DEVICE BREAKAGE ('DEVICE BREAKAGE') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, TONSILLECTOMY IN 2007, BACK PAIN IN 2003, TYMPANOPLASTY (ALSO IN 2007) IN 1999, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (((B)(6))). ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO PLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD, AMOXICILLIN, NAPROXEN, HYDROCODONE, CYCLOBENZAPRINE, SIMVASTATIN, PROAIR HFA, CLARITHROMYCIN, ZOVIRAX, BYSTOLIC, TOPIRAMATE, PAROXETINE, LORATADINE, DIZEPAM, ENPRESSE, SINGULAIR, FLUTICASONE PROP, FENOFIBRATE, OMEPRAZOLE, VENTORLIN, DIPHENHYDRAMINE, ONDANSETRON, PRENAPLUS, PRENATAL PLUS, CAMILA, FLUCONAZOLE, IMITREX, NORTRIPTYLINE, MIDRIN, AMITRIPTYLINE, CAMILA, VIT. D AND CEPHALEXIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (TRIVORA) FROM 2009 TO 2011 FOR BIRTH CONTROL AS WELL AS ATENOLOL SINCE 2010, AZITHROMYCIN SINCE 2010, ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), FLUTICASONE SINCE 2010, IBUPROFEN FROM 2009 TO 2010, KETOROLAC SINCE 2010, PAROXETINE (PAROXETIN) FROM 2009 TO 2010, PROMETHAZINE SINCE 2010, SULFAMETHOXAZOLE AND VITAMIN D NOS (VITAMIN D) SINCE 2010. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),/ TAMPON OUT WITH BIG CLOT"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), PROCEDURAL NAUSEA ("VERY NAUSEOUS"), CYSTITIS ("BLADDER INFECTION") AND FLANK PAIN ("LEFT SIDE HURTING") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TEST URINE ¿ ON (B)(6) 2012 RESULT: POSITIVE."). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY / HYSTEROSCOPY D AND C LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL NAUSEA, CYSTITIS AND FLANK PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FLANK PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL NAUSEA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ANY COMPLICATIONS FROM YOUR ESSURE REMOVAL PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT. HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: RESULTS: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2010: RESULTS: 9MML TEMPORAL CAVERNOUS ANGIOMA WITH ENHANCEMENT.. PATHOLOGY TEST - ON (B)(6) 2015: A. ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH ARCHITECTURAL DISARRAY. FRAGMENTS OF ENDOMETRIAL POLYP. FRAGMENTS OF BENIGN ENDOCERVICAL TISSUE. NO ENDOMETRIAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. B. RIGHT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. C. LEFT FALLOPIAN TUBE, SALPINGECTOMY: SEGMENT OF UNREMARKABLE FALLOPIAN TUBE, COMPLETELY TRANSECTED. GROSS DESCRIPTION A. RECEIVED FRESH ON A BLOOD STAINED TELFA PAD LABELED ENDOMETRIAL CURETTINGS, ARE MULTIPLE PORTIONS OF BLOOD AND TAN TISSUE AGGREGATING TO 2.5 X 2 X 0.3 CM. ALL-1. B. RECEIVED FRESH LABELED ESSURE RIGHT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE RECEIVED IN TWO PIECES, MEASURING 1.5 CM IN LENGTH X 0.7 CM DIAMETER AND 4.2 CM IN LENGTH X 0.7 CM DIAMETER. LOOSE IN THE CONTAINER ARE TWO PORTIONS OF COILED TUBING MEASURING 1.2 AND 2 CM IN LENGTH. THE SEGMENT OF FALLOPIAN TUBE ARE SECTIONED REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN WITH A METALLIC COILED WIRE WITHIN THE LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. C. RECEIVED IN FORMALIN LABELED ESSURE LEFT TUBE. THE SPECIMEN CONSISTS OF A FALLOPIAN TUBE WITH DETACHED PORTION OF FIMBRIA, MEASURING 4.5 CM IN LENGTH X 0.7 CM DIAMETER AND 1.8 X 1.2 X 10.9 CM FROM RESPECTIVELY. THERE IS A PORTION OF DETACHED COILED WIRE MEASURING 2.5 CM IN LENGTH. THE FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A GROSSLY UNREMARKABLE, COMPLETE PINPOINT LUMEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: POSITIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ("LEFT ESSURE COIL MIGRATED/MIGRATION OF ESSURE DEVICE: LEFT MESOSALPINX") AND EMBEDDED DEVICE ("WAS LOCATED WITHIN THE LEFT MESOSALPINX") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93872) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BACK PAIN IN 2003, MIGRAINE IN 2007, TYMPANOPLASTY (ALSO IN 2007) IN 1999, TONSILLECTOMY IN 2007, HYPERTENSION, NON-SMOKER, HEADACHE, NAUSEA, PHOTOPHOBIA, JOINT DISORDER, HYPERLIPIDEMIA, DEPRESSION, LUMBAR DISCECTOMY, ADENOIDECTOMY, MYRINGOTOMY, ADENOIDECTOMY, EAR INFECTION, PINCHED NERVE, GRAVIDA I AND PARITY 1 (((B)(6) 2013)). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HEADACHES: EXCEDRIN; FOR AN UNREPORTED INDICATION: IUD ON (B)(6) 2013, AMITRIPTYLINE AND MIDRIN. CONCURRENT CONDITIONS INCLUDED ABSTAINS FROM ALCOHOL, CAFFEINE CONSUMPTION, PELVIC PAIN, MENSES IRREGULAR, CANDIDIASIS, LEUKOPLAKIA AND OBESITY. FAMILY HISTORY INCLUDED BLOOD PRESSURE HIGH (FATHER), MIGRAINE (AUNT), BLOOD PRESSURE HIGH (FATHER AND MOTHER), HIGH CHOLESTEROL (FATHER AND MOTHER), HEART DISORDER (GRANDFATHER), STROKE (GRANDMOTHER) AND DEMENTIA (GREAT GRANDMOTHER). CONCOMITANT PRODUCTS INCLUDED ANOVLAR (MICROGESTIN). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 8 MONTHS 7 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES/ABNORMAL BLEEDING MENORRHAGIA"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY PATENT; ON (B)(6) 2014: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY PATENT.; ON (B)(6) 2014: TOTAL B/L OCCLUSION,FAILURE TO OCCLUDE (CLOSE) FT PREGNANCY TEST URINE - ON (B)(6) 2012: POSITIVE. ON (B)(6) 2010, NUCLEAR MAGNETIC RESONANCE IMAGING REVEALED 9MML TEMPORAL CAVERNOUS ANGIOMA WITH SOME ENHANCEMENT AND EVIDENCE OF PRIOR BLEEDING ON GRADIENT ECHO IMAGING. REST OF BRAIN WAS NORMAL. ON (B)(6) 2014, HYSTEROSALPINGOGRAM REVEALED THAT THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES FILL WITH CONTRAST MATERIAL. THERE WAS SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. THERE WAS EVIDENCE OF VENOUS INTRASTATION. IMPRESSION: THERE WAS FILL AND SPILL OF THE BILATERAL FALLOPIAN TUBES INTO THE PERITONEAL CAVITY. ON (B)(6) 2014, RADIOLOGY THAT TUBES WERE NOT CLOSED. ON (B)(6) 2014, ULTRASOUND SCAN VAGINA REVEALED THAT NORMAL SONOGRAPHIC APPEARANCE OF THE UTERUS AND OVARIES WITHOUT EVIDENCE OF OVARIAN TORSION. ON (B)(6) 2014, A PRELIMINARY PLAIN FILM OF THE PELVIS DEMONSTRATES NO UNUSUAL CALCIFICATIONS. BILATERAL RADIOPAQUE, CURVILINEAR STRUCTURES ARE NOTED WITHIN THE PELVIS CONSISTENT WITH ESSURE DEVICES. A HYSTEROSALPINGOGRAM WAS THEN PERFORMED BY A RADIOLOGIST THE UTERINE CAVITY WAS WELL DELINEATED, AND BOTH FALLOPIAN TUBES DO NOT FILL WITH CONTRAST MATERIAL. THERE WAS NO SPILL OF CONTRAST MATERIAL INTO THE PERITONEAL CAVITY BILATERALLY. POST PROCEDURAL FILM DEMONSTRATED NO FREE CONTRAST MATERIAL WITHIN THE PELVIC PERITONEAL CAVITY. THERE WERE NO ADDITIONAL ABNORMALITIES. ON (B)(6) 2015, HYSTEROSCOPY REVEALED NO ESSURE MICRO INSERT COILS VISUALIZED ON IN BILATERAL OSTIA, NO POLYPS, NO FIBROIDS LAPAROSCOPY: NO ABDOMINAL OR PELVIC ADHESIONS, LEFT ESSURE MICRO INSERT IN MESOSALPINX, OTHERWISE NORMAL APPEARING UTERUS, BILATERAL FALLOPIAN TUBES AND BILATERAL OVARIES. THE FIRST HSG TEST THE HEALTHCARE PROVIDER INDICATED THAT HER FALLOPIAN TUBES WERE NOT BLOCKED. THE SECOND TEST CONFIRMED THAT HER TUBES WERE OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: VAGINAL DISCHARGE, DYSMENORRHEA AND DYSPAREUNIA.¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. EVENT ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PELVIC REGION PAIN, LOWER LEFT ABDOMEN PAIN. LOT NUMBER ADDED. 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 ("LEFT ESSURE COIL MIGRATED") AND EMBEDDED DEVICE ("WAS LOCATED WITHIN THE LEFT MESOSALPINX") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES"), THE SECOND EPISODE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, DYSMENORRHOEA, MENORRHAGIA, THE LAST EPISODE OF ABDOMINAL PAIN, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, VAGINAL DISCHARGE, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY PATENT; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY PATENT. 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 |
|---|---|---|---|---|---|---|---|
| 632450 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B93872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ATENOLOL| ATENOLOL| ATENOLOL| ATENOLOL| ATENOLOL| ATENOLOL| ATENOLOL| ATENOLOL| ATENOLOL| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| KETOROLAC| KETOROLAC| KETOROLAC| KETOROLAC| KETOROLAC| KETOROLAC| KETOROLAC| KETOROLAC| KETOROLAC| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| MICROGESTIN| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| PAROXETIN| PAROXETIN| PAROXETIN [PAROXETINE]| PAROXETIN [PAROXETINE]| PAROXETIN [PAROXETINE]| PAROXETIN [PAROXETINE]| PAROXETIN [PAROXETINE]| PAROXETIN [PAROXETINE]| PAROXETIN [PAROXETINE]| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| SKELAXIN| SKELAXIN| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| TRIVORA| TRIVORA| TRIVORA| TRIVORA| TRIVORA| TRIVORA| TRIVORA| TRIVORA| TRIVORA| VITAMIN D| VITAMIN D| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS] |