ESSURE
Report
- Report Number
- 2951250-2017-01581
- Event Type
- Injury
- Date Received
- April 21, 2017
- Date of Event
- September 1, 2013
- Report Date
- July 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS"), FALLOPIAN TUBE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS/ LEFT MALPOSITION ABOVE THE FALLOPIAN TUBE"), DEVICE BREAKAGE ("ESSURE DEVICE AND PHYSICIAN REMOVED IN SEVERAL PIECES/FRACTURING OF THE IMPLANT"), THE FIRST EPISODE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MALPOSITIONED IN THE LEFT CORNUA OF THE UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), THE SECOND EPISODE OF DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE,/ MIGRATION : UTERUS"), OVARIAN CYST ("LEFT OVARIAN CYST") AND PELVIC ADHESIONS ("ADHESIONS") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420, 830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE" ON (B)(6) 2013 AND MEDICAL DEVICE MONITORING ERROR "PT HAD ESSURE WITH ABLATION". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED INFECTION AND SEASONAL ALLERGY. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ENDOCERVICAL SQUAMOUS METAPLASIA, PARAKERATOSIS, FIBROADENOSIS OF BREAST, CHRONIC GASTRITIS, REFLUX ESOPHAGITIS, ENDOMETRIAL CURETTAGE, VAGINITIS, VULVOVAGINITIS, EAR INFECTION, BRONCHITIS, BLOATING, VAGINAL HAEMORRHAGE, SORE THROAT AND COUGH. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013, NORLESTRIN FE (JUNEL FE), NSAID'S SINCE 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2007. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). IN 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES / HEADACHES"), THE SECOND EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("MOOD SWINGS"), HOT FLUSH ("HOT FLASHES"), VISION BLURRED ("BLURRINESS"), UTERINE LEIOMYOMA ("UTERINE FIBROID") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE, DISCOMFORT AND BACK PAIN, FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S"), OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH OMEPRAZOLE (PRILOSEC), ANTIBIOTICS, PARACETAMOL (PAIN RELIEF), PARACETAMOL (TYLENOL), CODEINE, VICODIN (NORCO), SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016), SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016), SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL OOPHORECTOMY), SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016), SURGERY (DRAINAGE AND EXCISION OF LEFT OVARIAN CYST) AND SURGERY (LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, THE LAST EPISODE OF DEVICE EXPULSION, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, MOOD SWINGS, HOT FLUSH, AUTOIMMUNE THYROIDITIS, VISION BLURRED, UTERINE LEIOMYOMA AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN AND THE URINARY TRACT INFECTION, DYSPAREUNIA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE THYROIDITIS, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, OVARIAN CYST, PELVIC ADHESIONS, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, WEIGHT DECREASED, THE FIRST EPISODE OF DEVICE EXPULSION AND THE SECOND EPISODE OF DEVICE EXPULSION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED. ACCORDING TO MEDICAL RECORDS: LEFT ESSURE DEVICE THAT WAS EMBEDDED IN THE LEFT CORNU POSSIBLY EXTENDING MORE INTO THE MYOMETRIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RIGHT TUBE OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: DEVICE BREAKAGE, DEVICE REMOVAL COMPLICATION, MEDICAL DEVICE MONITORING ERROR. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD WERE RECEIVED. EVENTS PER PFS: MOOD SWINGS, HOT FLASHES, HASHIMOTO'S, LEFT OVARIAN CYST, ADHESIONS, BLURRINESS, FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE, UTERINE FIBROID AND ENDOMETRIOSIS. EVENTS PER MR: PT HAD ESSURE WITH ABLATION. MEDICAL HISTORY, CONCURRENT CONDITION, LABORATORY DATA, CONCOMITANT 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 UTERINE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS"), FALLOPIAN TUBE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS"), THE FIRST EPISODE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND THE SECOND EPISODE OF DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE,") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420,830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVARIAN CYST AND UTERINE LEIOMYOMA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013 AND NORLESTRIN FE (JUNEL FE). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE AND DISCOMFORT, FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT"), PELVIC PAIN ("PAIN"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), THE SECOND EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH OMEPRAZOLE (PRILOSEC) AND SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, DEVICE BREAKAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, AUTOIMMUNE DISORDER, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, THE LAST EPISODE OF DEVICE EXPULSION, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE DISORDER, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED, THE FIRST EPISODE OF DEVICE EXPULSION AND THE SECOND EPISODE OF DEVICE EXPULSION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RIGHT TUBE OCCLUDED), MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET, NEW REPORTER, PATIENT DEMOGRAPHIC INFORMATION, LAB DATA, PATIENT RELEVANT INFORMATION, ESSURE INDICATION PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES ,CONCOMITANT PRODUCT, LOT NUMBER A571420, 830420,START STOP DATE UPDATED, CONCOMITANT PRODUCT, NEW EVENTS HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL),APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), AUTOIMMUNE DISORDER, AUTOIMMUNE DISORDER, NAUSEA, DEVICE BREAKAGE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), EXPULSION OF ESSURE DEVICE, VAGINAL DISCHARGE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS, HAIR LOSS WERE ADDED.THE EVENTS DEVICE LOCATION OF DEVICE: UTERUS, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERI, PERFORATION (OTHER) PLEASE DESCRIBE AND STATE THE LOCATION OF THE PERFORATION: FALLOPIAN TUBES, UTERUS, CLUBBED WITH PREVIOUS EVENT. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS/ MALPOSITION OF ESSURE DEVICE - LPCATION OF DEVICE: LEFT MALPOSITIONED IN LEFT CORNUA OF THE UTERUS"), FALLOPIAN TUBE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS/ LEFT MALPOSITION ABOVE THE FALLOPIAN TUBE"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MALPOSITIONED IN THE LEFT CORNUA OF THE UTERUS/ EXPULSION OF ESSURE DEVICE"), DEVICE BREAKAGE ("ESSURE DEVICE AND PHYSICIAN REMOVED IN SEVERAL PIECES/FRACTURING OF THE IMPLANT/ DEVICE BREAKAGE FRAGMENT OF THE DEVICE ABOVE THE RIGHT BODY OF THE UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), OVARIAN CYST ("LEFT OVARIAN CYST") AND PELVIC ADHESIONS ("ADHESIONS") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420,830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE" ON (B)(6) 2013 AND MEDICAL DEVICE MONITORING ERROR "PT HAD ESSURE WITH ABLATION". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED INFECTION AND SEASONAL ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BREO ELLIPTA. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ENDOCERVICAL SQUAMOUS METAPLASIA, PARAKERATOSIS, FIBROADENOSIS OF BREAST, CHRONIC GASTRITIS, REFLUX ESOPHAGITIS, ENDOMETRIAL CURETTAGE, VAGINITIS, VULVOVAGINITIS, EAR INFECTION, BRONCHITIS, ABDOMINAL BLOATING, VAGINAL HAEMORRHAGE, SORE THROAT, COUGH AND UTI. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013, MONTELUKAST (SINGULAIR), NORLESTRIN FE (JUNEL FE), NSAID'S SINCE 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2007. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE, DISCOMFORT AND BACK PAIN AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)/ UTIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND VISION BLURRED ("BLURRINESS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S/ HASHIMOTOS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE LEIOMYOMA ("UTERINE FIBROID") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND GENITAL PAIN ("PAIN IN/NEAR REPRODUCTIVE SYSTEM"). THE PATIENT WAS TREATED WITH OMEPRAZOLE (PRILOSEC), ANTIBIOTICS, PARACETAMOL (PAIN RELIEF), PARACETAMOL (TYLENOL), CODEINE, VICODIN (NORCO), SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL), OOPHORECTOMY (BILATERAL)),SURGERY (DRAINAGE AND EXCISION OF LEFT OVARIAN CYST) AND SURGERY (LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, MOOD SWINGS, HOT FLUSH, AUTOIMMUNE THYROIDITIS, VISION BLURRED, UTERINE LEIOMYOMA, ENDOMETRIOSIS AND GENITAL PAIN OUTCOME WAS UNKNOWN AND THE URINARY TRACT INFECTION, DYSPAREUNIA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE THYROIDITIS, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL PAIN, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, OVARIAN CYST, PELVIC ADHESIONS, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED ACCORDING TO MEDICAL RECORDS: LEFT ESSURE DEVICE THAT WAS EMBEDDED IN THE LEFT CORNU POSSIBLY EXTENDING MORE INTO THE MYOMETRIUM. CURRENT WEIGHT 160 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RIGHT TUBE OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: DEVICE BREAKAGE, DEVICE REMOVAL COMPLICATION, MEDICAL DEVICE MONITORING ERROR. A571420,830420-INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-SEP-2018: PFS RECEIVED. EVENT ADDED: PAIN IN/NEAR MY REPRODUCTIVE SYSTEM. CONCOMITANT DRUG AND HISTORICAL DRUG WAS 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS"), FALLOPIAN TUBE PERFORATION ("PERFORATION: FALLOPIAN TUBES, UTERUS/ LEFT MALPOSITION ABOVE THE FALLOPIAN TUBE"), DEVICE BREAKAGE ("ESSURE DEVICE AND PHYSICIAN REMOVED IN SEVERAL PIECES/FRACTURING OF THE IMPLANT"), THE FIRST EPISODE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MALPOSITIONED IN THE LEFT CORNUA OF THE UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), THE SECOND EPISODE OF DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE,/ MIGRATION : UTERUS"), OVARIAN CYST ("LEFT OVARIAN CYST") AND PELVIC ADHESIONS ("ADHESIONS") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420,830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE" ON (B)(6) 2013 AND MEDICAL DEVICE MONITORING ERROR "PT HAD ESSURE WITH ABLATION". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED INFECTION AND SEASONAL ALLERGY. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ENDOCERVICAL SQUAMOUS METAPLASIA, PARAKERATOSIS, FIBROADENOSIS OF BREAST, CHRONIC GASTRITIS, REFLUX ESOPHAGITIS, ENDOMETRIAL CURETTAGE, VAGINITIS, VULVOVAGINITIS, EAR INFECTION, BRONCHITIS, ABDOMINAL BLOATING, VAGINAL HAEMORRHAGE, SORE THROAT AND COUGH. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013, NORLESTRIN FE (JUNEL FE), NSAID'S SINCE 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2007. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). IN 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES / HEADACHES"), THE SECOND EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("MOOD SWINGS"), HOT FLUSH ("HOT FLASHES"), VISION BLURRED ("BLURRINESS"), UTERINE LEIOMYOMA ("UTERINE FIBROID") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE, DISCOMFORT AND BACK PAIN, FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S"), OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH OMEPRAZOLE (PRILOSEC), ANTIBIOTICS, PARACETAMOL (PAIN RELIEF), PARACETAMOL (TYLENOL), CODEINE, VICODIN (NORCO), SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016), SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016), SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL OOPHORECTOMY), SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016), SURGERY (DRAINAGE AND EXCISION OF LEFT OVARIAN CYST) AND SURGERY (LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, THE LAST EPISODE OF DEVICE EXPULSION, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, MOOD SWINGS, HOT FLUSH, AUTOIMMUNE THYROIDITIS, VISION BLURRED, UTERINE LEIOMYOMA AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN AND THE URINARY TRACT INFECTION, DYSPAREUNIA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE THYROIDITIS, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, OVARIAN CYST, PELVIC ADHESIONS, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, WEIGHT DECREASED, THE FIRST EPISODE OF DEVICE EXPULSION AND THE SECOND EPISODE OF DEVICE EXPULSION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED ACCORDING TO MEDICAL RECORDS: LEFT ESSURE DEVICE THAT WAS EMBEDDED IN THE LEFT CORNU POSSIBLY EXTENDING MORE INTO THE MYOMETRIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RIGHT TUBE OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: DEVICE BREAKAGE, DEVICE REMOVAL COMPLICATION, MEDICAL DEVICE MONITORING ERROR. A571420,830420-INVALID . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAIN. 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 UTERINE PERFORATION ('PERFORATION: FALLOPIAN TUBES, UTERUS/ MALPOSITION OF ESSURE DEVICE - LOCATION OF DEVICE: LEFT MALPOSITIONED IN LEFT CORNUA OF THE UTERUS'), FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES, UTERUS/ LEFT MALPOSITION ABOVE THE FALLOPIAN TUBE'), EMBEDDED DEVICE ('LEFT COIL BROKE AND WAS EMBEDDED IN A MUSCLE AND MY UTERUS'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MALPOSITIONED IN THE LEFT CORNUA OF THE UTERUS/ EXPULSION OF ESSURE DEVICE/2 COIL IN MY UTERUS'), DEVICE BREAKAGE ('ESSURE DEVICE AND PHYSICIAN REMOVED IN SEVERAL PIECES/FRACTURING OF THE IMPLANT/ DEVICE BREAKAGE FRAGMENT OF THE DEVICE ABOVE THE RIGHT BODY OF THE UTERUS'), DEVICE DISLOCATION ('A COIL IS IN MY BOWEL AND THE DOC TODAY SAID IT WAS IN MY PERITONEUM'), PNEUMONIA ('I HAD PLEURISY AFTER I HAD PNEUMONIA'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), OVARIAN CYST ('LEFT OVARIAN CYST') AND PELVIC ADHESIONS ('ADHESIONS') IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420,830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE" ON (B)(6) 2013 AND MEDICAL DEVICE MONITORING ERROR "PT HAD ESSURE WITH ABLATION". THE PATIENT'S MEDICAL HISTORY INCLUDED INFECTION, SEASONAL ALLERGY AND TONSILLOTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BREO ELLIPTA. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ENDOCERVICAL SQUAMOUS METAPLASIA, PARAKERATOSIS, FIBROADENOSIS OF BREAST, CHRONIC GASTRITIS, REFLUX ESOPHAGITIS, ENDOMETRIAL CURETTAGE, VAGINITIS, VULVOVAGINITIS, EAR INFECTION, BRONCHITIS, ABDOMINAL BLOATING, VAGINAL HAEMORRHAGE, SORE THROAT, COUGH AND UTI. CONCOMITANT PRODUCTS INCLUDED CIMICIFUGA RACEMOSA (BLACK COHOSH), ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (JUNEL FE), FAMOTIDINE;IBUPROFEN (DUEXIS) SINCE 2015, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013, MONTELUKAST SODIUM (SINGULAIR) AND PARACETAMOL (ACETAMINOPHEN) SINCE 2007. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE, DISCOMFORT AND BACK PAIN AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)/ UTIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND VISION BLURRED ("BLURRINESS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S/ HASHIMOTOS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID") AND EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PNEUMONIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GENITAL PAIN ("PAIN IN/NEAR REPRODUCTIVE SYSTEM"), PELVIC DISCOMFORT ("DISCOMFORT"), MENOPAUSE ("MENOPAUSE"), SWELLING ("SWELLING"), SCAR ("SCAR TIISUE"), DIZZINESS ("DIZZINESS"), BACK PAIN ("BACK PAIN OFTHEN RADIATES TO HIP "), PAIN IN EXTREMITY ("BURING PAIN OF LEG"), PARAESTHESIA ("TINGLING IN LEGS"), PLEURISY ("I HAD PLEURISY"), LYMPHADENOPATHY ("LYMPHOID ON MY NECK, IT GETS ENLARGE WHEN FIGHTING AN INFECTION"), ARTHRALGIA ("I HAD JOINT PAIN") AND PRURITUS ("MINE STARTED TO ITCH") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, CODEINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), OMEPRAZOLE (PRILOSEC), PARACETAMOL (PAIN RELIEF), PARACETAMOL (TYLENOL), PREDNISONE AND SURGERY (DRAINAGE AND EXCISION OF LEFT OVARIAN CYST, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL), OOPHORECTOMY (BILATERAL) AND LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION, DEVICE BREAKAGE, DEVICE DISLOCATION, PNEUMONIA, GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, MOOD SWINGS, HOT FLUSH, AUTOIMMUNE THYROIDITIS, VISION BLURRED, UTERINE LEIOMYOMA, ENDOMETRIOSIS, GENITAL PAIN, PELVIC DISCOMFORT, MENOPAUSE, SWELLING, SCAR, DIZZINESS, BACK PAIN, PLEURISY, LYMPHADENOPATHY, ARTHRALGIA AND PRURITUS OUTCOME WAS UNKNOWN, THE URINARY TRACT INFECTION, DYSPAREUNIA AND ALOPECIA WAS RESOLVING AND THE PAIN IN EXTREMITY AND PARAESTHESIA HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL PAIN, HORMONE LEVEL ABNORMAL, HOT FLUSH, LYMPHADENOPATHY, MENOPAUSE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, OVARIAN CYST, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC ADHESIONS, PELVIC DISCOMFORT, PELVIC PAIN, PLEURISY, PNEUMONIA, PRURITUS, RASH, SCAR, SWELLING, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED ACCORDING TO MEDICAL RECORDS: LEFT ESSURE DEVICE THAT WAS EMBEDDED IN THE LEFT CORNU POSSIBLY EXTENDING MORE INTO THE MYOMETRIUM. CURRENT WEIGHT 160 LBS. DISCREPANCY TUBES AND PART OF ESSURE REMOVED IN FEBRUARY. PATIENT HAD 3 DEVICES. RIGHT TUBE HAD AN INTACT DEVICE IN IT. LEFT HAD TWO DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: RIGHT TUBE OCCLUDED; ON (B)(6) 2013: RIGHT OCCLUSION HOWEVER LEFT TUBAL PATENCY IS NOTED. LEFT ESSURE PROJECTS OUTSIDE UTERINE CAVITY AND LEFT TUBE.; ON (B)(6) 2013: RESULTS OF ESSURE CONFIRMATION TEST: PERFORATION (OTHER) PLEASE DESCRIBE: FALLOPIAN TUBES, UTERUS, UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, BREAKAGE OF ESSURE DEVICE.. MAMMOGRAM - ON (B)(6) 2014: BREAST TISSUE: THE TISSUE 01 BOTH BREASTS IS HETEROGENEOUSLY DENSE. THERE ARE NO SIGNIFICANT MASSES, SUSPICIOUS CALCIFICATIONS OR SIONILIC3M AREAS 01 ARCHITECTURAL DISTORTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: DEVICE BREAKAGE, DEVICE REMOVAL COMPLICATION, MEDICAL DEVICE MONITORING ERROR, DEVICE DISLOCATION, PNEUMONIA, PLEURISY, LYMPHADENOPATHY, ARTHRALGIA, PRURITUS A571420, 830420-INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-NOV-2019: SOCIAL MEDIA RECEIVED- NEW EVENTS I HAD PLEURISY, I HAD PLEURISY AFTER I HAD PNEUMONIA, A COIL IS IN MY BOWEL AND THE DOC TODAY SAID IT WAS IN MY PERITONEUM, LYMPHOID ON MY NECK, IT GETS ENLARGE WHEN FIGHTING AN INFECTION, I HAD JOINT PAIN, MINE STARTED TO ITCH WERE ADDED. NEW REPORTER, MEDICAL HISTORY, CONCOMITANT AND TREATMENT DRUG WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER 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 UTERINE PERFORATION ('PERFORATION: FALLOPIAN TUBES, UTERUS/ MALPOSITION OF ESSURE DEVICE - LOCATION OF DEVICE: LEFT MALPOSITIONED IN LEFT CORNUA OF THE UTERUS'), FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES, UTERUS/ LEFT MALPOSITION ABOVE THE FALLOPIAN TUBE'), EMBEDDED DEVICE ('LEFT COIL BROKE AND WAS EMBEDDED IN A MUSCLE AND MY UTERUS'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MALPOSITIONED IN THE LEFT CORNUA OF THE UTERUS/ EXPULSION OF ESSURE DEVICE'), DEVICE BREAKAGE ('ESSURE DEVICE AND PHYSICIAN REMOVED IN SEVERAL PIECES/FRACTURING OF THE IMPLANT/ DEVICE BREAKAGE FRAGMENT OF THE DEVICE ABOVE THE RIGHT BODY OF THE UTERUS'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), OVARIAN CYST ('LEFT OVARIAN CYST') AND PELVIC ADHESIONS ('ADHESIONS') IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420,830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE" ON (B)(6) 2013 AND MEDICAL DEVICE MONITORING ERROR "PT HAD ESSURE WITH ABLATION". THE PATIENT'S MEDICAL HISTORY INCLUDED INFECTION AND SEASONAL ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BREO ELLIPTA. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ENDOCERVICAL SQUAMOUS METAPLASIA, PARAKERATOSIS, FIBROADENOSIS OF BREAST, CHRONIC GASTRITIS, REFLUX ESOPHAGITIS, ENDOMETRIAL CURETTAGE, VAGINITIS, VULVOVAGINITIS, EAR INFECTION, BRONCHITIS, ABDOMINAL BLOATING, VAGINAL HAEMORRHAGE, SORE THROAT, COUGH AND UTI. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (JUNEL FE), FAMOTIDINE;IBUPROFEN (DUEXIS) SINCE 2015, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013, MONTELUKAST SODIUM (SINGULAIR) AND PARACETAMOL (ACETAMINOPHEN) SINCE 2007. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE, DISCOMFORT AND BACK PAIN AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)/ UTIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND VISION BLURRED ("BLURRINESS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S/ HASHIMOTOS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID") AND EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GENITAL PAIN ("PAIN IN/NEAR REPRODUCTIVE SYSTEM"), PELVIC DISCOMFORT ("DISCOMFORT"), MENOPAUSE ("MENOPAUSE"), SWELLING ("SWELLING"), SCAR ("SCAR"), DIZZINESS ("DIZZINESS"), ARTHRALGIA ("BACK PAIN OFTEN RADIATES TO HIP "), PAIN IN EXTREMITY ("BURNING PAIN OF LEG") AND PARAESTHESIA ("TINGLING IN LEGS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, CODEINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), OMEPRAZOLE (PRILOSEC), PARACETAMOL (PAIN RELIEF), PARACETAMOL (TYLENOL) AND SURGERY (DRAINAGE AND EXCISION OF LEFT OVARIAN CYST, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL), OOPHORECTOMY (BILATERAL) AND LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, MOOD SWINGS, HOT FLUSH, AUTOIMMUNE THYROIDITIS, VISION BLURRED, UTERINE LEIOMYOMA, ENDOMETRIOSIS, GENITAL PAIN, PELVIC DISCOMFORT, MENOPAUSE, SWELLING, SCAR, DIZZINESS AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE URINARY TRACT INFECTION, DYSPAREUNIA AND ALOPECIA WAS RESOLVING AND THE PAIN IN EXTREMITY AND PARAESTHESIA HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, AUTOIMMUNE THYROIDITIS, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE EXPULSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL PAIN, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENOPAUSE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, OVARIAN CYST, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC ADHESIONS, PELVIC DISCOMFORT, PELVIC PAIN, RASH, SCAR, SWELLING, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED ACCORDING TO MEDICAL RECORDS: LEFT ESSURE DEVICE THAT WAS EMBEDDED IN THE LEFT CORNU POSSIBLY EXTENDING MORE INTO THE MYOMETRIUM. CURRENT WEIGHT 160 LBS. DISCREPANCY TUBES AND PART OF ESSURE REMOVED IN FEBRUARY. PATIENT HAD 3 DEVICES. RIGHT TUBE HAD AN INTACT DEVICE IN IT. LEFT HAD TWO DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: RIGHT TUBE OCCLUDED; ON (B)(6) 2013: RIGHT OCCLUSION HOWEVER LEFT TUBAL PATENCY IS NOTED. LEFT ESSURE PROJECTS OUTSIDE UTERINE CAVITY AND LEFT TUBE.; ON (B)(6) 2013: RESULTS OF ESSURE CONFIRMATION TEST: PERFORATION (OTHER). PLEASE DESCRIBE: FALLOPIAN TUBES, UTERUS, UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, BREAKAGE OF ESSURE DEVICE. MAMMOGRAM - ON (B)(6) 2014: BREAST TISSUE: THE TISSUE 01 BOTH BREASTS IS HETEROGENEOUSLY DENSE. THERE ARE NO SIGNIFICANT MASSES, SUSPICIOUS CALCIFICATIONS OR SIONILIC3M AREAS 01 ARCHITECTURAL DISTORTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: DEVICE BREAKAGE, DEVICE REMOVAL COMPLICATION, MEDICAL DEVICE MONITORING ERROR. A571420,830420-INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: FU 8 AND FU 9 PROCESSED TOGETHER. EVENT SWELLING ,MENOPAUSE ,SCAR TISSUE, DIZZY, LEFT COIL BROKE AND WAS EMBEDDED IN A MUSCLE OF UTERUS ,TINGLING AND BURNING PAIN OF LEGS WERE ADDED. ON 2-OCT-2019: FU 8 AND FU 9 PROCESSED TOGETHER. PLAINTIFF FACT SHEET RECEIVED: NEW EVENT - PELVIC DISCOMFORT 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 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 UTERINE PERFORATION ('PERFORATION: FALLOPIAN TUBES, UTERUS/ MALPOSITION OF ESSURE DEVICE - LOCATION OF DEVICE: LEFT MALPOSITIONED IN LEFT CORNUA OF THE UTERUS'), FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES, UTERUS/ LEFT MALPOSITION ABOVE THE FALLOPIAN TUBE'), EMBEDDED DEVICE ('LEFT COIL BROKE AND WAS EMBEDDED IN A MUSCLE AND MY UTERUS'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MALPOSITIONED IN THE LEFT CORNUA OF THE UTERUS/ EXPULSION OF ESSURE DEVICE/2 COIL IN MY UTERUS'), DEVICE BREAKAGE ('ESSURE DEVICE AND PHYSICIAN REMOVED IN SEVERAL PIECES/FRACTURING OF THE IMPLANT/ DEVICE BREAKAGE FRAGMENT OF THE DEVICE ABOVE THE RIGHT BODY OF THE UTERUS'), DEVICE DISLOCATION ('A COIL IS IN MY BOWEL AND THE DOC TODAY SAID IT WAS IN MY PERITONEUM'), PNEUMONIA ('I HAD PLEURISY AFTER I HAD PNEUMONIA'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), OVARIAN CYST ('LEFT OVARIAN CYST') AND PELVIC ADHESIONS ('ADHESIONS') IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A571420,830420) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE" ON (B)(6) 2013 AND MEDICAL DEVICE MONITORING ERROR "PT HAD ESSURE WITH ABLATION". THE PATIENT'S MEDICAL HISTORY INCLUDED INFECTION, SEASONAL ALLERGY AND TONSILLOTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BREO ELLIPTA. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ENDOCERVICAL SQUAMOUS METAPLASIA, PARAKERATOSIS, FIBROADENOSIS OF BREAST, CHRONIC GASTRITIS, REFLUX ESOPHAGITIS, ENDOMETRIAL CURETTAGE, VAGINITIS, VULVOVAGINITIS, EAR INFECTION, BRONCHITIS, ABDOMINAL BLOATING, VAGINAL HAEMORRHAGE, SORE THROAT, COUGH AND UTI. CONCOMITANT PRODUCTS INCLUDED CIMICIFUGA RACEMOSA (BLACK COHOSH), ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (JUNEL FE), FAMOTIDINE;IBUPROFEN (DUEXIS) SINCE 2015, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2012 TO 2013, MONTELUKAST SODIUM (SINGULAIR) AND PARACETAMOL (ACETAMINOPHEN) SINCE 2007. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, POLLAKIURIA, DECREASED APPETITE, HEADACHE, DISCOMFORT AND BACK PAIN AND DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT)/ UTIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND VISION BLURRED ("BLURRINESS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S/ HASHIMOTOS"). IN MARCH 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROID") AND EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PNEUMONIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), CYSTITIS ("INFECTION (BLADDER)"), VAGINAL INFECTION ("INFECTION (VAGINAL)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GENITAL PAIN ("PAIN IN/NEAR REPRODUCTIVE SYSTEM"), PELVIC DISCOMFORT ("DISCOMFORT"), MENOPAUSE ("MENOPAUSE"), SWELLING ("SWELLING"), SCAR ("SCAR TIISUE"), DIZZINESS ("DIZZINESS"), BACK PAIN ("BACK PAIN OF THEN RADIATES TO HIP "), PAIN IN EXTREMITY ("BURNING PAIN OF LEG"), PARAESTHESIA ("TINGLING IN LEGS"), PLEURISY ("I HAD PLEURISY"), LYMPHADENOPATHY ("LYMPHOID ON MY NECK, IT GETS ENLARGE WHEN FIGHTING AN INFECTION"), ARTHRALGIA ("I HAD JOINT PAIN") AND PRURITUS ("MINE STARTED TO ITCH") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES,"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, CODEINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), OMEPRAZOLE (PRILOSEC), PARACETAMOL (PAIN RELIEF), PARACETAMOL (TYLENOL), PREDNISONE AND SURGERY (DRAINAGE AND EXCISION OF LEFT OVARIAN CYST, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL), OOPHORECTOMY (BILATERAL) AND LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION, DEVICE BREAKAGE, DEVICE DISLOCATION, PNEUMONIA, GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, MOOD SWINGS, HOT FLUSH, AUTOIMMUNE THYROIDITIS, VISION BLURRED, UTERINE LEIOMYOMA, ENDOMETRIOSIS, GENITAL PAIN, PELVIC DISCOMFORT, MENOPAUSE, SWELLING, SCAR, DIZZINESS, BACK PAIN, PLEURISY, LYMPHADENOPATHY, ARTHRALGIA AND PRURITUS OUTCOME WAS UNKNOWN, THE URINARY TRACT INFECTION, DYSPAREUNIA AND ALOPECIA WAS RESOLVING AND THE PAIN IN EXTREMITY AND PARAESTHESIA HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GENITAL PAIN, HORMONE LEVEL ABNORMAL, HOT FLUSH, LYMPHADENOPATHY, MENOPAUSE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, OVARIAN CYST, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC ADHESIONS, PELVIC DISCOMFORT, PELVIC PAIN, PLEURISY, PNEUMONIA, PRURITUS, RASH, SCAR, SWELLING, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON 2010-2014, PATIENT TAKES HIZENTRA, ESSURE START DATES (B)(6) 2013 AND REMOVAL WAS ON (B)(6) 2016 PROVIDED ACCORDING TO MEDICAL RECORDS: LEFT ESSURE DEVICE THAT WAS EMBEDDED IN THE LEFT CORNU POSSIBLY EXTENDING MORE INTO THE MYOMETRIUM. CURRENT WEIGHT 160 LBS. DISCREPANCY TUBES AND PART OF ESSURE REMOVED IN FEBRUARY. PATIENT HAD 3 DEVICES. RIGHT TUBE HAD AN INTACT DEVICE IN IT. LEFT HAD TWO DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: RIGHT TUBE OCCLUDED; ON (B)(6) 2013: RIGHT OCCLUSION HOWEVER LEFT TUBAL PATENCY IS NOTED. LEFT ESSURE PROJECTS OUTSIDE UTERINE CAVITY AND LEFT TUBE.; ON (B)(6) 2013: RESULTS OF ESSURE CONFIRMATION TEST: PERFORATION (OTHER). PLEASE DESCRIBE: FALLOPIAN TUBES, UTERUS, UNILATERAL. OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, BREAKAGE OF ESSURE DEVICE.. MAMMOGRAM - ON (B)(6) 2014: BREAST TISSUE: THE TISSUE 01 BOTH BREASTS IS HETEROGENEOUSLY DENSE. THERE ARE NO SIGNIFICANT MASSES, SUSPICIOUS CALCIFICATIONS OR SIONILIC3M AREAS 01 ARCHITECTURAL DISTORTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: DEVICE BREAKAGE, DEVICE REMOVAL COMPLICATION, MEDICAL DEVICE MONITORING ERROR, DEVICE DISLOCATION, PNEUMONIA, PLEURISY, LYMPHADENOPATHY, ARTHRALGIA, PRURITUS A571420,830420-INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: SOCIAL MEDIA RECEIVED- NEW EVENTS I HAD PLEURISY, I HAD PLEURISY AFTER I HAD PNEUMONIA, A COIL IS IN MY BOWEL AND THE DOC TODAY SAID IT WAS IN MY PERITONEUM, LYMPHOID ON MY NECK, IT GETS ENLARGE WHEN FIGHTING AN INFECTION, I HAD JOINT PAIN, MINE STARTED TO ITCH WERE ADDED. NEW REPORTER, MEDICAL HISTORY, CONCOMITANT AND TREATMENT DRUG WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER 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 PERFORATION ("PERFORATION OF ORGANS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DEVICE BREAKAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: BASED ON THE TECHNICAL ASSESSMENT, NEITHER SAMPLE NOR LOT NUMBER WAS PROVIDED THEREFORE, THE QUALITY UNIT WAS UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD OR PERFORM A SAMPLE INVESTIGATION. THE QUALITY UNIT WAS UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME BECAUSE THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2017: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION REPORT REFERS TO UNSPECIFIED AGED FEMALE PLAINTIFF WHO HAD (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ON (B)(6) 2013 AND EXPERIENCED PERFORATION OF ORGANS, MIGRATION OF IMPLANT, HEAVY BLEEDING (REGARDED AS GENITAL BLEEDING) AND FRACTURING OF THE IMPLANT. SHE UNDERWENT SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016. UTERINE/FALLOPIAN TUBE PERFORATION MAY OCCUR WITH ANY TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE), INCLUDING INSERTION OF A FALLOPIAN TUBAL OCCLUSION INSERT (ESSURE). OFTEN MIGRATION IS REPORTED WHEN THE EXACT TIME POINT OF PERFORATION IS NOT KNOWN. THE PERFORATION OF ORGANS MAY OCCUR DURING HYSTEROSCOPY; THIS RISK IS INHERENT WITH ANY HYSTEROSCOPY PROCEDURE. GENITAL BLEEDING HAS MULTIPLE CAUSES. IN THIS CASE, THE EXACT MECHANISM OF THE EVENTS IS NOT KNOWN. ALSO LIMITED INFORMATION WAS PROVIDED REGARDING ESSURE INSERTION PROCEDURE. THE CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DEVICE BREAKAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS LITIGATION REPORT REFERS TO UNSPECIFIED AGED FEMALE PLAINTIFF WHO HAD (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ON (B)(6) 2013 AND EXPERIENCED PERFORATION OF ORGANS, MIGRATION OF IMPLANT, HEAVY BLEEDING (REGARDED AS GENITAL BLEEDING) AND FRACTURING OF THE IMPLANT. SHE UNDERWENT SURGERY TO REMOVE THE ESSURE ON (B)(6) 2016. UTERINE/FALLOPIAN TUBE PERFORATION MAY OCCUR WITH ANY TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE), INCLUDING INSERTION OF A FALLOPIAN TUBAL OCCLUSION INSERT (ESSURE). OFTEN MIGRATION IS REPORTED WHEN THE EXACT TIME POINT OF PERFORATION IS NOT KNOWN. THE PERFORATION OF ORGANS MAY OCCUR DURING HYSTEROSCOPY; THIS RISK IS INHERENT WITH ANY HYSTEROSCOPY PROCEDURE. GENITAL BLEEDING HAS MULTIPLE CAUSES. IN THIS CASE, THE EXACT MECHANISM OF THE EVENTS IS NOT KNOWN. ALSO LIMITED INFORMATION WAS PROVIDED REGARDING ESSURE INSERTION PROCEDURE. THE CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292779 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A571420,830420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| BLACK COHOSH [CIMICIFUGA RACEMOSA]| BLACK COHOSH [CIMICIFUGA RACEMOSA]| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DUEXIS| DUEXIS| DUEXIS| JUNEL FE| JUNEL FE| JUNEL FE| JUNEL FE| JUNEL FE| JUNEL FE| JUNEL FE| NSAID'S| NSAID'S| NSAID'S| SINGULAIR| SINGULAIR| SINGULAIR| SINGULAIR |