ESSURE
Report
- Report Number
- 2951250-2017-03729
- Event Type
- Injury
- Date Received
- September 18, 2017
- Date of Event
- August 1, 2013
- Report Date
- October 30, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN (SHARP CONSTANT) / PAIN"), UTERINE CANCER ("CANCEROUS CELLS") AND CERVIX CARCINOMA ("CANCEROUS CERVICAL CELLS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 (30SEP2011) AND WISDOM TEETH REMOVAL IN 2008. PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA IN OCTOBER 2011; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS FROM 2001 TO OCTOBER 2011 AND NSAID. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENSTRUATION IRREGULAR WITH DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY, HEAVY PERIODS, SINUSITIS, BAROSINUSITIS, FACIAL PAIN, SNORING, UVULECTOMY, NASAL SINUS IRRIGATION AND SLEEP APNEA. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2008, PARACETAMOL (ACETAMINOPHEN) AND PRENATAL VITAMINS SINCE 2008. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("SEVERE MIGRAINES/ MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND CYSTITIS ("BLADDER INFECTION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), VISION BLURRED ("BLURRED VISION"), EAR INFECTION ("EAR INFECTIONS"), ASTHENIA ("LACK OF ENERGY") AND NAUSEA ("NAUSEA"). IN FEBRUARY 2014, THE PATIENT EXPERIENCED DYSPNOEA ("DYSPNEA"), DYSPHAGIA ("DYSPHAGIA"), ANAEMIA ("ANEMIA") AND FATIGUE ("INCREASED FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ENVIRONMENTAL ALLERGIES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("STOMACH ACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION, PERIODS OF MENORRHAGIA"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), INFECTION ("INFECTION"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), AMENORRHOEA ("AMENORRHEA FOR YEARS AT A TIME"), EAR PAIN ("EAR PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH ALLERGY MEDICATION, IRON, NAPROXEN, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY.) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ABDOMINAL PAIN, VISION BLURRED, EAR INFECTION, ASTHENIA, HYPERSENSITIVITY, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN UPPER HAD RESOLVED AND THE UTERINE CANCER, CERVIX CARCINOMA, DIZZINESS, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, MIGRAINE, AMENORRHOEA, NAUSEA, DYSPNOEA, DYSPHAGIA, ANAEMIA, MENSTRUATION IRREGULAR, EAR PAIN, URINARY TRACT INFECTION, CYSTITIS, VAGINAL INFECTION, DEPRESSION, ANXIETY AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR CERVIX CARCINOMA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, AMENORRHOEA, ANAEMIA, ANXIETY, ASTHENIA, BLOOD COUNT ABNORMAL, CYSTITIS, DEPRESSION, DIZZINESS, DYSPHAGIA, DYSPNOEA, EAR INFECTION, EAR PAIN, FATIGUE, HEADACHE, HYPERSENSITIVITY, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, UTERINE CANCER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PARTIAL HYSTERECTOMY ON 15JUN2016 AND FULL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICE ON 23JUN2016. CURRENT WEIGHT: 216 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.8 KG/SQM. HAEMOGLOBIN (12 - 16) - ON 6-MAY-2016: 11.2 (DEPRESSED) HYSTEROSCOPY - ON AN UNKNOWN DATE: NORMAL CAVITY ON (B)(6) 2012, PATIENT UNDERWENT ESSURE CONFIRMATION TEST, HYSTEROSALPINGOGRAM. ON (B)(6) 2015, ULTRASOUND NON-OB TRANSVAGINAL REVEALED RETROVERTED UTERUS. TINY FUNDAL FIBROID. THIS DOES NOT INVOLVE THE ENDOMETRIUM. ESSURE COILS NOTED. RIGHT AND LEFT OVARY APPEAR. ON (B)(6) 2016, MODERATE DYSPLASIA OF CERVIX NOTED ON HYSTERECTOMY PATHOLOGY. PLAINTIFF STATES THAT IN SEP-2012, THE DOCTOR INFORMED THE PLAINTIFF THAT THE ESSURE WAS PLACED CORRECTLY AND THAT HER FALLOPIAN TUBES WERE OCCLUDED. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA MEDICAL RECORD: PELVIC PAIN; HEADACHES; MENSTRUATION; ABDOMINAL PAIN LOWER; BLOATING; BLURRED VISION; ALLERGIES; DIZZINESS AND ANEMIA.¿ CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- HAD HER ENERGY BACK. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: EVENT: STOMACH ACHE ADDED. EVENT ONSET DATE UPDATED. CONCOMITANT DRUGS ADDED. EVENT OUTCOME UPDATED. UNSTRUCTURED RELEVANT 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN (SHARP CONSTANT) / PAIN"), UTERINE CANCER ("CANCEROUS CELLS") AND CERVIX CARCINOMA ("CANCEROUS CERVICAL CELLS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6) 2011) AND WISDOM TEETH REMOVAL IN 2008. PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA IN OCTOBER 2011; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS FROM 2001 TO OCTOBER 2011 AND NSAID. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENSTRUATION IRREGULAR WITH DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY, HEAVY PERIODS, SINUSITIS, BAROSINUSITIS, FACIAL PAIN, SNORING, UVULECTOMY, NASAL SINUS IRRIGATION AND SLEEP APNEA. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN"), MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION, PERIODS OF MENORRHAGIA"), MIGRAINE ("SEVERE MIGRAINES/ MIGRAINES"), NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN APRIL 2013, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ENVIRONMENTAL ALLERGIES"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND CYSTITIS ("BLADDER INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), INFECTION ("INFECTION"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), VISION BLURRED ("BLURRED VISION"), EAR INFECTION ("EAR INFECTIONS"), AMENORRHOEA ("AMENORRHEA FOR YEARS AT A TIME"), ASTHENIA ("LACK OF ENERGY"), DYSPNOEA ("DYSPNEA"), DYSPHAGIA ("DYSPHAGIA"), ANAEMIA ("ANEMIA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), EAR PAIN ("EAR PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH ALLERGY MEDICATION, IRON, NAPROXEN, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY.) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ABDOMINAL PAIN, VISION BLURRED, EAR INFECTION, ASTHENIA, HYPERSENSITIVITY AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE UTERINE CANCER, CERVIX CARCINOMA, DIZZINESS, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, MIGRAINE, AMENORRHOEA, NAUSEA, DYSPNOEA, DYSPHAGIA, ANAEMIA, MENSTRUATION IRREGULAR, EAR PAIN, URINARY TRACT INFECTION, CYSTITIS, VAGINAL INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR CERVIX CARCINOMA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMENORRHOEA, ANAEMIA, ANXIETY, ASTHENIA, BLOOD COUNT ABNORMAL, CYSTITIS, DEPRESSION, DIZZINESS, DYSPHAGIA, DYSPNOEA, EAR INFECTION, EAR PAIN, HEADACHE, HYPERSENSITIVITY, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, UTERINE CANCER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2016 AND FULL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016. CURRENT WEIGHT: 216 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.8 KG/SQM. HAEMOGLOBIN (12 - 16) - ON (B)(6) 2016: 11.2 (DEPRESSED) HYSTEROSCOPY - ON AN UNKNOWN DATE: NORMAL CAVITY ON (B)(6) 2012, PATIENT UNDERWENT ESSURE CONFIRMATION TEST, HYSTEROSALPINGOGRAM. ON (B)(6) 2015, ULTRASOUND NON-OB TRANSVAGINAL REVEALED RETROVERTED UTERUS. TINY FUNDAL FIBROID. THIS DOES NOT INVOLVE THE ENDOMETRIUM. ESSURE COILS NOTED. RIGHT AND LEFT OVARY APPEAR. ON (B)(6) 2016, MODERATE DYSPLASIA OF CERVIX NOTED ON HYSTERECTOMY PATHOLOGY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA MEDICAL RECORD: PELVIC PAIN; HEADACHES; MENSTRUATION; ABDOMINAL PAIN LOWER; BLOATING; BLURRED VISION; ALLERGIES; DIZZINESS AND ANEMIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: AFTER COMPANY INTERNAL REVIEW FDA EVALUATION CODE WAS AMENDED. 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 (SHARP CONSTANT) / PAIN"), UTERINE CANCER ("CANCEROUS CELLS") AND CERVIX CARCINOMA ("CANCEROUS CERVICAL CELLS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6) 2011) AND WISDOM TEETH REMOVAL IN 2008. PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA IN (B)(6) 2011; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS FROM 2001 TO (B)(6) 2011 AND NSAID. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENSTRUATION IRREGULAR WITH DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY, HEAVY PERIODS, SINUSITIS, BAROSINUSITIS, FACIAL PAIN, SNORING, UVULECTOMY, NASAL SINUS IRRIGATION AND SLEEP APNEA. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). 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), HEADACHE ("HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN"), MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION, PERIODS OF MENORRHAGIA"), MIGRAINE ("SEVERE MIGRAINES/ MIGRAINES"), NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2013, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ENVIRONMENTAL ALLERGIES"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND CYSTITIS ("BLADDER INFECTION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FATIGUE ("INCREASED FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), INFECTION ("INFECTION"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), VISION BLURRED ("BLURRED VISION"), EAR INFECTION ("EAR INFECTIONS"), AMENORRHOEA ("AMENORRHEA FOR YEARS AT A TIME"), ASTHENIA ("LACK OF ENERGY"), DYSPNOEA ("DYSPNEA"), DYSPHAGIA ("DYSPHAGIA"), ANAEMIA ("ANEMIA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), EAR PAIN ("EAR PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH ALLERGY MEDICATION, IRON, NAPROXEN, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY.) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ABDOMINAL PAIN, VISION BLURRED, EAR INFECTION, ASTHENIA, HYPERSENSITIVITY AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE UTERINE CANCER, CERVIX CARCINOMA, DIZZINESS, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, MIGRAINE, AMENORRHOEA, NAUSEA, DYSPNOEA, DYSPHAGIA, ANAEMIA, MENSTRUATION IRREGULAR, EAR PAIN, URINARY TRACT INFECTION, CYSTITIS, VAGINAL INFECTION, DEPRESSION, ANXIETY AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR CERVIX CARCINOMA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMENORRHOEA, ANAEMIA, ANXIETY, ASTHENIA, BLOOD COUNT ABNORMAL, CYSTITIS, DEPRESSION, DIZZINESS, DYSPHAGIA, DYSPNOEA, EAR INFECTION, EAR PAIN, FATIGUE, HEADACHE, HYPERSENSITIVITY, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, UTERINE CANCER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2016 AND FULL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016. CURRENT WEIGHT: 216 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.8 KG/SQM. HAEMOGLOBIN (12 - 16) - ON (B)(6) 2016: 11.2 (DEPRESSED). HYSTEROSCOPY - ON AN UNKNOWN DATE: NORMAL CAVITY. ON (B)(6) 2012, PATIENT UNDERWENT ESSURE CONFIRMATION TEST, HYSTEROSALPINGOGRAM. ON (B)(6) 2015, ULTRASOUND NON-OB TRANSVAGINAL REVEALED RETROVERTED UTERUS. TINY FUNDAL FIBROID. THIS DOES NOT INVOLVE THE ENDOMETRIUM. ESSURE COILS NOTED. RIGHT AND LEFT OVARY APPEAR. ON (B)(6) 2016, MODERATE DYSPLASIA OF CERVIX NOTED ON HYSTERECTOMY PATHOLOGY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA MEDICAL RECORD: PELVIC PAIN; HEADACHES; MENSTRUATION; ABDOMINAL PAIN LOWER; BLOATING; BLURRED VISION; ALLERGIES; DIZZINESS AND ANEMIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT PER PFS: FATIGUE. 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 (SHARP CONSTANT)"), UTERINE CANCER ("CANCEROUS CELLS") AND CERVIX CARCINOMA ("CANCEROUS CERVICAL CELLS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6) 2011) AND WISDOM TEETH REMOVAL IN 2008. PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA IN (B)(6) 2011; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS FROM 2001 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION, PERIODS OF MENORRHAGIA"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), VISION BLURRED ("BLURRED VISION"), MIGRAINE ("SEVERE MIGRAINES"), EAR INFECTION ("EAR INFECTIONS"), AMENORRHOEA ("AMENORRHEA FOR YEARS AT A TIME"), ASTHENIA ("LACK OF ENERGY"), NAUSEA ("NAUSEA"), HYPERSENSITIVITY ("ENVIRONMENTAL ALLERGIES"), DYSPNOEA ("DYSPNEA"), DYSPHAGIA ("DYSPHAGIA"), ANAEMIA ("ANEMIA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS") AND EAR PAIN ("EAR PAIN"). THE PATIENT WAS TREATED WITH ALLERGY MEDICATION, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, PARTIAL HYSTERECTOMY.) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ABDOMINAL PAIN, VISION BLURRED, EAR INFECTION, ASTHENIA AND HYPERSENSITIVITY HAD RESOLVED AND THE UTERINE CANCER, CERVIX CARCINOMA, DIZZINESS, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, MIGRAINE, AMENORRHOEA, NAUSEA, DYSPNOEA, DYSPHAGIA, ANAEMIA, MENSTRUATION IRREGULAR AND EAR PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR CERVIX CARCINOMA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMENORRHOEA, ANAEMIA, ASTHENIA, BLOOD COUNT ABNORMAL, DIZZINESS, DYSPHAGIA, DYSPNOEA, EAR INFECTION, EAR PAIN, HEADACHE, HYPERSENSITIVITY, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, PELVIC PAIN, UTERINE CANCER, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2016 AND FULL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.1 KG/SQM. ON (B)(6) 2012, PATIENT UNDERWENT ESSURE CONFIRMATION TEST, HYSTEROSALPINGOGRAM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-FEB-2018: UPDATE OF QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 (SHARP CONSTANT) / PAIN"), UTERINE CANCER ("CANCEROUS CELLS") AND CERVIX CARCINOMA ("CANCEROUS CERVICAL CELLS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ON (B)(6) 2011) AND WISDOM TEETH REMOVAL IN 2008. PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA IN OCTOBER 2011; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS FROM 2001 TO OCTOBER 2011 AND NSAID. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENSTRUATION IRREGULAR WITH DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY, HEAVY PERIODS, SINUSITIS, BAROSINUSITIS, FACIAL PAIN, SNORING, AMPUTATION, NASAL SINUS IRRIGATION AND SLEEP APNEA. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION, PERIODS OF MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"). IN APRIL 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPERSENSITIVITY ("ENVIRONMENTAL ALLERGIES"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND CYSTITIS ("BLADDER INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), VISION BLURRED ("BLURRED VISION"), MIGRAINE ("SEVERE MIGRAINES"), EAR INFECTION ("EAR INFECTIONS"), AMENORRHOEA ("AMENORRHEA FOR YEARS AT A TIME"), ASTHENIA ("LACK OF ENERGY"), NAUSEA ("NAUSEA"), DYSPNOEA ("DYSPNEA"), DYSPHAGIA ("DYSPHAGIA"), ANAEMIA ("ANEMIA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), EAR PAIN ("EAR PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH ALLERGY MEDICATION, IRON, NAPROXEN, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, PARTIAL HYSTERECTOMY.) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ABDOMINAL PAIN, VISION BLURRED, EAR INFECTION, ASTHENIA AND HYPERSENSITIVITY HAD RESOLVED AND THE UTERINE CANCER, CERVIX CARCINOMA, DIZZINESS, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, MIGRAINE, AMENORRHOEA, NAUSEA, DYSPNOEA, DYSPHAGIA, ANAEMIA, MENSTRUATION IRREGULAR, EAR PAIN, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, CYSTITIS AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR CERVIX CARCINOMA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMENORRHOEA, ANAEMIA, ASTHENIA, BLOOD COUNT ABNORMAL, CYSTITIS, DIZZINESS, DYSPHAGIA, DYSPNOEA, EAR INFECTION, EAR PAIN, HEADACHE, HYPERSENSITIVITY, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, UTERINE CANCER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2016 AND FULL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.1 KG/SQM. HAEMOGLOBIN (12 - 16) - ON (B)(6) 2016: 11.2 (DEPRESSED). HYSTEROSCOPY - ON AN UNKNOWN DATE: NORMAL CAVITY. ON (B)(6) 2012, PATIENT UNDERWENT ESSURE CONFIRMATION TEST, HYSTEROSALPINGOGRAM. ON (B)(6) 2015, ULTRASOUND NON-OB TRANSVAGINAL REVEALED RETROVERTED UTERUS. TINY FUNDAL FIBROID. THIS DOES NOT INVOLVE THE ENDOMETRIUM. ESSURE COILS NOTED. RIGHT AND LEFT OVARY APPEAR. ON (B)(6) 2016, MODERATE DYSPLASIA OF CERVIX NOTED ON HYSTERECTOMY PATHOLOGY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA MEDICAL RECORD: PELVIC PAIN; HEADACHES; MENSTRUATION; ABDOMINAL PAIN LOWER; BLOATING; BLURRED VISION; ALLERGIES; DIZZINESS AND ANEMIA.¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2018: NEW PFS RECEIVED- NEW EVENTS ADDED, ABNORMAL BLEEDING(VAGINAL), BLADDER INFECTION, URINARY TRACT INFECTION, DID NOT UNDERGO CONFIRMATION TEST AND VAGINAL INFECTION" WERE ADDED. NEW REPORTER ADDED. HISTORICAL CONDITIONS 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 (SHARP CONSTANT)"), UTERINE CANCER ("CANCEROUS CELLS") AND CERVIX CARCINOMA ("CANCEROUS CERVICAL CELLS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6)) AND WISDOM TEETH REMOVAL IN 2008. PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA IN (B)(6) 2011; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS FROM 2001 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION, PERIODS OF MENORRHAGIA"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), VISION BLURRED ("BLURRED VISION"), MIGRAINE ("SEVERE MIGRAINES"), EAR INFECTION ("EAR INFECTIONS"), AMENORRHOEA ("AMENORRHEA FOR YEARS AT A TIME"), ASTHENIA ("LACK OF ENERGY"), NAUSEA ("NAUSEA"), HYPERSENSITIVITY ("ENVIRONMENTAL ALLERGIES"), DYSPNOEA ("DYSPNEA"), DYSPHAGIA ("DYSPHAGIA"), ANAEMIA ("ANEMIA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS") AND EAR PAIN ("EAR PAIN"). THE PATIENT WAS TREATED WITH ALLERGY MEDICATION, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY, PARTIAL HYSTERECTOMY) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ABDOMINAL PAIN, VISION BLURRED, EAR INFECTION, ASTHENIA AND HYPERSENSITIVITY HAD RESOLVED AND THE UTERINE CANCER, CERVIX CARCINOMA, DIZZINESS, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, MIGRAINE, AMENORRHOEA, NAUSEA, DYSPNOEA, DYSPHAGIA, ANAEMIA, MENSTRUATION IRREGULAR AND EAR PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, DIZZINESS, HEADACHE, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, UTERINE CANCER, VISION BLURRED, WEIGHT INCREASED, AMENORRHOEA, ANAEMIA, ASTHENIA, CERVIX CARCINOMA, DYSPHAGIA, DYSPNOEA, EAR INFECTION, EAR PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR AND NAUSEA TO BE RELATED TO ESSURE. THE REPORTER CAUSALITY COMMENT: PLAINTIFF UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2016 AND FULL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34.1 KG/SQM. ON (B)(6) 2012, PATIENT UNDERWENT ESSURE CONFIRMATION TEST, HYSTEROSALPINGOGRAM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JAN-2018: REPORTER INFORMATION AND ESSURE REMOVAL DATE UPDATED AND LOT NO ADDED, TREATMENT MEDICATIONS, HISTORICAL DRUG, HISTORICAL CONDITIONS, CONCOMITANT DISEASE, NEW EVENTS EAR INFECTIONS, AMENORRHOEA, LACK OF ENERGY, NAUSEA, HYPERSENSITIVITY, DYSPNEA, DYSPHAGIA, CERVIX CARCINOMA, IRREGULAR PERIODS AND EAR PAIN ADDED. OUTCOME FOR THE EVENTS PELVIC PAIN, ABDOMINAL PAIN, VISION BLURRED, HEADACHE, EAR INFECTIONS, ASTHENIA AND HYPERSENSITIVITY ADDED AS RECOVERED / RESOLVED. 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") AND UTERINE CANCER ("CANCEROUS CELLS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PLAINTIFF HAS ALSO SUFFERED FROM SEVERE MIGRAINES - FOR WHICH SHE HAD NO HISTORY OF SUFFERING PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. 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), UTERINE CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENORRHAGIA ("HEAVY AND ABNORMAL MENSTRUATION"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BLOOD COUNT ABNORMAL ("LOW BLOOD LEVELS"), VISION BLURRED ("BLURRED VISION") AND MIGRAINE ("SEVERE MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE CANCER, DIZZINESS, HEADACHE, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION, MENSTRUAL DISORDER, MENORRHAGIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, VISION BLURRED AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLOOD COUNT ABNORMAL, DIZZINESS, HEADACHE, INFECTION, IRON DEFICIENCY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, UTERINE CANCER, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 06-OCT-2017: EVENT: HEAVY ABNORMAL MENSTRUATION, SEVERE ABDOMINAL PAIN, CRAMPING, LOW BLOOD LEVELS, SEVERE MIGRAINES AND BLURRED VISION WERE ADDED. ON (B)(6) 2017, PLAINTIFF UNDERWENT A HYSTERECTOMY TO REMOVE THE ESSURE DEVICE AND CANCEROUS CELLS. EVENT OUTCOME WERE UNKNOWN. REPORTER CAUSALITY RELATED. ON 19-OCT-2017: CODING CORRECTION REQUESTED, RECEIVE WITH FOLLOW-UP REPORT. 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 ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), DIZZINESS ("DIZZINESS"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), IRON DEFICIENCY ("IRON DEFICIENCY"), ABDOMINAL DISTENSION ("BLOATING") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DIZZINESS, HEADACHE, INFECTION, WEIGHT INCREASED, IRON DEFICIENCY, ABDOMINAL DISTENSION AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DIZZINESS, HEADACHE, INFECTION, IRON DEFICIENCY, MENSTRUAL DISORDER, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 653388 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| IBUPROFEN| PRENATAL VITAMINS |