ESSURE
Report
- Report Number
- 2951250-2019-02978
- Event Type
- Injury
- Date Received
- June 20, 2019
- Date of Event
- September 1, 2011
- Report Date
- December 8, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PAIN,PELVIC AREA') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BIOPSY UTERUS, GENITAL HAEMORRHAGE, CRAMP IN LOWER ABDOMEN, BREAK THROUGH BLEEDING, ENDOMETRIAL BIOPSY, MENSTRUATION DELAYED, VENEREAL DISEASE NOS, ALLERGIC REACTION TO BEE STING, GYNECOLOGICAL EXAMINATION, MALIGNANT NEOPLASM OF CERVIX UTERI, CONTRACEPTION, THERAPEUTIC ABORTION, PAP SMEAR ABNORMAL, PROPHYLACTIC VACCINATION, FLU PROPHYLAXIS, STERILIZATION, WEIGHT GAIN, HOT FLASHES, HEMATURIA, MOOD SWINGS, HOT FLASHES, THROMBUS, FIBROIDS, POLYPS, FATIGUE, URINARY CALCULUS, BLEED IN LUTEAL CYST, DYSURIA, ACHE, BURNING SENSATION, CLOUDY URINE, URINE OUTPUT DECREASED, VENEREAL DISEASE NOS, UTI, SEXUALLY TRANSMITTED DISEASE, CARDIOVASCULAR DISEASE, UNSPECIFIED, SWELLING OF HANDS, ADENOMYOSIS, UTERINE INFLAMMATION AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO-CYCLEN, PREMARIN AND IBUPROFEN. CONCURRENT CONDITIONS INCLUDED TOBACCO USE DISORDER, POST COITAL BLEEDING, HEMATURIA, INFECTION AND ENDOMETRIOSIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ESTROGENS CONJUGATED (PREMARIN) SINCE 2008, ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2009 TO (B)(6) 2015, ETONOGESTREL (NEXPLANON) SINCE (B)(6) 2011, FERROUS SULFATE (FERROUS SULPHATE) SINCE 2007, HYDROCHLOROTHIAZIDE SINCE 2018, LORAZEPAM FROM (B)(6) 2010 TO (B)(6) 2015, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, METRONIDAZOLE (METRONIDAZOL) SINCE 2008, ONDANSETRON (ZOFRAN) SINCE 2006, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, TRAMADOL SINCE 2008 AND VARENICLINE TARTRATE (CHANTIX) FROM (B)(6) 2010 TO (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL AREA PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, MENOMETRORRHAGIA AND MENSTRUAL DISORDER HAD RESOLVED AND THE DYSMENORRHOEA, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLADDER/URINARY PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RESULT: 1. SMALL BOWEL THICKENING HAS RESOLVED. 2. A RIGHT ADNEXAL CYST HAS DEVELOPED, LIKELY OVARIAN IN ORIGIN.. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MENOMETRORRHAGIA, DEPO PROVERA, VAGINAL HAEMORRHAGE, PELVIC PAIN, DYSPAREUNIA., ANXIETY, DYSMENORRHEA, HYPERTENSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: OUTCOME OF EVENTS PAIN, ABNORMAL BLEEDING AND BLADDER/URINARY PROBLEMS WAS UPDATED TO RECOVERED/RESOLVED. 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 PAIN ('PHYSICAL PAIN/PAIN,PELVIC AREA') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BIOPSY UTERUS, GENITAL HAEMORRHAGE, CRAMP IN LOWER ABDOMEN, BREAK THROUGH BLEEDING, ENDOMETRIAL BIOPSY, MENSTRUATION DELAYED, VENEREAL DISEASE NOS, ALLERGIC REACTION TO BEE STING, GYNECOLOGICAL EXAMINATION, MALIGNANT NEOPLASM OF CERVIX UTERI, CONTRACEPTION, THERAPEUTIC ABORTION, PAP SMEAR ABNORMAL, PROPHYLACTIC VACCINATION, FLU PROPHYLAXIS, STERILIZATION, WEIGHT GAIN, HOT FLASHES, HEMATURIA, MOOD SWINGS, HOT FLASHES, THROMBUS, FIBROIDS, POLYPS, FATIGUE, URINARY CALCULUS, BLEED IN LUTEAL CYST, DYSURIA, ACHE, BURNING SENSATION, CLOUDY URINE, URINE OUTPUT DECREASED, VENEREAL DISEASE NOS, UTI, SEXUALLY TRANSMITTED DISEASE, CARDIOVASCULAR DISEASE, UNSPECIFIED, SWELLING OF HANDS, ADENOMYOSIS, UTERINE INFLAMMATION AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO-CYCLEN, PREMARIN AND IBUPROFEN. CONCURRENT CONDITIONS INCLUDED TOBACCO USE DISORDER, POST COITAL BLEEDING, HEMATURIA, INFECTION AND ENDOMETRIOSIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ESTROGENS CONJUGATED (PREMARIN) SINCE 2008, ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2009 TO (B)(6) 2015, ETONOGESTREL (NEXPLANON) SINCE (B)(6) 2011, FERROUS SULFATE (FERROUS SULPHATE) SINCE 2007, HYDROCHLOROTHIAZIDE SINCE 2018, LORAZEPAM FROM (B)(6) 2010 TO (B)(6) 2015, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, METRONIDAZOLE (METRONIDAZOL) SINCE 2008, ONDANSETRON (ZOFRAN) SINCE 2006, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, TRAMADOL SINCE 2008 AND VARENICLINE TARTRATE (CHANTIX) FROM (B)(6) 2010 TO (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL AREA PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, MENOMETRORRHAGIA AND MENSTRUAL DISORDER HAD RESOLVED AND THE DYSMENORRHOEA, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLADDER/URINARY PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RESULT: 1. SMALL BOWEL THICKENING HAS RESOLVED. 2. A RIGHT ADNEXAL CYST HAS DEVELOPED, LIKELY OVARIAN IN ORIGIN.. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MENOMETRORRHAGIA, DEPO PROVERA, VAGINAL HAEMORRHAGE, PELVIC PAIN, DYSPAREUNIA., ANXIETY, DYSMENORRHEA, HYPERTENSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: OUTCOME OF EVENTS PAIN, ABNORMAL BLEEDING AND BLADDER/URINARY PROBLEMS WAS UPDATED TO RECOVERED/RESOLVED. 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 PAIN ('PHYSICAL PAIN/PAIN,PELVIC AREA') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BIOPSY UTERUS, GENITAL HAEMORRHAGE, CRAMP IN LOWER ABDOMEN, BREAK THROUGH BLEEDING, ENDOMETRIAL BIOPSY, MENSTRUATION DELAYED, VENEREAL DISEASE NOS, ALLERGIC REACTION TO BEE STING, GYNECOLOGICAL EXAMINATION, MALIGNANT NEOPLASM OF CERVIX UTERI, CONTRACEPTION, THERAPEUTIC ABORTION, PAP SMEAR ABNORMAL, PROPHYLACTIC VACCINATION, FLU PROPHYLAXIS, STERILIZATION, WEIGHT GAIN, HOT FLASHES, HEMATURIA, MOOD SWINGS, HOT FLASHES, THROMBUS, FIBROIDS, POLYPS, FATIGUE, URINARY CALCULUS, BLEED IN LUTEAL CYST, DYSURIA, ACHE, BURNING SENSATION, CLOUDY URINE, URINE OUTPUT DECREASED, VENEREAL DISEASE NOS, UTI, SEXUALLY TRANSMITTED DISEASE, CARDIOVASCULAR DISEASE, UNSPECIFIED, SWELLING OF HANDS, ADENOMYOSIS, UTERINE INFLAMMATION AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO-CYCLEN, PREMARIN AND IBUPROFEN. CONCURRENT CONDITIONS INCLUDED TOBACCO USE DISORDER, POST COITAL BLEEDING, HEMATURIA, INFECTION AND ENDOMETRIOSIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ESTROGENS CONJUGATED (PREMARIN) SINCE 2008, ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2009 TO (B)(6) 2015, ETONOGESTREL (NEXPLANON) SINCE (B)(6) 2011, FERROUS SULFATE (FERROUS SULPHATE) SINCE 2007, HYDROCHLOROTHIAZIDE SINCE 2018, LORAZEPAM FROM (B)(6) 2010 TO (B)(6) 2015, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, METRONIDAZOLE (METRONIDAZOLE) SINCE 2008, ONDANSETRON (ZOFRAN) SINCE 2006, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, TRAMADOL SINCE 2008 AND VARENICLINE TARTRATE (CHANTIX) FROM (B)(6) 2010 TO (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL AREA PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA CRAMPING"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND DYSPAREUNIA ("DYSPAREUNIA PAINFUL SEXUAL INTERCOURSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES,HYSTERECTOMY FULL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, MENOMETRORRHAGIA AND MENSTRUAL DISORDER HAD RESOLVED AND THE DYSMENORRHOEA, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLADDER/URINARY PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS ON (B)(6) 2012: RESULT: 1. SMALL BOWEL THICKENING HAS RESOLVED. 2. A RIGHT ADNEXAL CYST HAS DEVELOPED, LIKELY OVARIAN IN ORIGIN. HYSTEROSALPINGOGRAM ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MENOMETRORRHAGIA, DEPO PROVERA, VAGINAL HAEMORRHAGE, PELVIC PAIN, DYSPAREUNIA, ANXIETY, DYSMENORRHEA, HYPERTENSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: OUTCOME OF EVENTS PAIN, ABNORMAL BLEEDING AND BLADDER/URINARY PROBLEMS WAS UPDATED TO RECOVERED/RESOLVED. 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 PAIN ('PHYSICAL PAIN/PAIN,PELVIC AREA') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BIOPSY UTERUS, GENITAL HAEMORRHAGE, CRAMP IN LOWER ABDOMEN, BREAK THROUGH BLEEDING, ENDOMETRIAL BIOPSY, MENSTRUATION DELAYED, VENEREAL DISEASE NOS, ALLERGIC REACTION TO BEE STING, GYNECOLOGICAL EXAMINATION, MALIGNANT NEOPLASM OF CERVIX UTERI, CONTRACEPTION, THERAPEUTIC ABORTION, PAP SMEAR ABNORMAL, PROPHYLACTIC VACCINATION, FLU PROPHYLAXIS, STERILIZATION, WEIGHT GAIN, HOT FLASHES, HEMATURIA, MOOD SWINGS, HOT FLASHES, THROMBUS, FIBROIDS, POLYPS, FATIGUE, URINARY CALCULUS, BLEED IN LUTEAL CYST, DYSURIA, ACHE, BURNING SENSATION, CLOUDY URINE, URINE OUTPUT DECREASED, VENEREAL DISEASE NOS, UTI, SEXUALLY TRANSMITTED DISEASE, CARDIOVASCULAR DISEASE, UNSPECIFIED, SWELLING OF HANDS, ADENOMYOSIS, UTERINE INFLAMMATION AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO-CYCLEN, PREMARIN AND IBUPROFEN. CONCURRENT CONDITIONS INCLUDED TOBACCO USE DISORDER, POST COITAL BLEEDING, HEMATURIA, INFECTION AND ENDOMETRIOSIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ESTROGENS CONJUGATED (PREMARIN) SINCE 2008, ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2009 TO (B)(6)2015, ETONOGESTREL (NEXPLANON) SINCE (B)(6) 2011, FERROUS SULFATE (FERROUS SULPHATE) SINCE 2007, HYDROCHLOROTHIAZIDE SINCE 2018, LORAZEPAM FROM (B)(6) 2010 TO (B)(6) 2015, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, METRONIDAZOLE (METRONIDAZOL) SINCE 2008, ONDANSETRON (ZOFRAN) SINCE 2006, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, TRAMADOL SINCE 2008 AND VARENICLINE TARTRATE (CHANTIX) FROM (B)(6) 2010 TO (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL AREA PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, MENOMETRORRHAGIA AND MENSTRUAL DISORDER HAD RESOLVED AND THE DYSMENORRHOEA, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLADDER/URINARY PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RESULT: SMALL BOWEL THICKENING HAS RESOLVED. A RIGHT ADNEXAL CYST HAS DEVELOPED, LIKELY OVARIAN IN ORIGIN.. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MENOMETRORRHAGIA, DEPO PROVERA, VAGINAL HAEMORRHAGE, PELVIC PAIN, DYSPAREUNIA., ANXIETY, DYSMENORRHEA, HYPERTENSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-DEC-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 PAIN ('PHYSICAL PAIN/PAIN,PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BIOPSY UTERUS, GENITAL HAEMORRHAGE, CRAMP IN LOWER ABDOMEN, BREAK THROUGH BLEEDING, ENDOMETRIAL BIOPSY, MENSTRUATION DELAYED, VENEREAL DISEASE NOS, ALLERGIC REACTION TO BEE STING, GYNECOLOGICAL EXAMINATION, MALIGNANT NEOPLASM OF CERVIX UTERI, CONTRACEPTION, THERAPEUTIC ABORTION, PAP SMEAR, VACCINATION, INFLUENZA, STERILIZATION, WEIGHT GAIN, HOT FLASHES, HEMATURIA, MOOD SWINGS, HOT FLASHES, THROMBUS, FIBROIDS, POLYPS, FATIGUE, URINARY CALCULUS, BLEED IN LUTEAL CYST, DYSURIA, ACHE, BURNING SENSATION, CLOUDY URINE, URINE OUTPUT DECREASED, VENEREAL DISEASE NOS, UTI, SEXUALLY TRANSMITTED DISEASE, CARDIOVASCULAR DISEASE, UNSPECIFIED, SWELLING OF HANDS, ADENOMYOSIS, UTERINE INFLAMMATION AND HYPERTENSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO-CYCLEN, PREMARIN AND IBUPROFEN. CONCURRENT CONDITIONS INCLUDED TOBACCO USE DISORDER, POST COITAL BLEEDING, HEMATURIA, INFECTION AND ENDOMETRIOSIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ESTROGENS CONJUGATED (PREMARIN) SINCE 2008, ETHINYLESTRADIOL; NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2009 TO (B)(6) 2015, ETONOGESTREL (NEXPLANON) SINCE (B)(6) 2011, FERROUS SULFATE (FERROUS SULPHATE) SINCE 2007, HYDROCHLOROTHIAZIDE SINCE 2018, LORAZEPAM FROM (B)(6) 2010 TO (B)(6) 2015, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, METRONIDAZOLE (METRONIDAZOL) SINCE 2008, ONDANSETRON (ZOFRAN) SINCE 2006, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, TRAMADOL SINCE 2008 AND VARENICLINE TARTRATE (CHANTIX) FROM (B)(6) 2010 TO (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL AREA PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, URINARY TRACT INFECTION, DEPRESSION, ANXIETY AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE MENOMETRORRHAGIA AND MENSTRUAL DISORDER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RESULT: SMALL BOWEL THICKENING HAS RESOLVED. A RIGHT ADNEXAL CYST HAS DEVELOPED, LIKELY OVARIAN IN ORIGIN. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MENOMETRORRHAGIA, DEPO PROVERA, VAGINAL HAEMORRHAGE, PELVIC PAIN, DYSPAREUNIA., ANXIETY, DYSMENORRHEA, HYPERTENSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: PFS AND MR RECEIVED: PAIN CLUBBED WITH PHYSICAL PAIN/PELVIC AREA PAIN, ABDOMINAL AREA PAIN, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),CONCOMITANT DRUGS, REPORTER, PATIENT HISTORY, OUTCOME, LAB DATA WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514177 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| CHANTIX| CHANTIX| CHANTIX| CHANTIX| CHANTIX| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| FERROUS SULPHATE [FERROUS SULFATE]| FERROUS SULPHATE [FERROUS SULFATE]| FERROUS SULPHATE [FERROUS SULFATE]| FERROUS SULPHATE [FERROUS SULFATE]| FERROUS SULPHATE [FERROUS SULFATE]| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| LORAZEPAM| LORAZEPAM| LORAZEPAM| LORAZEPAM| LORAZEPAM| METRONIDAZOL [METRONIDAZOLE]| METRONIDAZOL [METRONIDAZOLE]| METRONIDAZOL [METRONIDAZOLE]| METRONIDAZOL [METRONIDAZOLE]| METRONIDAZOL [METRONIDAZOLE]| NEXPLANON| NEXPLANON| NEXPLANON| NEXPLANON| NEXPLANON| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| PREMARIN| PREMARIN| PREMARIN| PREMARIN| PREMARIN| TRAMADOL| TRAMADOL| TRAMADOL| TRAMADOL| TRAMADOL| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ACETAMINOPHEN| CHANTIX| DEPO PROVERA| FERROUS SULPHATE (FERROUS SULFATE)| HYDROCHLOROTHIAZIDE| LORAZEPAM| METRONIDAZOL (METRONIDAZOLE)| NEXPLANON| NORGESTIMATE & ETHINYL ESTRADIOL| PREMARIN| TRAMADOL| ZOFRAN (ONDANSETRON) |