ESSURE
Report
- Report Number
- 2951250-2017-02532
- Event Type
- Injury
- Date Received
- July 18, 2017
- Date of Event
- January 1, 2011
- Report Date
- April 15, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN"), SEPSIS ("INFECTION : BLOOD"), INTRA-ABDOMINAL HAEMORRHAGE ("LOWER ABDOMINAL REGION ¿ BLOOD") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED C-SECTION AND LEIOMYOMA NOS. CONCURRENT CONDITIONS INCLUDED RECTUS SHEATH HEMATOMA, NAUSEA, VOMITING, HYPOKALEMIA AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED FLUOXETINE SINCE (B)(6) 2011. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN DURING MANSTRUATION / DYSMENORRHEA (CRAMPING)/MENSTRUATION PAIN"), ALOPECIA ("HAIR LOSS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS , WEIGHT GAIN / LOSS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEM") AND PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC AREA"). ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION/ PROLONGED AND ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) "), DYSGEUSIA ("METAL TASTE IN HER MOUTH"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FIBROMA ("FIBROID TUMORS"), DEPRESSION ("WORSENING OF DEPRESSION"), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), TOOTH DISORDER ("DENTAL PROBLEMS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SIGNS"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("ALLERGY TO NICKEL") WITH PRURITUS, OVARIAN CYST ("OVARIAN CYSTS"), COITAL BLEEDING ("BLEEDING FROM INTERCOURSE"), BACK PAIN ("BACK PAIN"), COMPLICATION OF DEVICE INSERTION ("DOCTOR WAS HAVING TROUBLE INSERTING THE DEVICE DURING THE PROCEDURE") AND CYSTITIS ("BLADDER INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SEPSIS, INTRA-ABDOMINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, DYSPAREUNIA, ALOPECIA, DYSGEUSIA, VAGINAL DISCHARGE, FATIGUE, FIBROMA, DEPRESSION, ANXIETY, WEIGHT FLUCTUATION, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, MENOPAUSAL SYMPTOMS, NAUSEA, ALLERGY TO METALS, OVARIAN CYST, COITAL BLEEDING, PELVIC FLUID COLLECTION, BACK PAIN, COMPLICATION OF DEVICE INSERTION AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, COITAL BLEEDING, COMPLICATION OF DEVICE INSERTION, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INTRA-ABDOMINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, OVARIAN CYST, PELVIC FLUID COLLECTION, PELVIC PAIN, SEPSIS, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED THOUGH SOME REMAIN. BILATERAL REMOVAL OF FALLOPIAN TUBES. SINCE THE SECOND SURGERY SHE HAVE BEEN ON HORMONE REPLACEMENT THERAPY AND RECEIVING TREATMENT FOR FATIGUE, HAIR LOSS. WEIGHT GAIN AND DEPRESSION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TUBAL OCCLUSION. SUCCESSFUL ON (B)(6) 2011 PATIENT UNDERWENT HYSTEROSALPINGOGRAM TEST. ON (B)(6) 2012 - MRI PELVIC WITHOUT AND WITH CONTRAST. IMPRESSION: THERE IS A RIDETERMINATE SOLID RIGHT OVARIAN MASS WITH ADJACENT NODULAR THICKENING EXTENDING SUPERIORLY ALONG THE COURSE OF THE OVARIAN VEIN. A SOLID OVARIAN NEOPLASM IS SUSPECTED. A PELVIC ULTRASOUND WITH DOPPLER EVALUATION MAY PROVIDE ADDITIONAL INFORMATION (SUCH AS A MORE ACCURATE ASSESSMENT OF THE SIZE OF THE MASS AS WELL AN POSSIBILITY OF INTERNAL FLOW. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING - SEVERE PAIN, PAIN IS MORE SEVERE AFTER SEXUAL INTERCOURSE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: QUALITY SAFETY EVALUATION FOR PTC. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN"), SEPSIS ("INFECTION : BLOOD"), INTRA-ABDOMINAL HAEMORRHAGE ("LOWER ABDOMINAL REGION ¿ BLOOD") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED C-SECTION AND LEIOMYOMA NOS. CONCURRENT CONDITIONS INCLUDED RECTUS SHEATH HEMATOMA, NAUSEA, VOMITING, HYPOKALEMIA AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM). IN 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS") AND NAUSEA ("NAUSEA AFTER SEX MOSTLY, BUT ALSO AT OTHER TIMES"). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATION / DYSMENORRHEA (CRAMPING)/MENSTRUATION PAIN"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FIBROMA ("FIBROID TUMORS/FIBROID ON RIGHT CERVIX"), WEIGHT INCREASED ("WEIGHT FLUCTUATIONS , WEIGHT GAIN / LOSS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), OVARIAN CYST ("OVARIAN CYSTS") AND PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC AREA"). IN (B)(6) 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("WORSENING OF DEPRESSION") AND ALLERGY TO METALS ("ALLERGY TO NICKEL") WITH PRURITUS AND RASH. ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOPAUSAL SYMPTOMS ("MENOPAUSAL SIGNS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("BLADDER OR URINARY PROBLEMS: URINARY TRACT INFECTION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED VOMITING ("VOMITING"). ON (B)(6) 2011, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION/ PROLONGED AND ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) "), DYSGEUSIA ("METAL TASTE IN HER MOUTH"), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), COITAL BLEEDING ("BLEEDING FROM INTERCOURSE"), BACK PAIN ("BACK PAIN"), COMPLICATION OF DEVICE INSERTION ("DOCTOR WAS HAVING TROUBLE INSERTING THE DEVICE DURING THE PROCEDURE/ DIFFICULTY IN OPENING UP ONE OF MY FALLOPIAN TUBES TO PLACE THE ESSURE."), CYSTITIS ("BLADDER INFECTION") AND TREMOR ("SHAKING AT THE TOME OF ESSURE PLACEMENT"). THE PATIENT WAS TREATED WITH IBUPROFEN, HORMONES NOS, VITAMINS, MINOXIDIL (ROGAINE), ANTIBIOTICS, FLUOXETINE AND SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SEPSIS, INTRA-ABDOMINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, DYSPAREUNIA, ALOPECIA, DYSGEUSIA, VAGINAL DISCHARGE, FATIGUE, DEPRESSION, ANXIETY, WEIGHT INCREASED, HYPERSENSITIVITY, TOOTH DISORDER, MENOPAUSAL SYMPTOMS, NAUSEA, ALLERGY TO METALS, OVARIAN CYST, COITAL BLEEDING, PELVIC FLUID COLLECTION, BACK PAIN, COMPLICATION OF DEVICE INSERTION, CYSTITIS, VOMITING, URINARY TRACT INFECTION AND TREMOR OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, FIBROMA AND FEMALE SEXUAL DYSFUNCTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, COITAL BLEEDING, COMPLICATION OF DEVICE INSERTION, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INTRA-ABDOMINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, OVARIAN CYST, PELVIC FLUID COLLECTION, PELVIC PAIN, SEPSIS, TOOTH DISORDER, TREMOR, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VOMITING AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED THOUGH SOME REMAIN. BILATERAL REMOVAL OF FALLOPIAN TUBES. SINCE THE SECOND SURGERY SHE HAVE BEEN ON HORMONE REPLACEMENT THERAPY AND RECEIVING TREATMENT FOR FATIGUE, HAIR LOSS. WEIGHT GAIN AND DEPRESSION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TUBAL OCCLUSION. SUCCESSFUL URINE ANALYSIS - ON (B)(6) 2013: BLOOD IN URINE . ON (B)(6) 2011 PATIENT UNDERWENT HYSTEROSALPINGOGRAM TEST. ON (B)(6) 2012 - MRI PELVIC WITHOUT AND WITH CONTRAST. IMPRESSION: THERE IS A RIDE TERMINATE SOLID RIGHT OVARIAN MASS WITH ADJACENT NODULAR THICKENING EXTENDING SUPERIORLY ALONG THE COURSE OF THE OVARIAN VEIN. A SOLID OVARIAN NEOPLASM IS SUSPECTED. A PELVIC ULTRASOUND WITH DOPPLER EVALUATION MAY PROVIDE ADDITIONAL INFORMATION (SUCH AS A MORE ACCURATE ASSESSMENT OF THE SIZE OF THE MASS AS WELL AN POSSIBILITY OF INTERNAL FLOW. SINGLE FILM DEMONSTRATES CONTRAST FILLING THE UTERUS BUT NOT FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING - SEVERE PAIN, PAIN IS MORE SEVERE AFTER SEXUAL INTERCOURSE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUL-2018: PLAINTIFF FACT SHEET RECEIVED, DEMOGRAPHIC CONDITION ADDED, EVENT ADDED: VOMITING, RASH, URINARY TRACT INFECTION, CONCOMITANT DRUG ADDED, TREATMENT DRUGS ADDED. EVENT WEIGHT FLUCTUATION WAS UPDATED TO WEIGHT GAIN. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN"), SEPSIS ("INFECTION : BLOOD"), HAEMATOMA INFECTION ("INFECTION (OTHER) DESCRIBE: INFECTED HEMATOMA/BLADDER OR URINARY PROBLEMS OR CHANGES LOWER ABDOMINAL REGION-INFECTED HEMATOMA"), INTRA-ABDOMINAL HAEMORRHAGE ("LOWER ABDOMINAL REGION ¿ BLOOD"), ABDOMINAL INFECTION ("LOWER ABDOMINAL INFECTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED C-SECTION, LEIOMYOMA NOS, PELVIC MASS, HEMATURIA, INTERVERTEBRAL DISC DEGENERATION AND GENITAL HERPES. CONCURRENT CONDITIONS INCLUDED RECTUS SHEATH HEMATOMA, NAUSEA, VOMITING, HYPOKALEMIA, ANEMIA, GENITAL HERPES, ADENOMYOMA, HAIR LOSS, STRESS, FEVER CHILLS, OVARIAN TORSION, PELVIC MASS, CHILLS, DIAPHORESIS, OVARIAN MASS, ACUTE APPENDICITIS AND DEPRESSION. FAMILY HISTORY INCLUDED MELANOMA (FATHER AND SISTER). CONCOMITANT PRODUCTS INCLUDED CITALOPRAM FROM ON (B)(6)2015 TO ON (B)(6) 2016, DIAZEPAM (VALIUM), DIAZEPAM SINCE ON (B)(6) 2012, ESTRADIOL (FEMRING) FROM ON (B)(6) 2012 TO ON (B)(6) 2018, FLUOXETINE HYDROCHLORIDE (FLUOXETINE HCL), FLUTICASONE SINCE ON (B)(6) 2016, LORAZEPAM FROM ON (B)(6) 2015 TO ON (B)(6) 2015, MINOXIDIL FROM ON (B)(6) 2016 TO ON (B)(6) 2017, PREDNISONE SINCE ON (B)(6) 2016, TINIDAZOLE, TRAZODONE FROM ON (B)(6) 2016 TO ON (B)(6) 2018, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) SINCE ON (B)(6) 2012, VALACICLOVIR HYDROCHLORIDE (VALTREX) SINCE ON (B)(6) 2013 AND ZOLPIDEM TARTRATE (ZOLPIDEM AL) SINCE ON (B)(6) 2012. IN 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS") AND NAUSEA ("NAUSEA AFTER SEX MOSTLY, BUT ALSO AT OTHER TIMES"). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN DURING MANSTRUATION / DYSMENORRHEA (CRAMPING)/MENSTRUATION PAIN"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), OVARIAN CYST ("TUMOR / TERATOMA / CANCER - TYPE : OVARIAN CYSTS"), THE FIRST EPISODE OF PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC AREA") AND SENSITIVE SKIN ("SENSITIVE SKIN") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER - TYPE : FIBROID TUMORS/FIBROID ON RIGHT CERVIX") AND WEIGHT INCREASED ("WEIGHT FLUCTUATIONS , WEIGHT GAIN / LOSS"), 26 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("WORSENING OF DEPRESSION / PSYCHOLOGICAL OR PYSCHIATRIC PROBLEMS - CONDITION : DEPRESSION") AND ALLERGY TO METALS ("ALLERGY TO NICKEL") WITH PRURITUS AND RASH. ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOPAUSAL SYMPTOMS ("MENOPAUSAL SIGNS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("BLADDER OR URINARY PROBLEMS: URINARY TRACT INFECTION"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VOMITING ("VOMITING"). ON (B)(6) 2011, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HAEMATOMA INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/FELT LIKE SOMETHING WAS HITTING ME INSIDE MY BODY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION/ PROLONGED AND ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSGEUSIA ("METAL TASTE IN HER MOUTH"), ANXIETY ("ANXIETY"), COITAL BLEEDING ("BLEEDING FROM INTERCOURSE /APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) BLEEDING"), BACK PAIN ("BACK PAIN"), COMPLICATION OF DEVICE INSERTION ("DOCTOR WAS HAVING TROUBLE INSERTING THE DEVICE DURING THE PROCEDURE/ DIFFICULTY IN OPENING UP ONE OF MY FALLOPIAN TUBES TO PLACE THE ESSURE."), CYSTITIS ("BLADDER INFECTION"), TREMOR ("SHAKING AT THE TOME OF ESSURE PLACEMENT") AND THE SECOND EPISODE OF PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, FLUOXETINE, HORMONES, IBUPROFEN, MINOXIDIL (ROGAINE), PROMETHAZINE, VITAMINS NOS AND SURGERY (UTERINE ABLATION AND TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SEPSIS, HAEMATOMA INFECTION, INTRA-ABDOMINAL HAEMORRHAGE, ABDOMINAL INFECTION, MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, DYSPAREUNIA, ALOPECIA, DYSGEUSIA, VAGINAL DISCHARGE, FATIGUE, DEPRESSION, ANXIETY, WEIGHT INCREASED, HYPERSENSITIVITY, TOOTH DISORDER, MENOPAUSAL SYMPTOMS, NAUSEA, ALLERGY TO METALS, OVARIAN CYST, COITAL BLEEDING, BACK PAIN, COMPLICATION OF DEVICE INSERTION, CYSTITIS, VOMITING, URINARY TRACT INFECTION, TREMOR, SENSITIVE SKIN AND THE LAST EPISODE OF PELVIC FLUID COLLECTION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, UTERINE LEIOMYOMA AND FEMALE SEXUAL DYSFUNCTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL INFECTION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, COITAL BLEEDING, COMPLICATION OF DEVICE INSERTION, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA INFECTION, HYPERSENSITIVITY, INTRA-ABDOMINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, OVARIAN CYST, PELVIC PAIN, SENSITIVE SKIN, SEPSIS, TOOTH DISORDER, TREMOR, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VOMITING, WEIGHT INCREASED, THE FIRST EPISODE OF PELVIC FLUID COLLECTION AND THE SECOND EPISODE OF PELVIC FLUID COLLECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 172.00 LBS. SYMPTOMS HAVE MOSTLY RESOLVED THOUGH SOME REMAIN. BILATERAL REMOVAL OF FALLOPIAN TUBES. SINCE THE SECOND SURGERY SHE HAVE BEEN ON HORMONE REPLACEMENT THERAPY AND RECEIVING TREATMENT FOR FATIGUE, HAIR LOSS. WEIGHT GAIN AND DEPRESSION LEFT CORNUA AND RIGHT CORNUA, NUMBER OF PROXIMAL COILS: 4 ON LEFT CORNUA AND 3 ON RIGHT CORNUA, PATIENT TOLERATED PLACEMENT WITHOUT DIFFICULTY. REMOVAL DETAILS: ON (B)(6) 2011, THE PATIENT UNDERWENT TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED): WITH LEFT SALPINGECTOMY AND PARTIAL RIGHT SALPINGECTOMY AND ON (B)(6)2012, BILATERAL OOPHERECTOMY: WITH PARTIAL RIGHT SALPINGECTOMY (REMAINING PART OF TUBE). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2011: RESULTS: TUBAL OCCLUSION. SUCCESSFUL. URINE ANALYSIS: ON (B)(6) 2013: RESULTS: BLOOD IN URINE. ON (B)(6) 2011: PATIENT UNDERWENT HYSTEROSALPINGOGRAM TEST. ON (B)(6) 2012: MRI PELVIC WITHOUT AND WITH CONTRAST. IMPRESSION: THERE IS A RIDETERMINATE SOLID RIGHT OVARIAN MASS WITH ADJACENT NODULAR THICKENING EXTENDING SUPERIORLY ALONG THE COURSE OF THE OVARIAN VEIN. A SOLID OVARIAN NEOPLASM IS SUSPECTED. A PELVIC ULTRASOUND WITH DOPPLER EVALUATION MAY PROVIDE ADDITIONAL INFORMATION (SUCH AS A MORE ACCURATE ASSESSMENT OF THE SIZE OF THE MASS AS WELL AN POSSIBILITY OF INTERNAL FLOW. SINGLE FILM DEMONSTRATES CONTRAST FILLING THE UTERUS BUT NOT FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING - SEVERE PAIN, PAIN IS MORE SEVERE AFTER SEXUAL INTERCOURSE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: UTERINE FIBROIDS, MENORRHAGIA, NAUSEA, VOMITING, LOWER ABDOMINAL PAIN,MODERATE AMOUNT OF FREE PELVIC FLUID QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-APR-2019: PFS RECEIVED : EVENT INFECTED HEMATOMA ADDED. ONSET DATE OF EVENTS ADDED. CONCOMITANT DRUGS, MEDICAL HISTORY 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 PELVIC PAIN ("PELVIC PAIN / PAIN"), SEPSIS ("INFECTION : BLOOD"), INTRA-ABDOMINAL HAEMORRHAGE ("LOWER ABDOMINAL REGION ¿ BLOOD"), ABDOMINAL INFECTION ("LOWER ABDOMINAL INFECTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED C-SECTION AND LEIOMYOMA NOS. CONCURRENT CONDITIONS INCLUDED RECTUS SHEATH HEMATOMA, NAUSEA, VOMITING, HYPOKALEMIA, ANEMIA AND GENITAL HERPES. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM) AND VALACICLOVIR HYDROCHLORIDE (VALTREX). IN 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS") AND NAUSEA ("NAUSEA AFTER SEX MOSTLY, BUT ALSO AT OTHER TIMES"). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATION / DYSMENORRHEA (CRAMPING)/MENSTRUATION PAIN"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), UTERINE LEIOMYOMA ("FIBROID TUMORS/FIBROID ON RIGHT CERVIX"), WEIGHT INCREASED ("WEIGHT FLUCTUATIONS , WEIGHT GAIN / LOSS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), OVARIAN CYST ("OVARIAN CYSTS") AND THE FIRST EPISODE OF PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC AREA"). IN (B)(6) 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("WORSENING OF DEPRESSION") AND ALLERGY TO METALS ("ALLERGY TO NICKEL") WITH PRURITUS AND RASH. ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOPAUSAL SYMPTOMS ("MENOPAUSAL SIGNS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("BLADDER OR URINARY PROBLEMS: URINARY TRACT INFECTION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED VOMITING ("VOMITING"). ON (B)(6) 2011, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION/ PROLONGED AND ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) "), DYSGEUSIA ("METAL TASTE IN HER MOUTH"), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), COITAL BLEEDING ("BLEEDING FROM INTERCOURSE"), BACK PAIN ("BACK PAIN"), COMPLICATION OF DEVICE INSERTION ("DOCTOR WAS HAVING TROUBLE INSERTING THE DEVICE DURING THE PROCEDURE/ DIFFICULTY IN OPENING UP ONE OF MY FALLOPIAN TUBES TO PLACE THE ESSURE."), CYSTITIS ("BLADDER INFECTION"), TREMOR ("SHAKING AT THE TOME OF ESSURE PLACEMENT"), PAIN OF SKIN ("SENSITIVE SKIN") AND THE SECOND EPISODE OF PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC"). THE PATIENT WAS TREATED WITH IBUPROFEN, HORMONES NOS, VITAMINS, MINOXIDIL (ROGAINE), ANTIBIOTICS, FLUOXETINE AND SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SEPSIS, INTRA-ABDOMINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, DYSPAREUNIA, ALOPECIA, DYSGEUSIA, VAGINAL DISCHARGE, FATIGUE, DEPRESSION, ANXIETY, WEIGHT INCREASED, HYPERSENSITIVITY, TOOTH DISORDER, MENOPAUSAL SYMPTOMS, NAUSEA, ALLERGY TO METALS, OVARIAN CYST, COITAL BLEEDING, BACK PAIN, COMPLICATION OF DEVICE INSERTION, CYSTITIS, VOMITING, URINARY TRACT INFECTION, TREMOR, PAIN OF SKIN AND THE LAST EPISODE OF PELVIC FLUID COLLECTION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, UTERINE LEIOMYOMA AND FEMALE SEXUAL DYSFUNCTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL INFECTION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, COITAL BLEEDING, COMPLICATION OF DEVICE INSERTION, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INTRA-ABDOMINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, OVARIAN CYST, PAIN OF SKIN, PELVIC PAIN, SEPSIS, TOOTH DISORDER, TREMOR, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VOMITING, WEIGHT INCREASED, THE FIRST EPISODE OF PELVIC FLUID COLLECTION AND THE SECOND EPISODE OF PELVIC FLUID COLLECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED THOUGH SOME REMAIN. BILATERAL REMOVAL OF FALLOPIAN TUBES. SINCE THE SECOND SURGERY SHE HAVE BEEN ON HORMONE REPLACEMENT THERAPY AND RECEIVING TREATMENT FOR FATIGUE, HAIR LOSS. WEIGHT GAIN AND DEPRESSION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TUBAL OCCLUSION. SUCCESSFUL. URINE ANALYSIS - ON (B)(6) 2013: BLOOD IN URINE. ON (B)(6) 2011 PATIENT UNDERWENT HYSTEROSALPINGOGRAM TEST. ON (B)(6) 2012 - MRI PELVIC WITHOUT AND WITH CONTRAST. IMPRESSION: THERE IS A RIDETERMINATE SOLID RIGHT OVARIAN MASS WITH ADJACENT NODULAR THICKENING EXTENDING SUPERIORLY ALONG THE COURSE OF THE OVARIAN VEIN. A SOLID OVARIAN NEOPLASM IS SUSPECTED. A PELVIC ULTRASOUND WITH DOPPLER EVALUATION MAY PROVIDE ADDITIONAL INFORMATION (SUCH AS A MORE ACCURATE ASSESSMENT OF THE SIZE OF THE MASS AS WELL AN POSSIBILITY OF INTERNAL FLOW. SINGLE FILM DEMONSTRATES CONTRAST FILLING THE UTERUS BUT NOT FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING - SEVERE PAIN, PAIN IS MORE SEVERE AFTER SEXUAL INTERCOURSE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2018: PLAINTIFF FACT SHEET: EVENTS SENSITIVE SKIN, LOWER ABDOMINAL INFECTION, ACCUMULATION OF FLUID IN PELVIC WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN"), SEPSIS ("INFECTION: BLOOD"), INTRA-ABDOMINAL HAEMORRHAGE ("LOWER ABDOMINAL REGION ¿ BLOOD") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED C-SECTION AND LEIOMYOMA NOS. CONCURRENT CONDITIONS INCLUDED RECTUS SHEATH HEMATOMA, NAUSEA, VOMITING, HYPOKALEMIA AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED FLUOXETINE SINCE (B)(6) 2011. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATION / DYSMENORRHEA (CRAMPING)/ MENSTRUATION PAIN"), ALOPECIA ("HAIR LOSS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS , WEIGHT GAIN / LOSS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEM") AND PELVIC FLUID COLLECTION ("ACCUMULATION OF FLUID IN PELVIC AREA"). ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION/ PROLONGED AND ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) "), DYSGEUSIA ("METAL TASTE IN HER MOUTH"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FIBROMA ("FIBROID TUMORS"), DEPRESSION ("WORSENING OF DEPRESSION"), ANXIETY ("ANXIETY"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), TOOTH DISORDER ("DENTAL PROBLEMS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SIGNS"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("ALLERGY TO NICKEL") WITH PRURITUS, OVARIAN CYST ("OVARIAN CYSTS"), COITAL BLEEDING ("BLEEDING FROM INTERCOURSE"), BACK PAIN ("BACK PAIN"), COMPLICATION OF DEVICE INSERTION ("DOCTOR WAS HAVING TROUBLE INSERTING THE DEVICE DURING THE PROCEDURE") AND CYSTITIS ("BLADDER INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SEPSIS, INTRA-ABDOMINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, DYSPAREUNIA, ALOPECIA, DYSGEUSIA, VAGINAL DISCHARGE, FATIGUE, FIBROMA, DEPRESSION, ANXIETY, WEIGHT FLUCTUATION, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, MENOPAUSAL SYMPTOMS, NAUSEA, ALLERGY TO METALS, OVARIAN CYST, COITAL BLEEDING, PELVIC FLUID COLLECTION, BACK PAIN, COMPLICATION OF DEVICE INSERTION AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, COITAL BLEEDING, COMPLICATION OF DEVICE INSERTION, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, INTRA-ABDOMINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, OVARIAN CYST, PELVIC FLUID COLLECTION, PELVIC PAIN, SEPSIS, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED THOUGH SOME REMAIN. BILATERAL REMOVAL OF FALLOPIAN TUBES. SINCE THE SECOND SURGERY SHE HAVE BEEN ON HORMONE REPLACEMENT THERAPY AND RECEIVING TREATMENT FOR FATIGUE, HAIR LOSS. WEIGHT GAIN AND DEPRESSION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TUBAL OCCLUSION. SUCCESSFUL. ON (B)(6) 2011 PATIENT UNDERWENT HYSTEROSALPINGOGRAM TEST. ON (B)(6) 2012 - MRI PELVIC WITHOUT AND WITH CONTRAST. IMPRESSION: THERE IS A INDETERMINATE SOLID RIGHT OVARIAN MASS WITH ADJACENT NODULAR THICKENING EXTENDING SUPERIORLY ALONG THE COURSE OF THE OVARIAN VEIN. A SOLID OVARIAN NEOPLASM IS SUSPECTED. A PELVIC ULTRASOUND WITH DOPPLER EVALUATION MAY PROVIDE ADDITIONAL INFORMATION (SUCH AS A MORE ACCURATE ASSESSMENT OF THE SIZE OF THE MASS AS WELL AN POSSIBILITY OF INTERNAL FLOW. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ ONES WERE DESCRIBED IN PATIENT¿S PFS: CONFIRMING - SEVERE PAIN, PAIN IS MORE SEVERE AFTER SEXUAL INTERCOURSE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS RECEIVED, PATIENT CONCOMITANT DRUG ADDED, EVENTS ADDED AS FOLLOWS: GENITAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, MENOPAUSAL SYMPTOMS, CYSTITIS, INTRA-ABDOMINAL HAEMORRHAGE, NAUSEA, ALLERGY TO METAL, OVARIAN CYST, COITAL BLEEDING, PELVIC FLUID COLLECTION, SEPSIS, BACK PAIN, COMPLICATION OF DEVICE INSERTION. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATION"), MENORRHAGIA ("HEAVY BLEEDING DURING MENSTRUATION/ PROLONGED AND ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), PRURITUS ("TOPICAL ITCHING"), ALOPECIA ("HAIR LOSS"), DYSGEUSIA ("METAL TASTE IN HER MOUTH"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), FATIGUE ("FATIGUE"), FIBROMA ("FIBROID TUMORS"), DEPRESSION ("WORSENING OF DEPRESSION"), ANXIETY ("ANXIETY") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED IN (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, DYSPAREUNIA, PRURITUS, ALOPECIA, DYSGEUSIA, VAGINAL DISCHARGE, VAGINAL INFECTION, FATIGUE, FIBROMA, DEPRESSION, ANXIETY AND WEIGHT FLUCTUATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FIBROMA, MENORRHAGIA, PELVIC PAIN, PRURITUS, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED THOUGH SOME REMAIN COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 502056 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | CITALOPRAM| DIAZEPAM| FEMRING| FLUOXETINE| FLUOXETINE| FLUOXETINE HCL| FLUTICASONE| LORAZEPAM| MINOXIDIL| PREDNISONE| TINIDAZOLE| TRAZODONE| VALACYCLOVIR HYDROCHLORIDE| VALIUM| VALIUM| VALIUM| VALTREX| VALTREX| ZOLPIDEM AL |