ESSURE
Report
- Report Number
- 2951250-2017-08262
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- December 24, 2014
- Report Date
- May 5, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE; EXTENDING OUT OF THE FALLOPIAN TUBES INTO THE ADNEXA, PERFORATED UTERUS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN/ ABDOMEN PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING.") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B882482, A73764) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SCOLIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: EFFEXOR IN 2013, PROZAC IN 2013, SEROQUEL IN 2013 AND ZANTAC. CONCURRENT CONDITIONS INCLUDED HEMATOCHEZIA, MIGRAINE, ENLARGEMENT UTERINE, DYSFUNCTIONAL UTERINE BLEEDING, DIFFICULTY SLEEPING, MOOD DISORDER AND NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2013, BUSPIRONE HYDROCHLORIDE (BUSPAR) FROM 2013 TO 2017, DOCUSATE SODIUM (COLACE) FROM MAY 2014 TO JULY 2014, GALENIC /PARACETAMOL/CODEINE/ (ACETAMINOPHEN W/CODEINE)(B)(6)2014 TO JANUARY 2015, NORETHISTERONE ACETATE (AYGESTIN) FROM 20-NOV-2014 TO 14-JAN-2015, OXYCOCET (PERCOCET) FROM 2013 TO 2014, PARACETAMOL (TYLENOL)4-JUN-2014 TO JANUARY 2015, RANITIDINE SINCE 2013, SERTRALINE SINCE 2013, TRAMADOL4-JUN-2014 TO JANUARY 2015, TRAZODONE SINCE 2013 AND VICODIN(B)(6)-2014 TO JANUARY 2015. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN JUNE 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6)2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN SEPTEMBER 2014, THE PATIENT EXPERIENCED RASH PAPULAR ("RED BUMPS"). ON (B)(6)2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER. ON (B)(6)2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN JANUARY 2015, THE PATIENT EXPERIENCED OVARIAN MASS ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY"), OVARIAN CYST ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY") AND INCISIONAL HERNIA ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE: DEVELOPED 2 HERNIAS AT INCISION SITE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, RASH PAPULAR AND INCISIONAL HERNIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND ALOPECIA HAD RESOLVED AND THE OVARIAN MASS AND OVARIAN CYST HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, FATIGUE, INCISIONAL HERNIA, MENORRHAGIA, OVARIAN CYST, OVARIAN MASS, RASH PAPULAR, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT JUL-2014, PLAINTIFF HAD MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SHE DID NOT HAD ANY COMPLICATIONS OR PROBLEMS AT THE TIME OF ESSURE PROCEDURE. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING CONDITION. PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY. LEFT 2, RIGHT 4. TRANSVAGINAL ULTRASOUND REPORT IMPRESSION: THERE ARE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. DIAGNOSTIC RESULTS: ON (B)(6)2014, PROCEDURE: HYSTEROSCOPIC STERILIZATION WITH BILATERAL FALLOPIAN TUBE CANNULATION TO INDUCE OCCLUSION BY PLACEMENT OF PERMANENT IMPLANTS. NUMBER OF COILS: LEFT 2, RIGHT 4. ON (B)(6)2014, HYSTEROSALPINGOGRAM: BILATERAL ESSURE MICROINSERTS IN GOOD POSITION WITHIN THE FALLOPIAN TUBES. BOTH FALLOPIAN TUBES ARE OCCLUDED. ON (B)(6)2014, TRANSVAGINAL ULTRASOUND REPORT, IMPRESSION: THERE WERE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. ON (B)(6)2015, SURGICAL PATHOLOGY REPORT, UTERUS AND BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX WITH INFLAMMATION AND REACTIVE CHANGES, AND WEAKLY PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO DIAGNOSTIC ABNORMALITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, DEPRESSION, RASH PAPULAR, ALLERGY TO METALS, ABDOMINAL PAIN, ANXIETY, INCISIONAL HERNIA AND UTERINE HAEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON ((B)(6)2018: PFS RECEIVED. HISTORICAL CONDITION, HISTORICAL DRUG, CONCOMITANT DRUG WERE ADDED, EVENTS DATES UPDATED. LOT NUMBER UPDATED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE; EXTENDING OUT OF THE FALLOPIAN TUBES INTO THE ADNEXA, PERFORATED UTERUS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN/ ABDOMEN PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING.") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B82482, A73754) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: EFFEXOR IN 2013, SEROQUEL IN 2013 AND PROZAC IN 2013. CONCURRENT CONDITIONS INCLUDED HEMATOCHEZIA, MIGRAINE, ENLARGEMENT UTERINE, DYSFUNCTIONAL UTERINE BLEEDING, DIFFICULTY SLEEPING, MOOD DISORDER AND NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2013, BUSPIRONE HYDROCHLORIDE (BUSPAR) FROM 2013 TO 2017, DOCUSATE SODIUM (COLACE) FROM MAY 2014 TO JULY 2014, GALENIC /PARACETAMOL/CODEINE/ (ACETAMINOPHEN W/CODEINE)4-JUN-2014 TO JANUARY 2015, OXYCOCET (PERCOCET) FROM 2013 TO 2014, PARACETAMOL (TYLENOL)4-JUN-2014 TO JANUARY 2015, RANITIDINE SINCE 2013, SERTRALINE SINCE 2013, TRAMADOL4-JUN-2014 TO JANUARY 2015, TRAZODONE SINCE 2013 AND VICODIN4-JUN-2014 TO JANUARY 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN JUNE 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON 1-JUL-2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN SEPTEMBER 2014, THE PATIENT EXPERIENCED RASH PAPULAR ("RED BUMPS"). ON 14-JAN-2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN JANUARY 2015, THE PATIENT EXPERIENCED OVARIAN MASS ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY"), OVARIAN CYST ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY") AND INCISIONAL HERNIA ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE: DEVELOPED 2 HERNIAS AT INCISION SITE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY).ESSURE WAS REMOVED ON 14-JAN-2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, RASH PAPULAR AND INCISIONAL HERNIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND ALOPECIA HAD RESOLVED AND THE OVARIAN MASS AND OVARIAN CYST HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, FATIGUE, INCISIONAL HERNIA, MENORRHAGIA, OVARIAN CYST, OVARIAN MASS, RASH PAPULAR, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT JUL-2014, PLAINTIFF HAD MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SHE DID NOT HAD ANY COMPLICATIONS OR PROBLEMS AT THE TIME OF ESSURE PROCEDURE. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING CONDITION. PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY. LEFT 2, RIGHT 4. TRANSVAGINAL ULTRASOUND REPORT IMPRESSION: THERE ARE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. DIAGNOSTIC RESULTS: ON 18-JUL-2014, PROCEDURE: HYSTEROSCOPIC STERILIZATION WITH BILATERAL FALLOPIAN TUBE CANNULATION TO INDUCE OCCLUSION BY PLACEMENT OF PERMANENT IMPLANTS. NUMBER OF COILS: LEFT 2, RIGHT 4. ON 20-OCT-2014, HYSTEROSALPINGOGRAM: BILATERAL ESSURE MICROINSERTS IN GOOD POSITION WITHIN THE FALLOPIAN TUBES. BOTH FALLOPIAN TUBES ARE OCCLUDED. ON 24-DEC-2014, TRANSVAGINAL ULTRASOUND REPORT, IMPRESSION: THERE WERE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. ON 14-JAN-2015, SURGICAL PATHOLOGY REPORT, UTERUS AND BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX WITH INFLAMMATION AND REACTIVE CHANGES, AND WEAKLY PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO DIAGNOSTIC ABNORMALITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, DEPRESSION, RASH PAPULAR, ALLERGY TO METALS, ABDOMINAL PAIN, ANXIETY, INCISIONAL HERNIA AND UTERINE HAEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, RELEVANT HISTORY AND LAB DATA UPDATED. ESSURE LOT NUMBER ADDED. ESSURE START DATE UPDATED FROM JUN-2014 TO 04-JUN-2014 AND REMOVAL DATE UPDATED FROM JAN-2015 TO 14-JAN-2015. EVENTS ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, ABDOMEN PAIN WERE CLUBBED WITH PREVIOUSLY REPORTED EVENTS. EVENTS ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, FATIGUE, INCISIONAL HERNIA, OVARIAN CYST, OVARIAN MASS, PELVIC PAIN, RASH PAPULAR, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE WERE NEWLY 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 ("MIGRATION OF ESSURE; EXTENDING OUT OF THE FALLOPIAN TUBES INTO THE ADNEXA, PERFORATED UTERUS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN/ ABDOMEN PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING.") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B882482, A73764) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SCOLIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: EFFEXOR IN 2013, PROZAC IN 2013, SEROQUEL IN 2013 AND ZANTAC. CONCURRENT CONDITIONS INCLUDED HEMATOCHEZIA, MIGRAINE, ENLARGEMENT UTERINE, DYSFUNCTIONAL UTERINE BLEEDING, DIFFICULTY SLEEPING, MOOD DISORDER AND NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2013, BUSPIRONE HYDROCHLORIDE (BUSPAR) FROM 2013 TO 2017, DOCUSATE SODIUM (COLACE) FROM (B)(6) 2014 TO (B)(6) 2014, GALENIC /PARACETAMOL/CODEINE/ (ACETAMINOPHEN W/CODEINE) (B)(6) 2014 TO (B)(6) 2015, NORETHISTERONE ACETATE (AYGESTIN) FROM (B)(6) 2014 TO (B)(6) 2015, OXYCOCET (PERCOCET) FROM 2013 TO 2014, PARACETAMOL (TYLENOL) (B)(6) 2014 TO (B)(6) 2015, RANITIDINE SINCE 2013, SERTRALINE SINCE 2013, TRAMADOL (B)(6) 2014 TO (B)(6) 2015, TRAZODONE SINCE 2013 AND VICODIN (B)(6) 2014 TO (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED RASH PAPULAR ("RED BUMPS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER. ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVARIAN MASS ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY"), OVARIAN CYST ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY") AND INCISIONAL HERNIA ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE: DEVELOPED 2 HERNIAS AT INCISION SITE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, RASH PAPULAR AND INCISIONAL HERNIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND ALOPECIA HAD RESOLVED AND THE OVARIAN MASS AND OVARIAN CYST HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, FATIGUE, INCISIONAL HERNIA, MENORRHAGIA, OVARIAN CYST, OVARIAN MASS, RASH PAPULAR, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6) 2014, PLAINTIFF HAD MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SHE DID NOT HAD ANY COMPLICATIONS OR PROBLEMS AT THE TIME OF ESSURE PROCEDURE. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING CONDITION. PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY. LEFT 2, RIGHT 4. TRANSVAGINAL ULTRASOUND REPORT IMPRESSION: THERE ARE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. DIAGNOSTIC RESULTS: ON (B)(6) 2014, PROCEDURE: HYSTEROSCOPIC STERILIZATION WITH BILATERAL FALLOPIAN TUBE CANNULATION TO INDUCE OCCLUSION BY PLACEMENT OF PERMANENT IMPLANTS. NUMBER OF COILS: LEFT 2, RIGHT 4. ON (B)(6) 2014, HYSTEROSALPINGOGRAM: BILATERAL ESSURE MICROINSERTS IN GOOD POSITION WITHIN THE FALLOPIAN TUBES. BOTH FALLOPIAN TUBES ARE OCCLUDED. ON (B)(6) 2014, TRANSVAGINAL ULTRASOUND REPORT, IMPRESSION: THERE WERE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. ON (B)(6) 2015, SURGICAL PATHOLOGY REPORT, UTERUS AND BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX WITH INFLAMMATION AND REACTIVE CHANGES, AND WEAKLY PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO DIAGNOSTIC ABNORMALITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, DEPRESSION, RASH PAPULAR, ALLERGY TO METALS, ABDOMINAL PAIN, ANXIETY, INCISIONAL HERNIA AND UTERINE HAEMORRHAGE. BATCH NUMBER: A73754, EXPIRATION DATE: 2015/11, MANUFACTURE DATE: 2012-11. BATCH NUMBER: B82482, EXPIRATION DATE: 2016/10, MANUFACTURE DATE: 2013/10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('MIGRATION OF ESSURE; EXTENDING OUT OF THE FALLOPIAN TUBES INTO THE ADNEXA, PERFORATED UTERUS'), ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN/ ABDOMEN PAIN'), UTERINE HAEMORRHAGE ('ABNORMAL UTERINE BLEEDING.'), CERVIX CARCINOMA ('CERVICAL CANCER') AND PULMONARY THROMBOSIS ('BLOOD CLOT IN MY LUNG') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B882482, A73764) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SCOLIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: EFFEXOR IN 2013, PROZAC IN 2013, SEROQUEL IN 2013 AND ZANTAC. CONCURRENT CONDITIONS INCLUDED HEMATOCHEZIA, MIGRAINE, ENLARGEMENT UTERINE, DYSFUNCTIONAL UTERINE BLEEDING, DIFFICULTY SLEEPING, MOOD DISORDER AND NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2013, BUSPIRONE HYDROCHLORIDE (BUSPAR) FROM 2013 TO 2017, CODEINE;PARACETAMOL (ACETAMINOPHEN;CODEINE) (B)(6) 2014 TO (B)(6) 2015, DOCUSATE SODIUM (COLACE) FROM (B)(6) 2014 TO (B)(6) 2014, HYDROCODONE BITARTRATE; PARACETAMOL (VICODIN) (B)(6) 2014 TO (B)(6) 2015, NORETHISTERONE ACETATE (AYGESTIN) FROM (B)(6) 2014 TO (B)(6) 2015, OXYCODONE HYDROCHLORIDE; PARACETAMOL (PERCOCET) FROM 2013 TO 2014, PARACETAMOL (TYLENOL) (B)(6) 2014 TO (B)(6) 2015, RANITIDINE SINCE 2013, SERTRALINE SINCE 2013, TRAMADOL (B)(6) 2014 TO (B)(6) 2015 AND TRAZODONE SINCE 2013. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED RASH PAPULAR ("RED BUMPS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER. ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVARIAN MASS ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY"), OVARIAN CYST ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY") AND INCISIONAL HERNIA ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE: DEVELOPED 2 HERNIAS AT INCISION SITE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), TOOTH FRACTURE ("BROKEN TEETH"), IMMUNODEFICIENCY ("WEAKEN IMMUNE SYSTEM"), PULMONARY THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MIGRAINE ("CHRONIC MIGRAINE") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, RASH PAPULAR, INCISIONAL HERNIA, CERVIX CARCINOMA, ENDOMETRIOSIS, WEIGHT INCREASED, TOOTH FRACTURE, IMMUNODEFICIENCY, PULMONARY THROMBOSIS AND MIGRAINE OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND ALOPECIA HAD RESOLVED AND THE OVARIAN MASS AND OVARIAN CYST HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, CERVIX CARCINOMA, DEPRESSION, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, IMMUNODEFICIENCY, INCISIONAL HERNIA, MENORRHAGIA, MIGRAINE, OVARIAN CYST, OVARIAN MASS, PULMONARY THROMBOSIS, RASH PAPULAR, TOOTH FRACTURE, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6) 2014, PLAINTIFF HAD MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SHE DID NOT HAD ANY COMPLICATIONS OR PROBLEMS AT THE TIME OF ESSURE PROCEDURE. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING CONDITION. PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY. LEFT 2, RIGHT 4. TRANSVAGINAL ULTRASOUND REPORT IMPRESSION: THERE ARE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. DIAGNOSTIC RESULTS: ON (B)(6) 2014, PROCEDURE: HYSTEROSCOPIC STERILIZATION WITH BILATERAL FALLOPIAN TUBE CANNULATION TO INDUCE OCCLUSION BY PLACEMENT OF PERMANENT IMPLANTS. NUMBER OF COILS: LEFT 2, RIGHT 4. ON (B)(6) 2014, HYSTEROSALPINGOGRAM: BILATERAL ESSURE MICROINSERTS IN GOOD POSITION WITHIN THE FALLOPIAN TUBES. BOTH FALLOPIAN TUBES ARE OCCLUDED. ON (B)(6) 2014, TRANSVAGINAL ULTRASOUND REPORT, IMPRESSION: THERE WERE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. ON (B)(6) 2015, SURGICAL PATHOLOGY REPORT, UTERUS AND BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX WITH INFLAMMATION AND REACTIVE CHANGES, AND WEAKLY PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO DIAGNOSTIC ABNORMALITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, DEPRESSION, RASH PAPULAR, ALLERGY TO METALS, ABDOMINAL PAIN, ANXIETY, INCISIONAL HERNIA AND UTERINE HAEMORRHAGE. BATCH NUMBER: A73754 EXPIRATION DATE: 2015/11 MANUFACTURE DATE: 2012-11. BATCH NUMBER: B82482 EXPIRATION DATE: 2016/10 MANUFACTURE DATE: 2013/10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED: EVENTS ADDED- CERVICAL CANCER, ENDOMETRIOSIS, WEIGHT GAIN, BROKEN TEETH, WEAKEN IMMUNE SYSTEM, BLOOD CLOT IN MY LUNG AND CHRONIC MIGRAINE. REPORTER ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('MIGRATION OF ESSURE; EXTENDING OUT OF THE FALLOPIAN TUBES INTO THE ADNEXA, PERFORATED UTERUS'), ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN/ ABDOMEN PAIN'), UTERINE HAEMORRHAGE ('ABNORMAL UTERINE BLEEDING.'), CERVIX CARCINOMA ('CERVICAL CANCER') AND PULMONARY THROMBOSIS ('BLOOD CLOT IN MY LUNG') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B82482, A73764) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SCOLIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: EFFEXOR IN 2013, PROZAC IN 2013, SEROQUEL IN 2013 AND ZANTAC. CONCURRENT CONDITIONS INCLUDED HEMATOCHEZIA, MIGRAINE, ENLARGEMENT UTERINE, DYSFUNCTIONAL UTERINE BLEEDING, DIFFICULTY SLEEPING, MOOD DISORDER AND NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2013, BUSPIRONE HYDROCHLORIDE (BUSPAR) FROM 2013 TO 2017, CODEINE;PARACETAMOL (ACETAMINOPHEN;CODEINE) 4-JUN-2014 TO 4-JUN-2014 , DOCUSATE SODIUM (COLACE) FROM (B)(6) 2014 TO (B)(6) 2014, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) 4-JUN-2014 TO JANUARY 2015, NORETHISTERONE ACETATE (AYGESTIN) FROM 20-NOV-2014 TO 14-JAN-2015, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) FROM 2013 TO 2014, PARACETAMOL (TYLENOL) 4-JUN-2014 TO JANUARY 2015, RANITIDINE SINCE 2013, SERTRALINE SINCE 2013, TRAMADOL 4-JUN-2014 TO JANUARY 2015 AND TRAZODONE SINCE 2013. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED RASH PAPULAR ("RED BUMPS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER. ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVARIAN MASS ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY"), OVARIAN CYST ("PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY") AND INCISIONAL HERNIA ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE: DEVELOPED 2 HERNIAS AT INCISION SITE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), TOOTH FRACTURE ("BROKEN TEETH"), IMMUNODEFICIENCY ("WEAKEN IMMUNE SYSTEM"), PULMONARY THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MIGRAINE ("CHRONIC MIGRAINE") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, RASH PAPULAR, INCISIONAL HERNIA, CERVIX CARCINOMA, ENDOMETRIOSIS, WEIGHT INCREASED, TOOTH FRACTURE, IMMUNODEFICIENCY, PULMONARY THROMBOSIS AND MIGRAINE OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND ALOPECIA HAD RESOLVED AND THE OVARIAN MASS AND OVARIAN CYST HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, CERVIX CARCINOMA, DEPRESSION, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, IMMUNODEFICIENCY, INCISIONAL HERNIA, MENORRHAGIA, MIGRAINE, OVARIAN CYST, OVARIAN MASS, PULMONARY THROMBOSIS, RASH PAPULAR, TOOTH FRACTURE, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6) 2014, PLAINTIFF HAD MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. SHE DID NOT HAD ANY COMPLICATIONS OR PROBLEMS AT THE TIME OF ESSURE PROCEDURE. ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING CONDITION. PROBLEMS CONTINUED WITH CYSTS AND MASSES ON OVARIES AFTER HYSTERECTOMY SURGERY. LEFT 2, RIGHT 4. TRANSVAGINAL ULTRASOUND REPORT IMPRESSION: THERE ARE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. DIAGNOSTIC RESULTS: ON (B)(6) 2014, PROCEDURE: HYSTEROSCOPIC STERILIZATION WITH BILATERAL FALLOPIAN TUBE CANNULATION TO INDUCE OCCLUSION BY PLACEMENT OF PERMANENT IMPLANTS. NUMBER OF COILS: LEFT 2, RIGHT 4. ON (B)(6) 2014, HYSTEROSALPINGOGRAM: BILATERAL ESSURE MICROINSERTS IN GOOD POSITION WITHIN THE FALLOPIAN TUBES. BOTH FALLOPIAN TUBES ARE OCCLUDED. ON (B)(6) 2014, TRANSVAGINAL ULTRASOUND REPORT, IMPRESSION: THERE WERE BILATERAL ESSURE DEVICES LOCATED PARTIALLY IN THE UTERUS IN THE VICINITY OF THE INTERSTITIAL TUBE AND PARTIALLY EXTENDING OUT IN THE DIRECTION OF THE ADNEXA BILATERALLY IN THE EXPECTED LOCATION. ALTHOUGH THIS APPEARS NORMAL, A TUBAL PERFORATION CANNOT BE FULLY RULED OUT. ON (B)(6) 2015, SURGICAL PATHOLOGY REPORT, UTERUS AND BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX WITH INFLAMMATION AND REACTIVE CHANGES, AND WEAKLY PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO DIAGNOSTIC ABNORMALITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, DEPRESSION, RASH PAPULAR, ALLERGY TO METALS, ABDOMINAL PAIN, ANXIETY, INCISIONAL HERNIA AND UTERINE HAEMORRHAGE. BATCH NUMBER: A73754 EXPIRATION DATE: 2015/11 MANUFACTURE DATE: 2012-11 . BATCH NUMBER: B82482 EXPIRATION DATE: 2016/10 MANUFACTURE DATE: 2013/10 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2020: QUALITY-SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING/PROLONGED MENSES"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), ALOPECIA ("HAIR LOSS") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY SUCCESSFULLY REMOVED ESSURE DEVICES.). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, ALLERGY TO METALS, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING ON OR ABOUT (B)(6) 2014, PLAINTIFF HAD MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2014: CONFIRMED FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836456 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B82482, A73764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ACETAMINOPHEN W/CODEINE| ACETAMINOPHEN W/CODEINE| ACETAMINOPHEN W/CODEINE| ACETAMINOPHEN,CODEINE| ACETAMINOPHEN,CODEINE| AYGESTIN| AYGESTIN| AYGESTIN| AYGESTIN| BUSPAR| BUSPAR| BUSPAR| BUSPAR| BUSPAR| COLACE| COLACE| COLACE| COLACE| COLACE| PERCOCET| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| SERTRALINE| SERTRALINE| SERTRALINE| SERTRALINE| SERTRALINE| TRAMADOL| TRAMADOL| TRAMADOL| TRAMADOL| TRAMADOL| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| TYLENOL| TYLENOL| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| VICODIN| VICODIN| VICODIN| VICODIN| VICODIN| XANAX| XANAX| XANAX| XANAX| XANAX |