ESSURE
Report
- Report Number
- 2951250-2017-02872
- Event Type
- Injury
- Date Received
- August 10, 2017
- Date of Event
- June 1, 2012
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS PARTIALLY OCCLUDED" ON (B)(6) 2013. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN, DISCOMFORT, FOGGY FEELING IN HEAD, SYPHILIS IN 2011, ASTHMA, MISCARRIAGE, MULTI GRAVIDA (G3), PARITY 1, C-SECTION ON (B)(6) 2012, PELVIC ADHESIONS, GESTATIONAL DIABETES MELLITUS AND CHOLECYSTECTOMY IN 2013. NO KNOWN ALLERGIES. CONCURRENT CONDITIONS INCLUDED HYDROSALPINX, OVARIAN CYST AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (VENTOLIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC REACTION/ALLERGIC OR HYPERSENSITIVITY: NICKEL,") WITH RASH, FATIGUE ("FATIGUE"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("HEADACHE/MIGRAINES / HEADACHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"). THE PATIENT WAS TREATED WITH ANALGESICS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, FATIGUE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, NAUSEA, ABDOMINAL PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED AND CONSTIPATION HAD RESOLVED AND THE HEADACHE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, CONSTIPATION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED, 4 COILS WERE NOTED PAST THE TUBAL OSTIA. THE SAME WAS PERFORMED ON THE OTHER SIDE AND ABOUT 6 COIL WERE NOTED PAST THE TUBAL OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS PARTIALLY OCCLUDED; ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2013, FINDINGS: PRELIMINARY IMAGE OF THE PELVIS DEMONSTRATES THE THIN METALLIC CURVILINEAR ESSURE INSERTS IN PLACE. THE LEFT ESSURE INSERT IS NOTABLE IN THAT THE PROXIMAL RADIOPAQUE PORTION DEMONSTRATES WHAT MAY BE DISCONTINUITY WITH THE REMAINDER OF THE INSERT. THERE IS A 3 MM SPACE BETWEEN IT AND THE REMAINDER OF THE INSERT AND IT MAKES A 90 DEGREE CHANGE IN ORIENTATION BETWEEN THE 2 VISUALIZED PARTS. CT SCAN AND ULTRASOUND DEMONSTRATED A COLLECTION ON THE LEFT SIDE OF THE PELVIS ADJACENT TO THE ESSURE. SHE WAS DISCHARGED TO HOME WITHOUT MEDICATION; SPECIFICALLY NO ANTIBIOTICS. A SPECULUM WAS PLACED AND THE EXTERNAL CERVICAL OS WAS VISUALIZED. ARISING FROM THE CERVICAL OS, THERE WAS THICK BROWNISH FLUID, AND SOME WAS NOTED POOLED WITHIN THE VAGINA AS WELL. AS INFECTION IS A CONTRAINDICATION FOR HYSTEROSALPINGOGRAM, THE PROCEDURE WAS TERMINATED AT THAT POINT, AS THE POSSIBILITY OF INFECTION COULD NOT BE EXCLUDED. ON (B)(6) 2014, HYSTEROSALPINGOGRAM- ESSURE DEVICE APPEAR PROPERLY POSITIONED AND FUNCTIONAL BILATERALLY WITH OCCLUSION OF THE FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. LOT NUMBER ADDED. CASE MEDICALLY CONFIRMED EVENTS ADDED AS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), RASHES OR SKIN CONDITIONS TYPE: CONSTANT RASH ON LEGS , MIGRAINES / HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), ABDOMINAL PAIN, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION. EVENT ALLERGIC REACTION UPDATED TO ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL. HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS PARTIALLY OCCLUDED" ON (B)(6) 2013. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN, DISCOMFORT, FOGGY FEELING IN HEAD, SYPHILIS IN 2011, ASTHMA, MISCARRIAGE, MULTI GRAVIDA (G3), PARITY 1, C-SECTION ON (B)(6) 2012, PELVIC ADHESIONS, GESTATIONAL DIABETES MELLITUS AND CHOLECYSTECTOMY IN 2013. NO KNOWN ALLERGIES. CONCURRENT CONDITIONS INCLUDED HYDROSALPINX, OVARIAN CYST AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (VENTOLIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC REACTION/ALLERGIC OR HYPERSENSITIVITY: NICKEL,") WITH RASH, FATIGUE ("FATIGUE"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF HEADACHE ("HEADACHE/MIGRAINES / HEADACHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"), GASTRIC DISORDER ("SO MANY ISSUES WITH STOMACH"), THE SECOND EPISODE OF HEADACHE ("HEADACHE"), ABDOMINAL DISTENSION ("BLOATING"), NERVOUSNESS ("NERVOUS") AND DEPRESSED LEVEL OF CONSCIOUSNESS ("LOOSING MIND"). THE PATIENT WAS TREATED WITH ANALGESICS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, FATIGUE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, NAUSEA, ABDOMINAL PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED AND CONSTIPATION HAD RESOLVED AND THE MENSTRUAL DISORDER, GASTRIC DISORDER, THE LAST EPISODE OF HEADACHE AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, CONSTIPATION, DEPRESSED LEVEL OF CONSCIOUSNESS, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, NERVOUSNESS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF HEADACHE AND THE SECOND EPISODE OF HEADACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED, 4 COILS WERE NOTED PAST THE TUBAL OSTIA. THE SAME WAS PERFORMED ON THE OTHER SIDE AND ABOUT 6 COIL WERE NOTED PAST THE TUBAL OSTIA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS PARTIALLY OCCLUDED; ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. (B)(6) 2013, FINDINGS: PRELIMINARY IMAGE OF THE PELVIS DEMONSTRATES THE THIN METALLIC CURVILINEAR ESSURE INSERTS IN PLACE. THE LEFT ESSURE INSERT IS NOTABLE IN THAT THE PROXIMAL RADIOPAQUE PORTION DEMONSTRATES WHAT MAY BE DISCONTINUITY WITH THE REMAINDER OF THE INSERT. THERE IS A 3 MM SPACE BETWEEN IT AND THE REMAINDER OF THE INSERT AND IT MAKES A 90 DEGREE CHANGE IN ORIENTATION BETWEEN THE 2 VISUALIZED PARTS. CT SCAN AND ULTRASOUND DEMONSTRATED A COLLECTION ON THE LEFT SIDE OF THE PELVIS ADJACENT TO THE ESSURE. SHE WAS DISCHARGED TO HOME WITHOUT MEDICATION; SPECIFICALLY NO ANTIBIOTICS. A SPECULUM WAS PLACED AND THE EXTERNAL CERVICAL OS WAS VISUALIZED. ARISING FROM THE CERVICAL OS, THERE WAS THICK BROWNISH FLUID, AND SOME WAS NOTED POOLED WITHIN THE VAGINA AS WELL. AS INFECTION IS A CONTRAINDICATION FOR HYSTEROSAIPINGOGRAM, THE PROCEDURE WAS TERMINATED AT THAT POINT, AS THE POSSIBILITY OF INFECTION COULD NOT BE EXCLUDED. (B)(6) 2014, HYSTEROSALPINGOGRAM- ESSURE DEVICE APPEAR PROPERLY POSITIONED AND FUNCTIONAL BILATERALLY WITH OCCLUSION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES STOMACH ISSUE, HEADACHE, BLOATING WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-APR-2018: PLAINTIFF FACT SHEET RECEIVED. NEW REPORTERS ADDED. NEW EVENTS SO MANY ISSUES WITH STOMACH, HEADACHES, LOOSING MIND, BLOATING AND NERVOUS WERE ADDED. ON 14-MAY-2018: NO NEW CLINICAL INFORMATION RECEIVED. 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 PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS PARTIALLY OCCLUDED" ON (B)(6) 2013. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN, DISCOMFORT, FOGGY FEELING IN HEAD, SYPHILIS IN 2011, ASTHMA, MISCARRIAGE, MULTI GRAVIDA (G3), PARITY 1, C-SECTION ON (B)(6) 2012, PELVIC ADHESIONS, GESTATIONAL DIABETES MELLITUS AND CHOLECYSTECTOMY IN 2013. NO KNOWN ALLERGIES. CONCURRENT CONDITIONS INCLUDED HYDROSALPINX, OVARIAN CYST AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (VENTOLIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGIC REACTION/ALLERGIC OR HYPERSENSITIVITY: NICKEL,") WITH RASH, FATIGUE ("FATIGUE"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA") AND VAGINAL INFECTION ("VAGINAL INFECTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE/MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION ISSUES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"), GASTRIC DISORDER ("SO MANY ISSUES WITH STOMACH"), ABDOMINAL DISTENSION ("BLOATING"), NERVOUSNESS ("NERVOUS") AND DEPRESSED LEVEL OF CONSCIOUSNESS ("LOOSING MIND"). THE PATIENT WAS TREATED WITH ANALGESICS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, HEADACHE, FATIGUE, MENSTRUAL DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, NAUSEA, ABDOMINAL PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED, CONSTIPATION, GASTRIC DISORDER, ABDOMINAL DISTENSION, NERVOUSNESS, DEPRESSED LEVEL OF CONSCIOUSNESS, DEPRESSION, DYSPAREUNIA, ANXIETY AND VAGINAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, CONSTIPATION, DEPRESSED LEVEL OF CONSCIOUSNESS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, NERVOUSNESS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED, 4 COILS WERE NOTED PAST THE TUBAL OSTIA. THE SAME WAS PERFORMED ON THE OTHER SIDE AND ABOUT 6 COIL WERE NOTED PAST THE TUBAL OSTIA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS PARTIALLY OCCLUDED; ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. (B)(6) 2013, FINDINGS: PRELIMINARY IMAGE OF THE PELVIS DEMONSTRATES THE THIN METALLIC CURVILINEAR ESSURE INSERTS IN PLACE. THE LEFT ESSURE INSERT IS NOTABLE IN THAT THE PROXIMAL RADIOPAQUE PORTION DEMONSTRATES WHAT MAY BE DISCONTINUITY WITH THE REMAINDER OF THE INSERT. THERE IS A 3 MM SPACE BETWEEN IT AND THE REMAINDER OF THE INSERT AND IT MAKES A 90 DEGREE CHANGE IN ORIENTATION BETWEEN THE 2 VISUALIZED PARTS. CT SCAN AND ULTRASOUND DEMONSTRATED A COLLECTION ON THE LEFT SIDE OF THE PELVIS ADJACENT TO THE ESSURE. SHE WAS DISCHARGED TO HOME WITHOUT MEDICATION; SPECIFICALLY NO ANTIBIOTICS. A SPECULUM WAS PLACED AND THE EXTERNAL CERVICAL OS WAS VISUALIZED. ARISING FROM THE CERVICAL OS, THERE WAS THICK BROWNISH FLUID, AND SOME WAS NOTED POOLED WITHIN THE VAGINA AS WELL. AS INFECTION IS A CONTRAINDICATION FOR HYSTEROSAIPINGOGRAM, THE PROCEDURE WAS TERMINATED AT THAT POINT, AS THE POSSIBILITY OF INFECTION COULD NOT BE EXCLUDED. (B)(6) 2014, HYSTEROSALPINGOGRAM- ESSURE DEVICE APPEAR PROPERLY POSITIONED AND FUNCTIONAL BILATERALLY WITH OCCLUSION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES STOMCH ISSUE ,HEADACHE,BLOATING WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-AUG-2018: PLAINTIFF FACT SHEET RECEIVED: VAGINAL INFECTION, DEPRESSION AND MENTAL ANGUISH AND DYSPAREUNIA EVENTS WAS ADDED AND EVENTS OUTCOME 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 PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS PARTIALLY OCCLUDED" ON (B)(6) 2013. THE PATIENT'S MEDICAL HISTORY INCLUDED PAIN, DISCOMFORT, FOGGY FEELING IN HEAD, SYPHILIS IN 2011, ASTHMA, MISCARRIAGE, MULTI GRAVIDA (G3), PARITY 1, C-SECTION ON (B)(6) 2012, PELVIC ADHESIONS, GESTATIONAL DIABETES MELLITUS AND CHOLECYSTECTOMY IN 2013. NO KNOWN ALLERGIES. CONCURRENT CONDITIONS INCLUDED HYDROSALPINX, OVARIAN CYST AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (MICRONOR) FROM (B)(6) 2012 TO (B)(6) 2014, PARACETAMOL (ACETAMINOPHEN) SINCE 2012 AND SALBUTAMOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND PELVIC INFECTION ("PELVIC INFECTION"), 14 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC REACTION/ALLERGIC OR HYPERSENSITIVITY: NICKEL,") WITH RASH, FATIGUE ("FATIGUE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA") AND VAGINAL INFECTION ("VAGINAL INFECTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE/MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION ISSUES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"), GASTRIC DISORDER ("SO MANY ISSUES WITH STOMACH"), ABDOMINAL DISTENSION ("BLOATING"), NERVOUSNESS ("NERVOUS"), DEPRESSED LEVEL OF CONSCIOUSNESS ("LOOSING MIND") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH ANALGESICS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, HEADACHE, FATIGUE, MENSTRUAL DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, NAUSEA, ABDOMINAL PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED, CONSTIPATION, GASTRIC DISORDER, ABDOMINAL DISTENSION, NERVOUSNESS, DEPRESSED LEVEL OF CONSCIOUSNESS, DEPRESSION, DYSPAREUNIA, ANXIETY AND VAGINAL INFECTION HAD RESOLVED AND THE PELVIC INFECTION AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, BACK PAIN, CONSTIPATION, DEPRESSED LEVEL OF CONSCIOUSNESS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, NERVOUSNESS, PELVIC INFECTION, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED, 4 COILS WERE NOTED PAST THE TUBAL OSTIA. THE SAME WAS PERFORMED ON THE OTHER SIDE AND ABOUT 6 COIL WERE NOTED PAST THE TUBAL OSTIA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: TOTAL BILATERAL OCCLUSION. THE COILS HAD NOT PERFORATED ANY SURROUNDING ORGANS AND THERE SHOULD NOT BE ANY PROBLEMS.; ON (B)(6) 2013: RESULTS: ESSURE DEVICE WAS PARTIALLY OCCLUDED THE COILS HAD NOT PERFORATED ANY SURROUNDING ORGANS AND THERE SHOULD NOT BE ANY PROBLEMS. ULTRASOUND SCAN - ON (B)(6) 2013: FINDINGS: PRELIMINARY IMAGE OF THE PELVIS DEMONSTRATES THE THIN METALLIC CURVILINEAR ESSURE INSERTS IN PLACE. THE LEFT ESSURE INSERT IS NOTABLE IN THAT THE PROXIMAL RADIOPAQUE PORTION DEMONSTRATES WHAT MAY BE DISCONTINUITY WITH THE REMAINDER OF THE INSERT. THERE IS A 3 MM SPACE BETWEEN IT AND THE REMAINDER OF THE INSERT AND IT MAKES A 90 DEGREE CHANGE IN ORIENTATION BETWEEN THE 2 VISUALIZED PARTS. CT SCAN AND ULTRASOUND DEMONSTRATED A COLLECTION ON THE LEFT SIDE OF THE PELVIS ADJACENT TO THE ESSURE. SHE WAS DISCHARGED TO HOME WITHOUT MEDICATION; SPECIFICALLY NO ANTIBIOTICS. A SPECULUM WAS PLACED AND THE EXTERNAL CERVICAL OS WAS VISUALIZED. ARISING FROM THE CERVICAL OS, THERE WAS THICK BROWNISH FLUID, AND SOME WAS NOTED POOLED WITHIN THE VAGINA AS WELL. AS INFECTION IS A CONTRAINDICATION FOR HYSTEROSAIPINGOGRAM, THE PROCEDURE WAS TERMINATED AT THAT POINT, AS THE POSSIBILITY OF INFECTION COULD NOT BE EXCLUDED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES STOMCH ISSUE ,HEADACHE,BLOATING WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-NOV-2018: PFS RECEIVED: EVENT PELVIC INFECTION AND BACK PAIN ADDED. CONCOMITANT DRUG ADDED. LAB TEST 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS PARTIALLY OCCLUDED" ON (B)(6) 2013. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN, DISCOMFORT, FOGGY FEELING IN HEAD, SYPHILIS IN 2011, ASTHMA, MISCARRIAGE, MULTI GRAVIDA (G3), PARITY 1, C-SECTION ON (B)(6) 2012, PELVIC ADHESIONS, GESTATIONAL DIABETES MELLITUS AND CHOLECYSTECTOMY IN 2013. NO KNOWN ALLERGIES. CONCURRENT CONDITIONS INCLUDED HYDROSALPINX, OVARIAN CYST AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (VENTOLIN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC REACTION/ALLERGIC OR HYPERSENSITIVITY: NICKEL,") WITH RASH, FATIGUE ("FATIGUE"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF HEADACHE ("HEADACHE/MIGRAINES / HEADACHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"), GASTRIC DISORDER ("SO MANY ISSUES WITH STOMACH"), THE SECOND EPISODE OF HEADACHE ("HEADACHE"), ABDOMINAL DISTENSION ("BLOATING"), NERVOUSNESS ("NERVOUS") AND DEPRESSED LEVEL OF CONSCIOUSNESS ("LOOSING MIND"). THE PATIENT WAS TREATED WITH ANALGESICS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, FATIGUE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, NAUSEA, ABDOMINAL PAIN, VAGINAL DISCHARGE, WEIGHT INCREASED AND CONSTIPATION HAD RESOLVED AND THE MENSTRUAL DISORDER, GASTRIC DISORDER, THE LAST EPISODE OF HEADACHE AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, CONSTIPATION, DEPRESSED LEVEL OF CONSCIOUSNESS, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, NERVOUSNESS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF HEADACHE AND THE SECOND EPISODE OF HEADACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED, 4 COILS WERE NOTED PAST THE TUBAL OSTIA. THE SAME WAS PERFORMED ON THE OTHER SIDE AND ABOUT 6 COIL WERE NOTED PAST THE TUBAL OSTIA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS PARTIALLY OCCLUDED; ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. (B)(6) 2013, FINDINGS: PRELIMINARY IMAGE OF THE PELVIS DEMONSTRATES THE THIN METALLIC CURVILINEAR ESSURE INSERTS IN PLACE. THE LEFT ESSURE INSERT IS NOTABLE IN THAT THE PROXIMAL RADIOPAQUE PORTION DEMONSTRATES WHAT MAY BE DISCONTINUITY WITH THE REMAINDER OF THE INSERT. THERE IS A 3 MM SPACE BETWEEN IT AND THE REMAINDER OF THE INSERT AND IT MAKES A 90 DEGREE CHANGE IN ORIENTATION BETWEEN THE 2 VISUALIZED PARTS. CT SCAN AND ULTRASOUND DEMONSTRATED A COLLECTION ON THE LEFT SIDE OF THE PELVIS ADJACENT TO THE ESSURE. SHE WAS DISCHARGED TO HOME WITHOUT MEDICATION; SPECIFICALLY NO ANTIBIOTICS. A SPECULUM WAS PLACED AND THE EXTERNAL CERVICAL OS WAS VISUALIZED. ARISING FROM THE CERVICAL OS, THERE WAS THICK BROWNISH FLUID, AND SOME WAS NOTED POOLED WITHIN THE VAGINA AS WELL. AS INFECTION IS A CONTRAINDICATION FOR HYSTEROSALPINGOGRAM, THE PROCEDURE WAS TERMINATED AT THAT POINT, AS THE POSSIBILITY OF INFECTION COULD NOT BE EXCLUDED. (B)(6) 2014, HYSTEROSALPINGOGRAM- ESSURE DEVICE APPEAR PROPERLY POSITIONED AND FUNCTIONAL BILATERALLY WITH OCCLUSION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES STOMACH ISSUE ,HEADACHE,BLOATING WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PTC INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS PARTIALLY OCCLUDED" ON (B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEADACHE ("HEADACHE"), FATIGUE ("FATIGUE") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HYPERSENSITIVITY, HEADACHE, FATIGUE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FATIGUE, HEADACHE, HYPERSENSITIVITY, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS PARTIALLY 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 |
|---|---|---|---|---|---|---|---|
| 564637 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| MICRONOR| MICRONOR| SALBUTAMOL| SALBUTAMOL| VENTOLIN| VENTOLIN| VENTOLIN| VENTOLIN |