ESSURE
Report
- Report Number
- 2951250-2019-11442
- Event Type
- Injury
- Date Received
- November 13, 2019
- Report Date
- September 29, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), ABORTION SPONTANEOUS ('MISCARRIAGE'), PERIHEPATITIS ('FITZ-HUGH-CURTIS SYNDROME') AND CERVIX CARCINOMA ('CERVICAL CANCER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED STILLBIRTH NOS. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) FROM 2007 TO 2015, ARIPIPRAZOLE (ABILIFY) FROM 2007 TO 2018, CLONAZEPAM (KLONOPIN), IBUPROFEN (MOTRIN), MEDROXYPROGESTERONE ACETATE (DEPOPROVERA) FROM 2003 TO 2004, MEDROXYPROGESTERONE ACETATE (PROVERA), ORAL CONTRACEPTIVE NOS FROM 2008 TO 2009 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6)2018. ON (B)(6)2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6)2006, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6)2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6)2006, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6)2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2007, THE PATIENT EXPERIENCED ATTENTION DEFICIT HYPERACTIVITY DISORDER ("PSYCH INJURY/ ADHD") AND BIPOLAR DISORDER ("BIPOLAR") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN") AND ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"). IN 2012, THE PATIENT EXPERIENCED FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC DISEASE") AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED HAEMORRHOIDS ("GI CONDITIONS/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INTERNAL HEMORRHOIDS") AND WAS FOUND TO HAVE BREAST NEOPLASM ("TUMORS/ BREAST TUMOR"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL); BACTERIAL"). IN 2018, THE PATIENT EXPERIENCED PREMATURE MENOPAUSE ("HORMONAL CHANGES/HORMONAL CHANGES DESCRIBE:EARLY MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("GEN. ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBS"), RASH ("RASH / SKIN CONDITION"), BLADDER DISORDER ("BLADDER PROBS"), URINARY TRACT DISORDER ("URINARY PROBS"), VAGINAL INFECTION ("VAG. INFECT"), VAGINAL DISCHARGE ("VAG DISCHARGE"), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL),OOPHORECTOMY (BILATERAL). AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, IRON DEFICIENCY ANAEMIA, FATIGUE, HAEMORRHOIDS, ALOPECIA, TOOTH DISORDER, PREMATURE MENOPAUSE, HEADACHE, NAUSEA, BREAST NEOPLASM, VISUAL IMPAIRMENT, WEIGHT INCREASED, WEIGHT DECREASED, ATTENTION DEFICIT HYPERACTIVITY DISORDER, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, BACTERIAL INFECTION, FEMALE SEXUAL DYSFUNCTION, ANXIETY, BIPOLAR DISORDER, ENDOMETRIOSIS, FIBROCYSTIC BREAST DISEASE, PERIHEPATITIS AND CERVIX CARCINOMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE (ESS205) OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, ANXIETY, ATTENTION DEFICIT HYPERACTIVITY DISORDER, BACK PAIN, BACTERIAL INFECTION, BIPOLAR DISORDER, BLADDER DISORDER, BREAST NEOPLASM, CERVIX CARCINOMA, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HAEMORRHOIDS, HEADACHE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6)2006: RESULT: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, DYSMENORRHEA, AND MENORRHAGIA, URINARY TRACT INFECTION, PELVIC PAIN, ENDOMETRIOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), ABORTION SPONTANEOUS ('MISCARRIAGE'), PERIHEPATITIS ('FITZ-HUGH-CURTIS SYNDROME') AND CERVIX CARCINOMA ('CERVICAL CANCER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED STILLBIRTH NOS. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) FROM 2007 TO 2015, ARIPIPRAZOLE (ABILIFY) FROM 2007 TO 2018, CLONAZEPAM (KLONOPIN), IBUPROFEN (MOTRIN), MEDROXYPROGESTERONE ACETATE (DEPOPROVERA) FROM 2003 TO 2004, MEDROXYPROGESTERONE ACETATE (PROVERA), ORAL CONTRACEPTIVE NOS FROM 2008 TO 2009 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2018. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2006, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2007, THE PATIENT EXPERIENCED ATTENTION DEFICIT HYPERACTIVITY DISORDER ("PSYCH INJURY/ ADHD") AND BIPOLAR DISORDER ("BIPOLAR") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN") AND ENDOMETRIOSIS ("EREPRODUCTIVE SYSTEM DISORDERCONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"). IN 2012, THE PATIENT EXPERIENCED FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC DISEASE") AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED HAEMORRHOIDS ("GI CONDITIONS/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INTERNAL HEMORRHOIDS") AND WAS FOUND TO HAVE BREAST NEOPLASM ("TUMORS/ BREAST TUMOR"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL); BACTERIAL"). IN 2018, THE PATIENT EXPERIENCED PREMATURE MENOPAUSE ("HORMONAL CHANGES/HORMONAL CHANGES DESCRIBE:EARLY MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBS"), RASH ("RASH / SKIN CONDITION"), BLADDER DISORDER ("BLADDER PROBS"), URINARY TRACT DISORDER ("URINARY PROBS"), VAGINAL INFECTION ("VAG. INFECT"), VAGINAL DISCHARGE ("VAG DISCHARGE"), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL),OOPHORECTOMY (BILATERAL). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, IRON DEFICIENCY ANAEMIA, FATIGUE, HAEMORRHOIDS, ALOPECIA, TOOTH DISORDER, PREMATURE MENOPAUSE, HEADACHE, NAUSEA, BREAST NEOPLASM, VISUAL IMPAIRMENT, WEIGHT INCREASED, WEIGHT DECREASED, ATTENTION DEFICIT HYPERACTIVITY DISORDER, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, BACTERIAL INFECTION, FEMALE SEXUAL DYSFUNCTION, ANXIETY, BIPOLAR DISORDER, ENDOMETRIOSIS, FIBROCYSTIC BREAST DISEASE, PERIHEPATITIS AND CERVIX CARCINOMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE (ESS205) OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, ANXIETY, ATTENTION DEFICIT HYPERACTIVITY DISORDER, BACK PAIN, BACTERIAL INFECTION, BIPOLAR DISORDER, BLADDER DISORDER, BREAST NEOPLASM, CERVIX CARCINOMA, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HAEMORRHOIDS, HEADACHE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2006: RESULT: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, DYSMENORRHEA, AND MENORRHAGIA, URINARY TRACT INFECTION, PELVIC PAIN, ENDOMETRIOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2020: PIF RECEIVED REMOVAL DATE UPADATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY'), ABORTION SPONTANEOUS ('MISCARRIAGE'), GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED'), PERIHEPATITIS ('FITZ-HUGH-CURTIS SYNDROME') AND CERVIX CARCINOMA ('CERVICAL CANCER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED STILLBIRTH NOS. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) FROM 2007 TO 2015, ARIPIPRAZOLE (ABILIFY) FROM 2007 TO 2018, CLONAZEPAM (KLONOPIN), IBUPROFEN (MOTRIN), MEDROXYPROGESTERONE ACETATE (DEPOPROVERA) FROM 2003 TO 2004, MEDROXYPROGESTERONE ACETATE (PROVERA), ORAL CONTRACEPTIVE NOS FROM 2008 TO 2009 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2018. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2006, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2007, THE PATIENT EXPERIENCED ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("PSYCH INJURY/ ADHD") AND BIPOLAR DISORDER ("BIPOLAR") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN") AND ENDOMETRIOSIS ("EREPRODUCTIVE SYSTEM DISORDERCONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"). IN 2012, THE PATIENT EXPERIENCED FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC DISEASE") AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED HAEMORRHOIDS ("GI CONDITIONS/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INTERNAL HEMORRHOIDS") AND WAS FOUND TO HAVE BREAST NEOPLASM ("TUMORS/ BREAST TUMOR"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL); BACTERIAL"). IN 2018, THE PATIENT EXPERIENCED PREMATURE MENOPAUSE ("HORMONAL CHANGES/HORMONAL CHANGES DESCRIBE:EARLY MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBS"), RASH ("RASH / SKIN CONDITION"), BLADDER DISORDER ("BLADDER PROBS"), URINARY TRACT DISORDER ("URINARY PROBS"), VAGINAL INFECTION ("VAG. INFECT"), VAGINAL DISCHARGE ("VAG DISCHARGE"), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL),OOPHORECTOMY (BILATERAL). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, IRON DEFICIENCY ANAEMIA, FATIGUE, HAEMORRHOIDS, ALOPECIA, TOOTH DISORDER, PREMATURE MENOPAUSE, HEADACHE, NAUSEA, BREAST NEOPLASM, VISUAL IMPAIRMENT, WEIGHT INCREASED, WEIGHT DECREASED, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, BACTERIAL INFECTION, FEMALE SEXUAL DYSFUNCTION, ANXIETY, BIPOLAR DISORDER, ENDOMETRIOSIS, FIBROCYSTIC BREAST DISEASE, PERIHEPATITIS AND CERVIX CARCINOMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE (ESS205) OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, BACK PAIN, BACTERIAL INFECTION, BIPOLAR DISORDER, BLADDER DISORDER, BREAST NEOPLASM, CERVIX CARCINOMA, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HAEMORRHOIDS, HEADACHE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2006: RESULT: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, DYSMENORRHEA, AND MENORRHAGIA, URINARY TRACT INFECTION, PELVIC PAIN, ENDOMETRIOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-NOV-2019: QUALITY-SAFETY EVALUATION OF PTC. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY'), ABORTION SPONTANEOUS ('MISCARRIAGE'), GENITAL HAEMORRHAGE ('GEN. ABNORMAL. BLEED'), PERIHEPATITIS ('FITZ-HUGH-CURTIS SYNDROME') AND CERVIX CARCINOMA ('CERVICAL CANCER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED STILLBIRTH NOS. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE; AMFETAMINE SULFATE; DEXAMFETAMINE SACCHARATE; DEXAMFETAMINE SULFATE (ADDERALL) FROM 2007 TO 2015, ARIPIPRAZOLE (ABILIFY) FROM 2007 TO 2018, CLONAZEPAM (KLONOPIN), IBUPROFEN (MOTRIN), MEDROXYPROGESTERONE ACETATE (DEPOPROVERA) FROM 2003 TO 2004, MEDROXYPROGESTERONE ACETATE (PROVERA), ORAL CONTRACEPTIVE NOS FROM 2008 TO 2009 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2018. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2006, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2007, THE PATIENT EXPERIENCED ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("PSYCH INJURY/ ADHD") AND BIPOLAR DISORDER ("BIPOLAR") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN") AND ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"). IN 2012, THE PATIENT EXPERIENCED FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC DISEASE") AND PERIHEPATITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED HAEMORRHOIDS ("GI CONDITIONS/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INTERNAL HEMORRHOIDS") AND WAS FOUND TO HAVE BREAST NEOPLASM ("TUMORS/ BREAST TUMOR"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL); BACTERIAL"). IN 2018, THE PATIENT EXPERIENCED PREMATURE MENOPAUSE ("HORMONAL CHANGES/HORMONAL CHANGES DESCRIBE:EARLY MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBS"), RASH ("RASH / SKIN CONDITION"), BLADDER DISORDER ("BLADDER PROBS"), URINARY TRACT DISORDER ("URINARY PROBS"), VAGINAL INFECTION ("VAG. INFECT"), VAGINAL DISCHARGE ("VAG DISCHARGE"), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, IRON DEFICIENCY ANAEMIA, FATIGUE, HAEMORRHOIDS, ALOPECIA, TOOTH DISORDER, PREMATURE MENOPAUSE, HEADACHE, NAUSEA, BREAST NEOPLASM, VISUAL IMPAIRMENT, WEIGHT INCREASED, WEIGHT DECREASED, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, BACTERIAL INFECTION, FEMALE SEXUAL DYSFUNCTION, ANXIETY, BIPOLAR DISORDER, ENDOMETRIOSIS, FIBROCYSTIC BREAST DISEASE, PERIHEPATITIS AND CERVIX CARCINOMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE (ESS205) OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, ANXIETY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, BACK PAIN, BACTERIAL INFECTION, BIPOLAR DISORDER, BLADDER DISORDER, BREAST NEOPLASM, CERVIX CARCINOMA, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HAEMORRHOIDS, HEADACHE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERIHEPATITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2006: RESULT: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, DYSMENORRHEA, AND MENORRHAGIA, URINARY TRACT INFECTION, PELVIC PAIN, ENDOMETRIOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-NOV-2019: PFS +MR RECEIVED. CASE BECOMES AN INCIDENT. NEW EVENTS ADDED(PFS): ABNORMAL BLEEDING (VAGINAL), INFECTION (BLADDER/ URINARY TRACT/VAGINAL); BACTERIAL, APAREUNIA, ANXIETY, BIPOLAR, DEPRESSION, ENDOMETRIOSIS, FIBROCYSTIC DISEASE; FITZ-HUGH-CURTIS SYNDROME, DEVICE BREAKAGE, CERVICAL CANCER, PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. NEW EVENTS ADDED(MR): PELVIC INFLAMMATORY DISEASE. PREVIOUSLY ADDED EVENTS HORMONAL CHANGES UPDATED TO HORMONAL CHANGES DESCRIBE: EARLY MENOPAUSE, EVENT PSYCH INJURY UPDATED TO ADHD, EVENT TUMORS UPDATED TO BREAST TUMOR. CONCOMITANT DRUGS, CONCOMITANT CONDITIONS, LAB DATA, REPORTERS WERE ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1109005 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ABILIFY| ABILIFY| ABILIFY| ABILIFY| ADDERALL| ADDERALL| ADDERALL| ADDERALL| DEPOPROVERA| DEPOPROVERA| DEPOPROVERA| DEPOPROVERA| KLONOPIN| KLONOPIN| KLONOPIN| KLONOPIN| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| PROVERA| PROVERA| PROVERA| PROVERA| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |